# EBO2.com

Independent, sourced guide to EBO2 (also called EBOO) ozone blood therapy: how it works, what the research shows, what it costs, and where to find US clinics.

Source: https://ebo2.com/
Editorial policy: https://ebo2.com/editorial-policy/
Medical disclaimer: https://ebo2.com/disclaimer/

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# What Is EBO2 (EBOO)? The Procedure, the Evidence, and What Regulators Say

Source: https://ebo2.com/what-is-ebo2/
Updated: 2026-10-04

Key takeaways:
- EBO2 (EBOO) pumps blood out of one arm, past an oxygen and ozone gas mixture, and back into the other arm for about an hour. Ozone therapy is not FDA-approved for any condition.
- The Siena group that invented EBOO used a purpose-built gas exchanger at 0.5 to 1 microgram of ozone per milliliter. A 2023 US paper used a dialysis chamber at 10 to 60; the inventors had judged dialysis membranes unsuitable for ozone.
- As of October 4, 2026, 53 of the 174 clinic EBO2 pages we could read state how much blood a session treats, from 1 to 7 liters; 31 say the circuit uses a dialysis filter, dialyzer, or dialysis membrane.
- The only randomized trial of EBOO enrolled 28 patients at the developers' hospital in 2005. We found no trial run independently of the developers.
- In July 2025 the FDA told a US maker of EBOO equipment that its devices were adulterated and misbranded.

EBO2 (also called EBOO) stands for extracorporeal blood oxygenation and
ozonation. Blood is pumped out of a vein in one arm, through a device where it
meets a mixture of oxygen and ozone gas, and back into a vein in the other arm,
continuously, for about an hour [1][2]. A nephrology group in
Siena, Italy, built the apparatus over the 1990s and published the first human
report in 2000 [3]. Ozone therapy is not FDA-approved for any
condition, and the FDA's device rules describe ozone as a toxic gas with no
known useful medical application [4].

This page is for checking what a clinic tells you against the primary sources.
It walks through the circuit as its developers and a US practitioner group
described it, sets the version sold in US clinics beside the one in the Siena
papers, compiles what clinic pages and regulators say, and ends with what is
and is not established.

The short answer

What it is. A blood circuit, not an injection: ozone reacts with blood
  outside the body and the blood is returned [5][1].
What is established. That the circuit can be run. By 2005 its developers
  reported more than 1,200 treatments in 82 patients and wrote that their
  apparatus treats up to 4,800 mL of blood in an hour "without technical or
  clinical problems" [5]. A California clinic group reported at
  least 400 sessions with no untoward effects [2]. Both are the
  practitioners' own accounts.
What is not. Whether it improves any health outcome. The only randomized
  trial enrolled 28 patients with peripheral artery disease at the developers'
  hospital [6].
Regulatory status. Not FDA-approved. In 2025 the FDA told a US maker of
  EBOO equipment its devices were adulterated and misbranded [7].

How the circuit works, step by step

The Siena papers and a 2023 measurement study from a California clinic describe
the same basic loop. Figures are as each paper states them.

Access. Blood is drawn from one vein and returned to a vein in the other
   arm [1]. The California group used a 20-gauge catheter in each arm
   and kept to that size to protect patients' veins over repeated sessions,
   although larger catheters allowed faster flow [2].
Anticoagulation. Blood outside the body clots, so the line is
   anticoagulated. The Siena review describes "heparinized blood"
   [5], although the developers' 1999 tests, circulating pig blood outside
   the body, found heparin "not an ideal anticoagulant for this system", and
   their sheep experiments then set a dose of sodium citrate [8]. The California
   group dripped in a liter of saline holding 15,000 units of heparin, of which
   about 300 mL reached the patient during the hour, with more of the solution
   used to prime and flush the lines [2]; by our arithmetic, at least about 4,500
   units.
   Medicine questions are in our guide to
   blood thinners and other medicines (/guides/eboo-blood-thinners-and-medications/).
Pump. A peristaltic pump moves the blood [1]. The California
   group ran it at 30, 35 or 40 mL per minute [2].
Gas exchange. Blood flows along one side of a bundle of hollow fibers
   while the oxygen-ozone mixture flows the opposite way, a countercurrent
   arrangement [8][2]. Siena's 2007 device used microporous,
   ozone-resistant polypropylene fibers with a phosphorylcholine coating on the
   blood side and 0.22 square meters of surface [9]. The California
   group used a cellulose triacetate dialysis chamber [2]. The next
   section explains why that difference matters.
Dose. The Siena review gives an ozone concentration of 0.5 to 1
   microgram per milliliter of oxygen [5]. The California group set
   its generator at 10 to 60 micrograms per milliliter, mostly 30 to 40, with 0.9
   liters of gas a minute, and sent the spent gas through an ozone-destruct unit
   before it reached room air [2].
Time and volume. The Siena review describes up to 4,800 mL of blood
   treated in one hour [5], and Bocci and colleagues later wrote that about 5
   liters can be treated within an hour [1]. The California treatments ran "exactly 1 hour"
   [2]; at their pump speeds that moves 1.8 to 2.4 liters through the
   circuit, by our arithmetic.
Return. The ozonated blood goes back through the second vein
   [1]. In the California setup the spent gas passed through a 2-liter
   canister that collected drainage from the dialysis chamber [2].
Course and monitoring. Siena's standard cycle was 14 one-hour sessions
   over 7 weeks [5]. After a session the developers measured a
   4- to 5-fold rise in thiobarbituric acid reactants, a marker of lipid
   oxidation, with a matching fall in plasma protein thiols and no appreciable
   breakdown of red cells, and proposed those tests for routine monitoring
   [5]. Bocci and colleagues wrote in 2011 that EBOO "must be performed by
   technicians specialized in extravascular blood circulation" [1].

The Siena procedure and the one US clinics sell

Set side by side, the Siena papers and the 2023 California paper describe two
different procedures under one name.

| | Siena papers, 1999 to 2011 | US practice, 2023 paper and 2025 FDA letter |
|---|---|---|
| Where blood meets the gas | A hydrophobic, ozone-resistant gas exchanger built for the job [8][9] | A cellulose triacetate dialysis chamber [2]; in one maker's EBOO kits, polyethersulfone hemodialyzers [7] |
| Ozone concentration | 0.5 to 1 µg/mL in the 2005 standard technique [5] | 10 to 60 µg/mL, mostly 30 to 40 [2] |
| Blood flow | Up to 4,800 mL in an hour, about 80 mL a minute [5][2] | 30 to 40 mL a minute [2] |
| Light | None in the abstracts we read | Ultraviolet light in one maker's devices [7]; a multi-wavelength light device at some clinics [10] |
| Setting | A hospital nephrology and dialysis department, which by 2002 called EBOO routine there [11][6] | An outpatient medical clinic [2] |
| Who was treated | Severe peripheral artery disease and other vascular conditions [5] | Clinic patients on routine, repeated sessions [2] |

The first row is the one the developers wrote most about. In 1999 they reported
trying "the classical dialysis-type technique" first and dropping it, because
semipermeable membranes "are unsuitable because they are hydrophilic and
vulnerable to O3" (Bocci 1999 (/research/bocci-1999-ozonation-gas-exchanger-sheep/))
[8]. In 2001 they added that such membranes transferred gas poorly and
allowed ultrafiltration, and that ozone made clotting in poorly coated fibers
"prohibitive" [12]. In 2010 a Siena team including Bocci tested four
dialysis filters against a purpose-built gas exchanger. The filters' gas
exchange ranged from 0 to 70 percent, their fibers were "somewhat altered by
ozone", and because their materials may not resist ozone, the authors wrote,
"they may release toxic compounds harmful for the patients". They added that
"some clinicians incautiously use them" as gas exchangers
(Travagli 2010 (/research/travagli-2010-dialysis-filters-ozone-transfer/))
[13].

These are bench findings by the technique's inventors, not patient outcomes,
and the 2010 abstract does not name the four filters' materials. The 2023
California paper does not take them up. Its authors call the method "ozone
dialysis", report at least 400 sessions with "no untoward effects observed",
and write that they do not know whether other dialysis chambers and materials
lose ozone the way theirs did [2].

Two other differences stand out. The dose differs: the typical
California setting of 30 to 40 micrograms per milliliter is 30 to 80 times the
Siena figure, by our arithmetic, at half the blood flow or less
[5][2]. And filtering is new. The full name contains no
filter. Where the seven Siena abstracts we read, from 1999 to 2007, describe the
device at all, it is a gas exchanger; none describes filtering anything out of blood,
and the 2001 paper counts ultrafiltration among the faults of dialysis membranes
[8][3][12][11][5][6][9].
The filtering that US clinic pages describe comes from the dialysis filter, a
part the Siena group chose not to use. What that filter takes out of blood, if
anything, has its own guide: what the EBO2 filter removes (/guides/what-the-filter-removes/).
The FDA classifies high-permeability hemodialysis systems as artificial kidney
devices for patients with renal failure, fluid overload or toxemic conditions
[14]. No study we found has compared the Siena and US versions.

How EBO2 differs from other ways of ozonating blood

| Method | What happens to the blood | Amount and dose, as the source states it |
|---|---|---|
| Direct intravenous gas | Ozone gas is injected into a vein | Listed among routes "not recommended for not being safe" by the field's consensus document [15]; Bocci and colleagues warned of oxygen embolism [1] |
| Major autohemotherapy (MAH) | A batch is drawn into a glass bottle with citrate or heparin, mixed with an equal volume of gas, and reinfused | 100 to 225 mL of blood at 20 to 80 µg/mL [1]; the Siena review put the MAH limit at 250 mL [5] |
| 10-pass (ozone high-dose therapy) | 200 mL is drawn into a vacuum flask holding 7,500 units of heparin, mixed under pressure with 200 mL of gas at 70 µg/mL and returned; repeated 10 times in about an hour | The paper says each pass "delivers 14,000 μg" and ten deliver 140,000 [16] |
| EBO2 / EBOO | Continuous circuit, as above | Up to 4,800 mL an hour at 0.5 to 1 µg/mL in Siena [5]; 30 to 40 mL a minute at 10 to 60 µg/mL in the California paper [2] |

Clinics often compare these methods by ozone dose. Several clinic pages quote
the figure that EBOO delivers "three or more times" the ozone of 10-pass, comes from the
California paper. It sets an uptake calculated from gas measurements in 12
patients against theoretical maximums for the other methods [2]. Our
EBO2 vs 10-pass ozone (/guides/ebo2-vs-10-pass-ozone/) guide separates what was
measured from what was assumed. No trial has compared the methods' effects on
patients.

What clinics say EBO2 is

As of October 4, 2026, we could read the EBO2 pages of 174 of the
177 clinics in our directory (/clinics/). The counts below are what
those pages say, which is not the same as what each clinic does. A few chains
repeat one page across locations, and each location counts once. For checking a
single clinic's page, see how to read a clinic's EBO2 page (/guides/how-to-read-a-clinic-ebo2-page/).

What the name means. Pages disagree. One says EBO2 is "simply another name"
for EBOO, with the 2 standing for oxygen [17]. Another expands it as
"Extracorporeal Blood Oxygenation and Ozonation 2.0" [18], a third as
"Enhanced Biologically Optimized Ozone Therapy" [19], and a fourth uses
EBO2 for EBOO plus a light device, at $1,250 against $1,050 for EBOO
[10]. Of the 174 pages, 36 use the term EBO2 at all.

How much blood. Of the 174 pages, 53 state how many liters a
session treats, with figures from 1 to 7 liters. Of those,
37 give an upper figure of 3 liters or less, near the 1.8 to 2.4 liters that the California
pump speeds move in an hour; 13 give 5 liters or more, one of them
calling it "your entire blood volume" [18]. The same sentence, that
traditional or 10-pass ozone treats "only a small portion" of the blood while
EBO2 "treats the majority", appears almost word for word on five pages. The Siena
group's own figure was up to 4.8 liters an hour [5]. One clinic
that offers the procedure calls volume pitches "mostly a marketing gimmick" and
says ozone dose is measured in micrograms per milliliter, not in liters of
blood [10].

Dialysis. Of the 174 pages, 31 say the circuit uses a dialysis filter,
dialyzer or dialysis membrane, three more describe a "dialysis-style"
or "dialysis-like" filter or membrane, and 21 compare the
procedure to dialysis without naming the part; 14 call it "ozone
dialysis" or say it goes by that name. One clinic that uses dialyzer filters
says the label is misleading, because dialysis cleans blood with large volumes
of dialysate fluid that EBOO does not use [10]. How the procedure compares
with hemodialysis itself is in EBO2 vs dialysis (/guides/eboo-vs-dialysis/).

Devices and dose. Of the 174 pages, 21 name a device or
brand, and two of those name an "EBOO Full Spectrum" machine. That is also the
name of a product in the FDA's 2025 warning letter to O3UV, LLC, but the pages
do not name a maker, so we cannot tell whether it is the same product
[7]. Only seven pages state an ozone concentration; the figures
they give run from 2.5 to 30 micrograms per milliliter, all above the Siena
range. Our guide to EBO2 devices and FDA status (/guides/eboo-devices-and-fda-status/)
explains how to look a device up.

Two computed summaries below, under "From our data", show what else the pages
state before you book and how they word FDA status.

What regulators say

United States. The FDA has not approved ozone for any medical use. Its
device labeling rule, dating from 1976, says ozone "is a toxic gas with no
known useful medical application in specific, adjunctive, or preventive
therapy", and treats a device that generates ozone as adulterated or misbranded
if it is used in a medical condition "for which there is no proof of safety and
effectiveness" [4]. In July 2025 the FDA's biologics center wrote to
O3UV, LLC of Grand Ledge, Michigan, about two devices meant to expose blood to
ozone and ultraviolet light during UV blood irradiation or EBOO, sold to
practitioners across the country. It found them adulterated because no
premarket approval was in effect and misbranded because the firm had not
notified the agency before selling them, and it listed quality-system failures,
among them hemodialyzer filters bought from a supplier the firm had not
evaluated [7]. A statement that equipment is "FDA registered" is not
approval: registration "does not in any way denote approval" [20], and
moderate-risk devices such as dialysis equipment reach the market through
"510(k) clearance" [21]. Our guide
Is EBO2 FDA approved? (/guides/is-ebo2-fda-approved/) covers this in full.

Italy. Italian health authorities were wary of ozone therapy during the years
the Siena papers appeared. In an opinion of 19 November 2003, relayed by the
Health Ministry in January 2005, the Superior Health Council said
oxygen-ozone therapy should be given only in ethics-approved trials in
hospitals, that no controlled clinical studies supported its efficacy, and that
it "can cause serious and potentially lethal side effects" (our translation)
[22]. In 2015 the regional health council of Tuscany, the region that
includes Siena, attached an opinion from the national blood centre and called
ozonated autohemotherapy "of doubtful clinical efficacy", adding that the blood
must be handled where there is no risk of microbial contamination (our
translation) [23].

Elsewhere. Brazil's Federal Council of Medicine in 2025 authorized ozone
therapy as an add-on for four kinds of wound (topical use only), knee
osteoarthritis and disc-related low back pain; no use that sends blood through
a circuit is on its list [24]. In Australia, a New South Wales commission
in 2025 barred an ozone clinic from providing health services for five years. It
found the practitioner used an ozone generator and a "Champion Full Spectrum UV"
device not approved by the national regulator, obtained heparin "from an unknown
source" and "is not authorised to be in possession of, or to administer" it, and
lacked infection control [25]; the same device name appears in
the FDA's O3UV letter [7]. The field's own consensus document, the
Madrid Declaration, lists EBOO among its recommended routes [15]; it
is written by ozone therapists, not by a regulator.

What the studies show

As of October 2, 2026, our research library tags six entries as
studies of EBOO as given to people; the
table under "From our data" lists them with the procedure each reports. Four
come from the Siena group. The other two are a 2023 series from a California
clinic that measured ozone uptake in 12 patients [2] and a 2025 single-patient
case report from New York [26].

The only randomized trial assigned 28 patients with peripheral artery disease to
EBOO or intravenous prostacyclin. The EBOO group showed significantly greater
regression of skin lesions and differed on pain, itching, heavy legs and
well-being, while neither group's leg circulation changed; no side effects were
recorded in 210 EBOO treatments [6]. The trial was run by the
technique's developers at their own hospital, and the abstract does not say how
patients were randomized or whether assessors were blinded [6].

The other Siena reports are a 2000 preliminary report that began with one of
the authors volunteering to test the device [3], a 2002 single case
[11] and a 2005 review [5]; the group's 2007 bench test of its gas exchanger in
saline [9] is filed with the background science. The 2025 case report followed
an 88-year-old woman through two series of three treatments: urinary
toxin-to-creatinine ratios fell on average, nickel rose overall, and there was
no control for ongoing exposure. Her hemoglobin fell from 7.4 to 6.8 g/dL after
the first series and was 7.5 after the second, and she reported feeling worse
after the second series; the paper has no adverse-events section and
attributes neither change to EBOO [26]. The California paper measured gas,
not outcomes [2]. For each study in a paragraph, see
Does EBO2 work? (/guides/does-ebo2-work/); for all of them side by side, the
studies compared (/reports/studies-compared/) report.

Safety, in brief

The EBOO papers report few problems, but they are small and written by the
people who use the method: more than 1,200 treatments in 82 patients "without
technical or clinical problems" [5], none in 210 trial treatments
[6], and none in at least 400 California sessions [2]. The 2025 case report has
no adverse-events section; it notes the fall in hemoglobin and the tiredness
described above without attributing either to EBOO [26].
The papers we read describe no independent safety monitoring and no registry.
Bocci's group called EBOO complex and invasive, since blood is taken from one
vein and returned through another [1]; the circuit also needs an
anticoagulant and handles blood outside the body. Italy's Superior Health
Council warned in 2003 of serious and potentially lethal side effects from
oxygen-ozone therapy in general [22]. Of the 174 clinic pages we
read, 31 mention G6PD somewhere on the pages we saved, either as a blood test
before treatment or as a reason not to treat. Injecting ozone gas straight into a vein is a different
procedure, which the field's consensus document advises against [15];
Bocci's group cites the risk of oxygen embolism [1]. See who should not get EBO2 (/guides/contraindications/),
side effects and safety (/guides/side-effects-and-safety/), and, for case
reports by route, ozone therapy adverse events (/guides/ozone-therapy-adverse-events/).

Cost, in brief

What clinics publish for a single session, with the range and median, is in our
price report (/reports/ebo2-prices/); the price check (/tools/price-check/)
compares a quote with it, and the cost guide (/guides/ebo2-cost/) explains
packages and add-ons.

What is established and what is not

Established, from the sources above:

The circuit can be run for an hour on about 2 to 5 liters of blood, and its
  practitioners report no serious problems in their own series
  [5][2].
Ozone reacts with blood in the circuit. The Siena group measured lipid
  oxidation products rising 4- to 5-fold after a session [5]. The
  California group found that, on average, about 37 percent of the ozone fed in
  did not come back out in the spent gas after allowing for losses in the empty
  equipment, which it took as uptake by blood [2].
Ozone therapy is not FDA-approved, and the FDA has acted against an EBOO
  device maker [4][7].

Not established:

Any health benefit in a trial run independently of the developers.
What the dialysis filter removes from blood, or whether it adds anything under
  ozone [13].
The right ozone concentration, blood flow or number of sessions. The Siena and
  US settings differ many times over, and we found no study comparing them.
How often serious complications happen. We know of no registry that would
  record them.

What we could not verify

We read only the abstracts of the Siena papers from 1999 to 2010; their full
  texts are not in PubMed Central's open collection. Bocci's 2011 review and
  the 2023 California paper we read in full.
Whether the dialyzers used in US clinics release anything into blood when
  exposed to ozone. The Siena team's 2010 warning has not, as far as we could
  find, been tested in published work.
Why the Siena group moved from sodium citrate in its 1999 sheep work to
  heparin in later descriptions; the abstracts do not say.
When the dialyzer version of EBOO began, and who first called it EBO2. The
  California paper says ozone dialysis has run for at least 22 years in Malaysia
  with more than 200,000 treatments, citing a source we have not read
  [2].
Whether the "EBOO Full Spectrum" machines named on clinic pages are the
  product in the FDA's letter.
Anything about a clinic beyond its own page. We did not observe sessions.

How this guide was made

This guide draws on 26 sources: papers read through PubMed,
PubMed Central and Europe PMC, regulatory documents read on the issuing
bodies' sites, and clinic pages saved by our research pass. The clinic figures
come from our dataset of 177 clinics, read between September 28, 2026 and October 4, 2026. We
counted the volume, dialysis, device and
dose statements from the saved pages and checked each count against
them, and we kept the list of pages behind every count. Translations from
Italian are ours. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: Is EBO2 the same as EBOO?
A: Usually, but not always. Both are short for extracorporeal blood oxygenation and ozonation, and one clinic calls EBO2 simply another name for EBOO. Other clinics use EBO2 for a different product: one expands it as Extracorporeal Blood Oxygenation and Ozonation 2.0, another as Enhanced Biologically Optimized Ozone Therapy, and another uses it for EBOO plus a light device at a higher price. Ask a clinic exactly what its version includes.

Q: Is EBO2 FDA approved?
A: No. Ozone therapy is not FDA-approved for any condition, and the FDA's device rule calls ozone a toxic gas with no known useful medical application. In July 2025 the FDA told a Michigan maker of EBOO equipment that its devices were adulterated and misbranded because they had no premarket approval or clearance.

Q: How much blood does an EBO2 session treat?
A: The Siena papers that introduced EBOO describe up to 4,800 mL of blood in one hour. A 2023 US paper ran the pump at 30 to 40 mL a minute for one hour, which moves 1.8 to 2.4 liters through the circuit. As of October 4, 2026, the 53 of 174 clinic pages we could read that state a volume give 1 to 7 liters. One clinic that offers the procedure calls volume pitches a marketing gimmick and says ozone dose is measured in micrograms per milliliter, not liters.

Q: Is EBO2 the same as dialysis?
A: No. Many US clinics pass blood through a dialysis filter, but no dialysate fluid is used; the filter is where blood meets the ozone gas. The Italian developers of EBOO rejected dialysis membranes for this job in 1999 and 2001, and in 2010 warned that dialysis filters used this way may release toxic compounds.

Q: How is EBO2 different from 10-pass ozone?
A: In 10-pass ozone, 200 mL of blood is drawn into a pressurized flask, mixed with ozone and returned, ten times in about an hour. EBO2 runs blood continuously through a circuit with a gas exchanger or dialysis filter. No trial has compared what the two do for patients.

Q: Does EBO2 work?
A: It has not been tested well enough to say. The one randomized trial, 28 patients with peripheral artery disease at the developers' hospital in 2005, reported better healing of skin lesions than with prostacyclin but no change in leg circulation. The rest of the EBOO literature is case reports, reviews, a series that measured ozone uptake, and bench tests of the equipment, and we found no trial run independently of the developers.

Sources:
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[2] Ozone dialysis delivers three or more times the ozone than other forms of ozone blood treatment. Medical Gas Research (PubMed Central), 2023. https://pmc.ncbi.nlm.nih.gov/articles/PMC9555023/
[3] Extracorporeal blood oxygenation and ozonation (EBOO) in man. Preliminary report. International Journal of Artificial Organs (PubMed), 2000. https://pubmed.ncbi.nlm.nih.gov/10741810/
[4] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
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[6] Extracorporeal blood oxygenation and ozonation (EBOO): a controlled trial in patients with peripheral artery disease. International Journal of Artificial Organs (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16288443/
[7] Warning Letter: O3UV, LLC (CBER 25-668840), July 7, 2025. US Food and Drug Administration (CBER), 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/o3uv-llc-668840-07072025
[8] Ozonation of blood during extracorporeal circulation. I. Rationale, methodology and preliminary studies. International Journal of Artificial Organs (PubMed), 1999. https://pubmed.ncbi.nlm.nih.gov/10532435/
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[10] EBOO/EBO2 Ozone Therapy. San Diego Center for Restorative Medicine, 2026. https://www.restorativemedicinecenter.com/eboo-ozone-therapy
[11] Necrotizing fasciitis successfully treated with extracorporeal blood oxygenation and ozonization (EBOO). International Journal of Artificial Organs (PubMed), 2002. https://pubmed.ncbi.nlm.nih.gov/12518965/
[12] Ozonation of blood during extracorporeal circulation. II. Comparative analysis of several oxygenator-ozonators and selection of one type. International Journal of Artificial Organs (PubMed), 2001. https://pubmed.ncbi.nlm.nih.gov/11831595/
[13] Are dialysis devices usable as ozone gas exchangers?. Artificial Organs (PubMed), 2010. https://pubmed.ncbi.nlm.nih.gov/19817737/
[14] 21 CFR 876.5860 High permeability hemodialysis system. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-876/subpart-F/section-876.5860
[15] Madrid Declaration on Ozone Therapy, 2nd edition (index of routes). ISCO3 (International Scientific Committee of Ozone Therapy), 2015. https://isco3.org/madrid-declaration-2nd-edition/
[16] Ozone high dose therapy (OHT) improves mitochondrial bioenergetics in peripheral blood mononuclear cells. Translational Medicine Communications (PubMed Central), 2022. https://pmc.ncbi.nlm.nih.gov/articles/PMC9301618/
[17] Difference Between EBOO and EBO2: What Sets Them Apart. BODYWELLE (Alonso Martin MD), 2026. https://alonsomartinmd.com/blog/difference-between-eboo-and-ebo2/
[18] EBO2 Therapy in Chicago. Bliss MD, 2026. https://www.blissmedicines.com/ebo2-therapy-in-chicago/
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[20] 21 CFR 807.39 Misbranding by reference to establishment registration or to registration number. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807/subpart-B/section-807.39
[21] Is It Really 'FDA Approved'?. US Food and Drug Administration, 2026. https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved
[22] Ossigeno-ozono terapia (circular DGFDM.III/P/1752/I.4.C.C., 20 January 2005), annexed to Tuscany opinion 10/2007. Italian Ministry of Health, Directorate General of Medicines and Medical Devices, 2005. https://www.regione.toscana.it/documents/10180/12096595/Allegato+3+Parere+n.+10-2007+%28Autore+Bailo+09-03-2007%29.pdf/f1bb981c-98e3-4ca9-8c8a-e111f32713fa?version=1.0&t=1416999155247&download=true
[23] Parere 67/2015: Prestazioni di idrocolonterapia, terapia chelante e ozonoterapia. Regione Toscana, Consiglio Sanitario Regionale, 2015. https://www.regione.toscana.it/documents/10180/13326460/Parere+67_15+Ozono+idrocolon+e+chelante.pdf/a1f11111-daac-4ae4-a7a9-437884a0d813?version=1.0&t=1460457106345&download=true
[24] Resolução CFM n° 2.445, de 21 de agosto de 2025. Conselho Federal de Medicina (Brazil), 2025. https://sistemas.cfm.org.br/normas/arquivos/resolucoes/BR/2025/2445_2025.pdf
[25] Ozone Healing Clinic, Penrith: Time-bound Prohibition Order. NSW Health Care Complaints Commission, 2025. https://www.hccc.nsw.gov.au/decisions-orders/prohibition-orders/ozone-healing-clinic-penrith-nsw
[26] Observed Reduction in Urinary Toxin Excretion With Extracorporeal Blood Oxygenation and Ozonation (EBOO) Treatment in an 88-Year-Old With Chronic Anemia: A Case Report. Cureus (PubMed Central), 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC12826612/

---

# At-Home Ozone Therapy vs EBO2 (EBOO): What Regulators Say About Home Ozone Devices

Source: https://ebo2.com/guides/at-home-ozone-therapy/
Updated: 2026-10-03

Key takeaways:
- EBO2 (also called EBOO) needs two venous lines, an anticoagulant, a pump and a sterile single-use circuit run by trained staff; we found no home version in any source. Ozone therapy is not FDA-approved for any condition.
- Federal rules treat an ozone-generating device as adulterated or misbranded if it releases more than 0.05 parts per million into rooms people occupy, or is used in a medical condition without proof of safety and effectiveness.
- The EPA reports that some ozone generators sold as air cleaners, run on high with interior doors closed, produced 0.20 to 0.30 ppm in a home, and that a large one in a small room reached 0.50 to 0.80 ppm.
- The FDA has received reports of asthma attacks, headaches and breathlessness after ozone CPAP cleaners, and Health Canada says no ozone sauna has been licensed for sale in Canada.
- The injuries in our regulatory records split by route: breathing ozone from devices at home, and gas or infection reaching the blood in clinic procedures. None is a documented injury from EBOO.

EBO2 (also called EBOO) is a clinic procedure: blood is pumped from one arm
through a device where it meets ozone gas and back into the other arm, with an
anticoagulant in the line, for about an hour [1][2]. Nothing
sold for home use does that. What people buy for home use are ozone generators
for room air, cleaners for CPAP machines, ozone saunas and tents, and kits for
putting ozone gas into a body cavity, and US and Canadian regulators have each
spoken about some of them [3][4][5][6]. Ozone
therapy is not FDA-approved for any condition [7].

This guide compiles what those regulators say, with their exact figures; lists
the injuries in our regulatory database by the route that caused them; and sets
out why a blood circuit is a different kind of exposure from anything a home
device produces. The four newest records in our database are shown under "From
our data".

What US rules say about ozone devices

The FDA's device labeling rule, dating from 1976, describes ozone as "a toxic gas
with no known useful medical application in specific, adjunctive, or
preventive therapy" [7]. Its main points for home devices:

The 0.05 ppm ceiling. A device that generates ozone, by design or as a
  byproduct, is adulterated or misbranded if it puts more than 0.05 parts per
  million into the air circulating through it, or lets ozone build up above
  0.05 ppm in enclosed spaces people occupy for long periods, such as houses,
  apartments, hospitals and offices [7].
The label. A device that releases ozone must state the maximum
  concentration it may produce and the smallest room it can be used in without
  exceeding the limit [7].
Medical use. Any ozone-generating device used or meant for use "in any
  medical condition for which there is no proof of safety and effectiveness" is
  adulterated or misbranded [7].
The warning signs. The rule says inhaled ozone irritates the lungs enough
  to cause pulmonary edema, that its onset "is usually delayed for some hours",
  and that because the sense of smell tires quickly, the odor of ozone is "not a
  reliable index" of how much is in the air [7].

The FDA treats medical ozone generators as devices that need its authorization.
In 2014 a dental practice recalled an ozone generator because it was "not
approved or cleared by the FDA for medical use"; 16 units had been distributed
[8]. In 2025 the FDA told a Michigan firm that its devices for exposing
blood to ozone and ultraviolet light were adulterated and misbranded for lack of
premarket approval or clearance [9], and federal prosecutors charged a
Virginia physician with offenses that included using three FDA-unapproved
medical ozone generators, charges that are allegations [10].

The EPA on ozone generators sold as air cleaners

The EPA's page on these machines, last updated in February 2026, makes five
points that apply to any ozone-producing device in a home [3]:

No approval. It says no agency of the federal government has approved
   ozone generators for use in occupied spaces, and that an EPA establishment
   number on the box "does not imply EPA endorsement".
Harm. "Whether in its pure form or mixed with other chemicals, ozone can
   be harmful to health." Relatively low amounts can cause chest pain, coughing,
   shortness of breath and throat irritation.
Following the instructions is not enough. In an EPA study in a home,
   some generators run on high with interior doors closed often produced 0.20 to
   0.30 ppm; in another study, a generator rated for spaces "up to 3,000 square
   feet" run on high in a 350-square-foot room reached 0.50 to 0.80 ppm, 5 to 10
   times public health limits.
The settings mislead. On some devices the high setting produced 10 times
   the level of the medium setting, and the ability to smell ozone "rapidly
   deteriorates in the presence of ozone".
Little benefit at safe levels. At concentrations within public health
   standards, ozone does little to remove indoor air contaminants, and it does
   not remove viruses, bacteria or mold from the air effectively.

The page sets those readings against the limits it lists: 0.05 ppm for indoor
medical devices under the FDA rule, 0.10 ppm for workers averaged over 8 hours,
and 0.08 ppm as an 8-hour outdoor standard [3]. A 1989 review of ozone in
outdoor air found that peak levels in areas home to more than half the US
population caused measurable, temporary changes in lung function, respiratory
symptoms and airway inflammation in healthy people exercising outdoors
[11].

CPAP cleaners, saunas and home kits

CPAP cleaners. The FDA's consumer update, current as of August 26, 2024, says
there are no FDA-cleared or approved devices for cleaning, disinfecting or
sanitizing CPAP machines, that most parts can be cleaned with mild soap and
water, and that it has received reports of "unexpected asthma attacks, headaches,
and breathlessness" after ozone cleaners were used. It adds that ozone can leak
from the equipment into the home during cleaning and that levels inside the
equipment "can be above safe limits even several hours after cleaning is
completed" [4].

Ozone saunas. Health Canada's 2022 advisory describes an individual steam
chamber fed by an ozone generator and a compressed-oxygen tank, used for about
30 minutes with the head outside, and advertised for detoxing and for treating
infections and cancer, among other uses. It says ozone saunas need a medical
device licence, that none has been licensed, and that it has received no
submissions with evidence for their treatment claims. The risks it lists are
headache, cough, dry throat and nausea, with shortness of breath and pulmonary
edema at higher levels; delayed treatment because users may not recognize the
symptoms; fire or explosion from the oxygen; burns or frostbite from escaping
oxygen; and a condition worsening if the sauna replaces standard treatment
[5].

Do-it-yourself setups. In April 2020 the FTC warned a San Diego seller whose
marketing said "You can do ozone therapy yourself if you invest in our oxygen
concentrator/ 5g machine and a tent", and told it to stop claiming its machine
treated or prevented COVID-19 [6].

Insufflation. Putting ozone gas into the rectum or vagina is among the routes
the field's consensus document recommends to practitioners [12]. Bocci's
group wrote that the rectal dose "remains unpredictable" because of gas loss and
bowel contents [2]. We found no regulator's statement specific to home
insufflation kits.

The injuries in the regulatory record, by route

As of September 28, 2026, our database holds 34 primary-source
regulatory records. The ones that
describe a person harmed, or a risk to people, fall into three routes, and none
of them is EBOO.

| Route | Record | What it records |
|---|---|---|
| Breathing ozone from a home device | FDA, CPAP cleaners, 2024 | Reports of asthma attacks, headaches and breathlessness after use [4] |
| Breathing ozone from a home device | Health Canada, ozone saunas, 2022 | A list of potential risks; no case counts [5] |
| Gas injected into a vein, in a clinic | Medical Board of California, 2024 | A patient lost consciousness during intravenous ozone treatment in 2020 and was diagnosed with air embolism and stroke [13] |
| Gas injected into a vein, in a clinic | New York appellate court, 2023 | A medical examiner attributed gas emboli and a patient's death to an intravenous injection of ozone [14] |
| Infection and blood handling, in a clinic | NSW Health Care Complaints Commission, 2025 | A patient's serious infection and septic shock, which an expert said the treatment most likely caused, at a clinic where the practitioner tried to sterilize single-use items for reuse and had no infection-control procedures [15] |

A published outbreak report, not a regulatory record, adds a case of the third
kind: in 2001, six of 31 patients tested after ozone autohemotherapy or ozone injections
at a Rome hospital outpatient department had hepatitis C, and the authors
concluded that transmission "may occur during medical procedures with limited
bleeding" [16].

The harms recorded for home devices come from breathing ozone. The harms
recorded in clinics come from putting gas into a vein or from handling blood
without infection control. Case reports from the medical literature, route by
route, are compiled in ozone therapy adverse events (/guides/ozone-therapy-adverse-events/).

Why a blood circuit is a different exposure

A home device puts ozone into the air or a body cavity. EBOO takes blood out of
the body and puts it back, and that is what creates its requirements. Each row
below is a control the published descriptions of EBOO depend on.

| What EBOO needs | Why, from the sources | A home device |
|---|---|---|
| Two venous lines and a pump | Blood is collected from one vein and returned to another; Bocci's group called this complex and invasive [2] | No access to the blood |
| An anticoagulant | The California circuit ran a heparin drip [1]; in Australia, one finding against a clinic was that its practitioner obtained prescription-only heparin "from an unknown source" and was "not authorised to be in possession of, or to administer" it [15] | None |
| Sterile, single-use handling of blood | Tuscany's health council says ozonated blood must be prepared where there is no risk of microbial contamination [17]; the Rome outbreak and the Penrith order record infections linked to ozone procedures [16][15] | Not applicable |
| No gas reaching the vein | The gas mixture "should never be directly injected" into blood vessels because of the risk of oxygen embolism [2]; Tuscany's clinical governance body says the same [18] | Not applicable |
| Spent gas destroyed before room air | The California circuit sends exhaust gas through an ozone-destruct unit [1] | Ozone generators release it into the room by design, and cleaners can leak it [3][4] |
| Trained staff | EBOO "must be performed by technicians specialized in extravascular blood circulation" [2] | Used by the buyer |

The comparison runs both ways. A home generator lacks the controls a blood
circuit needs, and a blood circuit is built to keep ozone out of the room air,
where home generators release it [1][3]. Neither tells you whether
ozone in the blood does anything useful; that question is covered in
does EBO2 work? (/guides/does-ebo2-work/), and the risks of the clinic
procedure in side effects and safety (/guides/side-effects-and-safety/).

Checks you can run on a home ozone device

These come from the regulators' own pages.

Is it authorized? The FDA tells CPAP users to make sure an add-on
   cleaner is FDA-authorized for that purpose [4]. Health Canada
   points buyers to its Medical Devices Active Licence Listing [5]. Our
   guide to EBO2 devices and FDA status (/guides/eboo-devices-and-fda-status/)
   shows how to look a device up in the FDA's databases.
Does the label state its ozone output? Under the federal rule, a device
   that releases ozone must give the maximum concentration and the smallest room
   it can be used in [7].
Does the seller claim it treats a disease? Advertising that a product
   treats or prevents disease requires "competent and reliable scientific
   evidence", which is what the FTC found missing in 2020 [6].
Would you notice too much ozone? Both the FDA rule and the EPA say smell
   is not a reliable guide, and the FDA rule says lung injury can appear hours
   later [7][3].

To find a clinic that offers the clinic procedure, see our
directory (/clinics/); to check what a clinic says about the FDA, see
Is EBO2 FDA approved? (/guides/is-ebo2-fda-approved/).

What we could not verify

Retail pages for home insufflation kits, which an earlier version of this page
  described. Under our rules for automated access we did not re-read them, so
  we have left out what they say.
Injury counts. The FDA and Health Canada describe reports and risks but give
  no numbers, and we know of no registry of injuries from home ozone devices.
Whether the EPA's figures, from studies it cites back to the 1990s, hold for
  devices sold today.
Any statement by a US regulator specific to home rectal or vaginal
  insufflation.
Whether the outbreak and court records involved equipment like that sold for
  home use. They concern clinic procedures.

How this guide was made

This guide draws on 18 sources: regulators' pages, rules, letters,
orders and court decisions read on the issuing bodies' sites, and papers read
through PubMed, PubMed Central and Europe PMC. The count of regulatory records
comes from our regulatory database as of September 28, 2026. Drafting used AI
tools. A human editor has not yet checked this guide claim by claim against its
sources, and no clinical reviewer has signed off yet.

FAQ:
Q: Can you do EBO2 at home?
A: No source we found describes a home version, and the procedure's requirements rule it out: a line in each arm, an anticoagulant such as heparin, a pump, a sterile single-use circuit, an ozone generator with a unit that destroys the spent gas, and staff trained in running blood outside the body. The technique's developers wrote that it must be performed by technicians specialized in extracorporeal circulation.

Q: Are home ozone generators legal?
A: Selling one is not in itself illegal in the US, but federal rules treat an ozone-generating device as adulterated or misbranded if it releases more than 0.05 ppm into occupied rooms or is used in a medical condition without proof of safety and effectiveness. The EPA says no federal agency has approved ozone generators for use in occupied spaces, and the FTC has warned sellers that marketed home ozone machines to treat disease.

Q: Is an ozone sauna safe to use at home?
A: Health Canada's 2022 advisory says not to buy or use one. It lists risks including headache, cough, nausea, shortness of breath and fluid in the lungs at higher exposures, delayed treatment because users may not recognize the symptoms, and fire or explosion from the oxygen supply. It also says no ozone sauna has been licensed for sale in Canada.

Q: Do ozone CPAP cleaners work?
A: The FDA says no device is cleared or approved to clean, disinfect or sanitize CPAP machines, that most parts can be cleaned with mild soap and water, and that ozone can leak into the home and stay above safe limits inside the equipment for hours. It has received reports of asthma attacks, headaches and breathlessness after ozone cleaners were used.

Q: Is rectal ozone insufflation the same as EBO2?
A: No. Insufflation puts ozone gas into a body cavity, and EBO2 exposes blood to ozone in a circuit outside the body. The two have different risks. One of EBOO's developers wrote that the dose from rectal insufflation is unpredictable, because of gas loss and bowel contents.

Sources:
[1] Ozone dialysis delivers three or more times the ozone than other forms of ozone blood treatment. Medical Gas Research (PubMed Central), 2023. https://pmc.ncbi.nlm.nih.gov/articles/PMC9555023/
[2] Oxygen/ozone as a medical gas mixture. A critical evaluation of the various methods clarifies positive and negative aspects. Medical Gas Research (PubMed Central), 2011. https://pmc.ncbi.nlm.nih.gov/articles/PMC3231820/
[3] Ozone Generators that are Sold as Air Cleaners. US Environmental Protection Agency, 2026. https://www.epa.gov/indoor-air-quality-iaq/ozone-generators-are-sold-air-cleaners
[4] Do You Need a Device That Claims to Clean a CPAP Machine?. US Food and Drug Administration, 2024. https://www.fda.gov/consumers/consumer-updates/do-you-need-device-claims-clean-cpap-machine
[5] Unlicensed ozone saunas may pose serious health risks to users and anyone in close proximity. Health Canada, 2022. https://recalls-rappels.canada.ca/en/alert-recall/unlicensed-ozone-saunas-may-pose-serious-health-risks-users-and-anyone-close-proximity
[6] Warning Letter to Forever Ozone: Unsubstantiated Claims for Coronavirus Prevention or Treatment. Federal Trade Commission, Southwest Region, 2020. https://www.ftc.gov/system/files/warning-letters/covid-19-letter_to_swro_forever_ozone.pdf
[7] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[8] Class 2 Device Recall Enaly 1000 BT12 Ozone Generator (Recall Number Z-1576-2014). US Food and Drug Administration, medical device recall database, 2014. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127001
[9] Warning Letter: O3UV, LLC (CBER 25-668840), July 7, 2025. US Food and Drug Administration (CBER), 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/o3uv-llc-668840-07072025
[10] U.S. Attorney Erik S. Siebert announces charges as part of DOJ's national health care fraud enforcement action. US Attorney's Office, Eastern District of Virginia, 2025. https://www.justice.gov/usao-edva/pr/us-attorney-erik-s-siebert-announces-charges-part-dojs-national-health-care-fraud
[11] Health effects of ozone. A critical review. JAPCA, Journal of the Air Pollution Control Association (PubMed), 1989. https://pubmed.ncbi.nlm.nih.gov/2659744/
[12] Madrid Declaration on Ozone Therapy, 2nd edition (index of routes). ISCO3 (International Scientific Committee of Ozone Therapy), 2015. https://isco3.org/madrid-declaration-2nd-edition/
[13] In the Matter of the Accusation Against German Zermeno, M.D., Case No. 800-2022-088393: Decision and Stipulated Settlement. Medical Board of California, 2024. https://www2.mbc.ca.gov/BreezePDL/document.aspx?path=%5CDIDOCS%5C20240621%5CDMRAAAJD2%5C&did=AAAJD240621215614354.DID
[14] Matter of Robins v New York City Off. of Chief Med. Examiner, 2023 NY Slip Op 00286. New York Supreme Court, Appellate Division, First Department, 2023. https://www.nycourts.gov/reporter/3dseries/2023/2023_00286.htm
[15] Ozone Healing Clinic, Penrith: Time-bound Prohibition Order. NSW Health Care Complaints Commission, 2025. https://www.hccc.nsw.gov.au/decisions-orders/prohibition-orders/ozone-healing-clinic-penrith-nsw
[16] A cluster of hepatitis C virus infections associated with ozone-enriched transfusion of autologous blood in Rome, Italy. Infection Control and Hospital Epidemiology (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16209382/
[17] Parere 67/2015: Prestazioni di idrocolonterapia, terapia chelante e ozonoterapia. Regione Toscana, Consiglio Sanitario Regionale, 2015. https://www.regione.toscana.it/documents/10180/13326460/Parere+67_15+Ozono+idrocolon+e+chelante.pdf/a1f11111-daac-4ae4-a7a9-437884a0d813?version=1.0&t=1460457106345&download=true
[18] Allegato alla Decisione CTS n. 20 del 11/12/2018. Regione Toscana, Organismo Toscano per il Governo Clinico, 2018. https://www.regione.toscana.it/documents/10180/16111184/Allegato+-+Decisione+20_2018.pdf/4edd57e6-44e0-4092-9f5e-d093691f6c36

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# Does EBO2 (EBOO) Work? The Evidence, Study by Study

Source: https://ebo2.com/guides/does-ebo2-work/
Updated: 2026-10-04

Key takeaways:
- Six papers in our library are about EBOO as given to people: one 28-patient randomized trial at the developers' own hospital, two single-patient case reports, a preliminary report with no patient count, a review by the developers, and ozone-uptake measurements in 12 patients at a Santa Rosa, California clinic.
- On October 2, 2026, ClinicalTrials.gov listed no registered study under the names extracorporeal blood oxygenation and ozonation, EBOO, EBO2, or ozone dialysis.
- As of October 4, 2026, 163 of the 174 clinics whose EBO2 page we could read state a health benefit. For autoimmune disease, fatigue, long COVID, Lyme or mold illness, longevity, and cancer, no study of EBOO itself in our library measured the outcome in patients.
- The larger trials in our library test ozone given other ways, mostly injections and major autohemotherapy, and a result for one route does not carry over to another.
- Ten checks on PubMed, Europe PMC, and ClinicalTrials.gov show what any study behind a clinic's claim did and did not test.

EBO2 (also called EBOO) has a small research record. Of the 78 studies in our library, six are about EBOO as given to people: one randomized trial of 28 patients run at the hospital where the method was developed, two single-patient case reports, a preliminary report that gives no patient count, a review by the developers, and a series that measured ozone uptake in 12 patients at a California clinic [1][2][3][4][6][7]. None is a large or independent trial. On October 2, 2026, ClinicalTrials.gov listed no registered study of the procedure under any of the names we searched [12]. That does not show that EBOO does nothing. It shows that the question has barely been tested. This guide lays out every study in our library with what it measured and found, sets clinic claims beside them, and ends with a check anyone can run on a study a clinic cites. Ozone therapy is not FDA-approved for any condition, and the FDA's regulation calls ozone "a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [13].

What counts as a study of EBOO itself

Our research library (/research/) files each paper in one of four groups: studies of EBO2 or EBOO as given to people, ozone therapy given some other way, safety reports, and background science. The grouping matters because the procedures differ. Major autohemotherapy usually draws about 200 mL of blood into a bag and mixes it with ozone [7], while the EBOO developers described treating up to 4,800 ml of blood in one hour of circulation [3]. A result for one does not carry over to the other. The studies compared report (/reports/studies-compared/) sorts the same library by design.

Two papers sit near the boundary. A 2023 series from a California clinic that calls the procedure "ozone dialysis" measured how much ozone blood absorbed during routine sessions, not how patients fared [7]; the paper says the method is "commonly referred to as" EBOO, and the library files it with the EBOO studies because it measured the procedure as given to patients. Our EBOO vs dialysis guide (/guides/eboo-vs-dialysis/) compares that circuit with kidney dialysis. A 2007 test of the developers' gas exchanger in a saline solution, with no blood and no patients [5], is filed as background science with the rest of their equipment work, described below. The table of procedure settings in the "From our data" section is built from the EBOO group.

The studies of EBOO itself

"Reports" means what the paper's text says, as our study notes record it. Each study name opens our notes, with the exact wording and the page it came from.

| Study | Design and participants | What was measured | What the paper reports | Limits |
|---|---|---|---|---|
| Di Paolo et al., 2000 (/research/di-paolo-2000-eboo-preliminary-report/) | Preliminary report: one author who volunteered, "a patient with Madelung disease and several patients with atherosclerotic vasculopathy"; no total given [1], though a German health insurance committee's 2001 report summarizes it as a pilot study of seven patients (see EBOO around the world (/guides/eboo-around-the-world/)) | Not stated beyond the lipomas | Two lipomas disappeared in the volunteer after six treatments; the authors call the results therapeutic and "without side-effects" [1] | No comparison group, no patient count, self-experimentation; abstract only |
| Di Paolo et al., 2002 (/research/di-paolo-2002-eboo-fasciitis-case/) | Case report: one dialysis patient with necrotizing fasciitis after "traditional therapies were unsuccessful" [2] | The patient's condition | "Patient condition improved radically after EBOO" [2] | One patient; a four-sentence abstract with no settings or follow-up |
| Di Paolo et al., 2005, review (/research/di-paolo-2005-eboo-review/) | Review by the developers, citing "more than 1200 treatments performed in 82 patients" [3] | Blood markers after a session | Thiobarbituric acid reactants rose four- to fivefold and plasma protein thiols fell, "without any appreciable erythrocyte haemolysis"; the standard course was 14 one-hour sessions over 7 weeks [3] | No new controlled data; the 82 patients are the authors' tally, not a study population |
| Di Paolo et al., 2005, trial (/research/di-paolo-2005-pad-trial/) | Randomized controlled trial: 28 patients with peripheral artery disease given EBOO or intravenous prostacyclin [4] | Skin lesions, pain, quality of life, blood supply to the legs | EBOO patients showed "highly significant regression of skin lesions" compared with prostacyclin; pain, pruritus, heavy legs, and well-being differed; no significant change in leg vascularisation in either group; no side effects recorded in 210 EBOO treatments [4] | One center, the developers' own; abstract only, with no arm sizes, randomization method, blinding, or EBOO settings |
| Bennett et al., 2025 (/research/bennett-2025-eboo-toxin-case/) | Case report: one 88-year-old woman with chronic anemia, two series of three treatments "as per clinic protocol," with about 2 liters of blood processed per treatment [6] | Urinary toxin-to-creatinine ratios on days 0, 70, and 131; hemoglobin | Average declines of 64.8% for mycotoxins, 25.7% for heavy metals, and 55.1% for environmental toxins; nickel was "the only toxin that showed an overall increase"; hemoglobin 7.4, 6.8, and 7.5 g/dL, and she reported feeling worse after the second series; the paper has no adverse-events section and attributes neither change to EBOO [6] | One patient; urine, not what the circuit removed; no control for exposure between tests |
| Rowen et al., 2023 (/research/rowen-2023-ozone-dialysis-uptake/) | Case series: 85 measurements in 12 patients during routine treatment at the authors' clinic [7] | Ozone taken up by the blood | Average uptake of 37% of the generator's output (range 25 to 50%); the authors calculate about 460,000 μg in a one-hour treatment at 30 μg/mL [7] | No patient outcomes; comparisons with other methods use theoretical figures |

The largest number of patients in any study of EBOO we found is 28 [4]. Four of the six come from the nephrology and physiology departments in Siena, Italy, where the method was built [1][2][3][4]; the other two were written by practitioners about their own patients, a 2023 series by the doctors who run a Santa Rosa, California clinic [7] and a 2025 case report by clinicians at a New York pain-management practice [6]. The 2005 review said that clinical trials "are under way to validate this new technique further" [3]. Apart from the 28-patient trial, published later that year [4], we found no trial from that group.

The same Siena group published the work that built the circuit, which our library files as background science. It tested equipment in saline, pig blood, and sheep and found dialysis-type membranes "unsuitable" [8]; compared several oxygenators before choosing one [9]; tested a new gas exchanger in a buffered saline solution, which it described as "very versatile and efficient" [5]; and measured ozone transfer through four dialysis filters against a purpose-built gas exchanger [10]. None measured how patients fared. Two recent animal studies of a different extracorporeal ozonation prototype, in pigs with sepsis, are listed with the background science below [53][54]. In a 2011 paper, Bocci and two colleagues described EBOO as "a procedure to be used in emergency conditions such as PAD stage 4" (PAD is peripheral arterial disease), citing its "complexity and invasiveness" [11].

What clinics claim, next to what was studied

Our clinic directory (/clinics/) records what each clinic states about its own EBO2 service. As of October 4, 2026, 163 of the 174 clinics whose EBO2 page we could read state a health benefit, and 26 of those 174 publish patient testimonials there. The table sets the kinds of benefit clinics name beside the studies of EBOO itself. Our rule: a study counts against a claim only if it measured that kind of outcome in patients. The review and the ozone-uptake series count for none.

| What clinics' EBO2 pages say it helps | Clinics stating it, of 174 | Studies of EBOO itself that measured it in patients |
|---|---|---|
| Detoxification | 151 | One case report: urinary toxins in one patient [6] |
| Energy or fatigue | 133 | None |
| Infections or pathogens | 119 | One case report: one patient with necrotizing fasciitis [2] |
| Autoimmune conditions | 104 | None |
| Other conditions | 94 | The 2000 preliminary report: lipomas and Madelung disease, no count [1] |
| Lyme disease or mold illness | 90 | None; the 2025 case measured urinary mycotoxins in a patient with anemia [6] |
| Heart and circulation | 87 | The 28-patient trial in peripheral artery disease [4], and the 2000 report's patients with atherosclerotic vasculopathy [1] |
| Longevity or anti-aging | 56 | None |
| Long COVID | 48 | None |
| Cancer | 22 | None |

The claim counts come from our clinic data, which the "From our data" section recomputes each time the site is built. The matching of studies to claims is our own judgment. Our cancer claims guide (/guides/eboo-cancer-claims/) looks at one category in detail.

Ozone therapy given other ways

These studies used injections, ozonated oil, or major autohemotherapy, not an EBOO circuit. Some are larger and better controlled than anything on EBOO, but the route and dose differ.

| Study | Ozone route, design, and participants | What the paper reports | Main limit |
|---|---|---|---|
| Elvis and Ekta, 2011 (/research/elvis-ekta-2011-ozone-therapy-clinical-review/) | Narrative clinical review [15] | History, proposed mechanisms, and uses; no new data [15] | No systematic search |
| Onishchenko et al., 2011 (/research/onishchenko-2011-plasmapheresis-cell-ozonation-uveitis/) | Plasmapheresis with ozonation of the returned cell mass; three groups, 179 people with uveitis [82] | The authors report an advantage for their method; the abstract gives no figures [82] | No assignment method, comparison treatment, or dose in the abstract |
| Borrelli et al., 2012 (/research/borrelli-2012-ozone-amd-rct/) | Major autohemotherapy; randomized open trial, 140 people with dry macular degeneration [16] | At 12 months, 25% of treated eyes gained a line of acuity against 0% of untreated eyes; 40% of controls lost two lines or more, against none of the treated [16] | Open label; the paper's table marks mean acuity changes as not significant |
| Magalhaes et al., 2012 (/research/magalhaes-2012-ozone-lbp-meta-analysis/) | Injection into or beside spinal discs; review of 8 observational studies and 4 randomized trials, low back pain [17] | Pooled odds ratio 2.66 (95% CI 1.94 to 3.63) in favor of ozone [17] | Three of the four trials had an active control, one a sham |
| Paoli et al., 2013 (/research/paoli-2013-ozonated-oil-cyclists-trial/) | Massage with ozonised oil; within-subject comparison, 15 cyclists [18] | Higher peak power and lower perceived fatigue after the ozonised-oil massage [18] | Topical oil; short-term performance only |
| Liu et al., 2015 (/research/liu-2015-ozone-diabetic-foot-cochrane/) | Diabetic foot ulcers; Cochrane review of 3 randomized trials, 212 people [19] | One trial favored ozone over antibiotics on ulcer area; two pooled trials found no difference from usual care; the authors were "unable to draw any firm conclusions" [19] | Trials at high or unclear risk of bias |
| Niu et al., 2018 (/research/niu-2018-ozone-disc-herniation-dose-rct/) | Injection into discs at 20, 40, or 60 μg/ml against drugs alone; randomized, 80 people [20] | The 40 μg/ml group had the most disc retraction; the 60 μg/ml group had higher IL-6 and pain scores than drugs alone [20] | Single center; blinding not described |
| Rowen, 2019 (/research/rowen-2019-ozone-infectious-disease-review/) | Review on infections [21] | Argues for ozone against drug-resistant infection; no new data [21] | Single-author advocacy review |
| Tirelli et al., 2021 (/research/tirelli-2021-ozone-pasc-fatigue-cohort/) | Major autohemotherapy; case series, 100 people with post-COVID fatigue [22] | Mean fatigue score fell by 67% [22] | No comparison group |
| Valdenassi et al., 2022 (/research/valdenassi-2022-ozone-sjogrens-case/) | Oxygen-ozone autohemotherapy; case report, one person with Sjögren syndrome [23] | Arthralgia score from 135 to 91; fatigue down 75% [23] | One patient |
| Wen et al., 2022 (/research/wen-2022-ozone-chronic-wounds-review/) | Topical and systemic ozone; review of 12 trials, chronic wounds [24] | Faster wound-area improvement and fewer amputations for diabetic foot ulcers; no difference in complete healing or hospital stay [24] | Authors rate reporting quality poor and could not judge safety |
| Serra et al., 2023 (/research/serra-2023-ozone-covid-evidence-gaps-map/) | Several routes; evidence and gaps map, 13 studies with 271 people with COVID-19 [25] | Maps reported outcomes; no effect sizes and no risk-of-bias assessment [25] | Six of the 13 studies are case reports |
| He et al., 2024 (/research/he-2024-ozone-pasc-rct/) | Major autohemotherapy plus usual care against usual care; pilot randomized trial, 73 people with post-COVID symptoms [26] | Response in 25 of 35 (71%) against 17 of 38 (45%) [26] | Pilot; blinding not described |
| Migliorini et al., 2024 (/research/migliorini-2024-ozone-knee-oa-meta-analysis/) | Knee injection against hyaluronic acid; meta-analysis, 424 people [27] | No difference in pain at 4 to 6 months [27] | No placebo arm |
| Franzini et al., 2025 (/research/franzini-2025-sioot-ozone-recommendations/) | Recommendations from an Italian ozone therapy society [28] | Inconsistent protocols and a lack of standard guidelines hinder adoption [28] | Position paper, no data |
| Kuculmez, 2026 (/research/kuculmez-2026-ozone-post-covid-cohort/) | Major autohemotherapy; case series from a retrospective record review, 40 people with post-COVID syndrome [29] | The authors report better fatigue, anxiety, depression, and some quality-of-life scores after 10 sessions [29] | No control group |

Safety reports and background science

Neither group tests whether EBOO helps anyone. The safety reports describe harms after other ozone routes. Most followed injections at or near the spine, with gas embolism or spine infection afterward; others followed ozonated blood or gas given into a vein. Our ozone therapy adverse events guide (/guides/ozone-therapy-adverse-events/) and side effects and safety guide (/guides/side-effects-and-safety/) discuss these harms in more depth.

| Route | Reports in our library |
|---|---|
| Ozone for back or neck problems, mostly injected into or beside the spine | Lo Giudice et al., 2004 (/research/lo-giudice-2004-ozone-retinal-hemorrhage-case/): bleeding in both eyes [59]; Corea et al., 2004 (/research/corea-2004-ozone-vertebrobasilar-stroke-case/): a vertebrobasilar stroke [60]; Gazzeri et al., 2007 (/research/gazzeri-2007-ozone-disc-septicemia-case/): fatal septicemia [61]; Vaiano et al., 2016 (/research/vaiano-2016-intradiscal-ozone-cortical-blindness/): transient cortical blindness [32]; Andrés-Cano et al., 2016 (/research/andres-cano-2016-ozone-cervical-spondylodiscitis/): a neck spine infection with an epidural abscess [62]; Vanni et al., 2016 (/research/vanni-2016-intraforaminal-ozone-adhesions-series/): adhesions around nerve roots found at later surgery [63]; Beyaz et al., 2018 (/research/beyaz-2018-epidural-ozone-cardiopulmonary-arrest/): cardiopulmonary arrest and air in the skull [55]; He et al., 2019 (/research/he-2019-intradiscal-ozone-paradoxical-embolism/): spinal cord injury and a heart attack [34]; Freund et al., 2019 (/research/freund-2019-ozone-gas-emboli-stroke-case/): strokes from gas emboli [64]; Chirchiglia et al., 2019 (/research/chirchiglia-2019-ozone-pulmonary-embolism-case/): a suspected pulmonary embolism and sudden death [65]; Shahi et al., 2020 (/research/shahi-2020-ozone-mycobacterium-abscessus-spondylodiscitis/): a mycobacterial spine infection [57]; Haggiag et al., 2021 (/research/haggiag-2021-ozone-encephalopathy-case-series/): encephalopathy in three patients [66]; Salaria et al., 2021 (/research/salaria-2021-ozone-spinal-tuberculosis-case/): tuberculosis of the spine [56]; Khosravi and Mirzaasgari, 2024 (/research/khosravi-2024-intradiscal-ozone-gas-embolism/): cerebral gas embolism and stroke [37]; Shamohammadi et al., 2025 (/research/shamohammadi-2025-lumbar-ozone-pneumoperitoneum/): free air in the abdomen [39]; Velluto et al., 2026 (/research/velluto-2026-ozone-spondylodiscitis-case-review/): a spine infection, with a review of earlier cases [58]; Elmas Dal, 2026 (/research/elmas-dal-2026-ozone-pneumocephalus-meningitis-case/): air in the skull with meningitis [67] |
| Ozonated blood or gas given into a vein | Marchetti and La Monaca, 2000 (/research/marchetti-2000-ozone-gas-embolism-death-case/): a death from gas embolism [68]; Faustini et al., 2005 (/research/faustini-2005-ozone-hepatitis-c-cluster/): a hepatitis C cluster among patients given ozone-enriched transfusions [69]; Üreyen et al., 2015 (/research/ureyen-2015-ozone-autohemotherapy-mi-case/): a heart attack with coronary spasm [70]; Tang et al., 2017 (/research/tang-2017-ozone-sinus-arrest-case/): high potassium and sinus arrest [33]; Bingham and Platt, 2020 (/research/bingham-2020-ozone-infusion-nstemi-case/): a non-ST-elevation heart attack [71]; Wong et al., 2025 (/research/wong-2025-intravenous-ozone-infarcts/): embolic brain infarcts [40]; Singh and Nevarez, 2026 (/research/singh-2026-ozone-gas-embolism-hyperbaric-case/): arterial gas embolism with transient blindness [72] |
| Other sites | Uzun et al., 2012 (/research/uzun-2012-ozone-diabetic-foot-injection-case/): forefoot necrosis after injections into a toe ulcer [73]; Gante and Dias, 2025 (/research/gante-2025-subcutaneous-ozone-encephalopathy/): encephalopathy after an injection under the skin [38]; Cortez et al., 2026 (/research/cortez-2026-ozone-shoulder-septic-arthritis-case/): a shoulder joint infection, route not reported [74] |
| Air pollution, not therapy | Calabrese et al., 1977 (/research/calabrese-1977-g6pd-ozone-hemolysis-model/): a model predicting hemolysis in G6PD deficiency [30]; Lippmann, 1989 (/research/lippmann-1989-ozone-health-effects-review/): lung effects of outdoor ozone [31]; Pan et al., 2023 (/research/pan-2023-air-pollution-sle-timeseries/): no link between outdoor ozone and lupus admissions [36] |
| Trials, reviews, and models | Steppan et al., 2010 (/research/steppan-2010-ozone-disc-herniation-meta-analysis/): a meta-analysis of 12 disc studies reporting a 0.064% likelihood of complications [75]; Re et al., 2020 (/research/re-2020-ozone-safety-pitfalls-review/): a review attributing most harms to infection or malpractice [76]; Shen et al., 2022 (/research/shen-2022-ozone-autohemotherapy-safety-rct/): a randomized trial of 118 people, 103 of whom completed follow-up, that observed no adverse complications in either group [35]; de Araújo et al., 2024 (/research/de-araujo-2024-ozone-musculoskeletal-pain-review/): a review of 27 pain studies, one author employed by a generator maker [77]; Franzini et al., 2025 (/research/franzini-2025-ozone-disc-herniation-safety/): a society paper putting severe events at 6.57 times as likely with disc injections [78]; Franzini et al., 2025 (/research/franzini-2025-ozone-autohemotherapy-glass-hemolysis/): a model of hemolysis in glass bottles and plastic bags [79]; Cacciatore et al., 2026 (/research/cacciatore-2026-ozone-umbrella-review/): an umbrella review that found safety inconsistently reported [80]; Casale et al., 2026 (/research/casale-2026-ozone-autohemotherapy-safety-review/): a scoping review that says incidence cannot be quantified [81] |

| Background paper | What it is | What it reports |
|---|---|---|
| Bocci et al., 1999 (/research/bocci-1999-ozonation-gas-exchanger-sheep/) | Saline, pig blood, and sheep | Dialysis-type membranes "unsuitable"; the exchanger clogged with cells in sheep [8] |
| Bocci et al., 2001 (/research/bocci-2001-oxygenator-ozonators-comparison/) | Human blood outside the body, several devices | Dialysis membranes inefficient for gas and "allowed ultrafiltration"; newer oxygenators treated up to 5 L in about an hour [9] |
| Bocci, 2004 (/research/bocci-2004-ozone-as-janus-review/) | Review by an ozone therapist | Argues for controlled blood ozonation; records four deaths from pulmonary embolism with gas given directly into a vein [41] |
| Tylicki et al., 2004 (/research/tylicki-2004-ozone-inflammation-controlled-trial/) | Single-blind crossover, 12 people on hemodialysis | No change in CRP or IL-6 after nine ozonated sessions against nine oxygen-only sessions [42] |
| Bocci et al., 2007 (/research/bocci-2007-eboo-device-invitro/) | A new gas exchange device for EBOO, bench-tested in a buffered saline solution; no blood, no patients | Described as "very versatile and efficient," with "minimal foreign surface contact, high gas transfer, and negligible priming volume"; no numbers in the abstract [5] |
| Bocci et al., 2009 (/research/bocci-2009-ozone-paradox-review/) | Review | Describes a calibrated dose as reactivating the blood's antioxidant system [43] |
| Travagli et al., 2010 (/research/travagli-2010-dialysis-filters-ozone-transfer/) | Four dialysis filters and a gas exchanger, bench | Filter ozone yields from 0 to 70%; fibers "somewhat altered by ozone" [10] |
| Tsuzuki et al., 2016 (/research/tsuzuki-2016-ozone-horses-antioxidant/) | 10 horses | An antioxidant marker was higher at 3 and 7 days, not at 14 [44] |
| Izadi et al., 2020 (/research/izadi-2020-ozone-ms-th17-cohort/) | Case series: 20 people with multiple sclerosis, before and after | Th17 cell frequency fell [45] |
| Scassellati et al., 2020 (/research/scassellati-2020-ozone-nrf2-aging-review/) | Review with pooled biomarker analyses | Antioxidant markers shifted, with very high heterogeneity (I2 = 97%) [46] |
| Mehdi et al., 2021 (/research/mehdi-2021-hormesis-aging-review/) | Biology-of-aging review | Does not mention ozone [47] |
| Tahmasebi et al., 2021 (/research/tahmasebi-2021-ozone-ms-treg-cohort/) | Case series: 20 people with multiple sclerosis, before and after | Regulatory T cells rose [48] |
| König and Lahodny, 2022 (/research/konig-lahodny-2022-oht-mitochondrial-case-series/) | 6 people given 10-pass ozone | A blood-cell energy index improved; an author developed the method [49] |
| Skorup et al., 2022 (/research/skorup-2022-extracorporeal-ozone-ecoli-sepsis/) | A different extracorporeal ozone prototype; infected human blood and 10 septic pigs | One pass cut live E. coli by 27%; in pigs, 30 minutes of treatment changed no circulatory or bacterial measure [53] |
| Gianos et al., 2024 (/research/gianos-2024-lipoprotein-apheresis-review/) | American Heart Association statement | Calls lipoprotein apheresis "valuable but underused" for lowering LDL cholesterol and lipoprotein(a) [50] |
| Sitoe et al., 2025 (/research/sitoe-2025-ozone-grain-preservation-review/) | Food-science review | Ozone in grain storage, not medicine [51] |
| Rundgren et al., 2025 (/research/rundgren-2025-extracorporeal-ozone-pseudomonas-sepsis/) | The same prototype; 13 pigs in septic shock | One pass cut live bacteria by 53%; bacteria in the bloodstream and survival did not differ [54] |
| Clark et al., 2026 (/research/clark-2026-dialysis-membranes-review/) | Nephrology review | How dialysis membranes are classified, including newer medium cut-off membranes with larger pores [52] |

How to read the study behind any EBO2 claim

These ten checks work on any paper a clinic cites. PubMed (pubmed.ncbi.nlm.nih.gov) and Europe PMC (europepmc.org) show the same records, and both are free.

Find the paper itself. Search the title the clinic gives. If a clinic cites no paper, ask which one supports the claim. A claim with no paper behind it cannot be checked.
Check what was given. EBOO, major autohemotherapy, an injection, and an oil are different procedures. The abstract's methods sentence says which.
Read the publication type. PubMed lists it under the abstract: "Randomized Controlled Trial," "Case Reports," "Review." A review or a bench test adds no patients.
Count the people and look for a comparison group. A before-and-after change in one group cannot be told apart from what would have happened anyway. The 2005 trial is the only study of EBOO in our library with a comparison group [4].
Check what was measured. A symptom score, a lab marker in blood or urine, and a property of the device are three different things. The 2025 case measured urine [6]; the 2007 study measured gas transfer in saline [5].
Check who judged the outcome. Look for "blind" or "masked" in the methods. None of the EBOO papers we read reports blinded assessment [1][2][4][6].
Check the follow-up. A result measured the day after a session says nothing about a month later.
Check who wrote and paid for it. The affiliations line and the conflict-of-interest statement say who the authors are. Developers studying their own method, or clinicians studying their own patients, are worth noting.
Check for notices. PubMed shows lines such as "Erratum in" or "Retraction in" near the top of a record. PubMed lists none for the six EBOO studies [1][2][3][4][6][7].
Check whether anyone repeated it. Search the title words on Europe PMC, and search ClinicalTrials.gov (clinicaltrials.gov) for a registered trial. Our searches there on October 2, 2026 for "extracorporeal blood oxygenation and ozonation," "EBOO," "EBO2," "ozone dialysis," and "recirculatory hemoperfusion" each returned no study [12]. A broader search for "extracorporeal ozone" returned only injection, shockwave, oil, and autohemotherapy trials [12].

A claim and a study can share words and still not match. A claim that the filter removes heavy metals is a different statement from a paper that measured metals in one patient's urine [6].

Why people report feeling better

People who say they felt better after EBO2 are usually describing something real, and a report like that still cannot show what the procedure itself did. Symptoms that come and go tend to drift back toward their usual level, people often change diet, sleep, or supplements at the same time, and an elaborate, expensive procedure carries strong expectations. People who felt no change are also less likely to write a testimonial. The National Center for Complementary and Integrative Health puts the general point this way: evidence from research studies "is stronger and more reliable than something you've seen in an advertisement or on a website, or something someone told you about that worked for them" [14]. It suggests asking whether there is "scientific evidence (not just personal stories)" behind a claim [14].

What would change the picture

A randomized trial of EBOO with a sham or standard-care comparison, outcome assessors who do not know who was treated, a prespecified clinical outcome, and authors with no stake in the procedure would change the picture. So would a registered trial that publishes whatever it finds, or a clinic registry that tracked outcomes and harms across many patients. None of these exists in the sources we found.

What we could not verify

We could read only the abstracts of four of the six EBOO studies, because the full texts are behind publishers. Arm sizes, randomization, blinding, ozone settings, and adverse-event methods in the 2005 trial are unknown to us [4].
The developers' figure of "more than 1200 treatments performed in 82 patients" [3] appears in no patient-level paper we found.
The ozone-uptake series reports "at least 400 sessions" at the authors' clinic "with no untoward effects observed" [7]. That is the practitioners' own statement, not a systematic safety record.
We searched ClinicalTrials.gov only. We did not search the WHO trial registry platform or European registers.
Matching studies to clinic claim categories is our judgment, and the claim categories come from our reading of clinic pages, not from the clinics.
New papers are added to our library as we read them. The counts here describe the library on October 2, 2026.

How this guide was made

This guide rests on 82 sources: 79 papers listed on PubMed, the FDA's ozone regulation, an NIH page, and a ClinicalTrials.gov search we ran on October 2, 2026. The claim and testimonial figures come from our own dataset of clinic pages, as of October 4, 2026. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources. No clinical reviewer has signed off on this guide yet.

FAQ:
Q: Are there any clinical trials of EBO2?
A: One randomized trial has been published: 28 patients with peripheral artery disease given EBOO or intravenous prostacyclin, at the Siena hospital where the method was developed, reported in 2005. We could read only its abstract. On October 2, 2026, ClinicalTrials.gov listed no registered trial under EBOO, EBO2, extracorporeal blood oxygenation and ozonation, or ozone dialysis.

Q: Why do so many people say it helped them?
A: A report that someone felt better cannot separate the procedure's own effect from the natural course of symptoms, other changes made at the same time, and the expectations that come with an expensive, hour-long procedure. Only a comparison with people who did not get the procedure can do that, and EBOO has one small comparison.

Q: Does evidence for other ozone therapy apply to EBO2?
A: Not automatically. Most of the stronger ozone evidence comes from injections into joints or spinal discs and from major autohemotherapy, which mixes about 200 mL of blood with ozone in a bag. EBO2 circulates several liters through a circuit for about an hour, so the route, dose, and blood volume all differ.

Q: Who wrote the EBOO studies?
A: Four of the six papers on EBOO as given to people come from the Siena, Italy group that developed the method. The other two were written by practitioners about their own patients: a 2023 ozone-uptake series by the doctors who run the California clinic where the measurements were taken, and a 2025 case report by clinicians at a New York practice.

Q: How can I check a study a clinic cites?
A: Find it on PubMed or Europe PMC, then read the publication type, the number of participants, whether there was a comparison group, what was measured, who wrote and paid for it, and whether any notice is attached. Our ten-step checklist in this guide lists where each of those appears on the page.

Sources:
[1] Extracorporeal blood oxygenation and ozonation (EBOO) in man. preliminary report. International Journal of Artificial Organs (PubMed), 2000. https://pubmed.ncbi.nlm.nih.gov/10741810/
[2] Necrotizing fasciitis successfully treated with extracorporeal blood oxygenation and ozonization (EBOO). International Journal of Artificial Organs (PubMed), 2002. https://pubmed.ncbi.nlm.nih.gov/12518965/
[3] Extracorporeal blood oxygenation and ozonation: clinical and biological implications of ozone therapy. Redox Report (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16156950/
[4] Extracorporeal blood oxygenation and ozonation (EBOO): a controlled trial in patients with peripheral artery disease. International Journal of Artificial Organs (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16288443/
[5] Oxygenation-ozonation of blood during extracorporeal circulation: in vitro efficiency of a new gas exchange device. Artificial Organs (PubMed), 2007. https://pubmed.ncbi.nlm.nih.gov/17725702/
[6] Observed Reduction in Urinary Toxin Excretion With Extracorporeal Blood Oxygenation and Ozonation (EBOO) Treatment in an 88-Year-Old With Chronic Anemia: A Case Report. Cureus (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/41583215/
[7] Ozone dialysis delivers three or more times the ozone than other forms of ozone blood treatment. Medical Gas Research (PubMed), 2023. https://pubmed.ncbi.nlm.nih.gov/36204785/
[8] Ozonation of blood during extracorporeal circulation. I. Rationale, methodology and preliminary studies. International Journal of Artificial Organs (PubMed), 1999. https://pubmed.ncbi.nlm.nih.gov/10532435/
[9] Ozonation of blood during extracorporeal circulation. II. Comparative analysis of several oxygenator-ozonators and selection of one type. International Journal of Artificial Organs (PubMed), 2001. https://pubmed.ncbi.nlm.nih.gov/11831595/
[10] Are dialysis devices usable as ozone gas exchangers?. Artificial Organs (PubMed), 2010. https://pubmed.ncbi.nlm.nih.gov/19817737/
[11] Oxygen/ozone as a medical gas mixture. A critical evaluation of the various methods clarifies positive and negative aspects. Medical Gas Research (PubMed), 2011. https://pubmed.ncbi.nlm.nih.gov/22146387/
[12] ClinicalTrials.gov search: extracorporeal blood oxygenation and ozonation. U.S. National Library of Medicine, 2026. https://clinicaltrials.gov/search?term=extracorporeal%20blood%20oxygenation%20and%20ozonation
[13] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[14] Are You Considering a Complementary Health Approach?. National Center for Complementary and Integrative Health (NIH), 2016. https://www.nccih.nih.gov/health/are-you-considering-a-complementary-health-approach
[15] Ozone therapy: a clinical review. Journal of Natural Science, Biology, and Medicine (PubMed), 2011. https://pubmed.ncbi.nlm.nih.gov/22470237/
[16] Effects of major ozonated autohemotherapy in the treatment of dry age related macular degeneration: a randomized controlled clinical study. International Journal of Ophthalmology (PubMed), 2012. https://pubmed.ncbi.nlm.nih.gov/23275905/
[17] Ozone therapy as a treatment for low back pain secondary to herniated disc: a systematic review and meta-analysis of randomized controlled trials. Pain Physician (PubMed), 2012. https://pubmed.ncbi.nlm.nih.gov/22430658/
[18] Sports massage with ozonised oil or non-ozonised oil: comparative effects on recovery parameters after maximal effort in cyclists. Physical Therapy in Sport (PubMed), 2013. https://pubmed.ncbi.nlm.nih.gov/23623301/
[19] Ozone therapy for treating foot ulcers in people with diabetes. Cochrane Database of Systematic Reviews (PubMed), 2015. https://pubmed.ncbi.nlm.nih.gov/26505864/
[20] Therapeutic Effect of Medical Ozone on Lumbar Disc Herniation. Medical Science Monitor (PubMed), 2018. https://pubmed.ncbi.nlm.nih.gov/29611536/
[21] Ozone and oxidation therapies as a solution to the emerging crisis in infectious disease management: a review of current knowledge and experience. Medical Gas Research (PubMed), 2019. https://pubmed.ncbi.nlm.nih.gov/31898609/
[22] Fatigue in post-acute sequelae of SARS-CoV2 (PASC) treated with oxygen-ozone autohemotherapy, preliminary results on 100 patients. European Review for Medical and Pharmacological Sciences (PubMed), 2021. https://pubmed.ncbi.nlm.nih.gov/34604980/
[23] Sjögren syndrome successfully treated with oxygen-ozone auto-hemotherapy (O2-O3-AHT). A case report. European Review for Medical and Pharmacological Sciences (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/36066166/
[24] A systematic review of ozone therapy for treating chronically refractory wounds and ulcers. International Wound Journal (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/34612569/
[25] Clinical effectiveness of medical ozone therapy in COVID-19: the evidence and gaps map. Medical Gas Research (PubMed), 2023. https://pubmed.ncbi.nlm.nih.gov/37077114/
[26] A pilot randomized controlled trial of major ozone autohemotherapy for patients with post-acute sequelae of COVID-19. International Immunopharmacology (PubMed), 2024. https://pubmed.ncbi.nlm.nih.gov/39018686/
[27] Intra-articular injections of ozone versus hyaluronic acid for knee osteoarthritis: a level I meta-analysis. European Journal of Orthopaedic Surgery & Traumatology (PubMed), 2024. https://pubmed.ncbi.nlm.nih.gov/39579218/
[28] SIOOT recommendations for the optimal application of the oxygen-ozone therapy in clinical medicine. International Immunopharmacology (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/39657536/
[29] Efficacy of major ozone autohemotherapy in patients with post-COVID syndrome. Frontiers in Medicine (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/41767530/
[30] Ozone: a possible cause of hemolytic anemia in glucose-6-phosphate dehydrogenase deficient individuals. Journal of Toxicology and Environmental Health (PubMed), 1977. https://pubmed.ncbi.nlm.nih.gov/846014/
[31] Health effects of ozone. A critical review. JAPCA (Journal of the Air Pollution Control Association) (PubMed), 1989. https://pubmed.ncbi.nlm.nih.gov/2659744/
[32] Transient cortical blindness after intradiscal oxygen-ozone therapy. Indian Journal of Ophthalmology (PubMed), 2016. https://pubmed.ncbi.nlm.nih.gov/28112142/
[33] Ozone therapy induced sinus arrest in a hypertensive patient with chronic kidney disease: A case report. Medicine, Baltimore (PubMed), 2017. https://pubmed.ncbi.nlm.nih.gov/29390373/
[34] A Case of Paradoxical Embolism Causing Anterior Spinal Cord Syndrome and Acute Myocardial Infarction Following the Intradiscal Oxygen-Ozone Therapy. Frontiers in Neurology (PubMed), 2019. https://pubmed.ncbi.nlm.nih.gov/30853936/
[35] Combining Ozonated Autohemotherapy with Pharmacological Therapy for Comorbid Insomnia and Myofascial Pain Syndrome: A Prospective Randomized Controlled Study. Pain Research & Management (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/37214227/
[36] Associations between particulate matter air pollutants and hospitalization risk for systemic lupus erythematosus: a time-series study from Xi'an, China. Environmental Geochemistry and Health (PubMed), 2023. https://pubmed.ncbi.nlm.nih.gov/36287357/
[37] Cerebral gas embolism and multifocal ischemic stroke during oxygen-ozone therapy: a case report. BMJ Neurology Open (PubMed), 2024. https://pubmed.ncbi.nlm.nih.gov/39720509/
[38] Ozone-Induced Encephalopathy Following Subcutaneous Ozone Injection: A Case Report. Cureus (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/41492606/
[39] Ozone therapy-associated pneumoperitoneum in a patient with low back pain: A case report. International Journal of Surgery Case Reports (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/40233642/
[40] Neurological Crisis Following Intravenous Ozone Therapy; a Case Report. Archives of Academic Emergency Medicine (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/40027218/
[41] Ozone as Janus: this controversial gas can be either toxic or medically useful. Mediators of Inflammation (PubMed), 2004. https://pubmed.ncbi.nlm.nih.gov/15203558/
[42] No effects of ozonated autohemotherapy on inflammation response in hemodialyzed patients. Mediators of Inflammation (PubMed), 2004. https://pubmed.ncbi.nlm.nih.gov/15770057/
[43] The ozone paradox: ozone is a strong oxidant as well as a medical drug. Medicinal Research Reviews (PubMed), 2009. https://pubmed.ncbi.nlm.nih.gov/19260079/
[44] Effects of ozonated autohemotherapy on the antioxidant capacity of Thoroughbred horses. Journal of Veterinary Medical Science (PubMed), 2016. https://pubmed.ncbi.nlm.nih.gov/26166812/
[45] Changes in Th17 cells frequency and function after ozone therapy used to treat multiple sclerosis patients. Multiple Sclerosis and Related Disorders (PubMed), 2020. https://pubmed.ncbi.nlm.nih.gov/32862036/
[46] Ozone: a natural bioactive molecule with antioxidant property as potential new strategy in aging and in neurodegenerative disorders. Ageing Research Reviews (PubMed), 2020. https://pubmed.ncbi.nlm.nih.gov/32810649/
[47] Oxidative stress, antioxidants, hormesis and calorie restriction: the current perspective in the biology of aging. Archives of Gerontology and Geriatrics (PubMed), 2021. https://pubmed.ncbi.nlm.nih.gov/33845417/
[48] The effects of oxygen-ozone therapy on regulatory T-cell responses in multiple sclerosis patients. Cell Biology International (PubMed), 2021. https://pubmed.ncbi.nlm.nih.gov/33724614/
[49] Ozone high dose therapy (OHT) improves mitochondrial bioenergetics in peripheral blood mononuclear cells. Translational Medicine Communications (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/35880042/
[50] Lipoprotein apheresis: utility, outcomes, and implementation in clinical practice: a scientific statement from the American Heart Association. Arteriosclerosis, Thrombosis, and Vascular Biology (PubMed), 2024. https://pubmed.ncbi.nlm.nih.gov/39370995/
[51] Advances in ozone technology for preservation of grains and end products. Comprehensive Reviews in Food Science and Food Safety (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/40260769/
[52] Dialysis membranes and hemodialyzers. Contributions to Nephrology (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42721103/
[53] Evaluation of an extracorporeal ozone-based bactericide system for the treatment of Escherichia coli sepsis. Intensive Care Medicine Experimental (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/35467176/
[54] Immunomodulation by extracorporeal ozone-based bactericide system in porcine Pseudomonas aeruginosa septic shock. Scientific Reports (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/40562794/
[55] Cardiopulmonary Arrest and Pneumoencephaly Developing after Epidural Oxygen-ozone Mixture Therapy. Anesthesia, Essays and Researches (PubMed), 2018. https://pubmed.ncbi.nlm.nih.gov/29628600/
[56] Mycobacterium tuberculosis Infection of the Spine Secondary to Oxygen - Ozone Therapy for Prolapse Intervertebral Disc: A Scoping Review. Journal of Orthopaedic Case Reports (PubMed), 2021. https://pubmed.ncbi.nlm.nih.gov/35437492/
[57] Mycobacterium abscessus mimicking tubercular spondylodiscitis following ozone therapy: A case report and review of literature. Surgical Neurology International (PubMed), 2020. https://pubmed.ncbi.nlm.nih.gov/32363058/
[58] Spondylodiscitis Following Oxygen-Ozone Therapy: A Case Report of Lactobacillus iners Infection and a Systematic Literature Review. Diseases, Basel (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/41892016/
[59] Acute bilateral vitreo-retinal hemorrhages following oxygen-ozone therapy for lumbar disk herniation. American Journal of Ophthalmology (PubMed), 2004. https://pubmed.ncbi.nlm.nih.gov/15234314/
[60] A case of vertebrobasilar stroke during oxygen-ozone therapy. Journal of Stroke and Cerebrovascular Diseases (PubMed), 2004. https://pubmed.ncbi.nlm.nih.gov/17903984/
[61] Fulminating septicemia secondary to oxygen-ozone therapy for lumbar disc herniation: case report. Spine (PubMed), 2007. https://pubmed.ncbi.nlm.nih.gov/17268255/
[62] Cervical Spondylodiscitis After Oxygen-Ozone Therapy for Treatment of a Cervical Disc Herniation: a Case Report and Review of the Literature. HSS Journal (PubMed), 2016. https://pubmed.ncbi.nlm.nih.gov/27703423/
[63] Intraforaminal ozone therapy and particular side effects: preliminary results and early warning. Acta Neurochirurgica (PubMed), 2016. https://pubmed.ncbi.nlm.nih.gov/26293228/
[64] Multifocal Stroke From Ozone Gas Emboli. Journal of Neuro-Ophthalmology (PubMed), 2019. https://pubmed.ncbi.nlm.nih.gov/30741783/
[65] Suspected Pulmonary Embolism after Oxygen-Ozone Therapy for Low Back Pain. Journal of Neurological Surgery Part A: Central European Neurosurgery (PubMed), 2019. https://pubmed.ncbi.nlm.nih.gov/31430795/
[66] Ozone-induced encephalopathy: A novel iatrogenic entity. European Journal of Neurology (PubMed), 2021. https://pubmed.ncbi.nlm.nih.gov/33657263/
[67] Simultaneous pneumocephalus and meningitis as a complication of ozone therapy. Northern Clinics of Istanbul (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42516792/
[68] An unexpected death during oxygen-ozone therapy. American Journal of Forensic Medicine and Pathology (PubMed), 2000. https://pubmed.ncbi.nlm.nih.gov/10871129/
[69] A cluster of hepatitis C virus infections associated with ozone-enriched transfusion of autologous blood in Rome, Italy. Infection Control and Hospital Epidemiology (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16209382/
[70] Myocardial Infarction after Ozone Therapy: Is Ozone Therapy Dr. Jekyll or Mr. Hyde?. Cardiology (PubMed), 2015. https://pubmed.ncbi.nlm.nih.gov/26139204/
[71] A Non-ST Elevation Myocardial Infarction Associated with Alternative Medicine Ozone Infusion. Journal of Emergency Medicine (PubMed), 2020. https://pubmed.ncbi.nlm.nih.gov/31708316/
[72] Hyperbaric Oxygen Treatment for Arterial Gas Embolism With Transient Cortical Blindness Following Intravenous Ozone Therapy: A Case Report. Undersea & Hyperbaric Medicine (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42365944/
[73] Pitfalls of Intralesional Ozone Injection in Diabetic Foot Ulcers: A Case Study. Journal of the American College of Clinical Wound Specialists (PubMed), 2012. https://pubmed.ncbi.nlm.nih.gov/26199878/
[74] Septic Arthritis of the Shoulder Following Ozone Therapy: A Case Report. Cureus (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/41728388/
[75] A metaanalysis of the effectiveness and safety of ozone treatments for herniated lumbar discs. Journal of Vascular and Interventional Radiology (PubMed), 2010. https://pubmed.ncbi.nlm.nih.gov/20188591/
[76] Safety, pitfalls, and misunderstandings about the use of ozone therapy as a regenerative medicine tool. A narrative review. Journal of Biological Regulators and Homeostatic Agents (PubMed), 2020. https://pubmed.ncbi.nlm.nih.gov/33176412/
[77] Medical Ozone as a Therapeutic Option in Musculoskeletal Pain Control: A Critical Review of Clinical Trials Considering Safety and Quality Indicators for Procedures and Devices. Yale Journal of Biology and Medicine (PubMed), 2024. https://pubmed.ncbi.nlm.nih.gov/39351322/
[78] How Safe Are Oxygen-Ozone Therapy Procedures for Spine Disc Herniation? The SIOOT Protocols for Treating Spine Disorders. Journal of Imaging (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/41440568/
[79] Haemolysis Generated with the Use of Glass Bottles Instead of PVC, DEHP-Free Blood Collection Bags in the Oxygen-Ozone Therapy. Maedica (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/40880716/
[80] Effectiveness and Safety of Ozone Therapy in Humans: An Umbrella Review of Systematic Reviews with Meta-Analyses of Randomized Clinical Trials. Medical Sciences (Basel) (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42346828/
[81] Oxygen-ozone autohaemotherapy in fibromyalgia: safety profile and adverse events. A scoping review. Clinical and Experimental Rheumatology (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42328943/
[82] Plasmapheresis combined with cell mass ozonation in endogenous uveitis treatment. Vestnik Oftalmologii (PubMed), 2011. https://pubmed.ncbi.nlm.nih.gov/22442992/

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# EBO2 (EBOO) and Cancer Claims: What Regulators and Cancer Bodies Say

Source: https://ebo2.com/guides/eboo-cancer-claims/
Updated: 2026-10-08

Key takeaways:
- Our research library holds no study of EBO2, or EBOO, given to people with cancer. An exact-phrase search of Europe PMC on October 2, 2026 returned 14 records for the procedure's full name, none of them a cancer study.
- Brazil's Federal Council of Medicine expressly bars ozone therapy for neoplastic wounds at any stage outside formally approved clinical research.
- The American Cancer Society, writing in its own journal, recommended that people with cancer not seek treatment from anyone promoting hyperoxygenation therapy, the family of claims that includes ozone, as an alternative.
- As of October 4, 2026, 22 of the 174 clinic EBO2 pages we could read state a cancer-related benefit, more often worded as support alongside conventional treatment than as treatment itself.

If a clinic has raised EBO2 (also called EBOO) with you or someone you love in connection with cancer, this page sets out the record so you can read it yourself: what our research library holds, how to repeat the literature search in a minute, what regulators and cancer organizations have actually written, and what to ask an oncologist. It is not medical advice, it cannot tell you anything about a particular cancer, and nothing here should be used to change or delay treatment. Its job is to make sure a decision about an expensive elective procedure is made from documents rather than from a sales page.

The answer first

There is no published study of EBO2 in people with cancer. Our library holds none, and the literature search below, which you can run yourself in under a minute, returns none. Several regulators and professional bodies have written about ozone therapy in connection with cancer, and every one of them has written against it. The clinics selling it are not citing trials, because there are none to cite.

What the literature search returns, and how to run it yourself

This is a check you can do without taking our word for anything.

Open europepmc.org, the European Bioinformatics Institute's free index of biomedical literature.
Search for the procedure's full name as an exact phrase, in quotation marks: "extracorporeal blood oxygenation and ozonation".
Read the titles.

On October 2, 2026 that search returned 14 records [12]. They cover a controlled trial in peripheral artery disease [11], a preliminary report of the method in people, a necrotizing fasciitis case, reviews of ozone in wounds and in musculoskeletal medicine, a 12-patient case series measuring ozone uptake during ozone dialysis, ozone sensor technology, and a 2025 case report on urinary toxin excretion. None is a study of people with cancer. Widening the search to combine the procedure's name with cancer terms adds records that mention cancer in passing inside general ozone reviews, not studies of the procedure in cancer.

The same holds in our own library, which annotates every study we hold with its design, population, and outcomes. No entry records EBO2, or any other ozone method, given to people with cancer. The block below lists every EBOO study we hold with the procedure parameters each one reports; reading down the "who" column is the fastest way to see what this literature is and is not about.

What the EBOO literature is actually about

The published EBOO record is small and concerns circulation and wounds. Its one controlled trial randomized 28 patients with peripheral artery disease to EBOO or to intravenous prostacyclin and reported on skin lesions, pain, and wellbeing [11]. The rest is a preliminary report in a small number of people, single-patient case reports, a series that measured ozone uptake in 12 patients, a review by the method's developers, and a laboratory test of their device. Study sizes are in the single or low double digits, follow-up is short, and the outcomes are blood markers, wound healing, or symptoms.

One line in that preliminary report is worth heading off, because it is the only growth-related observation in the entire EBOO literature. The 2000 paper describing the first human use of the apparatus records that an author who volunteered to test the system noted the disappearance of two lipomas after six treatments [13]. A lipoma is a benign fatty lump, not a cancer; the observation is one person reporting on himself, with no imaging protocol, control, or follow-up described. It is not evidence about tumours, and anyone who offers it as such is misreading it.

That matters for a cancer conversation in a specific way. When a page says the procedure is "backed by research", the research being gestured at is this: a handful of small reports about blood flow and wounds, from one group, mostly more than twenty years old. Transferring a result about leg circulation to a claim about cancer requires evidence that does not exist, in either direction.

What clinic pages say, in the aggregate

Our directory records what each clinic states about EBO2 on its own site, with the quote and the page, and we publish evaluative categories only as totals. As of October 4, 2026, of the 174 clinics whose EBO2 page we could read, 22 state a cancer-related benefit. That is the least common of the ten claim categories we record, well behind detoxification, energy, infections, and autoimmune conditions; the block below gives every category against the same denominator.

The wording in that category is worth understanding, because it is mostly not a direct treatment claim. The patterns are: listing cancer among the conditions the procedure is used for; offering it as support alongside conventional cancer care or after chemotherapy, in one case packaged with other infusions in a named cancer-support bundle; and, less often than the support wording, asserting that it improves how well chemotherapy works or acts on tumour cells. The last of these is the strongest kind of claim and the one with nothing behind it. We name no clinic in connection with any of this. The counts and the underlying quotes sit in our clinic directory (/clinics/) and our data downloads so that anyone can audit them.

Two pieces of context belong next to that count. Ozone therapy is not FDA-approved for any medical use, and the federal device labeling rule states that ozone "is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [8]. The word "adjunctive" in that sentence is the one that covers support alongside another treatment.

What regulators and professional bodies have written

Quoted exactly, oldest first.

| Who, when | What it concerned | The wording |
|---|---|---|
| FDA and FTC, 6 May 2020 | A clinic's website claims, including that ozone destroys viruses | The joint warning letter lists claims "that are not supported by competent and reliable scientific evidence" and directs the firm to stop them [10] |
| Department of Justice, 24 April 2020 | COVID-19 claims by a Dallas ozone therapy centre | A federal court entered an agreed permanent injunction against the centre and one of its principals, barring them from representing that ozone could be used to treat COVID-19; DOJ's release notes that the complaint's claims were allegations [9] |
| Health Canada, 2 November 2022 | Ozone saunas advertised for uses including treating cancer | The advisory states, "To date, Health Canada has not received any submissions with evidence to support medical treatment claims for ozone saunas" [7] |
| Federal Council of Medicine, Brazil, 21 August 2025 | Which uses of ozone therapy doctors may offer | Resolution 2.445/2025 states, "Fica expressamente vedada a utilização de ozonioterapia para o tratamento de feridas neoplásicas em qualquer estágio, exceto em contexto de pesquisa clínica formalmente aprovada": use of ozone therapy on neoplastic wounds at any stage is expressly barred, except within formally approved clinical research [6] |

Brazil's resolution is the most pointed of these, because it comes from a country that does authorize ozone therapy. The same document permits it as an adjuvant for specified wounds, knee osteoarthritis, and disc-related low back pain, and then carves cancer out explicitly [6]. A regulator that was prepared to allow the therapy for several conditions was not prepared to allow it here.

What the cancer organizations say

The National Cancer Institute publishes evidence-based summaries, called PDQ summaries, on individual integrative, alternative, and complementary therapies, from acupuncture and cannabis to intravenous vitamin C, mistletoe, and a list of older topics it no longer updates. When we read that list on October 2, 2026, it contained no summary for ozone therapy or for any blood-ozonation procedure [1]. Absence from a list is not a verdict, and we do not present it as one. What the same page does say, as a general statement, is that although claims by providers of these treatments "can sound promising, we do not know how safe many CAM treatments are or how well they work", and that "Some CAM therapies may interfere with standard treatment or even be harmful" [1].

The American Cancer Society has addressed this family of claims directly. Writing in its own journal, CA: A Cancer Journal for Clinicians, in 1993, it reviewed "hyperoxygenation" therapy, the umbrella term for treatments premised on the idea that cancer is caused by a lack of oxygen and can be addressed by exposing cells to more of it. The review names hydrogen peroxide, germanium sesquioxide, and ozone as the most promoted agents, describes the underlying concept as erroneous, and states that "there is little or no evidence that they are effective for the treatment of any serious disease, and each has demonstrated potential for harm". Its recommendation is that people with cancer not seek treatment from anyone promoting any form of hyperoxygenation therapy as an alternative [3]. That paper is more than thirty years old, which we note rather than hide: it is the Society's published position on this specific family of claims, and we found no later statement from it reversing that position.

The Society's current patient material, written with the American Society of Clinical Oncology, draws the distinction that matters most in practice. Integrative therapies are used alongside standard treatment; alternative therapies are used instead of it. On the second, it states: "Research has shown that people who use alternative methods instead of standard cancer treatment for the most common curable cancers have a greater risk of dying from their cancer" [2]. The NIH's complementary health centre makes the related point about delay, warning that fraudulent cancer treatments can be harmful in themselves and can also be indirectly harmful "because people may delay seeking medical care while they try them" [4].

How to read a cancer claim on any website

The FDA publishes a list of phrases it treats as red flags in cancer product marketing, drawn from its enforcement experience. Among them: "Treats all forms of cancer", "Shrinks malignant tumors", "Selectively kills cancer cells", "More effective than chemotherapy", and "Attacks cancer cells, leaving healthy cells intact" [5]. The FDA's own framing is that legitimate drugs and devices intended to treat cancer must gain its approval or clearance before they are marketed and sold, and that products outside that process may appear harmless but can cause harm by delaying or interfering with treatments that work [5].

Beyond the vocabulary, five checks work on any page, for any treatment.

Find the claim's subject. Is the page saying the procedure treats cancer, helps with the side effects of treatment, or makes another treatment work better? Each is a different claim needing different evidence.
Ask what is cited. A named, dated study with a link is a citation. A phrase such as "studies show" or a reference to a general mechanism is not.
Check the population in any study that is cited. Cells in a dish, mice, or healthy volunteers do not answer a question about people with cancer.
Check the route. Rectal, intramuscular, topical, intradiscal, and blood-circuit ozone are different treatments. A result for one is not a result for another.
Look for the word "adjunct" or "support" doing quiet work. It usually marks the point where a page retreats from a claim it cannot support while keeping the impression of one.

Our guide to what the evidence shows (/guides/does-ebo2-work/) applies the same checks to the whole EBO2 literature, our guide to FDA status (/guides/is-ebo2-fda-approved/) explains why "FDA-registered equipment" on a clinic page is not an approval of anything, and our record of ozone adverse events by route (/guides/ozone-therapy-adverse-events/) collects what has been reported when ozone procedures have gone wrong.

Questions to bring to an oncologist

Here is what the clinic says, in writing: does any part of it affect my treatment plan, my timing, or my eligibility for a trial?
Could a procedure that circulates and filters my blood interact with my chemotherapy, immunotherapy, or radiotherapy schedule, with my blood counts, or with a central line or port?
I have low platelets or I am on an anticoagulant: what does that mean for a procedure that requires anticoagulation of an external circuit?
If my goal is the symptom this clinic is addressing, fatigue, pain, neuropathy, or appetite, what supportive-care options with evidence behind them are available to me here?
Are there clinical trials I should be considering, and would having this procedure affect whether I could join one?
If I decide to go ahead anyway, what would you want to know about it, and what would you monitor?

Some patients take the clinic's own page, printed, to that appointment. The transparency block below shows how many clinics say who supervises a session or describe any screening before a first one. The questions-to-ask tool (/tools/doctor-questions/) builds a printable list, and our clinic directory (/clinics/) shows what each listed clinic publishes about its service.

What we could not verify

Whether EBO2 has any effect, good or bad, in people with cancer. No study exists either way, and this guide makes no claim about it.
Whether a study exists that our searches did not reach: one not indexed in Europe PMC, published in a language or venue outside it, or described by a name we did not search. We searched the full phrase and the abbreviations on October 2, 2026 and have given the search so it can be repeated.
Whether the American Cancer Society has published a more recent statement on ozone or hyperoxygenation than its 1993 journal review. We found none on its current patient pages, and its current material addresses integrative and alternative medicine in general rather than ozone by name.
What each of the 22 clinics in the cancer count means clinically. We recorded what their pages state, with the quote and the page; we did not ask them, and we do not evaluate individual clinics.
Whether any of the regulatory records above has been appealed, amended, or superseded since we read them on September 28, 2026. The regulatory tracker (/reports/regulatory-tracker/) carries the status we recorded for each.
Whether interactions exist between blood ozonation and cancer treatments. The question has not been studied, so neither safety nor harm has been shown; that is an open question, not a reassurance.

How this guide was made

This guide draws on 14 sources: nine primary regulatory and government records, three peer-reviewed papers, one patient-information page published by a cancer organization, and one literature-database search, which is reproduced above so it can be repeated. The claim counts come from our own directory of 177 US clinics, read between September 28, 2026 and October 4, 2026, with the denominator of 174 readable EBO2 pages stated wherever a count appears; the blocks below are computed from that dataset and our study library when the page is built. The literature searches were run on October 2, 2026. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources. No clinical reviewer has signed off on this page yet, and given the subject it should be read as a compilation of sources rather than as clinical guidance.

FAQ:
Q: Is there any study of EBO2 in people with cancer?
A: We have not found one, and we looked in a way you can repeat. Searching Europe PMC for the exact phrase "extracorporeal blood oxygenation and ozonation" on October 2, 2026 returned 14 records. They concern peripheral artery disease, a necrotizing fasciitis case, wound and musculoskeletal reviews, ozone delivery and sensor technology, and a case report on urinary toxin excretion. None reports the procedure given to people with cancer. Our own library holds no such study either.

Q: Clinics describe it as support alongside chemotherapy, not as a cancer treatment. Does that change anything?
A: It changes the wording, not the evidence. A supportive-care claim is still a claim about an outcome in people with cancer, and it would need the same kind of evidence: a controlled trial with a prespecified outcome such as symptom burden, treatment tolerance, or quality of life. We found no such trial of EBO2. There is also a specific risk in this framing, because a procedure given alongside cancer treatment can interact with it, and that interaction has not been studied either.

Q: What do the major cancer organizations say about ozone or oxygen therapies?
A: The National Cancer Institute's list of evidence-based summaries on integrative, alternative, and complementary therapies contained no summary for ozone therapy when we read it on October 2, 2026. The American Cancer Society, writing in its journal CA: A Cancer Journal for Clinicians in 1993, concluded of hydrogen peroxide, germanium sesquioxide, and ozone that there is little or no evidence that they are effective for treating any serious disease and that each has shown potential for harm.

Q: Has any regulator acted on ozone therapy and cancer specifically?
A: Yes. Brazil's Federal Council of Medicine resolution of August 21, 2025 expressly bars ozone therapy for neoplastic wounds at any stage except within formally approved clinical research. Health Canada's 2022 advisory on ozone saunas listed treating cancer among the advertised uses and said no evidence had been submitted to support medical treatment claims for those devices.

Q: What is this page for?
A: It sets out the actual wording of the record, so that a conversation about an expensive elective procedure can start from documents rather than from a sales page. It is not medical advice and cannot say anything about a specific cancer. Some patients and families take it, with the clinic's own page, to the oncology team treating them; the questions at the end of this guide are the kind an oncology team can answer.

Sources:
[1] Complementary and Alternative Medicine for Patients. National Cancer Institute (NCI), 2026. https://www.cancer.gov/about-cancer/treatment/cam/patient
[2] Understanding Integrative (Holistic) Medicine. American Cancer Society, with medical review by the American Society of Clinical Oncology, 2025. https://www.cancer.org/cancer/managing-cancer/treatment-types/complementary-and-integrative-medicine.html
[3] Questionable methods of cancer management: hydrogen peroxide and other 'hyperoxygenation' therapies. CA: A Cancer Journal for Clinicians (PubMed), 1993. https://pubmed.ncbi.nlm.nih.gov/8422605/
[4] Cancer and Complementary Health Approaches: What You Need To Know. National Center for Complementary and Integrative Health (NCCIH), NIH, 2021. https://www.nccih.nih.gov/health/cancer-and-complementary-health-approaches-what-you-need-to-know
[5] Products Claiming to Cure Cancer Are a Cruel Deception. FDA, Office of the Commissioner, 2020. https://www.fda.gov/consumers/consumer-updates/products-claiming-cure-cancer-are-cruel-deception
[6] Resolução CFM n° 2.445, de 21 de agosto de 2025. Conselho Federal de Medicina (CFM), Brazil, 2025. https://sistemas.cfm.org.br/normas/arquivos/resolucoes/BR/2025/2445_2025.pdf
[7] Unlicensed ozone saunas may pose serious health risks to users and anyone in close proximity. Health Canada, 2022. https://recalls-rappels.canada.ca/en/alert-recall/unlicensed-ozone-saunas-may-pose-serious-health-risks-users-and-anyone-close-proximity
[8] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[9] Court Prohibits Dallas Health Center from Touting Ozone Therapy as a COVID-19 Treatment. U.S. Department of Justice, Office of Public Affairs, 2020. https://www.justice.gov/archives/opa/pr/court-prohibits-dallas-health-center-touting-ozone-therapy-covid-19-treatment
[10] Warning letter to Center for New Medicine/Perfectly Healthy by Connealy MD (MARCS-CMS 605804). FDA and Federal Trade Commission, 2020. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/center-new-medicineperfectly-healthy-connealy-md-605804-05112020
[11] Extracorporeal blood oxygenation and ozonation (EBOO): a controlled trial in patients with peripheral artery disease. International Journal of Artificial Organs (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16288443/
[12] Europe PMC literature search: "extracorporeal blood oxygenation and ozonation". Europe PMC, European Bioinformatics Institute, 2026. https://europepmc.org/search?query=%22extracorporeal%20blood%20oxygenation%20and%20ozonation%22
[13] Extracorporeal blood oxygenation and ozonation (EBOO) in man. Preliminary report. International Journal of Artificial Organs (PubMed), 2000. https://pubmed.ncbi.nlm.nih.gov/10741810/

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# EBO2 (EBOO) Around the World: What Regulators Outside the US Have Said

Source: https://ebo2.com/guides/eboo-around-the-world/
Updated: 2026-10-03

Key takeaways:
- None of the regulators' documents we hold from Italy, Germany, Brazil, the United Kingdom, Canada, or Australia approves EBOO; the only one that names it, Germany's 2001 insurance review, judged the first EBOO study in patients unsuitable as evidence of efficacy.
- Germany has excluded ozone therapy, including ozone autohemotherapy, from statutory health insurance since March 2001; the exclusion is still listed in the version of the rule amended in March 2026.
- Brazil allows ozone therapy only as a complementary procedure, and its medical council and health regulator list specific wound, joint, spine, skin, and dental uses; no blood route is among them.
- Italy's Health Ministry relayed in 2005 its advisory council's view that no controlled studies supported oxygen-ozone therapy, and Tuscany, where EBOO was developed, has said that apart from a doctor acting on his or her own responsibility it belongs only in controlled clinical trials.
- The UK, Canadian, and Australian documents are an advertising ruling, a device advisory about ozone saunas, and orders against two clinics; each is about specific claims, products, or providers, not a ruling on the technique.

EBO2 (also called EBOO) is not approved by any regulator whose documents we hold, in the United States or anywhere else. In the US, ozone therapy is not FDA-approved for any condition [1]. Outside the US, we hold primary documents from Italy, Germany, Brazil, the United Kingdom, Canada, and Australia. None of them approves EBOO, and only one names it: a German insurance review from 2001 that judged the first EBOO study in patients unsuitable as evidence of efficacy [2][3][4][5][6][7]. This guide sets out what each says, with the original words and our English rendering, and what kind of document each one is, so that a claim of approval abroad can be checked against the document itself. Our guide on FDA status (/guides/is-ebo2-fda-approved/) covers the United States.

What kind of document each one is

A foreign document can matter a great deal or very little, depending on what kind of decision it records. A warning to one advertiser or one clinic is not a ruling on the technique.

| Kind of document | Examples below | What it can tell you | What it cannot tell you |
| --- | --- | --- | --- |
| A law or national regulation | Brazil's 2023 law [8] | The conditions under which the practice is allowed at all | That it works, or that any device is approved |
| A professional council's rule | Brazil's medical council, 2025 [4] | Which uses and routes a licensed doctor may offer | Anything about other professions or other countries |
| A health ministry or regional opinion | Italy's Health Ministry, 2005; Tuscany, 2006 to 2018 [2][9] | The official view of the evidence and where the practice belongs | A ban, unless a law says so; the 2005 circular calls an earlier note not legally binding [2] |
| An insurance coverage rule | Germany's statutory health insurance, 2001 to 2026 [10] | Whether public insurance pays | Whether a doctor may offer it privately |
| A device regulator's note or advisory | Brazil's Anvisa, 2026; Health Canada, 2022 [11][6] | Which device uses are recognized and licensed | What doctors may do with devices; Health Canada says that is regulated by provinces [6] |
| An advertising ruling | The UK's ASA, 2022 [5] | Whether one advertiser's claims were backed by evidence | Whether the treatment may be offered |
| An order against one provider | New South Wales, 2024 and 2025 [12][7] | What one regulator found at one clinic | A ruling on the technique as others practice it |

The documents side by side

Each quotation below is copied exactly from the document. Where the original is not in English, the translation that follows it is ours. Status is as we found it on October 2, 2026.

| Country | Body and date | The document's words, then our translation | Kind of document | Status |
| --- | --- | --- | --- | --- |
| Italy | Health Ministry, relaying the Superior Health Council, January 20, 2005 [2] | "a suo giudizio, non sono oggi disponibili studi clinici controllati a supporto dell'efficacia della OOT, e che questa metodica può causare effetti collaterali gravi e potenzialmente letali." Our translation: "in its judgment, no controlled clinical studies supporting the efficacy of OOT [oxygen-ozone therapy] are available today, and that this method can cause serious and potentially lethal side effects." | Ministry circular to the regions | Still cited by Tuscany in 2018 [13]; we have not found a later ministry document replacing it |
| Italy (Tuscany) | Regional Health Council, September 5, 2006 [9] | "Non esiste alcuna indicazione per altre affezioni." Our translation: "There is no indication for any other condition." (The opinion's only indication is symptomatic disc herniation, treated by injection.) | Regional advisory opinion | Cited in the region's 2018 decision [14] |
| Italy (Tuscany) | Regional Health Council, March 6, 2007 [15] | "le attività di ossigeno-ozono terapia sono possibili solo in regime di sperimentazione clinica controllata" Our translation: "oxygen-ozone therapy activities are possible only within controlled clinical trials" (apart from a doctor acting on his or her own responsibility) | Regional advisory opinion | Cited in the region's 2018 decision [14] |
| Italy (Tuscany) | Regional Health Council, November 3, 2015 [16] | "Questa pratica, di dubbia efficacia clinica, non rientra a nessun titolo nelle attività trasfusionali." Our translation: "This practice, of doubtful clinical efficacy, does not in any respect fall within transfusion activities." (The practice is autohemotherapy with added ozone and oxygen.) | Regional advisory opinion | Cited in the region's 2018 decision [14] |
| Italy (Tuscany) | Clinical governance body, December 11, 2018 [13] | "la miscela gassosa di ossigeno-ozono non deve essere utilizzata in somministrazione endovenosa diretta per il pericolo di embolia gassosa polmonare" Our translation: "the oxygen-ozone gas mixture must not be used by direct intravenous administration, because of the danger of pulmonary gas embolism" (summarizing Italian ozone therapy societies' guidelines) | Regional decision with annex | Published on the region's site |
| Italy | National public health institute (ISS), March 26, 2020 [17] | "L’ISS non ha rilasciato un’autorizzazione in tal senso ma, in un carteggio informale, ha invece sottolineato che le evidenze portate a sostegno dell’utilizzo di questa terapia per il trattamento del COVID-19, dovrebbero essere confermate" Our translation: "The ISS did not issue an authorization to that effect but, in informal correspondence, instead stressed that the evidence put forward in support of using this therapy to treat COVID-19 should be confirmed" (by a trial authorized by the Italian Medicines Agency) | Press release | A 2020 statement about COVID-19 claims |
| Germany | Federal Committee of Physicians and Health Insurance Funds, December 11, 2000, in force March 23, 2001 [3] | "keine belastbaren Nachweise für den Nutzen und medizinische Notwendigkeit einer Anwendung in der vertragsärztlichen Versorgung" Our translation: "no reliable evidence of benefit and medical necessity for use in statutory health insurance practice." On the first EBOO study in patients: "Veröffentlichung eignet sich nicht zum Wirksamkeitsnachweis." Our translation: "The publication is not suitable as evidence of efficacy." | Coverage decision for statutory health insurance | Still listed by the Federal Joint Committee (G-BA) in its rule as amended March 19, 2026 [10] |
| Brazil | National Congress and President, August 4, 2023 [8] | "Fica autorizada a realização da ozonioterapia como procedimento de caráter complementar, observadas as seguintes condições" Our translation: "Ozone therapy is authorized as a procedure of a complementary nature, subject to the following conditions" | Federal law | The official text we read on October 2, 2026 shows no amendment [8] |
| Brazil | Federal Council of Medicine (CFM), August 21, 2025 [4] | "Fica expressamente vedada a utilização de ozonioterapia para o tratamento de feridas neoplásicas em qualquer estágio, exceto em contexto de pesquisa clínica formalmente aprovada." Our translation: "The use of ozone therapy to treat neoplastic wounds at any stage is expressly prohibited, except in the context of formally approved clinical research." | Professional council resolution for physicians | In force since publication; replaced the 2018 resolution [4] |
| Brazil | Health regulator (Anvisa), June 16, 2026 [11] | "qualquer dispositivo emissor de ozônio somente poderá ser comercializado para as indicações previamente aprovadas e constantes nas respectivas instruções de uso." Our translation: "any ozone-emitting device may be marketed only for the indications previously approved and set out in its instructions for use." | Device regulator's technical note | In force; replaces Note 43/2022 [11] |
| United Kingdom | Advertising Standards Authority (ASA), March 2, 2022 [5] | "We had not previously seen evidence that oxygen therapy had health benefits or could prevent or treat illness or disease." (English original) | Advertising ruling on one clinic's web page | Still published [5] |
| United Kingdom | ASA and Committee of Advertising Practice, March 31, 2022 [18] | "Despite requests from the CAP Compliance team to remove or amend the health-related claims, The Detox Clinic Ltd continues to feature them on thedetoxclinicltd.com." (English original) | Listing of a non-compliant advertiser | Still on the list on October 2, 2026 [18] |
| Canada | Health Canada, November 2, 2022 [6] | "To date, Health Canada has not received any submissions with evidence to support medical treatment claims for ozone saunas." (English original) | Public advisory on ozone saunas | Last updated November 2, 2022 [6] |
| Australia (New South Wales) | Health Care Complaints Commission, August 1, 2024 [12] | The clinic "must not under any circumstances provide, or cause to be provided, any health service, including but not limited to the administration of any medication and/or intravenous and skin puncture procedures" (English original) | Interim order against one clinic | Ended May 6, 2025, according to the order's page [12] |
| Australia (New South Wales) | Health Care Complaints Commission, April 8, 2025 [7] | "Dr Phan was using equipment and devices in the provision of ozone therapy at the Clinic, that were not approved by the TGA, including the EXT120 Ozone Generator and the Champion Full Spectrum UV device." (English original) | Five-year prohibition order against one clinic | In effect for five years from April 8, 2025 [7] |

Italy: where EBOO began, and where it is limited to trials

The research group that described EBOO in the late 1990s and 2000s worked in Siena, in Tuscany [19][20]. Italy's national position comes from a Health Ministry circular of January 2005 to the regional health departments [2]. It says that a 2002 ministry note confining oxygen-ozone therapy to hospital trials is not legally binding, so a doctor may still use the method "sotto la propria diretta ed esclusiva responsabilità" (our translation: "under his or her own direct and exclusive responsibility") with the patient's informed consent [2]. It warns that departing from the Superior Health Council's views could expose a doctor, after an incident, to criminal or civil liability, and it relays that council's 2003 opinion that the therapy should be given only in ethics-approved trials in hospitals, with the words quoted in the table [2].

Tuscany's regional bodies have addressed the therapy four times. In 2006 the regional health council limited the therapy's indications to symptomatic disc herniation treated by injection [9]. In 2007 it said oxygen-ozone therapy is possible only in controlled clinical trials, apart from the doctor's own responsibility, "non esistendo alcuna indicazione suffragata da evidenze" (our translation: "since no indication supported by evidence exists") [15]. In 2015 it classed ozone therapy as an invasive procedure that needs authorized premises, and attached the National Blood Centre's opinion on autohemotherapy with added ozone and oxygen, the Italian text closest to EBOO: the practice must be prepared under sterile conditions and is "introduzione di materiale autologo manipolato" (our translation: "introduction of manipulated autologous material"), not venipuncture [16]. In 2018 the region's clinical governance body ruled on an intravenous "liquid polyatomic oxygen" therapy, said it is not oxygen-ozone therapy, allowed it only in authorized facilities within controlled trials, and recorded that Italian ozone therapy societies "hanno vietato questo uso dal 1984" (our translation: "have banned this use since 1984") for direct intravenous injection of the gas [14][13].

At the national level, a consensus conference that the ISS held on the therapy in 2006 addressed paravertebral injections for disc-related sciatica, not blood treatments [21]. In March 2020, after press reports that it had approved ozone therapy for COVID-19 patients, the ISS said that issuing such authorizations is not its role and that it had issued none [17].

Germany: excluded from statutory health insurance since 2001

On December 11, 2000, Germany's Federal Committee of Physicians and Health Insurance Funds assigned ozone therapy to Annex B, "nicht anerkannte Methoden" (our translation: "methods not recognized"), of its guidelines for evaluating medical methods in statutory health insurance; the decision, which the Federal Ministry of Health did not object to, was published in March 2001 and has been in force since March 23, 2001 [3]. The committee's 2001 report covers ozone therapy, ozone autohemotherapy, oxygen-ozone autohemotherapy, oxyon therapy, and hyperbaric ozone therapy, and concluded that for every indication reviewed it found no reliable evidence of benefit and medical necessity [3].

Of the foreign documents in this guide, the report is the only one that names EBOO. Its literature appendix summarizes the first EBOO report in patients, published in 2000 by the Siena group: a system for ozonating blood outside the body, tested first in sheep and then in a pilot study of seven patients with advanced arteriosclerosis, who had two one-hour sessions a week, 14 in all [3]. The paper's own abstract gives no patient total, as our guide to the evidence (/guides/does-ebo2-work/) notes; the count of seven is the committee's. The committee's verdict on that paper is the one in the table: not suitable as evidence of efficacy [3].

The exclusion is still in force. In the methods guideline of today's Federal Joint Committee (G-BA) as amended on March 19, 2026, Annex II, titled "Methoden, die nicht als vertragsärztliche Leistungen zu Lasten der Krankenkassen erbracht werden dürfen" (our translation: "methods that may not be provided as contract-physician services at the expense of the health insurance funds"), lists "Ozon-Therapie, Ozon-Eigenbluttherapie, Sauerstoff-Ozon-Eigenbluttherapie, Oxyontherapie, Hyperbare Ozontherapie" as item 35, and separately lists the intravascular insufflation of oxygen and other gases [10]. The guideline binds statutory insurers, their contracted doctors, and insured patients, and it notes an exception, set by Germany's Federal Constitutional Court, for patients with a life-threatening disease and no standard treatment [10]. It concerns what public insurance pays for; it does not address treatment that patients pay for privately.

An earlier version of our FDA guide, following a practitioner association's summary, dated this decision to December 2020. The committee's own report dates it to December 11, 2000 [3].

Brazil: legal as a complementary procedure, within listed uses

Of the countries in this guide, Brazil is the only one whose documents include a national law on ozone therapy. The 2023 law authorizes it as a complementary procedure on three conditions: a university-level health professional registered with a professional council performs it, using an ozone generator regularized by the health regulator Anvisa, and tells the patient that the procedure is complementary [8].

The Federal Council of Medicine's 2025 resolution sets the rules for physicians [4]. It authorizes ozone therapy as an adjuvant for diabetic foot ulcers, ischemic arterial ulcers, acute infected wounds, and chronic venous ulcers, applied "exclusivamente por via tópica" (our translation: "exclusively by the topical route"), and for knee osteoarthritis by injection into the joint and disc-related low back pain by spinal injection, with facility and specialist requirements [4]. It bars use on neoplastic wounds outside approved research, requires an Anvisa-regularized generator, and revoked the council's 2018 resolution [4]. The resolution does not mention EBOO. Its statement of reasons says the studies reviewed for fibromyalgia used "auto-hemotransfusão ozonizada" (our translation: "ozonated autohemotransfusion"), and that for fibromyalgia and other pain conditions the evidence was insufficient or of low quality, so those uses are not recommended outside clinical research [4].

Anvisa's 2026 technical note lists the uses it recognizes for ozone-emitting devices: skin cleansing with ozonated water vapor, local dental uses, and, as an adjunct, bagged ozone-oxygen gas for diabetic foot ulcers and acute infected wounds in adults [11]. It warns that exposure to ozone by routes, forms, or concentrations other than the approved indications "pode levar à ocorrência de danos severos" (our translation: "may lead to severe harm") [11]. No Brazilian document we hold authorizes treating blood with ozone outside the body. Anvisa's page for the note still uses the web address of the 2022 note it replaces; the page records that it was created in June 2022 and modified on June 26, 2026 [22].

United Kingdom: an advertising ruling, not a ruling on the technique

The UK documents we hold come from the advertising regulator. In March 2022 the Advertising Standards Authority upheld a complaint about one clinic's web page for "IV Ozone Therapy", which claimed that ozone raises dissolved oxygen in the blood and is anti-inflammatory, antibacterial, antiviral, and antifungal [5]. The clinic sent no evidence; the ASA said it understood IV ozone therapy to be a form of oxygen therapy, found the claims unsubstantiated and misleading, and told the clinic not to repeat them without "a substantive body of evidence" including "clinical trials conducted on people" [5]. Because the clinic kept making health claims, the ASA placed it on its list of non-compliant advertisers on March 31, 2022, and it was still there on October 2, 2026 [18].

The advertising code's own advice note on oxygen therapy, updated in February 2024, says the ASA and the code's committee "have yet to see convincing evidence" that oxygen used as an alternative therapy in hyperbaric chambers is effective for health conditions, and it states that it does not bind the ASA [23]. Neither document licenses or bans a treatment.

Canada: a licence is required for ozone saunas, and none has one

Health Canada's 2022 advisory concerns ozone saunas, steam cabinets fed by an ozone generator. It says they need a medical device licence to be imported and sold, that Health Canada has not licensed any, and that it is illegal to advertise, import, or sell medical devices in Canada without the appropriate licence [6]. It adds that the use of medical devices is part of the practice of medicine, "regulated at the provincial and territorial level", and points readers to Health Canada's Medical Devices Active Licence Listing (https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/licences/medical-devices-active-licence-listing.html) to check whether a device is licensed [6]. The advisory does not mention EBOO.

Australia: two orders against clinics, and what they say about devices

The New South Wales Health Care Complaints Commission barred a Castle Hill ozone clinic, and anyone working under it, from providing any health service while it investigated, from August 2024 until May 2025; the order's page states no findings [12]. In April 2025 it barred a Penrith clinic from providing any health service, including ozone therapy, for five years [7]. The Commission found that the clinic's non-registered practitioner used devices "not approved by the TGA", Australia's therapeutic goods regulator, including an ozone generator and a UV device; obtained heparin "from an unknown source" and "is not authorised to be in possession of, or to administer" it; had no infection-control procedures or patient records; and, according to expert opinion, most likely caused a patient's serious infection, which led to septic shock [7].

The Commission's statement of decision describes the procedures it examined: ozonated saline given by intravenous drip, and ultraviolet blood irradiation in which blood was mixed with ozonated saline and run through a UV device before being returned; the clinic's website also listed minor autohemotherapy and ozone saunas [24]. None of these is EBOO as our description of the procedure (/what-is-ebo2/) sets it out. It records the Therapeutic Goods Administration's statements that the devices were not on the Australian Register of Therapeutic Goods and "cannot be used in medical procedures in Australia" [24]. Among the devices, both the Commission and the FDA's July 2025 warning letter name a product called Champion Full Spectrum. The FDA letter says O3UV makes its Champion Full Spectrum devices, while the Commission attributes the device it found to a firm it calls Q-Tubes and lists quartz cuvettes made by O3UV among the other unregistered items [25][24]. Both orders concern one clinic each. Our guide to EBOO devices and FDA status (/guides/eboo-devices-and-fda-status/) reports what the FDA's databases show for that and other device names.

How to check a claim that EBOO is approved abroad

When a clinic, including any listed in our directory (/clinics/), says EBOO is approved, accepted, or standard in another country, these questions separate a regulator's decision from a reputation:

Which body? A ministry, a health regulator, a professional council, an insurer's committee, an advertising regulator, or a practitioners' association are different things, and only some of them decide anything.
Which document, and what kind? Use the first table above: a law, a professional rule, a coverage decision, an advisory, an advertising ruling, or an order against one clinic.
Which condition and which route? Brazil's authorizations are for named wounds, a joint, and the spine, by topical or injected routes [4]. A permission for one use says nothing about ozonating blood.
Is the device registered there? Each country's documents name its device register: Anvisa regularization in Brazil [8], Health Canada's licence listing [6], and the Australian Register of Therapeutic Goods [24]. On those regulators' own accounts, a device that is not on the register may not be sold for medical use (Brazil and Canada) or used in medical procedures (Australia) [11][6][24].
Does the document mention EBOO? Only one of the foreign documents in this guide does, the German committee's 2001 report, and it judged the EBOO study it reviewed unsuitable as evidence of efficacy [3].

What we could not verify

Countries without a primary document in our files. Practitioner associations publish accounts of where ozone therapy is regulated, including Spain, Greece, Portugal, Russia, and Cuba. Our sourcing rules let us read only public institutions' own documents directly, and we have none from those countries yet, so we make no claim about them.
Private practice in Germany. The G-BA documents govern statutory health insurance. We have no German document on whether, or under what conditions, doctors may offer ozone therapy to patients who pay privately.
Later changes. We could not search the Brazilian medical council's register of norms for later acts, or Italy's ministry archive for a document replacing the 2005 circular. Each status above is what the document's own page showed on October 2, 2026.
The Castle Hill outcome. The New South Wales order's page ends with the interim order expiring in May 2025 and records no findings or final order.
Device registers. We did not search Health Canada's licence listing, the Australian register, or Anvisa's product database for EBOO equipment.
European device law. We hold no document from the European Commission or a national device regulator in the European Union on ozone generators or EBOO systems.
Translations. The English renderings of Italian, German, and Portuguese passages are ours and have not been checked by a professional translator.

How this guide was made

This guide draws on 25 sources, all of them regulators', ministries', and professional bodies' own documents except two papers by EBOO's developers that establish where the technique began. We read each document in its original language, from the issuing body's site or, for the 2005 Italian circular, from the Tuscan region's published copy, and checked on October 2, 2026 that each regulator's document was still online and what its page said about its status. Where a quoted passage is not in English, the English rendering is ours. The "From our data" section lists the newest records in our regulatory dataset. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: Is EBOO approved in Europe?
A: We found no European approval of EBOO. Germany has excluded ozone therapy, including ozone autohemotherapy, from statutory health insurance since 2001, after a review that judged the first EBOO study in patients unsuitable as evidence of efficacy. Italy's national health bodies have said no controlled studies support oxygen-ozone therapy and that it belongs in clinical trials, with doctors otherwise acting on their own responsibility.

Q: Is ozone therapy legal in Brazil?
A: Yes, as a complementary procedure. A 2023 federal law authorizes it if a registered university-level health professional performs it with an ozone generator regularized by Anvisa and tells the patient it is complementary. The Federal Council of Medicine's 2025 resolution authorizes physicians to use it for listed wound, knee, and spine conditions and leaves other uses to research, and Anvisa recognizes ozone devices only for skin, dental, and wound-bag uses.

Q: Did Italy approve ozone therapy for COVID-19?
A: No. In March 2020 Italy's national public health institute, the ISS, said that granting such authorizations is not its role, that it had issued none, and that evidence for using ozone therapy against COVID-19 should be confirmed by a trial authorized by the Italian Medicines Agency.

Q: Is ozone therapy allowed in the UK?
A: We have no UK document that rules on ozone therapy as a practice. The UK advertising regulator ruled in 2022 that one clinic's health claims for IV ozone therapy were unsubstantiated and misleading, and still lists the clinic as a non-compliant advertiser. That is a ruling on advertising claims, not a licence decision.

Q: What should I ask if a clinic says EBOO is approved abroad?
A: Ask which body approved it, in which document, for which condition and route, and whether the document is a law, a professional rule, an insurance decision, an advertising ruling, or an order against one clinic. Then ask whether the device is registered with that country's regulator.

Sources:
[1] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[2] Ossigeno-ozono terapia (nota DGFDM.III/P/1752/I.4.C.C.), circular of 20 January 2005, published as an annex by Regione Toscana. Ministero della Salute (Italy), 2005. https://www.regione.toscana.it/documents/10180/12096595/Allegato+3+Parere+n.+10-2007+%28Autore+Bailo+09-03-2007%29.pdf/f1bb981c-98e3-4ca9-8c8a-e111f32713fa?version=1.0&t=1416999155247&download=true
[3] Ozon-Therapie, Ozon-Eigenbluttherapie, Sauerstoff-Ozon-Eigenbluttherapie, Oxyontherapie, Hyperbare Ozontherapie: Zusammenfassender Bericht des Arbeitsausschusses "Ärztliche Behandlung". Bundesausschuss der Ärzte und Krankenkassen, now Gemeinsamer Bundesausschuss (Germany), 2001. https://www.g-ba.de/downloads/40-268-248/HTA-Ozon-Therapie.pdf
[4] Resolução CFM nº 2.445, de 21 de agosto de 2025. Conselho Federal de Medicina (Brazil), 2025. https://sistemas.cfm.org.br/normas/arquivos/resolucoes/BR/2025/2445_2025.pdf
[5] ASA Ruling on The Detox Clinic Ltd. Advertising Standards Authority (UK), 2022. https://www.asa.org.uk/rulings/the-detox-clinic-ltd-a21-1119332-the-detox-clinic-ltd.html
[6] Unlicensed ozone saunas may pose serious health risks to users and anyone in close proximity (RA-72150). Health Canada, 2022. https://recalls-rappels.canada.ca/en/alert-recall/unlicensed-ozone-saunas-may-pose-serious-health-risks-users-and-anyone-close-proximity
[7] Ozone Healing Clinic, Penrith: Time-bound Prohibition Order. NSW Health Care Complaints Commission (Australia), 2025. https://www.hccc.nsw.gov.au/decisions-orders/prohibition-orders/ozone-healing-clinic-penrith-nsw
[8] Lei nº 14.648, de 4 de agosto de 2023: Autoriza a ozonioterapia no território nacional. Presidência da República (Brazil), 2023. https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2023/lei/L14648.htm
[9] Parere 31/2006: Ossigeno ozonoterapia. Regione Toscana, Consiglio Sanitario Regionale (Italy), 2006. https://www.regione.toscana.it/documents/10180/12161851/Parere+n.+31-2006.pdf/92a34289-3623-4f30-89af-3c73b9f70e7a?version=1.1&t=1576228147561&download=true
[10] Richtlinie Methoden vertragsärztliche Versorgung, version amended 19 March 2026 (Anlage II). Gemeinsamer Bundesausschuss (Germany), 2026. https://www.g-ba.de/downloads/62-492-4143/MVV-RL_2026-03-19_iK-2026-04-09.pdf
[11] Nota Técnica nº 41/2026/SEI/GQUIP/GGTPS/DIRE3/ANVISA. Agência Nacional de Vigilância Sanitária (Anvisa), Brazil, 2026. https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/produtos-para-saude/notas-tecnicas/nota-tecnica-no-43-2022-sei-gquip-ggtps-dire3-anvisa/@@display-file/file
[12] The Ozone Clinic, Castle Hill: Interim Prohibition Order. NSW Health Care Complaints Commission (Australia), 2024. https://www.hccc.nsw.gov.au/decisions-orders/prohibition-orders/the-ozone-clinic-castle-hill
[13] Allegato alla Decisione CTS n. 20 del 11/12/2018. Regione Toscana, Organismo Toscano per il Governo Clinico (Italy), 2018. https://www.regione.toscana.it/documents/10180/16111184/Allegato+-+Decisione+20_2018.pdf/4edd57e6-44e0-4092-9f5e-d093691f6c36
[14] Decisione n. 20 del 11/12/2018. Regione Toscana, Organismo Toscano per il Governo Clinico (Italy), 2018. https://www.regione.toscana.it/documents/10180/16111184/Decisione+20_2018.pdf/f7f8ccd9-d61b-4c41-9860-5d06b907db31
[15] Parere 10/2007: Utilizzo ossigeno-ozono terapia in strutture ambulatoriali private. Regione Toscana, Consiglio Sanitario Regionale (Italy), 2007. https://www.regione.toscana.it/documents/10180/12096595/Parere+n.+10-2007+%28Autore+Bailo+09-03-2007%29.pdf/9d6b1360-af79-482e-b9a2-13619e31a1df?version=1.1&t=1576228313360&download=true
[16] Parere 67/2015: Prestazioni di idrocolonterapia, terapia chelante e ozonoterapia. Regione Toscana, Consiglio Sanitario Regionale (Italy), 2015. https://www.regione.toscana.it/documents/10180/13326460/Parere+67_15+Ozono+idrocolon+e+chelante.pdf/a1f11111-daac-4ae4-a7a9-437884a0d813?version=1.0&t=1460457106345&download=true
[17] CS N° 25/2020: Ozonoterapia, non rientra nei compiti dell’ISS autorizzare sperimentazioni. Istituto Superiore di Sanità (Italy), 2020. https://www.iss.it/en/coronavirus/-/asset_publisher/1SRKHcCJJQ7E/content/id/5313647
[18] Non-compliant online advertisers: The Detox Clinic Ltd. Advertising Standards Authority and Committee of Advertising Practice (UK), 2022. https://www.asa.org.uk/non-compliant/the-detox-clinic-ltd.html
[19] Ozonation of blood during extracorporeal circulation. I. Rationale, methodology and preliminary studies. The International Journal of Artificial Organs (PubMed), 1999. https://pubmed.ncbi.nlm.nih.gov/10532435/
[20] Extracorporeal blood oxygenation and ozonation: clinical and biological implications of ozone therapy. Redox Report (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16156950/
[21] Conferenza di consenso: Ossigeno-ozono terapia nel trattamento delle lombosciatalgie da ernia discale con tecnica iniettiva intramuscolare paravertebrale (Rapporti ISTISAN 08/9). Istituto Superiore di Sanità (Italy), 2008. https://www.iss.it/documents/20126/45616/08-9+web.1208510331.pdf/3ef442c5-3897-763b-9bc1-5588793b0fd0?t=1581098533176
[22] Nota Técnica nº 41/2026 (page listing the note). Agência Nacional de Vigilância Sanitária (Anvisa), Brazil, 2026. https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/produtos-para-saude/notas-tecnicas/nota-tecnica-no-43-2022-sei-gquip-ggtps-dire3-anvisa
[23] Health: Oxygen therapy (AdviceOnline). Committee of Advertising Practice (UK), 2024. https://www.asa.org.uk/advice-online/health-oxygen-therapy.html
[24] Ozone Healing Clinic: Prohibition Order, Statement of Decision. NSW Health Care Complaints Commission (Australia), 2025. https://www.hccc.nsw.gov.au/ArticleDocuments/245/24%2001123%20-%20Ozone%20Healing%20Clinic%20-%20Prohibition%20Order%20-%20Statement%20of%20Decision%20(signed%20by%20MHenney).pdf.aspx
[25] Warning letter to O3UV, LLC (CBER 25-668840). U.S. Food and Drug Administration, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/o3uv-llc-668840-07072025

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# EBO2 (EBOO) Devices and FDA Status: The Filter, the Ozone Generator, and the Circuit

Source: https://ebo2.com/guides/eboo-devices-and-fda-status/
Updated: 2026-10-04

Key takeaways:
- We found no FDA approval, clearance, or De Novo authorization for any EBOO system, for an ozone generator meant to treat patients, or for the light units clinics add to the circuit.
- The filters in some EBOO circuits are hemodialyzers, which the FDA clears as parts of an artificial kidney system; a clearance covers only the uses written in that filter's 510(k), such as kidney failure.
- The one FDA-cleared device named simply 'Ozone Generator' disinfects a dialysis solution system that is then rinsed until no ozone remains; the other ten 510(k) records with ozone in the device name are sterilizers, dialysis water-system disinfection units, and a test strip.
- As of October 4, 2026, 21 of the 174 clinics whose EBO2 page we could read named a device; of the nine names they use, one is a cleared hemodialyzer model and none of the other eight returned a clearance, approval, or registration record.
- In July 2025 the FDA told the maker of two EBOO and ultraviolet blood irradiation devices that they were adulterated for lack of premarket approval or an investigational exemption.

EBO2 (also called EBOO) runs a patient's blood through an extracorporeal circuit (/glossary/#extracorporeal): tubing, a cartridge where the blood meets a mixture of medical oxygen and ozone, an ozone generator (/glossary/#ozone-generator), and at some clinics a light unit [1][2]. We found no FDA approval, clearance, or De Novo authorization for any EBOO system, for an ozone generator meant to treat patients, or for the light units clinics name [3][4]. The filters some circuits use are hemodialyzers [2], cleared for kidney failure and related uses, and each clearance covers only the uses in that filter's 510(k) [5][6]. This guide takes the parts one at a time, reports what the FDA's databases returned for the device names clinics give, and sets out how to look up a device yourself. Ozone therapy is not FDA-approved for any condition [7]; the wider question of FDA status is in our guide on whether EBO2 is FDA-approved (/guides/is-ebo2-fda-approved/).

What the FDA has said about each part of the circuit

| Part | What it does, per the sources | What we found in FDA records |
| --- | --- | --- |
| The cartridge | Where blood meets the oxygen and ozone gas. The technique's developers built a dedicated gas exchange device of ozone-resistant polypropylene hollow fibers, with the gas flowing inside the fibers [1]. The EBOO kits the FDA inspected in 2023 contained purchased high-flux hemodialyzers [2] | Hemodialyzers are Class II devices cleared through 510(k) as part of an artificial kidney system [5][8]. We found no FDA record for a gas exchanger under EBOO or ozone names [3] |
| The ozone generator | Supplies the gas: in the 2007 device, a mixture of about 99 percent medical oxygen and 1 percent ozone [1] | No device type with "ozone" in its name or definition in the FDA's classification data [3]. The only 510(k) device named "Ozone Generator" disinfects a dialysis solution system [9]. A 2014 recall of an ozone generator gave as its reason that it "is not approved or cleared by the FDA for medical use" [10] |
| A light unit | Some clinics say they add ultraviolet or multi-wavelength light to the circuit (clinic pages in our data) | The FDA's July 2025 letter found two devices that expose blood to ozone and ultraviolet light adulterated for lack of premarket approval [2]. No FDA record under the light-unit names clinics give [3][4] |
| Pumps and tubing | Move blood and fluids through the circuit | We found no FDA statement about the pumps or tubing used in EBOO. The 2025 letter's only finding about pumps, infusion pumps sold in the maker's ultraviolet bundles, was that the firm had not evaluated their supplier [2] |
| The circuit as a whole | The system a clinic runs | The 2025 letter found two EBOO and ultraviolet blood irradiation products adulterated because no premarket approval or investigational device exemption was in effect [2]. We found no PMA, 510(k), or De Novo record for any EBOO system [3][4] |

A part can be cleared while the system around it is not. A 510(k) decision letter finds a device substantially equivalent "for the indications for use stated in the enclosure" [6], and the FDA's 510(k) page says a new 510(k) is required when a device "is to be marketed for a new or different intended use" [11]. That rule governs how a manufacturer markets its device. It says nothing about EBOO either way, and we draw no conclusion from it about any clinic. The developers of EBOO wrote in 1999 that they had tried a dialysis-type technique first and found semipermeable membranes "unsuitable because they are hydrophilic and vulnerable to O3" [12]; our guide comparing EBOO with dialysis (/guides/eboo-vs-dialysis/) follows that history and the dialyzers now in use.

What an "FDA-cleared filter" claim covers

The FDA's classification rule for high-permeability hemodialysis systems, 21 CFR 876.5860, identifies them as "intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions" through hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration, and places them in Class II with special controls that include FDA guidance on 510(k)s for hemodialyzers [5]. The product code for high-permeability dialyzers is KDI, and openFDA lists 345 510(k) records under that code, dated December 1978 to July 2026 [6][13]. Cleared filters are therefore common. What matters for a claim is what a particular filter is cleared for.

The one hemodialyzer model that a clinic in our data names is the Elisio 9H. The FDA's records for Nipro's ELISIO-H line show:

K140191, cleared April 14, 2014, added the 09H and 25H sizes to the line. Its indications say hemodialysis with the dialyzer is indicated "for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate", and that it "may be indicated in the treatment of patients intoxicated with poisons or drugs" [14].
K260533, cleared March 19, 2026, states that the dialyzers "are intended for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate" [6].
AccessGUDID lists the ELISIO-09H model as in commercial distribution, with the device type "Hollow-fibre haemodialysis dialyser, single-use" [15].

Neither indications statement mentions ozone, oxygenation, or EBOO [14][6]. A clinic that calls a filter like this FDA-cleared would be describing the filter accurately and saying nothing about the rest of the circuit. A regulation states that a 510(k) clearance "does not in any way denote official approval of the device" [16], and the ozone generator and the procedure each need their own answer.

The device names clinics give, and what FDA records showed

As of October 4, 2026, 21 of the 174 clinics in our directory (/clinics/) whose EBO2 page we could read named the device or system they use, and their pages use nine names. On October 2, 2026, we searched each name in the 510(k), PMA, registration and listing, and unique device identifier data through openFDA, in the De Novo database and AccessGUDID directly, and in the FDA's warning letter list [3][4][15][17]. A matching word in an FDA record does not show that a clinic uses that product, and the absence of a match does not show that a device is unregistered or uncleared under some other name.

| Name on clinic pages | Clinics | What the pages say it is | What the FDA records showed |
| --- | --- | --- | --- |
| Hemealumen (also written HemaLumen) | 7 | A light unit added to the blood circuit | No record under either spelling in any database we searched, and no warning letter [3][4][15][17] |
| Stratos (also STRATOS) | 4 | An EBOO device or system | No ozone or blood device. The word belongs to unrelated products, among them a line of implantable pacemakers (PMA), a rib-fixation system (510(k)), dental articulators, and a wheelchair platform lift; no De Novo record or warning letter [3][4][17] |
| EBOO Full Spectrum | 2 | An EBOO machine | No record under "EBOO"; "full spectrum" matched only unrelated products, such as surgical laser fibers, a cervical cell collector, and an infrared sauna [3]. The FDA's July 2025 letter names a product called EBOO Full Spectrum UV, made by O3UV, LLC, which it says had no premarket approval or 510(k) [2]. A name on a clinic page does not identify the maker or model |
| EBOOSAFE | 2 | An EBOO machine | No record in any database we searched, and no warning letter [3][4][15][17] |
| Zotzmann | 2 | An EBOO machine from Germany, as the clinics describe it | No registered establishment, device, or warning letter under the name [3][15][17] |
| Trigen Kaizen EBOO System | 1 | An EBOO system | No EBOO record; "Trigen" matched orthopedic nails and "Kaizen" a maker of hearing protectors [3][17] |
| Elisio 9H hemodialyzer | 1 | The filter | Nipro ELISIO-H hemodialyzers, cleared through 510(k) under product code KDI; K140191 added the 09H size; listed in AccessGUDID as in commercial distribution; no warning letter names the model [14][15][17] |
| EBOOST | 1 | The clinic's own system | No record in any database we searched, and no warning letter [3][4][15][17] |
| EBO3 Full Spectrum | 1 | An EBOO system | No record under "EBO3", and no warning letter; "full spectrum" as above [3][15][17] |

The O3UV letter itself is consistent with these searches. It found that the firm had not registered and listed for fiscal year 2025 and had sent no information to the FDA's device identifier database [2], and our searches found no registration and listing record and no device identifier record for O3UV or for either of its product names [3][15]. The letter also names the hemodialyzers the firm bought for its kits, "ABLE® H-200 High Flux Polyethersulfone Disposable Haemodialysers" [2]. We found no 510(k), registration and listing, or device identifier record under that name [3]. The letter does not say who made those filters or whether they were cleared, and its finding about them concerned how the firm controlled its purchasing [2].

Regulators abroad have also acted on devices. In 2025 the New South Wales Health Care Complaints Commission found that a clinic's ozone generator and UV device were not approved by Australia's therapeutic goods regulator [18], and Brazil's health regulator recognizes ozone devices only for skin, dental, and wound-bag uses [19]. Our guide to regulators abroad (/guides/eboo-around-the-world/) has the details, and our guide on how to read a clinic's EBO2 page (/guides/how-to-read-a-clinic-ebo2-page/) covers branded names and other wording.

What the FDA has cleared that uses ozone

Eleven 510(k) records returned by openFDA on October 2, 2026, have "ozone" in the device name [13]:

| 510(k) | Device name in the record | Decision | What it is for |
| --- | --- | --- | --- |
| K873200 | Karlson Ozone Sterilizer Model 100B | 1989 | Sterilizer |
| K020875 | TSO3 Ozone Sterilizer, Model 125L | 2003 | Sterilizer |
| K021161 | TSO3 Ozone Chemical Indicator | 2003 | Sterilization process indicator |
| K051595 | TSO3 Ozone Sterilizer, Model 125L | 2006 | Sterilizer |
| K080198 | TSO3 Ozone Sterilization Wrap | 2008 | Sterilization wrap |
| K090636 | TSO3 Ozone Sterilizer, Model 125L | 2009 | Sterilizer |
| K043207 | Ozone Generator | 2005 | Disinfecting a dialysis solution mixing and distribution system |
| K093641 | Tango3 Water Storage Tank with Ozone Disinfection System | 2010 | Dialysis water storage tank |
| K132344 | E-Z Check Ozone Test Strips | 2014 | Showing whether ozone is present in water used for hemodialysis |
| K141213 | Ameriwater Ozone Disinfection System | 2014 | Dialysis water tank disinfection |
| K140984 | Tango3 Water Storage Tank with Ozone Disinfection System | 2015 | Dialysis water storage tank |

In the dialysis records, ozone disinfects equipment and is then removed [9][20]. The cleared ozone generator's indications end with the system being rinsed "until the system is residual free of ozone" [9], and the test strips are "designed to indicate the presence of ozone in water used in hemodialysis" [20]. None of the 11 is for exposing a patient or a patient's blood to ozone [13]. The FDA's own rule on ozone devices says any device that generates ozone is adulterated or misbranded if it is used "in any medical condition for which there is no proof of safety and effectiveness" [7], and a June 2025 federal indictment alleges that a Virginia physician used "three FDA-unapproved devices that produced medical ozone gas"; the Justice Department notes that charges are only allegations [21].

How to look up a device yourself

Get the maker, brand, model, and catalog number from the device's label, its instructions for use, or the clinic in writing. The FDA's unique device identifier rule requires a device to carry an identifier on its label and package unless an exception or alternative applies [6].
Find the device type in the Product Classification database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm). It gives the three-letter product code, the device class, and a link to the regulation behind it, if there is one [22][23]. High-permeability dialyzers, for example, are product code KDI under 21 CFR 876.5860, Class II [6]. We found no device type for an ozone generator meant to treat patients [3].
Search the 510(k) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm), PMA (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm), and De Novo (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm) databases by product code and company name, open the record, and download its summary. The Indications for Use page lists what the device is cleared for [22][6].
Search AccessGUDID (https://accessgudid.nlm.nih.gov/) by brand or model. A record shows the company, the model, the device type, and whether it is in commercial distribution [22][15]. Some records leave the premarket submission field empty: the openFDA copies of the ELISIO-H records we read did, although the line is cleared [3][14]. An empty field is not evidence either way.
Search Registration and Listing (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm) by proprietary name or company. Where premarket authorization is required, the listing should give the premarket submission number [22], and the FDA says the entry itself does not denote approval, clearance, or authorization [24].
Search the Total Product Life Cycle database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm) by product code, which pulls clearances, approvals, adverse event reports, and recalls into one report [22], and search the warning letter list (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters) by company and product names [17]. Our guide on whether EBO2 is FDA-approved (/guides/is-ebo2-fda-approved/) explains what a warning letter, a close-out letter, and an empty search each mean.

| Record | What it would tell you | What it would not tell you |
| --- | --- | --- |
| A product code and class | The generic device type and the level of FDA control that applies to it [25][22] | That a given product is cleared or approved |
| A 510(k) Indications for Use page | What that device is cleared for [6] | That it is cleared for other uses, for use with ozone, or for EBOO |
| An AccessGUDID record | The company, the model, and whether it is in commercial distribution [22] | Clearance or approval; the record may omit the premarket number |
| A listing with a premarket number | Which 510(k), De Novo, or PMA record to read next [22] | Approval of the device or of a procedure [24] |
| A listing without a number | That the firm listed the device with the FDA [26] | Whether the device needed clearance, or has it |

What we could not verify

The database search forms. The FDA's 510(k), PMA, and Registration and Listing search pages answered our automated requests with a blank form or an automated check, which we did not try to pass, so those searches ran through openFDA, which says not to rely on it for decisions about medical care and updates its 510(k) data monthly [13]. The De Novo database, AccessGUDID, and the warning letter list answered directly.
Makers and models. None of the nine names on clinic pages comes with a maker and model number that we could match to a record, apart from the Elisio dialyzer. A kit can contain parts bought from other makers, as the O3UV letter shows [2], so a search by the name on a clinic page can miss the maker of each part.
How the gas meets the blood in hemodialyzer circuits. We found no FDA document describing how EBOO kits route ozone through a hemodialyzer, and no labeling for any named filter that addresses use with ozone.
The full 510(k) files. We read the public summaries and decision letters, not the full submissions or each filter's instructions for use.
What clinics leave unsaid. As of October 4, 2026, 153 of the 174 clinics whose EBO2 page we could read did not name a device, so the table covers a minority of clinics.
Anything after October 2, 2026. Records added after our searches will not appear here.

How this guide was made

This guide draws on 26 sources: the FDA's own records, rules, and database descriptions, the FDA's July 2025 warning letter, a Justice Department release, two documents from regulators in Australia and Brazil, and two papers by the developers of EBOO. The device names and counts come from our clinic dataset as read between September 28, 2026 and October 4, 2026 (21 named devices among 174 readable pages of 177 listed clinics). The database results come from searches we ran on October 2, 2026, and we keep every query and result on file. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: Is the EBOO machine FDA approved?
A: We found no FDA approval, clearance, or De Novo authorization for any EBOO system. In July 2025 the FDA told the maker of two devices sold for EBOO and ultraviolet blood irradiation that they were adulterated because no premarket approval or investigational device exemption was in effect, and misbranded because no 510(k) notice had been filed.

Q: What does an 'FDA-cleared filter' mean for EBOO?
A: It refers to a filter, such as a hemodialyzer, cleared through 510(k). The clearance covers the indications in that filter's own 510(k), such as hemodialysis for kidney failure. It does not cover exposing blood to ozone, the ozone generator, or the EBOO procedure, and a federal rule says a 510(k) does not denote official approval.

Q: Are medical ozone generators FDA approved?
A: We found no FDA device type for an ozone generator meant to treat patients and no clearance or approval for one. The FDA's device rule says a device that generates ozone is adulterated or misbranded if it is used in a medical condition without proof of safety and effectiveness. The one cleared device named 'Ozone Generator' disinfects dialysis solution systems.

Q: How can I look up the device a clinic uses?
A: Ask for the manufacturer, brand, model, and any FDA number. Find the device type in the FDA's Product Classification database, open any 510(k), PMA, or De Novo record and read its Indications for Use, then check AccessGUDID and the Registration and Listing database for the model. This guide gives the addresses and what each result would and would not tell you.

Q: Do the light or UV units some clinics add have FDA clearance?
A: We found no FDA record under the light-unit names that clinics in our data use. The FDA's 2025 warning letter said two devices that expose blood to ozone and ultraviolet light had no premarket approval or clearance.

Sources:
[1] Oxygenation-ozonation of blood during extracorporeal circulation: in vitro efficiency of a new gas exchange device. Artificial Organs (PubMed), 2007. https://pubmed.ncbi.nlm.nih.gov/17725702/
[2] Warning letter to O3UV, LLC (CBER 25-668840). U.S. Food and Drug Administration, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/o3uv-llc-668840-07072025
[3] Medical Device API Endpoints (openFDA). U.S. Food and Drug Administration (openFDA), 2026. https://open.fda.gov/apis/device/
[4] Device Classification Under Section 513(f)(2) (De Novo) database. U.S. Food and Drug Administration, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm
[5] 21 CFR 876.5860 High permeability hemodialysis system. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-876/subpart-F/section-876.5860
[6] 510(k) K260533, ELISIO-H: decision letter and 510(k) summary. U.S. Food and Drug Administration, 2026. https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260533.pdf
[7] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[8] Is It Really 'FDA Approved'?. U.S. Food and Drug Administration, 2026. https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved
[9] 510(k) K043207, Ozone Generator: summary, decision letter, and indications for use. U.S. Food and Drug Administration, 2005. https://www.accessdata.fda.gov/cdrh_docs/pdf4/K043207.pdf
[10] Class 2 Device Recall Enaly 1000 BT12 Ozone Generator (Z-1576-2014). U.S. Food and Drug Administration, 2014. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127001
[11] Premarket Notification 510(k). U.S. Food and Drug Administration, 2024. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
[12] Ozonation of blood during extracorporeal circulation. I. Rationale, methodology and preliminary studies. The International Journal of Artificial Organs (PubMed), 1999. https://pubmed.ncbi.nlm.nih.gov/10532435/
[13] Device 510(k) Overview (openFDA). U.S. Food and Drug Administration (openFDA), 2026. https://open.fda.gov/apis/device/510k/
[14] 510(k) K140191, ELISIO-H hemodialyzer: summary and indications for use. U.S. Food and Drug Administration, 2014. https://www.accessdata.fda.gov/cdrh_docs/pdf14/K140191.pdf
[15] AccessGUDID: Global Unique Device Identification Database. U.S. National Library of Medicine and U.S. Food and Drug Administration, 2026. https://accessgudid.nlm.nih.gov/
[16] 21 CFR 807.97 Misbranding by reference to premarket notification. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807/subpart-E/section-807.97
[17] Warning Letters (list and search). U.S. Food and Drug Administration, 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
[18] Ozone Healing Clinic, Penrith: Time-bound Prohibition Order. NSW Health Care Complaints Commission (Australia), 2025. https://www.hccc.nsw.gov.au/decisions-orders/prohibition-orders/ozone-healing-clinic-penrith-nsw
[19] Nota Técnica nº 41/2026/SEI/GQUIP/GGTPS/DIRE3/ANVISA. Agência Nacional de Vigilância Sanitária (Anvisa), Brazil, 2026. https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/produtos-para-saude/notas-tecnicas/nota-tecnica-no-43-2022-sei-gquip-ggtps-dire3-anvisa/@@display-file/file
[20] 510(k) K132344, E-Z Check Ozone Test Strips: summary and indications for use. U.S. Food and Drug Administration, 2014. https://www.accessdata.fda.gov/cdrh_docs/pdf13/K132344.pdf
[21] U.S. Attorney Erik S. Siebert announces charges as part of DOJ's national health care fraud enforcement action. U.S. Attorney's Office, Eastern District of Virginia, 2025. https://www.justice.gov/usao-edva/pr/us-attorney-erik-s-siebert-announces-charges-part-dojs-national-health-care-fraud
[22] Medical Device Databases. U.S. Food and Drug Administration, 2022. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
[23] Premarket Approval (PMA). U.S. Food and Drug Administration, 2019. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma
[24] Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved?. U.S. Food and Drug Administration, 2021. https://www.fda.gov/medical-devices/consumers-medical-devices/are-there-fda-registered-or-fda-certified-medical-devices-how-do-i-know-what-fda-approved
[25] Product Code Classification Database. U.S. Food and Drug Administration, 2018. https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database
[26] Device Registration and Listing. U.S. Food and Drug Administration, 2025. https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

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# EBO2 (EBOO) for Athletes: Anti-Doping Rules, the Studies, and the Claims

Source: https://ebo2.com/guides/ebo2-for-athletes/
Updated: 2026-10-04

Key takeaways:
- Whether EBO2 is permitted for an athlete who competes under the WADA Prohibited List is a question only that athlete's anti-doping organization can answer. This guide reports the published wording and makes no ruling.
- None of the anti-doping agency pages we read names EBO2 or EBOO. Germany's agency summarises the List's blood-manipulation class as prohibiting, among other things, any form of intravascular manipulation of the blood or blood components by physical or chemical means.
- USADA's own guidance states that ozone autohemotherapy, in which blood is removed, exposed to ozone, and reinjected, is prohibited at all times, and that a wellness clinic does not count as a hospital setting for the 100 mL infusion rule.
- USADA sanctioned a UFC athlete for six months in 2018 after he declared ozone therapy on his doping control paperwork and his physician's records showed a prohibited route.
- No published study has tested EBO2 in athletes. The nearest research is a 15-cyclist trial of ozonised massage oil and an antioxidant study in ten horses that the authors said could not be applied to racehorses under their sport's own blood rule.

For an athlete who competes under an anti-doping code, the first question about EBO2 (also called EBOO) is usually eligibility rather than recovery: whether the procedure is permitted under the rules that athlete is tested against. This guide sets out the rule wording as anti-doping organizations publish it, the one documented sanction involving ozone therapy, what the published research has measured, and how many clinic pages in our directory market the procedure to athletes. It does not say whether the procedure is permitted for any athlete; only that athlete's anti-doping organization can answer that.

The Harper announcement, and what it is not

In December 2025 Philadelphia Phillies player Bryce Harper posted that he had undergone EBOO, describing a procedure in which a third of his blood was drawn, passed through a filtration and ozonation device, and returned, and crediting it with better circulation, less inflammation, and more energy [11][12]. Sports coverage reported that the FDA has not approved ozone therapy for treating or preventing illness, and that nothing indicated he had broken a league rule [11][13].

A public account of how a treatment made someone feel is not a measurement. No blood test, power output, or blinded comparison attaches to it, and an offseason contains simultaneous changes to training, sleep, and nutrition that no anecdote can separate. Its real effect has been commercial: a well-known name attached to a procedure that, as the sections below show, has no study behind it in athletes and an unresolved eligibility question in front of it.

Why eligibility comes first

Anti-doping rules work on strict liability: the athlete is responsible for what enters their body and for the methods used on them, whether or not anyone intended an advantage and whether or not the clinic knew the rules. That makes the order of questions unusual here. For most elective treatments the questions are benefit, risk, and cost. For a competing athlete, a method that turns out to be prohibited can carry a sanction measured in years of eligibility (the standard period in the one ozone case below was two years [5]), so the eligibility question comes first.

Two features of EBO2 make this a live question rather than a formality. Blood leaves the body and is returned to it. And the volume of fluid going back into a vein is far larger than the threshold that anti-doping rules set for infusions. Both are addressed in the rule wording below, and neither depends on whether EBO2 does anything useful.

What the Prohibited List says, as anti-doping agencies word it

The World Anti-Doping Agency's International Standard, the Prohibited List, is revised each year, and each new List takes effect on 1 January [3]. WADA's website refused our automated requests for the 2026 and 2027 Lists, so we have not read either document; the wording below is as three anti-doping organizations publish it on their own pages [1][2][3]. None of those three pages names EBO2, EBOO, or ozone therapy.

The List's M1 class, Manipulation of Blood and Blood Components, is prohibited at all times, in and out of competition [1]. Germany's national anti-doping agency, NADA, summarises the class on its English-language page: "blood transfusions, dialysis (i.e. 'blood washing') and the administration of red blood cell products of any origin into the circulatory system are prohibited", and "Any form of intravascular manipulation of the blood or blood components by physical or chemical means is also prohibited" [1].

The Athletics Integrity Unit, summarising WADA's explanatory note for 2026, reports a clarification in the same class: "The withdrawal of blood or blood components is prohibited", unless it is for analytical purposes, such as medical testing or doping control, or for donation at an accredited collection centre. In the unit's words, this "closes a gap in earlier wording by recognising that manipulation begins at the point of withdrawal, not only reinfusion", and "Platelet-Rich Plasma (PRP) procedures remain not prohibited" [2].

Under the M2 class, Chemical and Physical Manipulation, NADA lists intravenous infusions among its examples [1]. USADA states the infusion rule as a volume limit, 100 mL in a 12-hour period outside hospital, surgical, and diagnostic settings, in the wording quoted in the next section [4][6].

A widely shared sports write-up about EBO2 told readers that the Prohibited List "explicitly targets techniques in which blood leaves the body, undergoes manipulation, and returns—ozone-based and ultraviolet-light treatments included", and linked to WADA's 2019 list [13]. We could not read that List, or the current ones, to check the claim. The agency pages we read describe the blood rules in general terms and do not name ozone or ultraviolet treatments; only USADA's separate guidance, quoted below, names ozone autohemotherapy. That is one reason the answer for any athlete rests with an anti-doping organization rather than with a sports column.

What USADA tells athletes about ozone therapy and clinic IVs

The United States Anti-Doping Agency publishes guidance for athletes on treatments sold by wellness and anti-aging clinics, and it addresses ozone therapy by name. Its page states: "With one type of ozone therapy, blood is removed from a vein, infused with ozone, and then reinjected back into the body. This method of ozone therapy, called autohemotherapy, is prohibited at all times. While ozone itself is not prohibited as a substance, all treatments that remove and reintroduce blood into the circulatory system are prohibited." The same page states that ozone therapy given by rectal insufflation is permitted [4].

The page addresses the infusion volume separately: "All intravenous injections of more than 100 mL in a 12-hour period are prohibited at all times, regardless of what is in the IV bag", with the exception of an IV "legitimately received in the course of hospital treatment, surgical procedures, or clinical diagnostic investigations". It then adds a sentence about clinics: "For the purpose of anti-doping rules, wellness or anti-aging clinics are not considered a hospital setting" [4]. USADA's longer note on infusions lists the settings where an over-threshold IV is still prohibited, among them "any type of health clinic, health center, wellness clinic, or any kind of IV clinic, dialysis center, or treatment room outside of a hospital facility that is not part of a surgery or diagnostic test" [6].

How this maps onto EBO2 is a question for an athlete's anti-doping organization, not for us. What we can say is that the description clinics give of EBO2, blood drawn from one arm, passed through a filter and an ozone circuit, and returned through the other (see what EBO2 is (/what-is-ebo2/)), is a description of blood being removed from and reintroduced into the circulatory system, and of a return volume far above 100 mL. Nothing in USADA's guidance names EBO2, and we make no ruling about any individual's eligibility.

The one documented sanction

The clearest evidence that this is not a theoretical risk is a case USADA published. On March 8, 2018, USADA announced that UFC athlete Ion Cutelaba "has accepted a six-month sanction after declaring the use of an alternative therapeutic treatment that is prohibited under certain routes of administration" [5]. He had declared ozone therapy on his doping control paperwork during out-of-competition tests in October 2017. USADA then asked for details of the route of administration, and, in USADA's words, "Cutelaba's physician subsequently provided documentation indicating that the treatment was administered on October 3, 2017, and October 17, 2017, in a prohibited manner, as it involved a blood transfusion" [5].

Three things in that account are worth carrying forward. The athlete declared the treatment and, by USADA's account, was unaware of the violation, which earned a reduction from the standard two-year period to six months [5]. The route of administration, not the substance, decided the case. And the evidence that settled it came from his own physician's records, which is a reminder that a clinic's paperwork becomes the athlete's paperwork.

What clinic pages tell athletes

Athlete marketing is a visible part of how EBO2 is sold, and our directory lets us measure it rather than assert it. As of October 4, 2026, of the 174 clinics whose EBO2 page our research pass could read, 26 have at least one saved paragraph that mentions athletes and also mentions EBO2, EBOO, or ozone. The phrasing in those paragraphs runs to faster recovery, reduced exercise-induced inflammation, better oxygen delivery to muscle, and performance optimization, sometimes alongside a recommended cadence of sessions per year for people under heavy physical load. Using the same method, 43 of the 174 have a paragraph pairing "performance" with the procedure and 75 have one pairing "recovery" with it. We name no clinic in connection with a benefit claim; the aggregate below shows the categories of condition claim across the whole directory.

None of the pages we read cited a study in athletes, because, as the next section sets out, there is none to cite. Ozone therapy is not FDA-approved for any medical use, and federal device labeling rules state that ozone "is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [10]. A claim on a clinic's page is a claim, and our clinic directory (/clinics/) records what each one states so you can compare it against the research record yourself.

What the research closest to this question measured

Our library holds no study of EBO2 in athletes, in any sport, at any level, and no study of EBO2 with a performance or recovery outcome of any kind. Two studies sit closest to the question, and it is worth being precise about what each one did.

| Study | What was given | To whom | What was measured | What it cannot support |
|---|---|---|---|---|
| Paoli 2013 (/research/paoli-2013-ozonated-oil-cyclists-trial/), a within-subject comparison | Sports massage with ozonised oil, massage with plain oil, or passive rest after three fatiguing Wingate tests | 15 male competitive cyclists at one university department | Peak power, heart rate, a visual analogue fatigue score, blood lactate clearance | Anything about blood treated with ozone: the oil is applied to skin [7] |
| Tsuzuki 2016 (/research/tsuzuki-2016-ozone-horses-antioxidant/), one treatment, same animals as their own controls | Ozonated autohemotherapy: 400 mL of blood withdrawn, 20 µg/kg of ozone added, blood returned | 10 Thoroughbred geldings, described as non-race horses | Biological antioxidant potential, reactive oxygen metabolites, an oxidative stress index, before treatment and to 14 days after | Any performance or injury outcome, in horses or people; no filtration circuit was used [8] |

The cyclists trial reported higher peak power and a lower fatigue score after the ozonised-oil condition, and faster lactate decline, with no difference in heart rate [7]. It is a single-centre study of 15 men measuring the hours after a laboratory fatigue protocol, and the intervention is a massage oil.

The horse study reported that the antioxidant marker rose by three days after treatment and was no longer measurable at 14 days, with no change in the reactive-oxygen marker, and no abnormal blood counts or clinical signs during the study [8]. Its authors also wrote the sentence most relevant to an athlete reading it: "the Paris Agreement prohibits the re-administration of blood in racehorses; thus, application of OAHT to this group is currently limited" [8]. The one study that ozonated blood in a performance animal concluded that the sport's own blood rule kept it out of competition animals.

Recovery with a larger evidence base behind it

For contrast, consider what the recovery literature looks like when it is large. A 2025 systematic review followed PRISMA methods across 41 randomized or crossover trials of post-exercise recovery in soccer players of both sexes and all levels, and grouped them into categories including active recovery, cold-water immersion, compression garments, sleep and naps, and nutritional interventions. It reported that cold-water immersion consistently improved jump performance and perceptions of fatigue, soreness, and wellbeing, with positive but more variable findings for active recovery, compression, sleep interventions, and nutritional supplementation, and it flagged heterogeneity in methods and outcomes as a limit on generalizing [9]. That is the shape of an evidence base: dozens of trials, named outcomes, stated limits. The ozone-and-performance literature is one massage-oil trial and ten horses.

Questions to ask before you book

Which anti-doping code applies to me, and have I asked that organization, in writing, about this specific procedure by its full description rather than by its brand name?
What total volume of fluid is returned to my circulation in a session, and over what period? The number matters because USADA's statement of the rule turns on 100 mL per 12 hours outside hospital, surgical, and diagnostic settings [4][6].
Will the clinic give me the complete treatment record, including the device, the ozone concentration, the blood volume processed, and the anticoagulant used? In the one published sanction, the physician's records decided the outcome [5]. The transparency block below shows how many clinics even name their device or say who supervises a session.
Is there a published study in athletes that the clinic can name, with a citation that can be checked against the research library (/research/) or PubMed?
What is the full course being recommended and what does it cost over a season? The block below shows what clinics across our directory recommend and sell.
Who is physically present during the session, and what is the plan if something goes wrong? Our guide to side effects and safety (/guides/side-effects-and-safety/) and our record of adverse events by route (/guides/ozone-therapy-adverse-events/) set out what has been reported after ozone procedures.

What we could not verify

Whether EBO2 is prohibited, permitted, or requires a Therapeutic Use Exemption in any particular sport. No anti-doping organization we read names EBO2 or EBOO. Only an athlete's own anti-doping organization can answer for a given case, and this guide does not answer it.
The Prohibited List itself. WADA's website refused our automated requests for the 2026 and 2027 Lists and the 2026 explanatory note, returning a bot challenge rather than the documents, and the anti-doping agency pages we could read summarise the List rather than reproduce it. The rule wording in this guide is as NADA, the Athletics Integrity Unit, and USADA publish it [1][2][3][4][6]. We could not check WADA's own clause wording or numbering, whether either edition names ozone therapy or ultraviolet treatment, or how the List classes these methods when a sanction is calculated.
Major League Baseball's Joint Drug Prevention and Treatment Program document was not read directly for this guide, so the statements about league rules here rest on sports reporting [11][13] rather than on our own reading of the program text.
Whether any athlete other than the 2018 UFC case has been sanctioned in connection with ozone therapy. We found no other published decision, which is not the same as there being none.
What the 26 clinics counted above mean by recovery or performance claims in clinical terms. We counted paragraphs in pages they published; we did not ask the clinics, and we did not evaluate the claims.
Whether ozonised massage oil and ozonated blood act by any shared mechanism. The two studies above used different routes and measured different things, and neither tested the other's method.

How this guide was made

This guide draws on 13 sources: three anti-doping organizations' pages on the WADA Prohibited List (NADA's, the Athletics Integrity Unit's, and USADA's), three further USADA publications, three peer-reviewed papers, one federal regulation, and three news reports of a public announcement by an athlete. The counts of athlete, performance, and recovery marketing come from our own directory of 177 US clinics and the saved page text behind it, read between September 28, 2026 and October 4, 2026, with the denominator of 174 readable EBO2 pages stated wherever a count appears; the blocks below are computed from that dataset and from our study library at build time. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources. No clinical reviewer has signed off on this page yet.

FAQ:
Q: Is EBO2 allowed under anti-doping rules?
A: We cannot answer that for any sport or any athlete; only the athlete's own anti-doping organization can. What we can report is how anti-doping agencies word the rules. None of the agency pages we read names EBO2 or EBOO. Germany's agency, NADA, summarises the Prohibited List's blood-manipulation class as covering blood transfusions, dialysis, and any form of intravascular manipulation of the blood by physical or chemical means, and the Athletics Integrity Unit reports that the 2026 List prohibits withdrawing blood except for testing or donation at an accredited centre. USADA's guidance for athletes states that ozone autohemotherapy, where blood is removed, exposed to ozone, and reinjected, is prohibited at all times. Clinics describe EBO2 as drawing blood, passing it through a filter and ozone circuit, and returning it. Some athletes ask their anti-doping organization for an answer in writing before a session.

Q: Has any athlete actually been sanctioned over ozone therapy?
A: Yes. USADA announced on March 8, 2018 that UFC athlete Ion Cutelaba accepted a six-month sanction after declaring ozone therapy on his doping control paperwork during out-of-competition tests. USADA says his physician's documentation showed the treatment had been given in a prohibited manner because it involved a blood transfusion. USADA reduced the standard two-year period because he had declared the treatment and was unaware of the violation.

Q: Does EBO2 improve recovery, power output, or VO2 max?
A: No published human study has measured any of those outcomes after EBO2. The closest human study applied ozonised oil during a sports massage to 15 cyclists, which is a treatment of the skin rather than of blood. The closest study of blood exposed to ozone was done in ten horses and measured antioxidant markers, not performance.

Q: What do clinics tell athletes EBO2 does?
A: Of the 174 clinics whose EBO2 page we could read as of October 4, 2026, 26 have a saved paragraph that mentions athletes alongside EBO2, EBOO, or ozone, typically describing faster recovery, reduced inflammation, or performance optimization. Those are statements on sales pages, not trial results, and no clinic page we read cited a study in athletes.

Q: Is this the same thing as blood doping?
A: Classic blood doping stores and reinfuses blood, or uses drugs such as EPO, to raise oxygen-carrying capacity, and EBO2 is not described that way. That distinction does not settle eligibility. As anti-doping agencies summarise it, the Prohibited List's blood-manipulation class covers the withdrawal and reintroduction of blood and any intravascular manipulation of it, not only oxygen-carrying capacity, and USADA states a separate limit on intravenous infusions of 100 mL per 12 hours outside hospital, surgical, or diagnostic settings.

Sources:
[1] Prohibited List. Nationale Anti Doping Agentur Deutschland (NADA), 2026. https://www.nada.de/en/medicine/prohibited-list
[2] Understand the Prohibited List. Athletics Integrity Unit, 2026. https://www.athleticsintegrity.org/know-the-rules/understand-the-prohibited-list
[3] World Anti-Doping Agency (WADA) Prohibited List. U.S. Anti-Doping Agency (USADA), 2026. https://www.usada.org/substances/prohibited-list/
[4] What Athletes Need to Know about Wellness and Anti-Aging Clinics. U.S. Anti-Doping Agency (USADA), 2026. https://www.usada.org/spirit-of-sport/wellness-and-anti-aging-clinics/
[5] UFC Athlete Ion Cutelaba Accepts Sanction for Anti-Doping Policy Violation. U.S. Anti-Doping Agency (USADA), 2018. https://www.usada.org/sanction/ion-cutelaba-accepts-doping-sanction/
[6] IV Infusion: Explanatory Note. U.S. Anti-Doping Agency (USADA), 2026. https://www.usada.org/athlete-advisory/iv-infusions-explanatory-note/
[7] Sports massage with ozonised oil or non-ozonised oil: comparative effects on recovery parameters after maximal effort in cyclists. Physical Therapy in Sport (PubMed), 2013. https://pubmed.ncbi.nlm.nih.gov/23623301/
[8] Effects of ozonated autohemotherapy on the antioxidant capacity of Thoroughbred horses. Journal of Veterinary Medical Science (PubMed Central), 2016. https://pmc.ncbi.nlm.nih.gov/articles/PMC4710722/
[9] Post-Exercise Recovery Modalities in Male and Female Soccer Players of All Ages and Competitive Levels: A Systematic Review. Sports (Basel) (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/41150478/
[10] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[11] Phillies' Bryce Harper announces he underwent blood procedure. ClutchPoints via Yahoo Sports, 2025. https://sports.yahoo.com/articles/phillies-bryce-harper-announces-underwent-225559154.html
[12] Bryce Harper Had A Third Of His Blood Removed Then Put Back In (Which Is Good). OutKick, 2025. https://www.outkick.com/sports/bryce-harper-eboo-blood-therapy-offseason-treatment
[13] Phillies Star Caught in Controversy After Rare Treatment Goes Viral. Heavy.com, 2025. https://heavy.com/sports/mlb/philadelphia-phillies/bryce-harper-treatment-mlb-blood-doping/

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# EBO2 (EBOO) for Autoimmune Conditions: Clinic Claims, the MS and Sjögren's Studies, and Standard Care

Source: https://ebo2.com/guides/ebo2-for-autoimmune-conditions/
Updated: 2026-10-04

Key takeaways:
- As of October 4, 2026, 104 of the 174 clinics whose EBO2 pages we could read claim a benefit for autoimmune conditions, but the claim wording we recorded names a specific autoimmune disease for only 23 of them.
- No study has tested EBO2 in any autoimmune disease. The ozone studies we found used autohemotherapy, rectal insufflation, or ozone gas applied to skin ulcers.
- The two multiple sclerosis studies in our library gave 20 patients ozone autohemotherapy twice a week for six months and measured immune-cell markers, not relapses or disability.
- The one Sjögren's report is a single case with conflicting session counts, and the one rheumatoid arthritis trial we found added rectal ozone to methotrexate for 20 days.
- NIH describes trials of MS drugs that measured relapses, disability, and brain lesions, and the treatments NIH lists for lupus, Sjögren's, and rheumatoid arthritis do not include ozone.

If a clinic has offered EBO2 (also called EBOO) for an autoimmune disease such as multiple sclerosis, rheumatoid arthritis, lupus, or Sjögren's, this guide sets the offer against the record: what clinics' own pages claim, what the ozone studies in these diseases tested and measured, what regulators have said, and the care that NIH and specialist bodies describe. The short answer is that no study has given EBO2 to people with an autoimmune disease. The ozone studies that exist used other methods, were small, mostly lacked a comparison group, and mostly measured laboratory markers rather than relapses, disability, or joint damage. Questions to take to a clinic, and the searches we ran, are near the end.

What clinics' EBO2 pages say about autoimmune disease

We read the EBO2 pages of the clinics in our directory (/clinics/) and recorded, in each clinic's own words, the health benefits each claims. As of October 4, 2026, we could read the pages of 174 clinics. 163 of them claim at least one health benefit, and 104 claim one for autoimmune conditions; the "From our data" section below shows the full breakdown.

What stands out is how general the claim is. Across all 174 readable clinics, the claim wording we recorded names a specific autoimmune disease for only 24: rheumatoid arthritis for 14, multiple sclerosis for 12, lupus for 10, inflammatory bowel disease for 7, and Hashimoto's thyroiditis for 2. None names Sjögren's. We save up to four quotes per clinic, so these counts are a floor. Within the 104 clinics:

Autoimmune disease is usually one item in a list. Of the 100 whose recorded wording names it, 74 name it in the same sentence or list as other conditions. 78 of the 104 also claim a benefit for Lyme disease or mold illness, and 37 for long COVID.
The wording is about the immune system in general. Across all readable clinics, the recorded wording of 18 says the procedure modulates, regulates, resets, or balances the immune system, and that of 2 lists Lyme disease among autoimmune conditions, although CDC describes it as an illness caused by bacteria [20].
Most pages do not say whether EBO2 is FDA-approved. 86 of the 104 EBO2 pages do not say whether EBO2 or its equipment is FDA-approved, 15 say EBO2 is not FDA-approved, and 3 say their equipment is FDA-cleared, registered, or approved, which concerns a device and not the treatment; our guide to EBOO devices and FDA status (/guides/eboo-devices-and-fda-status/) explains the difference.
23 of the 104 pages carry patient testimonials.

We publish these claims only as counts. A claim on a clinic's page is the clinic's statement, not evidence; our guide to reading a clinic's EBO2 page (/guides/how-to-read-a-clinic-ebo2-page/) covers the wording to look for.

What the studies in our library tested

None of the six entries our research library (/research/) tags as EBOO studies, listed in the "From our data" table below, reports on anyone with an autoimmune disease; the 2023 ozone-uptake series (/research/rowen-2023-ozone-dialysis-uptake/) among them does not say what its 12 patients were treated for. The library holds three ozone-therapy papers in autoimmune disease and one air-pollution study about lupus.

| Study | Design | Who took part | What was measured | Result, as the paper reports it | Limits |
|---|---|---|---|---|---|
| Izadi 2020 (/research/izadi-2020-ozone-ms-th17-cohort/) [7] | Described by its authors as a "non-controlled study" | 20 people with multiple sclerosis given major autohemotherapy (100 mL of blood with ozone at 25 µg/mL) twice a week for six months | Th17 immune cells and related genes and cytokines | Th17 cells and several inflammatory markers lower after treatment than before | Abstract only; it also mentions comparisons with "control groups" it does not describe; laboratory markers, not relapses or disability |
| Tahmasebi 2021 (/research/tahmasebi-2021-ozone-ms-treg-cohort/) [8] | Before-and-after comparison | 20 people with relapsing-remitting multiple sclerosis given ozone twice a week for six months | Regulatory T cells and related markers | Regulatory T cells, FoxP3, IL-10, and TGF-β higher after treatment | Abstract only, with no numbers or dose; no untreated group; shares four authors and the same design with Izadi 2020 |
| Valdenassi 2022 (/research/valdenassi-2022-ozone-sjogrens-case/) [9] | Case report | One 69-year-old woman with primary Sjögren's, given oxygen-ozone autohemotherapy (100 mL of blood, 45 µg/mL) weekly in two rounds | Dryness, joint pain, fatigue questionnaires; antinuclear antibodies | Symptoms improved; joint-pain score fell from 135 to 91 and fatigue by 75% | One patient, no comparison; the paper gives 2 sessions in its abstract and 3 in a figure caption; it reports p-values for one person's scores; authors affiliated with the Italian ozone-therapy society |
| Pan 2023 (/research/pan-2023-air-pollution-sle-timeseries/) [10] | Time-series study of air pollution and hospital admissions | Lupus admissions at one hospital in Xi'an, China | Daily air pollutants against admissions | Fine and coarse particles were linked to more lupus admissions; ambient ozone was not | Not a study of ozone therapy; outdoor air only |

Air-pollution studies are what a search for ozone and lupus mostly returns. Pan 2023 found "null associations" between ambient ozone and lupus admissions [10]; it says nothing about medical ozone, and we found no study of ozone therapy in lupus at all.

What else has been published, outside our library

A search of titles and abstracts finds more ozone studies in autoimmune disease than our library holds. We read these from their PubMed records; none used EBO2.

Rheumatoid arthritis. A 2016 randomized trial from Cuba gave 60 people methotrexate, folic acid, and ibuprofen, with or without ozone by rectal insufflation, for 20 days. The ozone group's disease activity score fell while the comparison group "merely showed a tendency to decrease", and no side effects were observed [11]. The abstract describes no sham insufflation or blinding, and one author is affiliated with a German medical society for ozone therapy. The other clinical rheumatoid arthritis studies our search found came from the same group.
Multiple sclerosis. A 2017 Cuban study gave ozone by rectal insufflation three times a week for a month and reported better antioxidant and inflammatory markers [12]. A 2014 Italian study measured brain oxygenation by near-infrared light during and after autohemotherapy in 20 people with MS and 20 controls [13]. A 2020 letter by a professor of pharmaceutical technology in Siena, in the journal that published Izadi 2020, is titled "The right therapeutic method of ozone therapy used to treat multiple sclerosis patients"; PubMed holds no abstract [14]. None of these reports relapse rates or disability as an outcome in what we read.
Systemic sclerosis. This is the one autoimmune disease in which we found more than one randomized trial, and both treated skin ulcers on the fingers locally, not the blood. An Egyptian trial of 50 women added 20 days of ozone gas, applied in a bag around the hand, to standard medicine and reported healing in 96% against 44% [15]. A Turkish trial of 25 patients with ulcers that had resisted treatment reported 92% against 42% with local ozone [16].

None of this work used EBO2, and most of it is small and measures markers rather than outcomes. Proponents explain the expected benefit through a mechanism: a calibrated dose of ozone in blood is said to "reactivate the antioxidant system" [18]. A proposed mechanism is a reason to run a trial, not a result.

Why marker changes do not answer the question

Relapsing-remitting multiple sclerosis and lupus both flare and settle. NIH describes relapsing-remitting MS as attacks followed by "total or partial recovery", and lupus as alternating "periods of illness (flares) and periods of wellness (remission)" [2][24]. A before-and-after comparison in a disease like that can show improvement that would have happened anyway. The FTC's guidance on health claims makes the same point in general terms: human studies "should have both a treatment group and a control group", because improvement in a treated group alone could come from "a placebo effect, spontaneous changes in subjects' health" or other factors [22]. And a change in a blood marker is not the outcome a patient or a neurologist cares about. NIH describes the evidence for MS drugs in terms of those outcomes: for three of them, it notes, clinical trials showed they "decrease the number of relapses, delay the progression of physical disability, and slow the development of brain lesions" [2]. No ozone study we found measured those outcomes.

Safety of the ozone methods used in these studies

The autoimmune studies report few or no side effects, but they are small and mostly do not describe how adverse events were collected. A 2026 scoping review of systemic oxygen-ozone autohemotherapy, the method used in the MS and Sjögren's studies, found reports of hemolysis and kidney failure with ozone above 60 µg/mL, high potassium, heart attack and other ischemic events, gas embolism to the brain, reactions to rapid reinfusion, allergic reactions linked to equipment, and infections from breaches of protocol, and said that their overall incidence "cannot be reliably quantified" [17]. The same review found no pattern of frequent serious unexpected harm when a standardized protocol was followed, and it drew mostly on case reports [17]. Our compilation of ozone therapy adverse events (/guides/ozone-therapy-adverse-events/) covers these by route. For people on immunosuppressants or biologics, no study we found looked at interactions; our guide to EBOO, blood thinners, and medications (/guides/eboo-blood-thinners-and-medications/) covers the circuit's anticoagulant and what to ask.

What regulators have said

No regulatory record in our tracker (/reports/regulatory-tracker/) addresses EBO2 for an autoimmune disease by name. The records that apply are general.

FDA. Its device rule states that "Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [23]. Ozone therapy is not FDA-approved for any autoimmune disease or any other condition.
UK advertising regulator. In 2022 the Advertising Standards Authority ruled against a UK clinic's claims that IV ozone therapy was "Anti-Inflammatory", among others, and told it not to repeat them without "a substantive body of evidence to support those claims, including clinical trials conducted on people" [21].
FTC standard for health claims. The FTC's 2022 guidance says health benefits generally need "randomized, controlled human clinical testing" and that anecdotal evidence about consumers' experiences is "never sufficient to substantiate claims about the effects of a health product" [22].

What NIH and specialist bodies describe as care

This section describes what NIH and specialist bodies say; it is information, not a treatment plan. In autoimmune diseases, NIH explains, "autoantibodies target the body's own healthy tissues by mistake" [1].

Multiple sclerosis. NIH says treatments can reduce the number and severity of relapses and delay long-term progression. Corticosteroids given for three to five days speed recovery from attacks, and FDA-approved disease-modifying therapies, given by infusion, injection, or mouth, are "designed to regulate or suppress the inflammatory reactions of the disease" [2].
Rheumatoid arthritis. NIH gives the goals as relieving pain, reducing inflammation, and preventing, slowing, or stopping joint and organ damage, and notes that joint damage can begin in the first year or two and generally cannot be reversed. Medicines include anti-inflammatories, corticosteroids, disease-modifying antirheumatic drugs, biologics, and JAK inhibitors [5]. The 2021 American College of Rheumatology guideline makes 44 recommendations on these drugs, 7 of them strong, including their use in people with liver disease, heart failure, or a history of serious infections [6].
Lupus. NIH lists the goals as managing symptoms, preventing and limiting flares, and preventing organ damage, with anti-inflammatories, antimalarials, corticosteroids, immunosuppressants, and two kinds of biologic drug [3].
Sjögren's. NIH says treatment focuses on relieving symptoms and preventing complications, through eye drops and plugs, saliva substitutes and stimulants, and, for joint pain and other serious effects, disease-modifying and antimalarial drugs that "have not specifically been approved for Sjögren's disease" [4].

Some blood-processing procedures do have their evidence graded disease by disease. The American Society for Apheresis grades the evidence for plasma exchange and related procedures disease by disease; its tenth edition, published in 2026, has 93 fact sheets with 183 graded indications [19]. Our comparison of EBO2 and plasmapheresis (/guides/ebo2-vs-plasmapheresis/) explains the difference. We found no comparable grading for EBO2.

Questions to ask a clinic that offers EBO2 for an autoimmune disease

These are questions, not a verdict on any clinic. Our questions for your doctor (/tools/doctor-questions/) tool builds a printable list.

Which study tested EBO2 in this specific disease, and did it measure relapses, disability, or joint damage? (We found none that did.)
Is EBO2 offered instead of, or alongside, the treatment the rheumatologist or neurologist prescribes, and will the clinic coordinate with that physician?
Has the clinic checked the session plan against current immunosuppressants, biologics, or infusion schedules, and against the circuit's anticoagulant?
What will be measured before and after the sessions, and at what point would the clinic recommend stopping?
How many sessions, at what total cost in writing, and what is refunded if sessions stop? The session cost planner (/tools/session-cost/) helps with the arithmetic.

How to check for evidence yourself

We ran these searches on October 2, 2026, and anyone can repeat them for free.

Europe PMC, the free index that includes PubMed, searching titles and abstracts: `TITLE_ABS:(ozone OR "oxygen-ozone" OR ozonated OR autohemotherapy) AND TITLE_ABS:("multiple sclerosis")`, then the same with "rheumatoid arthritis", lupus, Sjögren's, or "systemic sclerosis" in place of the disease. Many results are studies of ozone as an air pollutant; the clinical studies of ozone therapy are the ones described above.
Europe PMC, EBOO and autoimmune disease: the same searches with `EBOO OR "extracorporeal blood oxygenation"` in place of the ozone terms returned no studies in these diseases.
ClinicalTrials.gov, with ozone as the intervention, returned no registered studies for multiple sclerosis, rheumatoid arthritis, lupus, or Sjögren's. For systemic sclerosis it returned three completed studies: the Egyptian digital-ulcer trial (NCT02733978), a digital-ulcer study of 25 people at a university in Türkiye (NCT04826419), and an Egyptian trial of local ozone injection against methylprednisolone for carpal tunnel syndrome in people with scleroderma (NCT03742466).

What we could not verify

Whether the two Iranian MS studies describe the same 20 patients. They share four authors and the same design, and neither abstract says [7][8].
What the "control groups" in Izadi 2020 were. The abstract mentions them without size or makeup [7].
What the 2020 letter on "the right therapeutic method" for MS says. PubMed holds no abstract [14].
The full texts of the Cuban rheumatoid arthritis trial, the 2021 American College of Rheumatology guideline, and the apheresis guideline. We read their abstracts only, so we cannot say how ozone was dosed and controlled in the trial, whether the guidelines mention ozone, or which category the apheresis guideline gives any specific disease [6][11][19].
How many people with autoimmune disease have had EBO2, and with what results. Our dataset records clinics' claims, not outcomes.

How this guide was made

This guide rests on 24 sources: six NIH pages, a CDC page, 14 papers and guidelines read through PubMed, six of them entries in our study library, and FDA, FTC, and UK regulatory documents. The clinic figures come from our own dataset of clinic pages, as of October 4, 2026 (174 readable pages), the searches were run on October 2, 2026, and the library study details come from our study cards, each quoted from the paper. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: Has EBO2 been studied for autoimmune disease?
A: No. We found no study that gave EBO2 (EBOO) to people with an autoimmune disease. The ozone studies that exist used other methods: major autohemotherapy, in which about 100 mL of blood is mixed with ozone in a bottle and returned, rectal insufflation, or ozone gas applied to skin ulcers. Most are small, uncontrolled, and measure laboratory markers.

Q: Does ozone therapy help multiple sclerosis?
A: No study has shown an effect on relapses or disability. The two MS studies in our library treated 20 patients with ozone autohemotherapy for six months and reported changes in immune-cell markers, comparing patients mainly with their own earlier results. The FDA-approved MS drugs that NIH describes were tested on relapse rates, disability progression, and brain lesions.

Q: Is there any evidence for ozone in rheumatoid arthritis?
A: One small randomized trial from Cuba, published in 2016, gave 60 people methotrexate with or without rectal ozone for 20 days and reported lower disease activity with ozone added. It did not use EBO2, describes no sham procedure in its abstract, and comes from a single research group working with a German ozone-therapy society. We found no independent replication.

Q: Can I have EBO2 while taking biologics or immunosuppressants?
A: No study has looked at this. None of the ozone studies we read enrolled people on biologic drugs or examined interactions. The 2021 American College of Rheumatology guideline addresses the use of disease-modifying drugs in people with a history of serious infections, which is one reason to raise any blood-handling procedure with the physician who prescribes them.

Q: Is plasma exchange the same as EBO2?
A: No. Plasma exchange removes and replaces plasma, and the American Society for Apheresis grades the evidence for it and related procedures disease by disease: its 2026 edition has 93 fact sheets with 183 graded indications. We found no comparable evidence grading for EBO2 by any professional body.

Sources:
[1] Autoimmune Diseases. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH), 2023. https://www.niams.nih.gov/health-topics/autoimmune-diseases
[2] Multiple Sclerosis. National Institute of Neurological Disorders and Stroke (NIH), 2025. https://www.ninds.nih.gov/health-information/disorders/multiple-sclerosis
[3] Lupus: Diagnosis, Treatment, and Steps to Take. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH), 2022. https://www.niams.nih.gov/health-topics/lupus/diagnosis-treatment-and-steps-to-take
[4] Sjögren's Disease: Diagnosis, Treatment, and Steps to Take. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH), 2024. https://www.niams.nih.gov/health-topics/sjogrens-disease/diagnosis-treatment-and-steps-to-take
[5] Rheumatoid Arthritis: Diagnosis, Treatment, and Steps to Take. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH), 2022. https://www.niams.nih.gov/health-topics/rheumatoid-arthritis/diagnosis-treatment-and-steps-to-take
[6] 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis & Rheumatology (PubMed), 2021. https://pubmed.ncbi.nlm.nih.gov/34101376/
[7] Changes in Th17 cells frequency and function after ozone therapy used to treat multiple sclerosis patients. Multiple Sclerosis and Related Disorders (PubMed), 2020. https://pubmed.ncbi.nlm.nih.gov/32862036/
[8] The effects of oxygen-ozone therapy on regulatory T-cell responses in multiple sclerosis patients. Cell Biology International (PubMed), 2021. https://pubmed.ncbi.nlm.nih.gov/33724614/
[9] Sjögren syndrome successfully treated with oxygen-ozone auto-hemotherapy (O2-O3-AHT). A case report. European Review for Medical and Pharmacological Sciences (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/36066166/
[10] Associations between particulate matter air pollutants and hospitalization risk for systemic lupus erythematosus: a time-series study from Xi'an, China. Environmental Geochemistry and Health (PubMed), 2023. https://pubmed.ncbi.nlm.nih.gov/36287357/
[11] Medical ozone increases methotrexate clinical response and improves cellular redox balance in patients with rheumatoid arthritis. European Journal of Pharmacology (PubMed), 2016. https://pubmed.ncbi.nlm.nih.gov/27450487/
[12] Medical ozone promotes Nrf2 phosphorylation reducing oxidative stress and pro-inflammatory cytokines in multiple sclerosis patients. European Journal of Pharmacology (PubMed), 2017. https://pubmed.ncbi.nlm.nih.gov/28623000/
[13] Ozone autohemotherapy induces long-term cerebral metabolic changes in multiple sclerosis patients. International Journal of Immunopathology and Pharmacology (PubMed), 2014. https://pubmed.ncbi.nlm.nih.gov/25280029/
[14] The right therapeutic method of ozone therapy used to treat multiple sclerosis patients. Multiple Sclerosis and Related Disorders (PubMed), 2020. https://pubmed.ncbi.nlm.nih.gov/33022586/
[15] Non-invasive Oxygen-Ozone therapy in treating digital ulcers of patients with systemic sclerosis. Acta Reumatologica Portuguesa (PubMed), 2018. https://pubmed.ncbi.nlm.nih.gov/30414369/
[16] Efficacy of local oxygen-ozone therapy for the treatment of digital ulcer refractory to medical therapy in systemic sclerosis: a randomized controlled study. Modern Rheumatology (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/34865095/
[17] Oxygen-ozone autohaemotherapy in fibromyalgia: safety profile and adverse events. A scoping review. Clinical and Experimental Rheumatology (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42328943/
[18] The ozone paradox: ozone is a strong oxidant as well as a medical drug. Medicinal Research Reviews (PubMed), 2009. https://pubmed.ncbi.nlm.nih.gov/19260079/
[19] Guidelines on the Use of Therapeutic Apheresis in Clinical Practice: Evidence-Based Approach From the Writing Committee of the American Society for Apheresis, The Tenth Special Issue. Journal of Clinical Apheresis (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42747330/
[20] Treatment and Intervention for Lyme Disease. CDC, 2026. https://www.cdc.gov/lyme/treatment/index.html
[21] ASA Ruling on The Detox Clinic Ltd. Advertising Standards Authority (UK), 2022. https://www.asa.org.uk/rulings/the-detox-clinic-ltd-a21-1119332-the-detox-clinic-ltd.html
[22] Health Products Compliance Guidance. Federal Trade Commission, 2022. https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance
[23] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[24] Lupus (Systemic Lupus Erythematosus). National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIH), 2022. https://www.niams.nih.gov/health-topics/lupus

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# EBO2 (EBOO) for Long COVID: What Clinics Claim and What Has Been Studied

Source: https://ebo2.com/guides/ebo2-for-long-covid/
Updated: 2026-10-04

Key takeaways:
- As of October 4, 2026, 48 of the 174 clinics whose EBO2 pages we could read claim a benefit for long COVID, usually in a list that also names conditions such as Lyme disease, mold illness, or autoimmune disease.
- No published study has given EBO2 to people with long COVID. The post-COVID studies in our library used major ozone autohemotherapy, a batch method that treated 100 to 200 mL of blood per session where the papers report it.
- The only randomized trial, a 73-patient pilot, compared ozone plus conventional therapy with conventional therapy alone, with no sham procedure described, and its authors say the findings need validation.
- In 2020 the FTC told ozone marketers their COVID-19 claims lacked competent and reliable scientific evidence, and a federal court barred a Dallas center from making them.
- CDC and NIH say there are no approved treatments for long COVID. NIH's placebo-controlled RECOVER trials have tested other options, and none involved ozone.

If a clinic has offered EBO2 (also called EBOO) for long COVID, this guide is for checking that offer against the record: what clinics' own pages claim, what has been studied and how, what regulators have said, and what US health agencies describe as care. The short answer is that no published study has given EBO2 to people with long COVID. The studies that exist tested a different ozone method, the only randomized one was a 73-patient pilot with no sham comparison described, and CDC states that there are no approved treatments for long COVID [3]. A list of questions to take to a clinic, and the searches we ran so the check can be repeated, are near the end. For a description of the procedure itself, see what EBO2 is (/what-is-ebo2/).

What clinics' EBO2 pages say about long COVID

We read the EBO2 pages of the clinics in our directory (/clinics/) and recorded, with the clinic's own words, whether each page claims a health benefit and for what. As of October 4, 2026, we could read the pages of 174 clinics. 163 of them claim at least one health benefit, and 48 claim one for long COVID or lingering symptoms after COVID-19. The counts here and in the "From our data" section below are computed from the current records each time the site is built.

Within those 48 clinics:

Long COVID is rarely claimed on its own. Of the 46 whose recorded wording names long COVID, post-COVID symptoms, or "long haul" COVID, 36 name it in the same sentence or list as other conditions, such as Lyme disease, mold illness, chronic fatigue, or autoimmune disease. 42 of the 48 also claim a benefit for Lyme disease or mold illness, and 37 for autoimmune conditions.
Most pages do not say whether EBO2 is FDA-approved. 35 of the 48 EBO2 pages do not say whether EBO2 or its equipment is FDA-approved. 10 say EBO2 is not FDA-approved, and 3 say their equipment is FDA-cleared, registered, or approved, which is a statement about a device rather than about the treatment; is EBO2 FDA approved (/guides/is-ebo2-fda-approved/) and our guide to EBOO devices and FDA status (/guides/eboo-devices-and-fda-status/) explain the difference.
12 of the 48 pages carry patient testimonials, which report experiences and are not evidence of effect.

We save up to four quotes per clinic, so counts drawn from the wording are a floor. We publish these claims only as counts, never clinic by clinic. A claim on a clinic's page is the clinic's statement, not a finding. To compare what clinics say about price, session length, and supervision, see the clinic transparency report (/reports/clinic-transparency/); our guide to reading a clinic's EBO2 page (/guides/how-to-read-a-clinic-ebo2-page/) covers the wording to look for.

What the studies in our library tested

None of the post-COVID studies in our research library (/research/) used EBO2. The six entries our library tags as EBOO studies are listed with their procedures in the "From our data" table below, and none of them reports on people with COVID-19 or long COVID; the 2023 ozone-uptake series (/research/rowen-2023-ozone-dialysis-uptake/) among them does not say what its 12 patients were treated for. The three post-COVID studies we hold used major ozone autohemotherapy (/glossary/#mah), in which a fixed volume of blood is drawn into a bottle or bag, mixed with ozone-oxygen gas, and returned through the vein. Two more entries cover COVID-19 itself: an evidence map, in the table, and an umbrella review, described after it.

| Study | Design | Who took part | What was measured | Result, as the paper reports it | Limits |
|---|---|---|---|---|---|
| He 2024 (/research/he-2024-ozone-pasc-rct/) [9] | Randomized controlled pilot trial, one hospital in Wuhan, China | 73 adults with post-acute sequelae of COVID-19: 35 given autohemotherapy plus conventional therapy, 38 conventional therapy alone | Share with at least a 50% drop in symptom score; lung function; 6-minute walk; blood markers | 25 of 35 (71%) responded with ozone added, 17 of 38 (45%) without (P = 0.0325) | Comparison group got conventional therapy alone, with no sham procedure or blinding described in the abstract; dose, schedule, and the conventional therapy are not described there; we have read the abstract only |
| Tirelli 2021 (/research/tirelli-2021-ozone-pasc-fatigue-cohort/) [10] | Case series at two Italian clinics, no comparison group | 100 adults with post-COVID fatigue | Fatigue Severity Scale, at least a week after treatment | Fatigue scores fell by a mean of 67%; the authors say about 40% "quite completely recovered" | No control group; authors include members of the Italian oxygen-ozone therapy society (SIOOT); the authors write that confounders "should be statistically calculated and reported"; no adverse events reported |
| Kuculmez 2026 (/research/kuculmez-2026-ozone-post-covid-cohort/) [11] | Retrospective review of hospital records, one university hospital in Türkiye | 40 adults with musculoskeletal symptoms lasting at least 12 weeks after confirmed COVID-19 (45 enrolled, 5 excluded for missing data) | Fatigue, anxiety, depression, sleep, and quality-of-life questionnaires before and after 10 sessions | Fatigue score median 31.0 before and 9.5 after (p = 0.001), on a scale the paper says rises with fatigue; most other scores also improved | No control group; the author names the small sample, the retrospective design, and the missing control group as limits; adverse events not reported |
| Serra 2023 (/research/serra-2023-ozone-covid-evidence-gaps-map/) [12] | Evidence and gaps map | 13 studies with 271 patients who had COVID-19 itself | Which outcomes the studies reported | Lists outcomes such as symptom improvement and lower C-reactive protein, without effect sizes | Excluded post-COVID studies by design, listing the Tirelli series among them; no meta-analysis or risk-of-bias assessment; authors affiliated with the Brazilian Society of Medical Ozone Therapy and the World Federation of Ozone Therapy |

For COVID-19 itself, rather than its aftermath, the newest synthesis in our library is a 2026 umbrella review of meta-analyses of randomized trials [24]. For COVID-19 it found lower PCR positivity at follow-up, which the authors judged a non-important surrogate outcome, and no significant benefit for hospital stay, intensive-care admission, or death, with the certainty of the evidence rated low or very low [24]. None of the seven meta-analyses it included concerned long COVID [24].

One newer study is not yet in our library. A 2026 open-label study from Murcia, Spain gave rectal ozone insufflation (/glossary/#insufflation) for 12 weeks to 23 people who had had long COVID for more than five months, and reported better handgrip strength and quality-of-life scores at 6 weeks, with no further significant change between weeks 6 and 12 [13]. Its own summary says there was no control group, so the authors cannot say ozone caused the improvements [13].

No study used EBO2, and none compared ozone with a sham or placebo procedure, so the effect of expecting to feel better, and of the attention that comes with repeated visits, cannot be separated from any effect of ozone. None of the papers we read reports adverse events in people with long COVID; the He trial's full text, which we have not read, may. Our compilation of ozone therapy adverse events (/guides/ozone-therapy-adverse-events/) covers what has been reported for blood-based ozone methods in other patients.

How EBO2 differs from the method these studies used

In the Kuculmez study each session drew 100 mL of blood into a citrated bottle, mixed it with an equal volume of ozone-oxygen gas, and returned it through the vein within 15 minutes [11]. The Tirelli series treated 150 to 200 mL per session [10]. EBO2 instead circulates blood continuously through an extracorporeal (/glossary/#extracorporeal) circuit, as what EBO2 is (/what-is-ebo2/) describes, and the one EBOO case report in our library describes about 2 liters of blood processed in each treatment under that clinic's protocol [14]. A result from autohemotherapy, positive or negative, does not tell us what a procedure that handles ten to twenty times as much blood does. Our comparison of EBO2 and 10-pass ozone (/guides/ebo2-vs-10-pass-ozone/) covers the other ozone methods.

What regulators have said about ozone and COVID-19

No regulatory record in our tracker (/reports/regulatory-tracker/) addresses long COVID by name. The records that exist concern COVID-19 claims made in 2020, and they set out the standard any health claim is held to.

FTC, April 2020. In its third set of COVID-19 warning letters, the Federal Trade Commission said the targets included treatments "that may appear more medically sophisticated to consumers, such as acupuncture, intravenous (IV) 'therapies' with high doses of Vitamin C, ozone therapy, and purported stem cell treatments" [15]. Three recipients were grouped under ozone therapy, and a fourth, grouped with IV therapies, had ozone therapy among the services named [15].
FTC letter to a Santa Rosa, California clinic, April 10, 2020. The letter cites the clinic's "Treating Coronavirus" page and states the legal standard: health claims need "competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies" [16]. It continues: "For COVID-19, no such study is currently known to exist for the services identified above" [16]. It also told the clinic to review all its other claims against the same standard [16].
FDA and FTC, June 30, 2020. A joint warning letter to a clinic in Soquel, California lists, among claims "not supported by competent and reliable scientific evidence", a weekly injection of "a small amount of your own blood, mixed with saline and ozone" [17].
FTC, November 2020. Announcing its ninth set of letters, which brought the total to more than 330 recipients, the FTC said of the products and therapies involved, ozone therapy among them, that "currently there is no scientific evidence that these products or services can prevent or treat the disease" [18].
Department of Justice, April 24, 2020. A federal court in the Northern District of Texas entered an agreed permanent injunction barring a Dallas ozone center and one of its principals from representing that ozone could be used to treat COVID-19 [19]. Court filings alleged the center had called its treatments 95 percent effective; the Justice Department notes these were allegations [19].
Italy, March 26, 2020. Italy's national public health institute, the Istituto Superiore di Sanità, answered press reports that it had approved ozone therapy for COVID-19 by saying it had issued no such authorization and that the evidence offered should be confirmed in a trial authorized by the Italian Medicines Agency [20].

Behind all of these sits the FDA's device rule, which states: "Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [21]. The same rule considers an ozone-generating device adulterated or misbranded when it is used "in any medical condition for which there is no proof of safety and effectiveness" [21]. Ozone therapy is not FDA-approved for long COVID or for any other condition.

What CDC describes as care for long COVID

This section describes what CDC tells clinicians; it is information, not a treatment plan. CDC defines long COVID as an infection-associated chronic condition that can follow SARS-CoV-2 infection and lasts at least three months, affecting one or more organ systems [1]. Its possible causes, in CDC's list, include organ damage from the acute infection, a dysregulated inflammatory state, microvascular dysfunction, persisting virus, autoimmunity, and an inadequate antibody response [1].

On diagnosis, CDC states: "Currently, no laboratory test can be used to definitively diagnose or rule out Long COVID or to distinguish Long COVID from conditions with different etiologies" [2]. On treatment, its page for the public says living with long COVID is harder because "there are no approved tests that can determine if your symptoms or conditions are due to Long COVID and there are no approved treatments" [3]. NIH wrote in October 2024 that "there are no approved therapies to treat Long COVID or its symptoms" [4].

What CDC describes instead is symptom-based care. For most patients, it says, the goal "is to optimize function and quality of life through established symptom management approaches", including focusing on the symptoms the patient finds most burdensome, a rehabilitation plan, management of underlying conditions, and symptom diaries [2]. It adds that treatment "should be tailored to a patient's specific symptoms or conditions, including FDA-approved or over-the-counter medications" [2]. CDC singles out post-exertional malaise, the worsening of symptoms "following even minor physical or mental exertion", which typically appears 12 to 48 hours later and can last days or weeks [2]. It also points clinicians to approaches used for conditions with overlapping symptoms, among them myalgic encephalomyelitis/chronic fatigue syndrome, fibromyalgia, and post-treatment Lyme disease syndrome; our Lyme disease guide (/guides/ebo2-for-lyme-disease/) covers the last [2].

What NIH's long COVID trials are testing

NIH launched its RECOVER Initiative in 2021 [4], and its trials show what a test of a long COVID treatment looks like. RECOVER-VITAL randomized 963 people to a 15- or 25-day course of the antiviral Paxlovid or to placebo, with participants, care providers, and investigators all kept unaware of who got what [7]. RECOVER-NEURO enrolled 328 people to test a brain-training program, a goal-management program, and a brain-stimulation device against an active comparison activity and a sham device [8]. RECOVER-AUTONOMIC was designed to assign people with postural orthostatic tachycardia syndrome after COVID-19 at random to intravenous immunoglobulin, the heart-rate drug ivabradine, or placebo [6]. RECOVER-SLEEP compares two wakefulness drugs with placebo, and melatonin and bright light therapy with placebo and low-intensity light [5]. RECOVER-ENERGIZE compares personalized cardiopulmonary rehabilitation with basic exercise education, screening out people with post-exertional malaise, and for those who have it compares structured pacing with basic education about the condition [5]. NIH wrote that "structured pacing is the only intervention used to treat PEM" [5].

None of these trials involves ozone. Their sizes and controls are the contrast that matters: the largest ozone study after COVID-19 had 100 participants and no comparison group [10], and the only randomized one had 73 and no sham [9]. NIH's next phase, RECOVER-TLC, announced in 2024, says it will assess new ideas and run further trials, and it asked for ideas for therapeutics to be submitted [4]. ClinicalTrials.gov, the registry where these trials are listed, shows which are recruiting.

Questions to ask a clinic that offers EBO2 for long COVID

These are questions, not a verdict on any clinic. Our questions for your doctor (/tools/doctor-questions/) tool builds a printable list.

Which study supports EBO2 for long COVID? If the answer is the Wuhan pilot or the Italian case series, did either use EBO2? (Neither did.)
How was long COVID diagnosed, given CDC's statement that no laboratory test can confirm or rule it out [2]?
What will be measured before and after the sessions, and at what point would the clinic recommend stopping?
How many sessions are planned, what is the total cost in writing, and what is refunded if sessions are stopped? The session cost planner (/tools/session-cost/) and price check (/tools/price-check/) help with the arithmetic.
How does the schedule account for post-exertional malaise, if it applies?
Which anticoagulant is used in the circuit, and has it been checked against current medications? Our guide to EBOO, blood thinners, and medications (/guides/eboo-blood-thinners-and-medications/) covers what to ask.
Who supervises the session, and what happens if a reaction occurs? The contraindications guide (/guides/contraindications/) lists what clinics screen for, and the side effects guide (/guides/side-effects-and-safety/) covers reported reactions.

How to check a clinic's study citation yourself

We ran these searches on October 2, 2026; anyone can repeat them for free.

Europe PMC, the free index that includes PubMed. Searching titles and abstracts with `TITLE_ABS:(EBOO OR "extracorporeal blood oxygenation") AND TITLE_ABS:(COVID OR "SARS-CoV-2" OR coronavirus)` returned one record, a 2020 review of drug targets for coronavirus infection; no study gave EBOO to people with COVID-19 or long COVID.
Europe PMC, ozone and long COVID: `TITLE_ABS:(ozone) AND TITLE_ABS:("long COVID" OR "post-COVID" OR "post-acute sequelae" OR PASC)` returned 22 records. Four are clinical studies of ozone therapy after COVID-19: the three in the table above and the Murcia study. The rest were a preprint of the Wuhan trial, a letter, reviews, and air-pollution research.
Europe PMC, spike protein: `TITLE_ABS:"spike protein" AND TITLE_ABS:("ozone therapy" OR EBOO OR autohemotherapy OR ozonation)` returned one record when we re-ran it on October 3, 2026: a 2022 review of oxygen-ozone in COVID-19, which did not measure spike protein after a treatment.
ClinicalTrials.gov. With "long COVID" as the condition and "ozone" as the intervention, the registry returned no studies. With "COVID-19" as the condition it returned 10, one of them about air pollution, and none with results posted. Two of the 10 concern lasting effects after COVID-19: an inhaled "ozone plasma" study in Mexico, last updated in 2021 [22], and an observational study in Türkiye. "EBOO" as an intervention returned none.

A clinic that cites a study should be able to give its title or PubMed number. The test is whether that study enrolled people with long COVID, used EBO2, and compared it with something.

What we could not verify

The He trial's full text, which would show the ozone dose and schedule, what "conventional therapy" included, whether assessors were blinded, and any adverse events. We read the abstract only [9].
A randomized study of 140 people with post-COVID syndrome, cited in the Kuculmez paper as comparing drug treatment with and without ozone [11]. We have not found or read it.
A 2024 letter commenting on the use of ozone in post-COVID patients, published in the journal that carried the Wuhan trial. Its authors include authors of the Tirelli series and members of SIOOT, and PubMed holds no abstract for it [23]. We have not read it.
Whether any clinic tracks outcomes in its long COVID patients. Our dataset records what clinics claim, not results, and we found no clinic outcome data.
How EBO2 sessions affect people with post-exertional malaise. Nothing we found measured it.

How this guide was made

This guide rests on 24 sources: CDC and NIH pages, ClinicalTrials.gov records, five peer-reviewed studies, an evidence map, an umbrella review, a published letter, and primary regulatory documents from the FTC, FDA, Justice Department, the eCFR, and Italy's national health institute. The clinic figures come from our own dataset of clinic pages, as of October 4, 2026 (174 readable pages), the searches were run on October 2, 2026, with the spike-protein search re-run on October 3, and the study details come from our study cards, each quoted from the paper. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: Has EBO2 been studied for long COVID?
A: No. We found no published study that gave EBO2 (EBOO) to people with long COVID. On October 2, 2026, a Europe PMC search of titles and abstracts for EBOO with COVID terms returned one record, a 2020 review, and ClinicalTrials.gov listed no registered EBOO trial of any kind. The post-COVID studies that do exist used major ozone autohemotherapy or rectal ozone, which are different procedures.

Q: What did the ozone trial for long COVID find?
A: A 2024 pilot trial in Wuhan, China randomized 73 people with post-acute sequelae of COVID-19 to major ozone autohemotherapy plus conventional therapy or to conventional therapy alone. 25 of 35 in the ozone group and 17 of 38 in the comparison group had at least a 50% drop in symptom score. The comparison group had no sham procedure described in the abstract, the trial did not test EBO2, and the authors wrote that further research is needed to validate the findings.

Q: Is ozone therapy FDA-approved for long COVID?
A: No. Ozone therapy is not FDA-approved for long COVID or for any other condition. The FDA device rule at 21 CFR 801.415 calls ozone a toxic gas with no known useful medical application, and CDC states that there are no approved treatments for long COVID at all.

Q: Can EBO2 remove spike protein?
A: We found no study that measured spike protein in people after EBO2 or any other ozone therapy. A Europe PMC search of titles and abstracts for spike protein with ozone therapy or EBOO returned one record on October 3, 2026, a 2022 review of oxygen-ozone in COVID-19, which did not measure spike protein after a treatment.

Q: Where can I find a long COVID clinical trial?
A: NIH runs its long COVID treatment trials through the RECOVER Initiative, and registered trials, including RECOVER's, are listed on ClinicalTrials.gov with their enrollment status and sites. Searching ClinicalTrials.gov for the condition 'long COVID' shows which trials are recruiting near a given location.

Q: Could an EBO2 session worsen post-exertional malaise?
A: No study has measured this. CDC describes post-exertional malaise as symptoms that typically worsen 12 to 48 hours after even minor physical or mental exertion and can last days or weeks. How a person's pattern of post-exertional malaise fits with repeated hour-long clinic sessions is a fair question for the clinic and for the clinician who manages the condition.

Sources:
[1] Clinical Overview of Long COVID. CDC, 2026. https://www.cdc.gov/long-covid/hcp/clinical-overview/index.html
[2] Long COVID Clinical Guidance. CDC, 2026. https://www.cdc.gov/long-covid/hcp/clinical-guidance/index.html
[3] Long COVID Basics. CDC, 2026. https://www.cdc.gov/long-covid/about/index.html
[4] NOT-AI-25-007: Request for Information (RFI): Researching COVID to Enhance Recovery Treating Long COVID (RECOVER-TLC). National Institutes of Health, 2024. https://grants.nih.gov/grants/guide/notice-files/NOT-AI-25-007.html
[5] NIH to open long COVID clinical trials to study sleep disturbances, exercise intolerance, and post exertional malaise. National Institutes of Health, 2024. https://www.nih.gov/news-events/news-releases/nih-open-long-covid-clinical-trials-study-sleep-disturbances-exercise-intolerance-post-exertional-malaise
[6] NIH opens long COVID trials to evaluate treatments for autonomic nervous system dysfunction. National Institutes of Health, 2024. https://www.nih.gov/news-events/news-releases/nih-opens-long-covid-trials-evaluate-treatments-autonomic-nervous-system-dysfunction
[7] RECOVER-VITAL: Platform Protocol to Measure the Effects of Antiviral Therapies on Long COVID Symptoms (NCT05595369). ClinicalTrials.gov, 2026. https://clinicaltrials.gov/study/NCT05595369
[8] RECOVER-NEURO: Platform Protocol to Measure the Effects of Cognitive Dysfunction Interventions on Long COVID Symptoms (NCT05965752). ClinicalTrials.gov, 2026. https://clinicaltrials.gov/study/NCT05965752
[9] A pilot randomized controlled trial of major ozone autohemotherapy for patients with post-acute sequelae of COVID-19. International Immunopharmacology (PubMed), 2024. https://pubmed.ncbi.nlm.nih.gov/39018686/
[10] Fatigue in post-acute sequelae of SARS-CoV2 (PASC) treated with oxygen-ozone autohemotherapy, preliminary results on 100 patients. European Review for Medical and Pharmacological Sciences (PubMed), 2021. https://pubmed.ncbi.nlm.nih.gov/34604980/
[11] Efficacy of major ozone autohemotherapy in patients with post-COVID syndrome. Frontiers in Medicine (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/41767530/
[12] Clinical effectiveness of medical ozone therapy in COVID-19: the evidence and gaps map. Medical Gas Research (PubMed), 2023. https://pubmed.ncbi.nlm.nih.gov/37077114/
[13] Ozone therapy by rectal insufflation in long COVID syndrome: a preliminary study with thermographic evaluation and quality of life measurement. Future Science OA (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42478179/
[14] Observed Reduction in Urinary Toxin Excretion With Extracorporeal Blood Oxygenation and Ozonation (EBOO) Treatment in an 88-Year-Old With Chronic Anemia: A Case Report. Cureus (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/41583215/
[15] FTC Sends 21 Letters Warning Marketers to Stop Making Unsupported Claims That Their Products and Therapies Can Effectively Treat Coronavirus. Federal Trade Commission, 2020. https://www.ftc.gov/news-events/news/press-releases/2020/04/ftc-sends-21-letters-warning-marketers-stop-making-unsupported-claims-their-products-therapies-can
[16] Warning Letter to RowenSu Clinic: Unsubstantiated Claims for Coronavirus Treatment. Federal Trade Commission, 2020. https://www.ftc.gov/system/files/warning-letters/covid-19-letter_to_rowensu.pdf
[17] Warning letter to Center for Wellness and Integrative Medicine (MARCS-CMS 608693). FDA and Federal Trade Commission, 2020. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/center-wellness-and-integrative-medicine-608693-06302020
[18] FTC Sends Letters Warning 20 More Marketers to Stop Making Unsupported Claims That Their Products and Therapies Can Effectively Prevent or Treat COVID-19. Federal Trade Commission, 2020. https://www.ftc.gov/news-events/news/press-releases/2020/11/ftc-sends-letters-warning-20-more-marketers-stop-making-unsupported-claims-their-products-therapies
[19] Court Prohibits Dallas Health Center from Touting "Ozone Therapy" as a COVID-19 Treatment. U.S. Department of Justice, 2020. https://www.justice.gov/archives/opa/pr/court-prohibits-dallas-health-center-touting-ozone-therapy-covid-19-treatment
[20] CS N° 25/2020: Ozonoterapia, non rientra nei compiti dell'ISS autorizzare sperimentazioni. Istituto Superiore di Sanità, 2020. https://www.iss.it/en/coronavirus/-/asset_publisher/1SRKHcCJJQ7E/content/id/5313647
[21] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[22] Effect of Inhalation Administration of Ozone Plasma on Lung Function and Inflammatory Parameters in Patients With Pulmonary Sequelae Associated With Coronavirus 19 Infection (NCT05089305). ClinicalTrials.gov, 2021. https://clinicaltrials.gov/study/NCT05089305
[23] Comments on the use of ozone therapy in post-acute sequelae of COVID-19 (PASC) patients. International Immunopharmacology (PubMed), 2024. https://pubmed.ncbi.nlm.nih.gov/39098230/
[24] Effectiveness and Safety of Ozone Therapy in Humans: An Umbrella Review of Systematic Reviews with Meta-Analyses of Randomized Clinical Trials. Medical Sciences (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42346828/

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# EBO2 (EBOO) for Longevity: What the Aging Research Does and Does Not Show

Source: https://ebo2.com/guides/ebo2-for-longevity/
Updated: 2026-10-04

Key takeaways:
- No study in our library tested EBO2, or any ozone therapy, against lifespan, a validated aging clock, or the rate of age-related disease. The anti-aging case is a mechanism argument, not an outcome.
- The ozone-and-aging review most often cited pooled biomarker studies, in people for its main antioxidant analysis and with cell and animal samples mixed in for a second, reported very high heterogeneity, and described itself as building a rationale for future clinical studies.
- The trial those authors announced was registered, completed in November 2023, and has published a protocol but, as of October 2, 2026, no results. It used rectal insufflation, not blood filtration.
- The hormesis review in our library is about aging biology, antioxidant supplements, and calorie restriction. Its abstract does not mention ozone at all, so it cannot support an ozone claim.
- Regulators have acted on anti-aging and wellness wording rather than ignoring it: a UK ruling ordered ozone efficacy claims withdrawn, and Health Canada said no evidence had been submitted for ozone device treatment claims.

EBO2 (also called EBOO) is sold at longevity and biohacking clinics as a way to slow aging from the inside, usually alongside a mechanism story about controlled oxidative stress. This guide does something the sales pages do not: it reads the two aging papers that story rests on, says exactly what each one measured, follows the clinical trial those authors announced to see what became of it, sets the regulators' wording on anti-aging claims next to it, and gives you the questions that separate a mechanism from a result. Nothing here says EBO2 does or does not affect aging; nothing published lets anyone say that.

The answer first

As of October 2, 2026, our research library holds no study, of EBO2 or of any other ozone therapy, that measured lifespan, a validated aging clock, or the rate of age-related disease in people. What exists is a mechanism literature about how ozone interacts with an antioxidant signalling pathway, almost all of it in cells, animals, or short-term blood markers. A mechanism is a reason to run a trial. It is not the trial.

What the two aging papers in our library actually say

Longevity marketing for ozone generally traces back to two kinds of paper. The first is the "ozone paradox" argument: prolonged ozone inhalation is harmful, while a single, carefully calibrated dose dissolved in blood outside the body is proposed to trigger a controlled burst of oxidative stress (/glossary/#oxidative-stress) that the body answers with antioxidant and repair responses [5]. The second is the hormesis literature in the biology of aging. Both are in our library, and neither does the work the marketing asks of it.

Mehdi 2021 (/research/mehdi-2021-hormesis-aging-review/) is a review of aging biology covering oxidative damage at the molecular, mitochondrial, cellular, and organ level, and discussing antioxidant supplementation, hormesis, and calorie restriction as anti-aging strategies [2]. Its abstract does not mention ozone, EBO2, or any ozone method anywhere. It is a legitimate source for the idea that a controlled stress can provoke a protective response. It is not a source for any claim about this procedure, and a clinic page that cites hormesis in general has not cited evidence about the treatment it is selling.

Scassellati 2020 (/research/scassellati-2020-ozone-nrf2-aging-review/) is the paper that makes the ozone-specific argument. It proposes that ozone interacts with Nrf2 (/glossary/#nrf2), a transcription factor that switches on a cell's own antioxidant genes, and pools biomarker studies to support that. Read closely, it describes its own standing plainly. Its stated aim is "a potential new strategy to delay neurodegeneration", and its conclusion is that, "With the awareness that further studies are needed, this review reports substantial scientific evidence for building a rationale of using the O2-O3 therapy to delay aging processes and neurodegeneration" [1]. A rationale for use is not a demonstration of effect, and the authors say so.

Three details about its meta-analysis matter for anyone deciding what it proves.

| What the review reports | The figure it gives | Why it limits the conclusion |
|---|---|---|
| Effect of ozone on the endogenous antioxidant-Nrf2 system, pooled from human studies | Odds ratio 1.71, 95% confidence interval 1.17 to 2.25, p < 0.00001 [1] | The outcome is a set of oxidative-stress biomarkers, not a clinical event or any measure of aging |
| Heterogeneity across the pooled studies | p < 0.00001, I² = 97% [1] | At that level the studies disagree so much that a single pooled number says little about any one setting |
| What the review says explains that heterogeneity | "the type of pathology, different concentration of O3 linked to different administration procedures and duration time treatments, age of the sample" [1] | The pooled studies differ in disease, dose, route, length of treatment, and age, so the single figure averages across settings that are not alike |

A second pooled analysis in the same review, of the Nrf2, HO-1, and Hsp70 molecules (odds ratio 1.80), combines human, cell, and animal samples; the review attributes its heterogeneity, I² = 66%, to "different sources of samples (human, cell and animal models) and different methodology" [1]. That figure mixes laboratory and animal results with human ones, so it is not a human clinical finding either.

The review also carries a safety sentence that gets quoted on clinic pages: "The side effects are minimal; the World Federation of Ozone therapy (WFOT) estimates the incidence of complications at 0.0007%" [1]. That is a figure the review relays from an ozone-therapy trade body, not a rate the review measured, and no method for it is given. One of the review's authors is affiliated with an oxygen-ozone therapy scientific society, which is a declared position worth weighing rather than a disqualification; the paper states that the authors declared no conflict of interest and that the work was supported by grants from the Italian Ministry of Health [1].

What happened to the trial that review announced

This is the part that is usually missing from pages citing the Nrf2 argument. In 2020 the review's authors wrote that they had begun a randomized double-blind trial to test the therapy in a cognitive frailty cohort [1]. We followed it.

The trial is registered as NCT06071611, "Cognitive Frailty and Oxygen-ozone Therapy", sponsored by the institute where the review's first author works. The registry record lists an actual start in July 2019, an actual enrollment of 75 older people, randomized, double-blind, with three arms, and an actual completion date of November 17, 2023. When we read the record on October 2, 2026, it carried no posted results [4]. A protocol paper appeared in 2024 setting out the design and the endpoints, from frailty indices and memory tests to transcriptomic, proteomic, and metabolomic markers at 3, 9, and 15 months [3]. Searching the biomedical literature for the registration number, the authors, and the subject on the same date returned that protocol and a preprint of it, and no results paper.

One detail in the protocol deserves attention from anyone considering EBO2 specifically. The treatment arm was not blood filtration or anything resembling it. Participants received "a total amount of 150 cc of O2-O3 mixture at the concentration of 30 µg of O3 per cc of O2" by rectal insufflation, three sessions a week for five weeks, against pure oxygen and against air [3]. The flagship aging trial in this field used a route, a dose, and a schedule that have nothing in common with passing several litres of blood through an external circuit. Whatever it eventually reports will not be evidence about EBO2.

What clinics say, in the aggregate

Our directory records what each clinic states about EBO2 on its own website, with the quote and the page. As of October 4, 2026, of the 174 clinics whose EBO2 page we could read, 56 state a longevity or anti-aging benefit. That is one of the ten claim categories we record, and it sits on the same pages as claims about detoxification (the most common, at 151), energy or fatigue (133), infections, autoimmune conditions, and circulation. The block below shows every category with its count and the same denominator. We name no clinic in connection with a claim; the point is the pattern, which is that about a third of these clinics advertise an anti-aging benefit that has not been studied.

Two kinds of supporting material appear on some of those pages. One is the mechanism language above, cited to reviews rather than to trials. The other is before-and-after blood work, which is where the next section comes in.

Biomarker panels are a measurement, not an outcome

Some clinics point to inflammatory markers, blood counts, or a proprietary "biological age" score taken before and after a course. Four problems recur, and each one is a question you can ask.

A marker is a surrogate. Blood pressure and LDL cholesterol earned their status as stand-ins for outcomes through decades of studies linking them to events. Most panels sold in longevity medicine have not been through that, so a movement in the number has no established meaning for how long or how well someone lives.
Values move on their own. Hydration, a recent meal, sleep, a minor infection, and ordinary assay variation all shift results between two draws.
Extreme first readings drift back toward the middle on a second measurement whatever happened in between, so a single before-and-after pair cannot distinguish that drift from a treatment effect.
Many "biological age" scores are proprietary, meaning the company selling the test also defines the score, and the validation is not independent.

Reporting a favourable panel is a statement about the panel. A 2026 newspaper review of wellness and longevity treatments made the same general point about this category of clinic offering, noting that mechanisms demonstrated in laboratory or animal work routinely fail to translate into demonstrated human benefit [11].

What regulators have said about this kind of claim

No regulator we have found has ruled specifically on EBO2 for anti-aging. Several have ruled on the wider class of claim, in wording worth reading directly.

| Who, when | What it concerned | The wording |
|---|---|---|
| Advertising Standards Authority, UK, 2 March 2022 | A clinic page for intravenous ozone therapy claiming raised blood oxygen, improved energy, and anti-inflammatory effects | The ruling was upheld; the ASA stated "We had not previously seen evidence that oxygen therapy had health benefits or could prevent or treat illness or disease", and told the advertiser not to repeat the claims without a substantive body of evidence including trials in people [7] |
| Health Canada, 2 November 2022 | Ozone saunas advertised for uses including detoxing | "To date, Health Canada has not received any submissions with evidence to support medical treatment claims for ozone saunas" [8] |
| Regione Toscana health council, Italy, 5 September 2006 | Which uses of oxygen-ozone therapy have an indication | Limiting indications to symptomatic disc herniation by injection, it states "Non esiste alcuna indicazione per altre affezioni": there is no indication for other conditions [9] |
| Federal Council of Medicine, Brazil, 21 August 2025 | Which uses doctors may offer | Resolution 2.445/2025 authorizes ozone therapy as an adjuvant only for specified wounds, knee osteoarthritis, and disc-related low back pain [10] |

Underneath all of this sits the United States position on the gas itself. Ozone therapy is not FDA-approved for any medical use, and the federal device labeling rule states that ozone "is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [6]. The phrase "preventive therapy" is the one that bears on a longevity sale, because prevention is exactly what an anti-aging course is sold as.

What a longevity course costs, and over how long

Longevity marketing frames EBO2 as maintenance rather than a short course for a problem, so the arithmetic that matters is annual, not per visit. The block below shows how many clinics in our directory publish a single-session price, the range, and the median, computed when the page is built. The cost of a plan is the session price times the cadence a clinic proposes, times the number of years in the plan. A 2026 report on the longevity clinic industry quoted a gerontologist's assessment that "Public enthusiasm has outpaced scientific validation", and observed that the interventions with the strongest evidence for extending healthy years, physical activity, nutrition, sleep, vaccination, and early detection of disease, tend to be the cheapest [12]. That is the comparison a multi-year protocol has to win.

Questions to ask a clinic selling this for aging

Which published study tested this procedure with an aging outcome in people, and was that outcome lifespan, disease incidence, or a marker?
Was the study you are citing done in people, in animals, or in cells, and was it this procedure or a different ozone method? The routes differ enormously, and results do not transfer between them.
Which biological age test do you use, who validated it against long-term outcomes, and in what population?
What is the recommended cadence, for how many years, and what is the total cost at your prices? The transparency block below shows how many clinics state a recommended course or a price on their page at all.
What are the stopping rules? If the panel does not move, or moves the wrong way, what changes?
Ask our questions to take to your doctor (/tools/doctor-questions/) and check a quote against published prices with the price check tool (/tools/price-check/).

What we could not verify

Whether EBO2 has any effect, in either direction, on human aging. No study exists to answer it, and this guide makes no claim about it.
Whether the completed frailty trial has results that have not yet been published, or whether they were reported somewhere our searches did not reach. We searched the trial registry and the biomedical literature by registration number, by author, and by subject on October 2, 2026, and found only the protocol.
What the clinics in the longevity count mean by anti-aging in clinical terms. We recorded what their pages state; we did not ask them, and we did not evaluate the claims.
The basis of the complication rate relayed in the 2020 review. The figure is attributed to a trade body, with no method given, and we could not trace it to a published dataset.
Whether any regulator has considered EBO2 specifically as an anti-aging treatment. The records above concern ozone therapy and ozone devices more generally.
How prices behave over a multi-year course. Our price data is a snapshot of published single-session prices and packages, not a record of what people were actually charged over years. The clinic directory (/clinics/) shows what each clinic published and when we read it.

How this guide was made

This guide draws on 12 sources: five peer-reviewed papers and trial documents, five primary regulatory records, and two news reports used only for industry context. The claim counts come from our own directory of 177 US clinics, read between September 28, 2026 and October 4, 2026, with the denominator of 174 readable EBO2 pages stated wherever a count appears; price, course, and transparency figures in the blocks below are computed from that dataset at build time. The trial status was read from the public registry record and the biomedical literature on October 2, 2026. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources. No clinical reviewer has signed off on this page yet.

FAQ:
Q: Does EBO2 slow aging?
A: No controlled study has tested it. Our library holds no study of EBO2, or of any ozone therapy, with lifespan, a validated aging biomarker, or age-related disease incidence as an outcome. The claim rests on a mechanism argument built from laboratory, animal, and biomarker work, which is a reason to run a trial rather than a result from one.

Q: What is oxidative preconditioning, and is it real?
A: It is the idea that a small, controlled oxidative stress prompts a cell's own antioxidant and repair systems to respond more strongly afterwards. Hormesis of that general kind is a mainstream idea in the biology of aging, most often illustrated with exercise and calorie restriction. That a mechanism is real in one setting does not show that a particular therapy produces it in a person, at a useful size, safely.

Q: What happened to the ozone-and-aging clinical trial?
A: The 2020 review that proposed the ozone and Nrf2 link said its authors had begun a randomized double-blind trial in people with cognitive frailty. That trial is registered as NCT06071611, enrolled 75 older people, and is listed as completed on November 17, 2023. A protocol paper appeared in 2024. We found no published results and the registry showed none when we checked on October 2, 2026.

Q: Do biological age panels show that it is working?
A: A panel measures a marker, not an outcome. Values move with hydration, recent food, illness, and ordinary day-to-day variation, and an unusually high or low first reading tends to drift back toward the middle on a second one whatever happened in between. Ask which specific test is being used, who validated it against long-term outcomes, and in whom.

Q: What would actually count as evidence?
A: A controlled trial in people, with a prespecified outcome that matters: survival, the incidence of age-related disease over years, or a change on an aging measure that has itself been validated against those outcomes, compared against a placebo or sham group. Until that exists, 'supports longevity' describes a hypothesis.

Sources:
[1] Ozone: a natural bioactive molecule with antioxidant property as potential new strategy in aging and in neurodegenerative disorders. Ageing Research Reviews (PubMed Central), 2020. https://pmc.ncbi.nlm.nih.gov/articles/PMC7428719/
[2] Oxidative stress, antioxidants, hormesis and calorie restriction: the current perspective in the biology of aging. Archives of Gerontology and Geriatrics (PubMed), 2021. https://pubmed.ncbi.nlm.nih.gov/33845417/
[3] Cognitive, Neuropsychological and Biological Effects of Oxygen-Ozone Therapy on Frailty: A Study Protocol for a 5-Week, Randomized, Placebo-Controlled Trial. Journal of Personalized Medicine (PubMed Central), 2024. https://pmc.ncbi.nlm.nih.gov/articles/PMC11355685/
[4] Cognitive Frailty and Oxygen-ozone Therapy (NCT06071611). ClinicalTrials.gov, US National Library of Medicine, 2023. https://clinicaltrials.gov/study/NCT06071611
[5] The ozone paradox: ozone is a strong oxidant as well as a medical drug. Medicinal Research Reviews (PubMed), 2009. https://pubmed.ncbi.nlm.nih.gov/19260079/
[6] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[7] ASA Ruling on The Detox Clinic Ltd. Advertising Standards Authority (UK), 2022. https://www.asa.org.uk/rulings/the-detox-clinic-ltd-a21-1119332-the-detox-clinic-ltd.html
[8] Unlicensed ozone saunas may pose serious health risks to users and anyone in close proximity. Health Canada, 2022. https://recalls-rappels.canada.ca/en/alert-recall/unlicensed-ozone-saunas-may-pose-serious-health-risks-users-and-anyone-close-proximity
[9] Parere 31/2006: Ossigeno ozonoterapia. Regione Toscana, Consiglio Sanitario Regionale, 2006. https://www.regione.toscana.it/documents/10180/12161851/Parere+n.+31-2006.pdf/92a34289-3623-4f30-89af-3c73b9f70e7a?version=1.1&t=1576228147561&download=true
[10] Resolução CFM n° 2.445, de 21 de agosto de 2025. Conselho Federal de Medicina (CFM), Brazil, 2025. https://sistemas.cfm.org.br/normas/arquivos/resolucoes/BR/2025/2445_2025.pdf
[11] Tempted to try a wellness or longevity treatment? Here's what experts say.. The Atlanta Journal-Constitution, 2026. https://www.ajc.com/news/2026/07/tempted-to-try-a-wellness-or-longevity-treatment-heres-what-experts-say/
[12] Asia's super-aging societies are sparking a boom in high-end longevity clinics, even if 'public enthusiasm' is outpacing the science. Fortune, 2026. https://fortune.com/2026/07/08/asia-longevity-aging-population-science/

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# EBO2 (EBOO) for Lyme Disease: Clinic Claims, the Missing Evidence, and Standard Care

Source: https://ebo2.com/guides/ebo2-for-lyme-disease/
Updated: 2026-10-04

Key takeaways:
- As of October 4, 2026, the claim wording we recorded from 76 of the 174 clinics whose EBO2 pages we could read names Lyme disease, and 64 of those 76 name it in a list with other conditions.
- We found no study, in the laboratory, in animals, or in people, that tested ozone or EBO2 against Borrelia burgdorferi, the bacterium that causes Lyme disease, and ClinicalTrials.gov lists no such trial.
- Reviews of alternative Lyme treatments in 2015 and 2026 found no trial evidence that oxygen-based therapies such as ozone help; the 2026 review describes a critical lack of well-designed trials.
- CDC lists antibiotic courses of 10 to 28 days, depending on the form of the disease, and says more antibiotics are unlikely to help people whose symptoms persist after treatment.
- CDC has documented serious infections, including septic shock and a death, among people given unproven treatments after a diagnosis of chronic Lyme disease.

If a clinic has offered EBO2 (also called EBOO) for Lyme disease, or for symptoms that have lasted after treatment for Lyme disease, this guide sets the offer against what the record holds: what clinics' own pages claim, what has been tested, what regulators have said, and the care CDC describes. The short answer is that we found no study of ozone or EBO2 against Borrelia burgdorferi, the bacterium that causes Lyme disease, in the laboratory, in animals, or in people. Two reviews of alternative Lyme treatments, in 2015 and 2026, found no trial evidence that oxygen-based therapies help [16][17]. CDC lists antibiotic courses for every form of the disease and says that, after a recommended course, more antibiotics are unlikely to help lasting symptoms [1][2]. Questions to take to a clinic, and the searches we ran so anyone can repeat them, are near the end.

What clinics' EBO2 pages say about Lyme disease

We read the EBO2 pages of the clinics in our directory (/clinics/) and recorded, in each clinic's own words, the health benefits it claims. As of October 4, 2026, we could read the pages of 174 clinics, and 90 of them claim a benefit for Lyme disease or for mold illness; we record the two together, so the "From our data" bar below counts them as one. To separate them we use the claim wording itself. Of those 90, the claim wording we recorded names Lyme disease for 76 clinics and mold, mycotoxins, or biotoxins for 51. We save up to four quotes per clinic, so these splits are a floor: a clinic can name Lyme disease on a page without that sentence being among its saved quotes.

Within the 76 clinics whose recorded wording names Lyme disease:

Lyme disease is usually one item in a list. 64 of the 76 name it in the same sentence or list as other conditions. 72 of the 76 also claim a benefit against infections or pathogens, 69 for autoimmune conditions, and 35 for long COVID.
Most pages do not say whether EBO2 is FDA-approved. 60 of the 76 EBO2 pages do not say whether EBO2 or its equipment is FDA-approved, 14 say EBO2 is not FDA-approved, and 2 say their equipment is FDA-cleared, registered, or approved, which concerns a device and not the treatment; our guide to EBOO devices and FDA status (/guides/eboo-devices-and-fda-status/) explains the difference.
17 of the 76 pages carry patient testimonials.

Across all 174 readable clinics, the recorded wording of 29 says the procedure kills, destroys, inactivates, or neutralizes bacteria, viruses, or other microbes, and 17 of those 29 also name Lyme disease. (We count a clinic when one recorded quote pairs one of those four verbs with a word for a microbe, such as bacteria, virus, pathogen, fungus, mold, or parasite; looser rules, such as matching the verb and the microbe in different quotes, give slightly higher counts.) On September 28, 2026, at least one page said EBOO had been found to destroy the bacterium that causes Lyme disease, and we found no such study; as of October 4, 2026, none of the claims we recorded says it. The recorded wording of 15 clinics refers to "co-infections", and that of 2 lists Lyme disease among autoimmune conditions, although CDC describes it as an illness caused by bacteria spread by blacklegged ticks [1]. We publish these claims only as counts. A claim on a clinic's page is the clinic's statement, not evidence; our guide to reading a clinic's EBO2 page (/guides/how-to-read-a-clinic-ebo2-page/) covers the wording to look for.

What has been tested: ozone against bacteria, and nothing against Borrelia

No entry in our research library (/research/) tests ozone against Borrelia, and none of the six entries the library tags as EBOO studies, listed in the "From our data" table below, reports on anyone with Lyme disease; the 2023 ozone-uptake series (/research/rowen-2023-ozone-dialysis-uptake/) among them does not say what its 12 patients were treated for. The closest evidence we hold is three papers on ozone and bacteria.

| Study | What it is | Who or what was studied | What it found, as the paper reports it | Limits |
|---|---|---|---|---|
| Rowen 2019 (/research/rowen-2019-ozone-infectious-disease-review/) [18] | Review by one author | Published experience with ozone in infections, such as drug-resistant infections and Ebola | Argues ozone could serve alone or alongside other treatment for infections | No systematic search and no new data; no study of ozone against Borrelia or Lyme disease |
| Skorup 2022 (/research/skorup-2022-extracorporeal-ozone-ecoli-sepsis/) [20] | Laboratory runs plus a randomized pig study of an extracorporeal ozone prototype | E. coli in human blood (6 runs); 10 pigs with E. coli sepsis, 5 treated | In the laboratory, one pass lowered viable E. coli in the blood by 27%; in the pigs, bacteria in blood and organs did not differ with treatment | Not the EBOO device; 30 minutes of treatment in a short model; funded by Sangair AB, which two of the authors own or work for |
| Rundgren 2025 (/research/rundgren-2025-extracorporeal-ozone-pseudomonas-sepsis/) [19] | Pig study of the same kind of prototype | 13 pigs with Pseudomonas septic shock, 7 treated | One pass lowered viable bacteria by 53%; bacteria in the pigs' blood and survival did not differ (median 134 minutes with ozone, 159 without) | Not the EBOO device; small 4-hour study, groups allocated rather than stated as randomized; funded by Sangair AB, with two authors who own or work for it |

The two pig studies are the most direct test in our library of what a blood circuit with ozone does to bacteria in the blood. A single pass through the device reduced the bacteria in the blood flowing through it, in human blood in the laboratory in one study and in the pigs in the other, yet in neither study did the animals' circulating bacteria fall compared with untreated animals [19][20]. Neither involved Borrelia. Lyme disease adds a further problem: if untreated, CDC's report says, the bacterium "can disseminate throughout the body to cause meningitis, carditis, neuropathy, or arthritis" [10], so much of the infection sits in tissues that a blood circuit does not pass through.

Two reviews have looked at oxygen-based treatments marketed for Lyme disease. In 2015, a review in Clinical Infectious Diseases searched clinic websites and the medical literature, found more than 30 alternative treatments, including "oxygen and reactive oxygen therapy", and reported that the literature "did not substantiate efficacy or, in most cases, any rationale for the advertised treatments" [16]. In 2026, a review in the journal Brain, whose authors include researchers at NIH's National Institute of Neurological Disorders and Stroke, noted that some laboratory and animal studies and case reports suggest oxygen-based treatments, ozone among them, may improve well-being in chronic Lyme disease, then concluded: "there is a critical lack of well-designed, large-scale clinical trials to substantiate the clinical benefits of oxygen or reactive oxygen species" [17]. It added that such a treatment "might appear effective in some individuals and not others simply because their symptoms have a different underlying cause" [17].

What the antibiotic trials show about lasting symptoms

At least five randomized, placebo-controlled trials have tested longer antibiotic courses for symptoms that last after Lyme disease [10], and their placebo groups matter for anyone weighing an uncontrolled report of improvement.

Klempner, 2001. Two trials gave 30 days of intravenous ceftriaxone and 60 days of oral doxycycline, or matching placebos, to 129 people with lasting symptoms; they were stopped early because a difference was highly unlikely. Among seropositive patients, 37% on antibiotics and 40% on placebo improved [12].
Krupp, 2003. In 55 people with severe fatigue, 28 days of intravenous ceftriaxone, compared with placebo, improved fatigue but not thinking speed or a laboratory marker of infection, and the authors concluded the study "does not support the use of additional antibiotic therapy" [13].
Fallon, 2008. In 37 people with memory problems randomized to 10 weeks of intravenous ceftriaxone or placebo, ceftriaxone brought a moderate improvement at week 12 that was not sustained at week 24 [14].
Berende, 2016. After 2 weeks of intravenous ceftriaxone for everyone, 281 people were randomized to 12 weeks of doxycycline, clarithromycin with hydroxychloroquine, or placebo. Quality of life did not differ between the groups, and it rose significantly from baseline in all three, placebo included [15].

CDC says that people with lasting symptoms "usually get better over time without additional antibiotics, but it can take many months to feel completely well", and that careful studies have generally found extended antibiotic treatment no better than placebo [2]. The trials also show what an uncontrolled before-and-after report cannot: in the two that report it, many people on placebo got better [12][15]. The FTC makes the same point about health claims generally, that improvement in a treated group alone "could result from a placebo effect, spontaneous changes in subjects' health" or other factors unrelated to the product [22].

What regulators have said

No regulatory record in our tracker (/reports/regulatory-tracker/) addresses ozone or EBO2 for Lyme disease by name. The records that apply are general.

FDA. Its device rule states that "Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [25]. Ozone therapy is not FDA-approved for Lyme disease or any other condition.
FTC standard for health claims. The FTC's 2022 guidance says that substantiation of health benefits "will need to be in the form of randomized, controlled human clinical testing", and that anecdotal evidence about consumers' experiences is "never sufficient to substantiate claims about the effects of a health product" [22]. When the FTC warned a California clinic in 2020 about ozone claims for COVID-19, it also told the clinic to review all its other claims against that standard [23].
UK advertising regulator. In 2022 the Advertising Standards Authority ruled against a UK clinic's claims that IV ozone therapy was "Anti-Bacterial, Anti-Viral and Anti-Fungal", and told it not to repeat such claims unless it held "a substantive body of evidence to support those claims, including clinical trials conducted on people" [24].
CDC. Its 2017 report states that treatments offered for chronic Lyme disease, "such as prolonged antibiotic or immunoglobulin therapy, lack data supporting effectiveness and are not recommended" [10].

What CDC describes as care for Lyme disease

This section describes what CDC tells patients and clinicians; it is information, not a treatment plan. CDC says most cases "can be treated with 10 days to 4 weeks of antibiotics", and that people treated with appropriate antibiotics early "usually recover rapidly and completely" [1]. Its clinician pages list regimens by form of the disease, consistent with the 2020 guideline of the Infectious Diseases Society of America, the American Academy of Neurology, and the American College of Rheumatology [5][11]. For adults, without doses:

| Form of Lyme disease | Antibiotics CDC lists | Course |
|---|---|---|
| Erythema migrans rash (early) | Oral doxycycline, amoxicillin, or cefuroxime [6] | 10 to 14 days for doxycycline, 14 days for the others [6] |
| Facial palsy | Oral doxycycline [7] | 14 to 21 days [7] |
| Meningitis or nerve-root inflammation | Oral doxycycline or intravenous ceftriaxone [7] | 14 to 21 days [7] |
| Carditis, mild | Oral doxycycline, amoxicillin, or cefuroxime [8] | 14 to 21 days [8] |
| Carditis, severe | Intravenous ceftriaxone in hospital, with a switch to oral antibiotics once it resolves [8] | 14 to 21 days [8] |
| Arthritis, first episode | Oral doxycycline, amoxicillin, or cefuroxime [9] | 28 days [9] |
| Arthritis that persists after the first course | Intravenous ceftriaxone is CDC's preferred second course [9] | 14 to 28 days [9] |

Two points in CDC's pages bear on an EBO2 offer. First, timing: untreated infection can bring later signs, days to months after the bite, that include arthritis of the large joints, an irregular heartbeat, facial palsy, nerve pain, and inflammation of the brain and spinal cord [4], and CDC tells clinicians to treat suspected Lyme carditis with antibiotics immediately, without waiting for test results, and to hospitalize suspected severe cases [8]. Second, testing: CDC recommends FDA-cleared antibody tests used in two steps, warns that some laboratories that do not accept private insurance may offer tests that are not FDA-cleared, and notes that antibody tests stay positive for months to years after the bacteria are gone, so a positive result alone does not show an active infection [3].

For symptoms that last after treatment, CDC uses the name post-treatment Lyme disease syndrome, says its cause is unknown, and discourages the term chronic Lyme disease "because it implies that prolonged symptoms are caused by an ongoing bacterial infection when, in fact, the cause is not currently known" [2]. It says "more antibiotics are unlikely to help", lists other causes of the same symptoms, including other infections, medications, depression, diabetes, and cancer, and suggests strategies developed for myalgic encephalomyelitis/chronic fatigue syndrome [2]. For persistent Lyme arthritis it suggests referral to a rheumatologist [9]. On co-infections, CDC says the most common one, anaplasmosis, is treated with the same antibiotic as Lyme disease, that babesiosis needs different medicines, and that "there is no evidence" Bartonella or Mycoplasma are spread by ticks [3]. Our long COVID guide (/guides/ebo2-for-long-covid/) covers CDC's similar advice for symptoms after COVID-19.

Risks for people with a Lyme diagnosis

The risk CDC has documented is from unproven treatment itself. Its 2017 report describes five people given treatments for chronic Lyme disease, most through long-term intravenous lines, whose complications included septic shock, Clostridium difficile colitis, an infection of the spinal bones and disc, an abscess, and one death [10]. CDC lists among such treatments intravenous hydrogen peroxide and hyperbaric oxygen [10], which the 2026 review groups with ozone as oxygen-based treatments [17], and warns of "missed opportunities to diagnose and treat the actual underlying cause" [10]. EBO2 was not among the treatments the report names. Ozone given through the blood has a record of its own: after an outbreak investigation at a hospital outpatient department in Rome, six of 31 patients tested had hepatitis C, one of them known to be infected since 1986, and all six had received ozone-enriched transfusions of their own blood in the first half of 2001 [21]. Our compilation of ozone therapy adverse events (/guides/ozone-therapy-adverse-events/) covers the reported harms by route, and the side effects guide (/guides/side-effects-and-safety/) covers the procedure itself.

Questions to ask a clinic that offers EBO2 for Lyme disease

These are questions, not a verdict on any clinic. Our questions for your doctor (/tools/doctor-questions/) tool builds a printable list.

Which study shows that ozone or EBO2 affects Borrelia, in a dish or in a person? (We found none.)
How was Lyme disease diagnosed, and was it an FDA-cleared two-step test [3]? If the diagnosis is a co-infection such as Bartonella, what does the clinic make of CDC's statement on tick transmission [3]?
Is EBO2 offered instead of, or alongside, the antibiotics CDC lists, and does the clinic coordinate with the physician who prescribes them?
What will be measured before and after the sessions, and at what point would the clinic recommend stopping?
How many sessions, at what total cost in writing, and what is refunded if sessions stop? The session cost planner (/tools/session-cost/) helps with the arithmetic.
Which anticoagulant is used in the circuit, and has it been checked against current medicines, including any long antibiotic course? Our guide to EBOO, blood thinners, and medications (/guides/eboo-blood-thinners-and-medications/) covers what to ask.

How to check for evidence yourself

We ran these searches on October 2, 2026, and anyone can repeat them for free.

Europe PMC, the free index that includes PubMed, searching titles and abstracts: `TITLE_ABS:(ozone OR ozonated OR ozonation OR "oxygen-ozone") AND TITLE_ABS:(Borrelia OR Lyme OR borreliosis)` returned three records. All three are studies of the health effects of climate change that count air pollution and Lyme disease among their measures; none tested ozone against Borrelia.
Europe PMC, EBOO and Lyme: `TITLE_ABS:(EBOO OR "extracorporeal blood oxygenation") AND TITLE_ABS:(Lyme OR Borrelia OR borreliosis)` returned none.
ClinicalTrials.gov, with "Lyme disease" as the condition and "ozone" as the intervention, returned no registered studies; "EBOO" as an intervention returned none for any condition.

A clinic that cites a study should be able to give its title or PubMed number. The test is whether that study tested ozone against Borrelia or enrolled people with Lyme disease, and whether it compared the treatment with something.

What we could not verify

The full text of the 2020 IDSA, AAN, and ACR guideline. The publisher refused our automated request, so we read only its abstract [11], which does not mention ozone; we rely on CDC's statement that its regimens follow the guideline [5].
The laboratory and animal studies the 2026 review cites as suggesting benefit from oxygen-based treatments in chronic Lyme disease [17]. We could not identify them from the review's text.
The full text of the 2015 review of alternative treatments, which we read as an abstract only [16].
The study behind the clinic page that said, on September 28, 2026, that EBOO destroys the bacterium that causes Lyme disease. We could not trace it.
How many people with a Lyme diagnosis have had EBO2, and with what results. CDC notes that the number of people who undergo treatments for chronic Lyme disease is unknown, as is the number of complications [10], and our dataset records clinics' claims, not outcomes.

How this guide was made

This guide rests on 25 sources: nine CDC pages and a CDC report, the 2020 Lyme disease guideline and six other papers read through PubMed, four entries from our study library, and FDA, FTC, and UK regulatory documents. The clinic figures come from our own dataset of clinic pages, as of October 4, 2026 (174 readable pages), the searches were run on October 2, 2026, and study details come from our study cards, each quoted from the paper. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: Does ozone kill Borrelia, the bacterium that causes Lyme disease?
A: We found no study that tested ozone against Borrelia burgdorferi in the laboratory, in animals, or in people. The closest work in our library tested an extracorporeal ozone device against other bacteria in pigs with sepsis: one pass through the device lowered the bacteria in the blood passing through it, but bacteria in the animals' circulating blood did not differ from untreated animals. Lyme bacteria also spread into the joints, heart, and nervous system, which a blood circuit does not reach directly.

Q: Is EBO2 recommended for Lyme disease?
A: No guideline or CDC page we read recommends EBO2 or any ozone therapy for Lyme disease. CDC lists antibiotics for every form of the disease, consistent with the 2020 guideline from the Infectious Diseases Society of America, the American Academy of Neurology, and the American College of Rheumatology. Ozone therapy is not FDA-approved for Lyme disease or any other condition.

Q: What is post-treatment Lyme disease syndrome?
A: CDC uses the name post-treatment Lyme disease syndrome (PTLDS) for fatigue, body aches, or difficulty thinking that last after a recommended course of antibiotics. Its cause is unknown. CDC discourages the term chronic Lyme disease because it implies an ongoing bacterial infection when the cause is not known, and it says more antibiotics are unlikely to help.

Q: Can EBO2 help with Lyme co-infections?
A: No study we found tested ozone or EBO2 against any tick-borne co-infection. CDC says the most common co-infection, anaplasmosis, is treated with the same antibiotic as Lyme disease, that babesiosis needs different medicines, and that there is no evidence Bartonella or Mycoplasma are spread by ticks.

Q: Why do some people feel better after EBO2?
A: Feeling better after a treatment does not show the treatment caused it. In the placebo-controlled trials of long antibiotic courses for persistent Lyme symptoms, many people on placebo improved too: 40% of the seropositive placebo group in one 2001 trial, and every group, placebo included, in a 2016 trial. The FTC notes that improvement in a treated group alone can come from a placebo effect or spontaneous change.

Q: Is it risky to choose EBO2 instead of antibiotics?
A: CDC says people treated early with appropriate antibiotics usually recover rapidly and completely, and that untreated infection can spread to cause arthritis, heart rhythm problems, facial palsy, and inflammation of the brain and spinal cord. It tells clinicians to treat suspected Lyme carditis right away. Delaying antibiotics for a treatment with no evidence carries the risk of those later stages.

Sources:
[1] Treatment and Intervention for Lyme Disease. CDC, 2026. https://www.cdc.gov/lyme/treatment/index.html
[2] Chronic Symptoms and Lyme Disease. CDC, 2026. https://www.cdc.gov/lyme/signs-symptoms/chronic-symptoms-and-lyme-disease.html
[3] Testing and Diagnosis for Lyme disease. CDC, 2024. https://www.cdc.gov/lyme/diagnosis-testing/index.html
[4] Signs and Symptoms of Untreated Lyme Disease. CDC, 2024. https://www.cdc.gov/lyme/signs-symptoms/index.html
[5] Clinical Care of Lyme Disease. CDC, 2026. https://www.cdc.gov/lyme/hcp/clinical-care/index.html
[6] Clinical Treatment of Erythema Migrans Rash. CDC, 2026. https://www.cdc.gov/lyme/hcp/clinical-care/erythema-migrans-rash.html
[7] Clinical Care and Treatment of Neurologic Lyme Disease. CDC, 2025. https://www.cdc.gov/lyme/hcp/clinical-care/neurologic-lyme-disease.html
[8] Clinical Care and Treatment of Lyme Carditis. CDC, 2026. https://www.cdc.gov/lyme/hcp/clinical-care/lyme-carditis.html
[9] Clinical Care and Treatment of Lyme Arthritis. CDC, 2024. https://www.cdc.gov/lyme/hcp/clinical-care/lyme-arthritis.html
[10] Serious Bacterial Infections Acquired During Treatment of Patients Given a Diagnosis of Chronic Lyme Disease, United States. MMWR (CDC), 2017. https://www.cdc.gov/mmwr/volumes/66/wr/mm6623a3.htm
[11] Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR): 2020 Guidelines for the Prevention, Diagnosis and Treatment of Lyme Disease. Clinical Infectious Diseases (PubMed), 2021. https://pubmed.ncbi.nlm.nih.gov/33417672/
[12] Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. New England Journal of Medicine (PubMed), 2001. https://pubmed.ncbi.nlm.nih.gov/11450676/
[13] Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial. Neurology (PubMed), 2003. https://pubmed.ncbi.nlm.nih.gov/12821734/
[14] A randomized, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy. Neurology (PubMed), 2008. https://pubmed.ncbi.nlm.nih.gov/17928580/
[15] Randomized Trial of Longer-Term Therapy for Symptoms Attributed to Lyme Disease. New England Journal of Medicine (PubMed), 2016. https://pubmed.ncbi.nlm.nih.gov/27028911/
[16] Unorthodox alternative therapies marketed to treat Lyme disease. Clinical Infectious Diseases (PubMed), 2015. https://pubmed.ncbi.nlm.nih.gov/25852124/
[17] Designing studies for post-treatment Lyme disease and other infection-associated chronic illnesses. Brain (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42148664/
[18] Ozone and oxidation therapies as a solution to the emerging crisis in infectious disease management: a review of current knowledge and experience. Medical Gas Research (PubMed), 2019. https://pubmed.ncbi.nlm.nih.gov/31898609/
[19] Immunomodulation by extracorporeal ozone-based bactericide system in porcine Pseudomonas aeruginosa septic shock. Scientific Reports (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/40562794/
[20] Evaluation of an extracorporeal ozone-based bactericide system for the treatment of Escherichia coli sepsis. Intensive Care Medicine Experimental (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/35467176/
[21] A cluster of hepatitis C virus infections associated with ozone-enriched transfusion of autologous blood in Rome, Italy. Infection Control and Hospital Epidemiology (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16209382/
[22] Health Products Compliance Guidance. Federal Trade Commission, 2022. https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance
[23] Warning Letter to RowenSu Clinic: Unsubstantiated Claims for Coronavirus Treatment. Federal Trade Commission, 2020. https://www.ftc.gov/system/files/warning-letters/covid-19-letter_to_rowensu.pdf
[24] ASA Ruling on The Detox Clinic Ltd. Advertising Standards Authority (UK), 2022. https://www.asa.org.uk/rulings/the-detox-clinic-ltd-a21-1119332-the-detox-clinic-ltd.html
[25] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415

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# EBO2 (EBOO) for Mold Toxicity and CIRS: Clinic Claims, Mycotoxin Tests, and the Evidence

Source: https://ebo2.com/guides/ebo2-for-mold-toxicity/
Updated: 2026-10-04

Key takeaways:
- As of October 4, 2026, the claim wording we recorded from 51 of the 174 clinics whose EBO2 pages we could read names mold, mycotoxins, biotoxins, or CIRS, and 151 of the 174 claim detoxification.
- No study has tested EBO2 or any other ozone therapy in people with mold-related illness or CIRS. The one EBOO case report on mycotoxins followed a single 88-year-old woman being treated for anemia.
- In that case, 4 of the 29 urinary mycotoxins tested were above the laboratory's range at the start and none at the end, but 9 of the 29 were higher at the end, nickel rose overall, and she later reported feeling more tired.
- CDC says there is no FDA-approved test for mycotoxins in human urine, that mycotoxins are found in the urine of healthy people, and that it does not recommend such testing for people in water-damaged buildings.
- CDC's advice for a moldy building is to fix the moisture problem and remove the mold. Ozone's documented use against mycotoxins is in treating stored grain and food.

If a clinic has offered EBO2 (also called EBOO) to clear mold toxins, or has suggested a urine mycotoxin test to decide whether you need it, this guide sets both against the record: what clinics' own pages claim, what the tests can and cannot show, what the one EBOO case report on mycotoxins measured, and what CDC and medical societies describe as the response to a moldy building. The short answer is that no study has tested EBO2 in people with mold-related illness. The single case report that measured urinary toxins followed one 88-year-old woman, without a comparison, and its own table shows several results higher at the last test than at the first. CDC says there is no FDA-approved test for mycotoxins in human urine [3]. A list of questions to take to a clinic is near the end.

What clinics' EBO2 pages say about mold

We read the EBO2 pages of the clinics in our directory (/clinics/) and recorded, in each clinic's own words, the health benefits it claims. As of October 4, 2026, we could read the pages of 174 clinics. 151 of them claim detoxification of some kind, and 90 claim a benefit for Lyme disease or mold illness; we record those two together, so the "From our data" bar below counts them as one. To separate them we use the wording itself: the claim wording we recorded names mold, mycotoxins, biotoxins, or chronic inflammatory response syndrome (CIRS) for 51 clinics. We save up to four quotes per clinic, so that count is a floor.

Within those 51 clinics:

Mold is almost always one item in a list. 48 of the 51 name it in the same sentence or list as other conditions, and 40 of the 51 also name Lyme disease.
Detoxification is the frame. 49 of the 51 also claim detoxification. In the wording of 7, the procedure removes, neutralizes, or destroys mold or mycotoxins.
Most pages do not say whether EBO2 is FDA-approved. 43 of the 51 EBO2 pages do not say whether EBO2 or its equipment is FDA-approved, 6 say EBO2 is not FDA-approved, and 2 say their equipment is FDA-cleared, registered, or approved, which concerns a device and not the treatment; our guide to EBOO devices and FDA status (/guides/eboo-devices-and-fda-status/) explains the difference.
12 of the 51 pages carry patient testimonials.

The specific terms are rarer than the general ones: across all 174 readable clinics, the recorded wording of 8 uses the word mycotoxin, 3 biotoxin, and 2 CIRS. We publish these claims only as counts. A claim on a clinic's page is the clinic's statement, not evidence. Our guide to reading a clinic's EBO2 page (/guides/how-to-read-a-clinic-ebo2-page/) covers "detox" wording, and our guide to what the filter removes (/guides/what-the-filter-removes/) looks at the device side of the "toxin" claim.

What has been studied: one case report and a food-science literature

No entry in our research library (/research/) tests EBO2 or any other ozone therapy in people with mold-related illness or CIRS. Of the six entries the library tags as EBOO studies, listed in the "From our data" table below, one measured mycotoxins. The other relevant entry is about grain.

| Study | What it is | Who or what was studied | What it reports | Limits |
|---|---|---|---|---|
| Bennett 2025 (/research/bennett-2025-eboo-toxin-case/) [8] | Case report | One 88-year-old woman with long-standing iron-deficiency anemia, given two series of three EBOO treatments | Average declines in urinary toxin-to-creatinine ratios from the first test to the last of 64.8% for seven selected mycotoxins, 25.7% for four heavy metals, and 55.1% for four environmental toxins; nickel rose overall | One patient, no comparison, ongoing exposure at home, urine rather than blood, and the details below |
| Sitoe 2025 (/research/sitoe-2025-ozone-grain-preservation-review/) [9] | Food-science review | Ozone gas applied to stored grain and grain products | Describes ozone's use against microbes and mycotoxins in grain, and the regulatory approvals for that use | Concerns food preservation only; no human subject and no blood |

What the one EBOO case report measured

The Bennett report is the only published measurement we found of toxins before and after EBOO, so its details matter. Read in full, it shows the following [8].

The patient and her exposure. She came to the clinic about heavy metal toxicity as a possible contributor to anemia she had had for about 10 years. She lived in an old building with plumbing and wiring from the 1930s and described being constantly exposed to heavy metals, mold, and other toxins there; the report describes no change to that exposure, although its own background section says management of high mycotoxin levels "is primarily supportive and focuses on preventing further exposure".
The tests. Urine samples went to a clinical laboratory that based its reference ranges on national survey data and about 1,000 apparently healthy people, with the upper limit at the 95th percentile. Results are given as toxin per gram of creatinine, and her urine creatinine varied from 1.59 to 0.49 to 2.28 mg/mL across the three tests, the last above the laboratory's range.
What was selected. The laboratory panel covered 29 mycotoxins. Four were above the laboratory's range at the first test and none at the last. The 64.8% average decline is for the seven mycotoxins the report lists as "high and suboptimal" at baseline, and three of those seven were inside the range to begin with. Of all 29, nine were higher at the last test than at the first, all within range; ochratoxin A, for example, went from 1.74 to 3.00 ng/g.
The metals. All four heavy metals the authors tracked were within the laboratory's range at the first test. Nickel rose from 7.47 to 9.77 µg/g, and barium rose between the two series after falling during the first.
The patient's course. Her hemoglobin was 7.4 g/dL at the start, 6.8 after the first series, and 7.5 after the second, which the report calls largely unchanged. At a later visit she said she felt more tired than after the first series, and her care turned to her anemia under her hematologist.
The authors' own words. They write that the mechanism "cannot be established from a single case" and that follow-up monitoring could show "whether the EBOO is the source of the large decline in toxin levels". They declare no financial relationships with organizations interested in the work.
Reporting. The paper dates the first test both December 19, 2024 and December 19, 2025, while the later tests are dated February and April 2025.

With no untreated comparison, the report cannot separate any effect of EBOO from the tendency of unusually high results to be lower when retested, or from changes in diet, which CDC gives as the reason mycotoxins appear in the urine of healthy people [3]. The FTC, describing what it expects of health claims, lists "spontaneous changes in subjects' health" among the explanations for improvement in a treated group alone [11].

What CDC and medical societies say about mycotoxin tests

CDC addressed urine mycotoxin testing directly in a 2015 report from its National Institute for Occupational Safety and Health, after a worker's direct-to-consumer urine test led to a mold-toxicity diagnosis and an inspection that found no water damage [3]. Its statements are short:

"There is no FDA-approved test for mycotoxins in human urine." [3]
"Low levels of mycotoxins are found in many foods; therefore, mycotoxins are found in the urine of healthy persons." [3]
"Mycotoxin levels that predict disease have not been established." [3]
"CDC does not recommend biologic testing of persons who work or live in water-damaged buildings nor routine environmental sampling for mold." [3]

The same report notes that a laboratory's CLIA certification covers its quality standards but does "not address the clinical validity of testing" [3]. CDC's current mold pages add that it "does not recommend mold testing" in homes, because health effects differ from person to person and "there are no set standards" for an acceptable amount of mold [1], and that for Stachybotrys chartarum, a greenish-black mold, "no test exists that proves an association" with particular symptoms [2].

Specialist reviews reach similar conclusions. A 2006 position paper in The Journal of Allergy and Clinical Immunology describes mold causing disease "through several well-defined mechanisms", among them asthma, allergic rhinitis, sinusitis, and hypersensitivity pneumonitis, while "many new mold-related illnesses have been hypothesized in recent years that remain largely or completely unproved" [4]. A 2003 review in the Journal of Occupational and Environmental Medicine concludes that the link between indoor molds and building-related symptoms "remains weak and unproven, particularly with respect to causation by mycotoxins", and notes that Stachybotrys "is blamed for a diverse array of maladies when it is found indoors" [5]. A 2024 review built on Germany's 2023 medical guideline on indoor mold says indoor measurements of mold fungi, microbial volatile organic compounds, or mycotoxins are "generally not indicated" as part of a medical evaluation, "nor are blood or urine tests for particular mold components or metabolites" [6].

What the CIRS literature says, and does not say

CIRS is described by its proponents as an immune disorder that follows exposure to water-damaged buildings [7]. The 2024 review that makes the case for it searched for treatments and found 13 articles, concluding that "the only treatment with documented clinical efficacy was the Shoemaker Protocol" [7]. That protocol's first step, the review says, is avoiding exposure through inspection, remediation, cleaning or replacing contaminated items, or moving, followed by drugs such as cholestyramine [7]. The review's own table lists two randomized trials, with 8 and 13 participants, both with Shoemaker as lead author; the rest are case series, open-label trials, case-control studies, and descriptive reports [7]. Its statement that CIRS "can affect up to 25% of the population" rests on a cited estimate that about a quarter of people are genetically susceptible [7]. The authors list no university or hospital affiliation, and the review does not mention ozone, EBO2, or EBOO anywhere [7]. A clinic that offers EBO2 under a CIRS banner is not offering the protocol that review endorses.

What regulators have said

No regulatory record in our tracker (/reports/regulatory-tracker/) addresses EBO2 for mold illness by name. The records that apply are general.

FDA. Its device rule states that "Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [12]. Ozone therapy is not FDA-approved for mold toxicity, CIRS, or any other condition. CDC notes separately that no urine mycotoxin test is FDA-approved [3].
UK advertising regulator. In 2022 the Advertising Standards Authority ruled against a UK clinic's claims that IV ozone therapy was "Anti-Bacterial, Anti-Viral and Anti-Fungal", and told it not to repeat them without "a substantive body of evidence to support those claims, including clinical trials conducted on people" [10].
FTC standard for health claims. The FTC's 2022 guidance says health benefits generally need "randomized, controlled human clinical testing" and that anecdotal evidence about consumers' experiences is "never sufficient to substantiate claims about the effects of a health product" [11].

What CDC describes as the response to mold

This section describes what CDC and the guideline-based review say; it is information, not a treatment plan. CDC's first step is the building: "If mold is growing in your home, you need to clean up the mold and fix the moisture problem", and "You do not need to know the type of mold" [1]. It recommends keeping indoor humidity no higher than 50%, fixing leaks, and drying out within 24 to 48 hours after a flood [1].

On health effects, CDC says exposure "may cause a variety of health effects, or none at all", lists stuffy nose, sore throat, coughing or wheezing, burning eyes, and skin rash, notes more severe reactions in people with asthma or mold allergy, and lung infections in people with weakened immune systems or chronic lung disease [1]. It cites a 2004 Institute of Medicine finding of sufficient evidence linking indoor mold with upper respiratory symptoms, cough, and wheeze in otherwise healthy people, asthma symptoms in people with asthma, and hypersensitivity pneumonitis in susceptible people [1]. For persistent symptoms, CDC says to see a physician [2].

The 2024 guideline-based review sets out what that evaluation involves: a history and physical examination with attention to allergy and immune compromise; allergy testing by skin prick or specific IgE antibodies when there are signs of allergy; immediate removal from exposure as the priority for anyone whose immune system is compromised; and full testing for a suspected invasive fungal infection [6]. Ozone's documented use against mycotoxins is in a different setting altogether, the treatment of stored grain and food with ozone gas [9]; that work involves no patients and no blood.

Questions to ask a clinic that offers EBO2 for mold

These are questions, not a verdict on any clinic. Our questions for your doctor (/tools/doctor-questions/) tool builds a printable list.

Which study shows that EBO2 lowers mycotoxins in a person's blood, and did it compare treated people with untreated ones? (The one EBOO report measured urine in one patient.)
If a urine mycotoxin test is offered, is it FDA-approved, and what level would show disease? CDC says no such test is approved and no such level has been established [3].
Has the building been inspected and the moisture source fixed? Without that, a person keeps being exposed, as the patient in the case report did [8].
Has an allergist or a physician evaluated the symptoms for asthma, allergy, or infection, the conditions mold is known to cause [1][4]?
What will be measured before and after the sessions, how many sessions are planned, and what is the total cost in writing? The session cost planner (/tools/session-cost/) helps with the arithmetic.
Which anticoagulant is used in the circuit, and has it been checked against current medicines? Our guide to EBOO, blood thinners, and medications (/guides/eboo-blood-thinners-and-medications/) covers what to ask.

How to check for evidence yourself

We ran these searches on October 2, 2026, and anyone can repeat them for free.

Europe PMC, the free index that includes PubMed, searching titles and abstracts: `TITLE_ABS:(EBOO OR "extracorporeal blood oxygenation") AND TITLE_ABS:(mycotoxin* OR mold OR mould OR CIRS OR "water-damaged" OR toxin*)` returned one record, the Bennett case report.
Europe PMC, ozone therapy and mold illness: `TITLE_ABS:(ozone OR ozonated OR "oxygen-ozone" OR autohemotherapy) AND TITLE_ABS:("chronic inflammatory response syndrome" OR CIRS OR "mold illness" OR "water-damaged building*" OR mycotoxicosis)` returned none.
Europe PMC, ozone and mycotoxins in people: `TITLE_ABS:(ozone OR ozonated OR ozonation) AND TITLE_ABS:(mycotoxin) AND TITLE_ABS:(patient OR human OR urine OR serum OR plasma OR "whole blood")` returned 32 records. All but the Bennett report concern removing mycotoxins from food or animal feed.
ClinicalTrials.gov, with mold, mycotoxin, chronic inflammatory response syndrome, or damp buildings as the condition and ozone as the intervention, returned no registered studies.

What we could not verify

Whether the laboratory's urine mycotoxin panel has been validated. The case report describes how the reference ranges were set but cites no validation, and CDC says no urine mycotoxin test is FDA-approved [3][8].
Whether anything besides EBOO changed between the case report's tests. It says she was advised to start oral iron, vitamin B12, and folate and to ask her hematologist about higher-dose iron infusions, but it describes no other treatment aimed at toxins and no change in her housing [8].
How many people have had EBO2 for mold-related illness, and with what results. Our dataset records clinics' claims, not outcomes.
The evidence behind the statement, on at least one clinic page, that EBO2 removes mold toxins more effectively than other treatments. We found no comparative study.

How this guide was made

This guide rests on 12 sources: two CDC pages and a CDC report, five papers and reviews read through PubMed, two entries from our study library, and FDA, FTC, and UK regulatory documents. The clinic figures come from our own dataset of clinic pages, as of October 4, 2026 (174 readable pages), the searches were run on October 2, 2026, and the case-report details come from its full text, which we read alongside our study card. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: Does EBOO remove mycotoxins from the blood?
A: No study has shown that. The only EBOO report on mycotoxins is a 2025 case report of one 88-year-old woman, and it measured toxins in urine, not blood. Seven selected mycotoxins fell by an average of 64.8%, but the report had no comparison, the woman kept living in the building she blamed for her exposure, 9 of the 29 mycotoxins tested were higher at the end, and nickel rose overall.

Q: Are urine mycotoxin tests accurate?
A: CDC says there is no FDA-approved test for mycotoxins in human urine, that low levels of mycotoxins in many foods mean they turn up in the urine of healthy people, and that levels that predict disease have not been established. A 2024 review built on Germany's 2023 medical guideline on indoor mold says blood or urine tests for mold components or metabolites are generally not indicated.

Q: Is CIRS a recognized diagnosis?
A: Its proponents describe chronic inflammatory response syndrome as an immune disorder that follows exposure to water-damaged buildings. A 2006 position paper in The Journal of Allergy and Clinical Immunology described many newer mold-related illnesses as largely or completely unproved. The 2024 review that supports CIRS found only one treatment with documented efficacy, the Shoemaker Protocol, and its two randomized trials had 8 and 13 participants. That review does not mention ozone or EBOO.

Q: What does CDC recommend after mold exposure?
A: CDC says to remove mold and fix the moisture problem that let it grow, whatever kind of mold it is. It does not recommend mold testing in homes, and it says people with persistent symptoms should see their physician. Mold can cause stuffy nose, coughing, wheezing, and eye or skin irritation, and more severe reactions in people with asthma, mold allergy, or weakened immune systems.

Q: Can ozone destroy mycotoxins?
A: In stored grain and other foods, yes: a food-science literature describes ozone gas lowering mycotoxin levels in crops and feed. That work involves no patients. No study we found measured mycotoxins in a person's blood before and after ozone treatment.

Sources:
[1] Mold (CDC mold and health basics). CDC, 2024. https://www.cdc.gov/mold-health/about/index.html
[2] Facts About Stachybotrys chartarum. CDC, 2024. https://www.cdc.gov/mold-health/data-research/facts-stats/index.html
[3] Notes from the field: Use of unvalidated urine mycotoxin tests for the clinical diagnosis of illness, United States, 2014. MMWR (CDC), via PubMed, 2015. https://pubmed.ncbi.nlm.nih.gov/25695323/
[4] The medical effects of mold exposure. Journal of Allergy and Clinical Immunology (PubMed), 2006. https://pubmed.ncbi.nlm.nih.gov/16514772/
[5] Adverse human health effects associated with molds in the indoor environment. Journal of Occupational and Environmental Medicine (PubMed), 2003. https://pubmed.ncbi.nlm.nih.gov/12762072/
[6] Indoor Mold: Important Considerations for Medical Advice to Patients. Deutsches Ärzteblatt International (PubMed), 2024. https://pubmed.ncbi.nlm.nih.gov/38381662/
[7] Chronic inflammatory response syndrome: a review of the evidence of clinical efficacy of treatment. Annals of Medicine and Surgery (PubMed), 2024. https://pubmed.ncbi.nlm.nih.gov/39649915/
[8] Observed Reduction in Urinary Toxin Excretion With Extracorporeal Blood Oxygenation and Ozonation (EBOO) Treatment in an 88-Year-Old With Chronic Anemia: A Case Report. Cureus (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/41583215/
[9] Advances in ozone technology for preservation of grains and end products: application techniques, control of microbial contaminants, mitigation of mycotoxins, impact on quality, and regulatory approvals. Comprehensive Reviews in Food Science and Food Safety (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/40260769/
[10] ASA Ruling on The Detox Clinic Ltd. Advertising Standards Authority (UK), 2022. https://www.asa.org.uk/rulings/the-detox-clinic-ltd-a21-1119332-the-detox-clinic-ltd.html
[11] Health Products Compliance Guidance. Federal Trade Commission, 2022. https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance
[12] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415

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# EBO2 (EBOO) Side Effects and Safety: What Studies, Case Reports, and Regulators Record

Source: https://ebo2.com/guides/side-effects-and-safety/
Updated: 2026-10-08

Key takeaways:
- Our library classes six papers as studies of EBOO as given to people, four from the Siena group that developed the method. None attributes an adverse event to the procedure, though a 2025 case report notes a fall in hemoglobin and that the patient felt worse after her second series, and none was designed to detect uncommon events.
- We found no published case report of a serious adverse event during EBO2 (EBOO) itself, which reflects how little has been studied rather than proof of safety.
- The serious events in published reports followed other ozone procedures, such as injections and blood mixed with ozone in a bag, and include strokes, blindness, heart attacks, infections, and deaths; their authors most often attribute them to gas entering the bloodstream.
- A New York medical examiner, the Medical Board of California, and an Australian health commission have each recorded harm after ozone treatment, and FDA found that one maker of EBOO equipment had no procedure for handling complaints.
- Ozone therapy is not FDA-approved for any condition, and anyone can report a problem to FDA through MedWatch.

EBO2 (also called EBOO) has almost no safety record of its own. Our library classes six papers as studies of EBOO as given to people; four come from the Siena group that developed the method. None attributes an adverse event to the procedure, though one case report notes a fall in hemoglobin and that the patient felt worse after her second series, and none was built to detect uncommon events. We found no published case report of a serious adverse event during EBO2 itself. The serious harms documented with ozone, among them strokes, blindness, heart attacks, infections, and deaths, come from other procedures that put ozone into blood or tissue. This guide sets out what each kind of source records, so a reader can see where the evidence is thin and what to ask about it.

Ozone therapy is not FDA-approved for any condition, and federal regulation calls ozone "a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [18]. Our pillar guide (/what-is-ebo2/) explains the procedure; the case-by-case list of reported harms is in our ozone therapy adverse events guide (/guides/ozone-therapy-adverse-events/).

How much EBOO-specific safety data exists

Every paper our library classes as a study of EBOO as given to people, and what it says about adverse events:

| Paper | Design | Size | What it says about adverse events |
|---|---|---|---|
| Di Paolo 2000, Siena [1] | Preliminary report | One volunteer author and several patients | Describes the results as without side effects |
| Di Paolo 2002, Siena [2] | Case report | One dialysis patient with necrotizing fasciitis | Does not address them in the abstract we read |
| Di Paolo 2005, Siena [3] | Randomized trial against prostacyclin | 28 patients; 210 EBOO treatments | No side effects or complications recorded in the EBOO treatments |
| Di Paolo 2005, Siena [4] | Review | More than 1,200 treatments in 82 patients | Describes treating up to 4,800 mL of heparinized blood in an hour without technical or clinical problems |
| Rowen 2023, California [7] | Case series measuring ozone uptake | 85 measurements in 12 patients | Measured ozone uptake, not outcomes; the authors write that they have performed "at least 400 sessions of ozone dialysis with no untoward effects observed" |
| Bennett 2025, New York [6] | Case report | One 88-year-old woman with chronic anemia | Has no adverse-events section; notes that her hemoglobin fell from 7.4 to 6.8 g/dL after the first series (7.5 after the second) and that she felt worse, more tired, after the second series, and attributes neither to EBOO |

The ozone dialysis paper's 400 sessions are the practitioners' own statement, not a counted safety record [7]. One related circuit adds little: a six-patient pilot study of 10-pass ozone describes no adverse events [8]. The developers' 2007 bench test of their gas exchanger used a saline solution and no patients, so it holds no safety data about people [5]. The prostacyclin comparison group's side effects are not given in the trial's abstract, and the trial's full text is behind a paywall [3]. The table under "From our data" below shows the procedure each EBOO paper reports.

Small studies can miss uncommon events, and none of these papers counted events in a way that would give a rate. A 2026 scoping review of autohemotherapy safety concluded that the overall rate of serious adverse events cannot be reliably estimated, for want of registries and of reliable counts of treatments given [21].

What clinics say about side effects

Clinic pages describe mild, short-lived effects. A Pennsylvania clinic says side effects are generally minimal but can include slight fatigue or localized bruising [9]. A California clinic mentions temporary fatigue or dizziness that typically resolves quickly [10]. An Arizona clinic lists brief fatigue, what it calls a detox response in the 24 hours after treatment, and temporary vein discomfort at the IV site as the most common effects [11]. The longest list comes from a Beverly Hills practice whose EBOO page offers a consultation about the procedure without saying it performs it: infection, clotting, bleeding in people taking blood thinners, damage to red blood cells, low blood pressure, fainting, and vein injury, as reported and potential risks [12].

These are statements by medical businesses, three of which sell the procedure. None of the pages gives a number of patients treated or events seen, so they describe what a clinic chooses to say, not what its patients experienced.

Risks specific to an extracorporeal circuit

EBO2 draws blood from a vein in one arm, runs it through an extracorporeal (/glossary/#extracorporeal) circuit with a filter and gas exchanger, and returns it through a vein in the other arm. The NIH kidney institute's page on hemodialysis, another procedure that circulates blood outside the body, lists an access that becomes infected or blocked by a blood clot, blood loss if a needle comes out, and a sudden drop in blood pressure during treatment, which it attributes to sudden changes in the body's water and chemical balance [13]. MedlinePlus, writing for people with a dialysis access, lists bleeding from the access, signs of infection, a fever of 100.3°F (38.0°C) or higher, and a hand that turns cold, numb, or weak among the reasons to call a provider [14]. A temporary IV is not a surgical dialysis access, but the access problems are of the same kind.

The circuit also needs an anticoagulant to keep blood from clotting in the tubing. The EBOO review describes the blood as heparinized [4], and the label of a heparin product approved by FDA warns that bleeding, including fatal bleeding, has occurred with heparin, and lists a history of heparin-induced thrombocytopenia, a serious immune reaction to heparin, among the reasons not to use it [15]. What that means for people who take blood thinners is covered in our blood thinners and medicines guide (/guides/eboo-blood-thinners-and-medications/), and bleeding disorders in our contraindications guide (/guides/contraindications/).

The filter matters too. The Siena group that developed EBOO wrote in 1999 that dialysis-type semipermeable membranes were unsuitable for ozone because they are hydrophilic and vulnerable to it, and used ozone-resistant hollow fibers instead [41]. In 2010 the same group tested four dialysis filters, found gas exchange ranging from 0 to 70%, saw ozone alter the fibers, and warned that because their materials may not be ozone-resistant, they may release compounds harmful to patients [42]. FDA's 2025 warning letter describes a maker selling EBOO kits built around hemodialyzer filters [34], and the 2023 ozone dialysis paper used a cellulose triacetate dialysis chamber [7]. Our devices guide (/guides/eboo-devices-and-fda-status/) and our comparison of EBOO and dialysis (/guides/eboo-vs-dialysis/) cover the equipment.

Two effects come from the way blood is returned in related procedures. Bocci, the Siena physiologist whose group reported about 800 EBOO sessions, describes tingling of the lips and tongue near the end of reinfusion in autohemotherapy, which he attributes to excess citrate anticoagulant given too quickly, and a sudden, marked fall in blood pressure when ozonated blood was reinfused quickly into patients taking ACE inhibitors, an observation he calls unpublished and says he confirmed in two patients [16].

Risks specific to ozone

Breathing it. Federal regulation says inhaled ozone can irritate the lungs enough to cause pulmonary edema, usually some hours after exposure [18], and a 1989 review found that ozone at peak outdoor levels causes measurable, temporary changes in lung function, symptoms, and airway inflammation in healthy people [19]. FDA has received reports of asthma attacks, headaches, and breathlessness from people using ozone devices sold to clean CPAP machines [20].

G6PD deficiency. A 1977 paper modeled what might happen to people with glucose-6-phosphate dehydrogenase deficiency exposed to ozone at levels reached in some cities, and predicted they may experience acute hemolysis, the breakdown of red blood cells [17]. It is a one-sentence abstract about inhaled air, not a study of any ozone therapy. Bocci lists a significant G6PD deficit among the situations that preclude or limit ozone therapy and says patients should be checked for it [16]. See G6PD deficiency (/glossary/#g6pd-deficiency) and our contraindications guide.

Dose. The Siena review reports that a session of EBOO raised a blood marker of oxidation four- to five-fold without appreciable breakdown of red blood cells [4]. The 2026 scoping review links hemolysis and kidney failure to ozone concentrations above 60 μg/mL in autohemotherapy [21]. EBOO papers rarely state the dose a given patient received.

Complications reported in the wider ozone-therapy literature

| Procedure | What the published reports record | Examples |
|---|---|---|
| EBOO | No adverse event reported; no case report found | [1][3][4][6] |
| Major autohemotherapy (blood mixed with ozone in a bag or bottle, then returned) | Death from gas embolism; heart attacks; sinus arrest from high potassium; a hepatitis C cluster among patients; trials reporting no complications or brief facial redness | [22][23][24][25][39][40] |
| Intravenous ozone, as reported | Strokes and lasting cognitive problems after ozonated blood was returned; a death attributed to gas emboli after an intravenous ozone injection | [26][31] |
| Direct injection of gas into a vein | Four deaths from pulmonary embolism | [27] |
| Injection into or beside the spine | Strokes, blindness, spinal cord injury, cardiac arrest, infections, and deaths | [28][29] |
| Injection under the skin | Reversible encephalopathy | [30] |

The sinus-arrest case involved a woman with high blood pressure, diabetes, and chronic kidney disease whose potassium rose to 6.8 mmol/L after nine days of autohemotherapy; her authors hypothesize a link to the therapy, and her rhythm and potassium returned to normal with treatment [22]. In two randomized trials of autohemotherapy, one recorded no complications in either group [23] and one recorded temporary facial redness in 3% of patients [24].

Two patterns run through the serious reports. The neurological and heart events began during the procedure or within minutes, and most authors attribute them to gas entering the bloodstream; several patients had a patent foramen ovale, an opening between the heart's upper chambers that the authors describe as the route bubbles took to the brain [26][28][29]. The infections followed both blood procedures and injections, and authors tie them to lapses in sterile technique [39]. The full list, by route and with each paper's own causation wording, is in our adverse events guide (/guides/ozone-therapy-adverse-events/).

What regulators and courts have recorded

These records use their own words, quoted here.

New York, 2023. Upholding a medical examiner's finding that a podiatrist's patient died by homicide due to extreme medical negligence, the Appellate Division wrote: "The medical examiner also observed gas emboli and concluded, based on their existence in both small and large blood vessels, that they were attributable to the injection of ozone." The court cites evidence that he injected the patient intravenously with ozone gas and that cardiac arrest followed within 15 minutes [31].
California, 2024. A physician admitted an accusation that, during intravenous ozone therapy in 2020, a patient's IV made sounds "indicating a potential air leak", after which she lost consciousness and was diagnosed with air embolism and stroke. The Medical Board of California's order states: "During probation, Respondent is prohibited from performing intravenous ozone therapy treatment." [32]
New South Wales, 2025. The Health Care Complaints Commission barred an ozone clinic from providing health services for five years, finding that its practitioner's treatment "was, according to expert opinion, the most likely reason that she contracted a serious infection which led to septic shock". It also found that he obtained heparin "from an unknown source" and "is not authorised to be in possession of, or to administer" it, that he tried to sterilize single-use items for reuse, and that he used a "Champion Full Spectrum UV device" not approved in Australia [33].
FDA, 2025. A warning letter to O3UV, LLC says its "Champion Full Spectrum" and "EBOO Full Spectrum UV" autohemotherapy devices lack premarket approval or clearance, and that the firm "had no complaint procedure in place to receive, review, and evaluate complaints". It notes that the firm's EBOO kits included hemodialyzer filters bought from another company without supplier controls [34].
FDA, 2024. On ozone CPAP cleaners: "The FDA has received reports from people who use CPAPs that they experienced unexpected asthma attacks, headaches, and breathlessness after using devices claiming to use ozone gas to clean CPAP accessories such as hoses and masks." [20]
FDA, 2014. A Class 2 recall of an ozone generator gives the reason as: "William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use." The record concerns marketing status, not an injury [35].
Italy, 2005. The Health Ministry relayed the national health council's 2003 opinion that no controlled clinical studies support oxygen-ozone therapy and that the method can cause serious and potentially lethal side effects (our translation) [36].

The FTC's 2020 warning letters to ozone clinics concerned marketing claims about COVID-19, not the physical safety of the procedure [37]. The regulatory tracker (/reports/regulatory-tracker/) holds every record with its exact language.

Signs described in the sources

MedlinePlus lists bleeding from the access site, redness, swelling, soreness, pain, warmth, or pus around it, a fever of 100.3°F (38.0°C) or higher, an arm that swells with a cold hand on that side, and a hand that gets cold, numb, or weak as reasons for people with a vascular access to call their provider [14]. In the case reports of other ozone procedures, the serious events showed as chest pain, fainting, a seizure, sudden loss of vision, weakness on one side, confusion, or trouble speaking, usually within minutes [26][28][29][30].

Questions to ask a clinic, and checks to run

Our guide to choosing a clinic (/guides/how-to-choose-a-clinic/) has a longer list; these come from the sources above.

Who places the lines, who supervises, and is a physician on site for the whole session?
What happens if something goes wrong? Bocci writes that anyone giving ozone therapy should know basic life support and keep a breathing bag, medical oxygen, a defibrillator, and emergency drugs at hand [16].
Which anticoagulant does the circuit use, and how much? What does the clinic do for someone who takes a blood thinner?
What ozone concentration and session length does the clinic use, and is the filter and gas exchanger new for each patient?
Which device is used, and what is its FDA status? Our guide to whether EBO2 is FDA-approved (/guides/is-ebo2-fda-approved/) explains the terms.
What should I watch for afterwards, and how do I reach the clinic after hours?
Has the clinic had any adverse events, and did it report them to FDA?

Checks a reader can run: search FDA's MAUDE database for the device's name and read the MedWatch steps in our adverse events guide (/guides/ozone-therapy-adverse-events/); look for the clinic or its physicians in our regulatory tracker (/reports/regulatory-tracker/); compare what clinics publish in our clinic directory (/clinics/); and build a list of questions for your own doctor with our doctor questions tool (/tools/doctor-questions/). Problems can be reported to FDA through the MedWatch form [38].

What we could not verify

The size of the risk with EBO2. No study was designed to measure it, and no registry or reporting system collects EBO2 outcomes.
The EBOO trial's full text, which might describe side effects in more detail than its abstract, including in the comparison group.
The ACE inhibitor observation, which rests on an unpublished report and two patients described in a book chapter.
Whether today's EBO2 equipment matches the Siena prototype. FDA's 2025 letter shows at least one maker selling EBOO kits built around hemodialyzer filters from another company [34]. No study we found measured what such filters release into a patient during a session, the concern the Siena group raised in 2010 [42].
Dose. Few EBOO papers report the ozone concentration given, so no dose and harm pattern can be drawn.

How this guide was made

We used 43 sources: the six EBOO papers in our library, three Siena equipment papers, one related study, fourteen other papers and reviews and one book chapter read through NCBI and Europe PMC, eleven government and court records, an FDA-approved drug label, two patient-education pages, and four clinic pages we saved on September 28, 2026, labeled clinic-stated. The table under "From our data" is computed from our study cards when the site is built, and the regulators' records shown there come from our regulatory dataset. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: Is EBO2 safe?
A: No study has measured how safe EBO2 is. The handful of EBOO papers, mostly from the Italian group that developed the method, attribute no side effects to the procedure in small numbers of patients, and none was designed to find uncommon events. Serious harms have been documented with other ways of giving ozone, so the honest answer is that the risk of EBO2 itself is unknown.

Q: What side effects do clinics describe?
A: Clinic pages we read describe mild, short-lived effects such as tiredness, dizziness, bruising, or vein discomfort at the IV site. One Beverly Hills practice's page on EBOO lists infection, clotting, bleeding in people taking blood thinners, damage to red blood cells, low blood pressure, fainting, and vein injury as reported and potential risks. None of these pages gives counts of patients or events.

Q: Can EBO2 cause an embolism?
A: No EBOO paper we found describes one. Gas embolism is the explanation authors most often give for serious events after other blood-based ozone procedures, including two reports in which ozonated blood, not raw gas, was returned to a vein, and a California case in which an IV line appeared to leak air. Whether EBO2's equipment changes that risk has not been studied.

Q: Who should not get EBO2?
A: Sources commonly list G6PD deficiency, pregnancy, uncontrolled hyperthyroidism, low platelets or bleeding problems, and serious heart instability, and clinics add their own lists. Our contraindications guide compares what each source says and where they disagree.

Q: How do I report a side effect from ozone therapy?
A: Through FDA's MedWatch program at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm, using Form 3500B as a patient or Form 3500 as a health professional. Our adverse-events guide walks through MedWatch and FDA's MAUDE database step by step.

Sources:
[1] Extracorporeal blood oxygenation and ozonation (EBOO) in man. Preliminary report. International Journal of Artificial Organs (PubMed), 2000. https://pubmed.ncbi.nlm.nih.gov/10741810/
[2] Necrotizing fasciitis successfully treated with extracorporeal blood oxygenation and ozonization (EBOO). International Journal of Artificial Organs (PubMed), 2002. https://pubmed.ncbi.nlm.nih.gov/12518965/
[3] Extracorporeal blood oxygenation and ozonation (EBOO): a controlled trial in patients with peripheral artery disease. International Journal of Artificial Organs (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16288443/
[4] Extracorporeal blood oxygenation and ozonation: clinical and biological implications of ozone therapy. Redox Report (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16156950/
[5] Oxygenation-ozonation of blood during extracorporeal circulation: in vitro efficiency of a new gas exchange device. Artificial Organs (PubMed), 2007. https://pubmed.ncbi.nlm.nih.gov/17725702/
[6] Observed Reduction in Urinary Toxin Excretion With Extracorporeal Blood Oxygenation and Ozonation (EBOO) Treatment in an 88-Year-Old With Chronic Anemia: A Case Report. Cureus (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/41583215/
[7] Ozone dialysis delivers three or more times the ozone than other forms of ozone blood treatment. Medical Gas Research (PubMed), 2023. https://pubmed.ncbi.nlm.nih.gov/36204785/
[8] Ozone high dose therapy (OHT) improves mitochondrial bioenergetics in peripheral blood mononuclear cells. Translational Medicine Communications (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/35880042/
[9] EBOO Extracorporeal Blood Oxygenation and Ozonation. Burick Center (Mechanicsburg, PA), 2026. https://burickcenter.com/eboo-extracorporeal-blood-oxygenation-and-ozonation/
[10] EBOO Therapy. Envista Medical (Bakersfield, CA), 2026. https://envistamedical.com/eboo/
[11] EBOO IV Therapy. Enovative Wellness, 2026. https://enovativewellness.com/eboo-iv-therapy/
[12] EBOO: Evidence, Risks, and Medical Consultation in Beverly Hills. My Concierge MD (Beverly Hills, CA), 2026. https://www.myconciergemd.com/extracorporeal-blood-oxygenation-ozonation/
[13] Hemodialysis. National Institute of Diabetes and Digestive and Kidney Diseases (NIH), 2018. https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/hemodialysis
[14] Taking care of your vascular access for hemodialysis. MedlinePlus Medical Encyclopedia (NIH National Library of Medicine), 2024. https://medlineplus.gov/ency/patientinstructions/000591.htm
[15] Heparin Sodium in Sodium Chloride Injection: prescribing information (Hospira). DailyMed (NIH National Library of Medicine), 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0413f511-6b34-4c15-e48b-3fad08baacbe
[16] The Potential Toxicity of Ozone: Side Effects and Contraindications of Ozonetherapy. Ozone: A New Medical Drug, 2nd ed. (Springer), via PMC, 2011. https://pmc.ncbi.nlm.nih.gov/articles/PMC7498876/
[17] Ozone: a possible cause of hemolytic anemia in glucose-6-phosphate dehydrogenase deficient individuals. Journal of Toxicology and Environmental Health (PubMed), 1977. https://pubmed.ncbi.nlm.nih.gov/846014/
[18] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[19] Health effects of ozone. A critical review. JAPCA (PubMed), 1989. https://pubmed.ncbi.nlm.nih.gov/2659744/
[20] Do You Need a Device That Claims to Clean a CPAP Machine?. U.S. Food and Drug Administration, 2024. https://www.fda.gov/consumers/consumer-updates/do-you-need-device-claims-clean-cpap-machine
[21] Oxygen-ozone autohaemotherapy in fibromyalgia: safety profile and adverse events. A scoping review. Clinical and Experimental Rheumatology (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42328943/
[22] Ozone therapy induced sinus arrest in a hypertensive patient with chronic kidney disease: A case report. Medicine, Baltimore (PubMed), 2017. https://pubmed.ncbi.nlm.nih.gov/29390373/
[23] Combining Ozonated Autohemotherapy with Pharmacological Therapy for Comorbid Insomnia and Myofascial Pain Syndrome: A Prospective Randomized Controlled Study. Pain Research and Management (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/37214227/
[24] Effects of major ozonated autohemotherapy in the treatment of dry age related macular degeneration: a randomized controlled clinical study. International Journal of Ophthalmology (PubMed), 2012. https://pubmed.ncbi.nlm.nih.gov/23275905/
[25] An unexpected death during oxygen-ozone therapy. American Journal of Forensic Medicine and Pathology (PubMed), 2000. https://pubmed.ncbi.nlm.nih.gov/10871129/
[26] Neurological Crisis Following Intravenous Ozone Therapy; a Case Report. Archives of Academic Emergency Medicine (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/40027218/
[27] Ozone as Janus: this controversial gas can be either toxic or medically useful. Mediators of Inflammation (PubMed), 2004. https://pubmed.ncbi.nlm.nih.gov/15203558/
[28] Cerebral gas embolism and multifocal ischemic stroke during oxygen-ozone therapy: a case report. BMJ Neurology Open (PubMed), 2024. https://pubmed.ncbi.nlm.nih.gov/39720509/
[29] A Case of Paradoxical Embolism Causing Anterior Spinal Cord Syndrome and Acute Myocardial Infarction Following the Intradiscal Oxygen-Ozone Therapy. Frontiers in Neurology (PubMed), 2019. https://pubmed.ncbi.nlm.nih.gov/30853936/
[30] Ozone-Induced Encephalopathy Following Subcutaneous Ozone Injection: A Case Report. Cureus (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/41492606/
[31] Matter of Robins v New York City Off. of Chief Med. Examiner, 2023 NY Slip Op 00286. New York Supreme Court, Appellate Division, First Department, 2023. https://www.nycourts.gov/reporter/3dseries/2023/2023_00286.htm
[32] In the Matter of the Accusation Against German Zermeno, M.D., Case No. 800-2022-088393: Decision and Stipulated Settlement. Medical Board of California, 2024. https://www2.mbc.ca.gov/BreezePDL/document.aspx?path=%5CDIDOCS%5C20240621%5CDMRAAAJD2%5C&did=AAAJD240621215614354.DID
[33] Ozone Healing Clinic, Penrith: Time-bound Prohibition Order. NSW Health Care Complaints Commission, 2025. https://www.hccc.nsw.gov.au/decisions-orders/prohibition-orders/ozone-healing-clinic-penrith-nsw
[34] Warning letter to O3UV, LLC (CBER 25-668840). U.S. Food and Drug Administration, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/o3uv-llc-668840-07072025
[35] Class 2 Device Recall Enaly 1000 BT12 Ozone Generator (Recall Number Z-1576-2014). U.S. Food and Drug Administration, medical device recall database, 2014. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127001
[36] Ossigeno-ozono terapia (nota N. DGFDM.III/P/1752/I.4.C.C.). Ministero della Salute (Italy), published by Regione Toscana, 2005. https://www.regione.toscana.it/documents/10180/12096595/Allegato+3+Parere+n.+10-2007+%28Autore+Bailo+09-03-2007%29.pdf/f1bb981c-98e3-4ca9-8c8a-e111f32713fa?version=1.0&t=1416999155247&download=true
[37] Warning Letter to RowenSu Clinic: Unsubstantiated Claims for Coronavirus Treatment. Federal Trade Commission, 2020. https://www.ftc.gov/system/files/warning-letters/covid-19-letter_to_rowensu.pdf
[38] MedWatch Online Voluntary Reporting Form. U.S. Food and Drug Administration, 2026. https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
[39] A cluster of hepatitis C virus infections associated with ozone-enriched transfusion of autologous blood in Rome, Italy. Infection Control and Hospital Epidemiology (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16209382/
[40] Myocardial Infarction after Ozone Therapy: Is Ozone Therapy Dr. Jekyll or Mr. Hyde?. Cardiology (PubMed), 2015. https://pubmed.ncbi.nlm.nih.gov/26139204/
[41] Ozonation of blood during extracorporeal circulation. I. Rationale, methodology and preliminary studies. International Journal of Artificial Organs (PubMed), 1999. https://pubmed.ncbi.nlm.nih.gov/10532435/
[42] Are dialysis devices usable as ozone gas exchangers?. Artificial Organs (PubMed), 2010. https://pubmed.ncbi.nlm.nih.gov/19817737/

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# EBO2 (EBOO) Therapy Cost in 2026: What US Clinics Publish and What a Quote Leaves Out

Source: https://ebo2.com/guides/ebo2-cost/
Updated: 2026-10-04

Key takeaways:
- As of October 4, 2026, 40 of the 174 clinics whose EBO2 pages we could read published a single-session price. The median was $1,500, and the middle half ran from $1,274 to $1,550.
- Of those 40 prices, 26 came with a condition on the clinic's own pages: a starting-price label, a member rate, protocol tiers, a bundle, or a separate fee.
- A quote can leave out a consultation or evaluation fee ($50 to $600 at the 10 of 174 readable clinics that list one anywhere on their saved pages), lab tests, add-ons such as light therapy, and a deposit.
- As of October 4, 2026, each of the 21 packages clinics published cost more than one fewer session at the same clinic's single price, so a package saved money only if every session was used.
- EBO2 is elective and not FDA-approved, and we found no evidence that health insurance pays for it; whether an HSA or FSA can is decided by the plan administrator, not the clinic.

EBO2 (also called EBOO) is sold by US clinics as an out-of-pocket service, and most of them do not publish a price.
This guide is built on what the clinics that do publish one show on their own pages: our dataset of 177 directory
listings, each read and quoted, with the pages saved [19]. It answers three questions a reader with a quote in hand
has: is this number in the usual range, what should it include, and does a package save money. To test a specific
number, use the price check (/tools/price-check/). To total a course with add-ons and travel, use the
session cost planner (/tools/session-cost/). The full distribution is in the price report (/reports/ebo2-prices/).

The short answer: as of October 4, 2026, 40 of the 174 clinics whose EBO2 pages we could read published a
single-session price. The prices ran from $750 to $2,500, the median was $1,500, and the middle half fell between
$1,274 and $1,550 [19]. Those figures are recomputed from the data each time the site is built, under "From our data"
at the end of this page. For what the procedure is, see the pillar guide (/what-is-ebo2/).

What do US clinics charge for one session?

Most clinics do not say. As of October 4, 2026, 134 of the 174 clinics whose EBO2 pages we could read publish no
single-session price [19], and some, such as one Atlanta clinic, say the price is discussed at a first consultation [8]. The 40 published prices
fall like this:

| Published single-session price | Clinics |
|---|---|
| Under $1,000 | 5 |
| $1,000 to $1,499 | 11 |
| Exactly $1,500 | 13 |
| More than $1,500 | 11 |

$1,500 is the most common figure by a wide margin: 13 of the 40 prices are exactly that, and 24 are $1,500 or more
[19]. We count listings, not businesses: the 40 prices come from 36
websites, because four businesses list two locations at the same price. We count a price only when it was
read on the clinic's own EBO2 page; a price recorded in our directory before that page could be read is left out of
every figure here, as it is from the blocks at the end of the page.

The prices do not support a comparison by state. They come from 17 states, and no state has more than 6 published
prices, which is too few to say EBO2 costs more in one state than another. We also checked whether price tracked
three things clinics state about the session: its length, a named device, and named clinicians. The median price in
every one of those groups stayed within about $100 of $1,500, a difference too small to read anything into with 40
prices read from clinic pages [19].

What does a published price leave out?

A published price is often not the whole price. As of October 4, 2026, 26 of the 40 published prices came with at
least one condition on the pages we saved [19]. A price can carry more than one:

| What the clinic's pages say alongside the price | Prices |
|---|---|
| A separate consultation, evaluation, or first-visit fee | 9 |
| Several prices by protocol or version; our dataset records the base or lowest | 5 |
| The price covers a bundle (a consultation, lab orders, light or other therapies) | 4 |
| A lower price for members | 3 |
| A floor rather than a fixed price ("starting at", "$850+") | 4 |
| An optional add-on with its own price | 3 |
| Later sessions priced lower than the first (two listings of one clinic) | 2 |
| No statement of whether the price is per session or per series | 1 |
| Final price "confirmed at your consultation" | 1 |
| A lower rate for one group of patients | 1 |

An Arizona clinic charges $1,500 for the first session and $1,250
for each one after [11]. An Illinois clinic charges $1,500 to non-members and $1,200 to members [12]. A San Diego
clinic charges $1,050 for EBOO and $1,250 for what it calls EBO2, which it defines as EBOO with a Hemealumen light
device [2]. An Oregon clinic lists five protocols from $1,299 to $1,799 per treatment and requires a $100
consultation first [6]. When we read it on September 28, 2026, a South Carolina clinic's $1,297 price was a package that
included lab orders, a PEMF session, and light-therapy beds; its page now gives no price [13]. The number at the top of
a pricing page answers only part of the question.

What should a quote itemize?

A consultation or evaluation fee

As of October 4, 2026, 10 of the 174 clinics whose pages we could read list a fee for a consultation, evaluation,
or first visit before EBO2 somewhere on the pages we saved; the one-line intake statement we recorded for each clinic
gives a fee for 5 of them [19]:

| Fee | What the clinic's page says it is | Credited toward treatment |
|---|---|---|
| $50 | An "EBOO Establish visit" of up to 30 minutes for patients new to the clinic, which can be by phone [10] | Not stated |
| $100 | A required EBOO medical consultation [6] | Not stated |
| $100 | A medical pre-screen consultation required before any EBOO treatment, waived for members [20] | Not stated |
| $125 | An EBOO consultation, listed with the session fees [14] | Not stated |
| $150 | A 30-minute consultation [15] | Not stated |
| $150 | An optional phone consultation [4] | Yes, toward the first session |
| $250 | A one-time consultation, required for non-members [9] | Not stated |
| $250 | A medical evaluation that includes required lab tests and a physician consultation [7] | $150 toward a three-session package |
| $250 or $450 | A first consultation, at $450 for cancer patients [8] | Not stated |
| $600 | A 60-minute regenerative medicine consultation that reviews suitability for EBOO, which established patients may not need [21] | Not stated |

Other clinics describe a free consultation, such as a free 15-minute phone call at one South Carolina clinic [13],
and one Texas clinic's $1,500 first appointment covers both a half-hour consultation and the first session [5]. A
quote that does not mention a consultation fee has not necessarily ruled one out.

Lab tests

Lab tests are mentioned far more often than they are priced. As of October 4, 2026, 33 of the 174 readable clinics mention
lab tests, bloodwork, or biomarkers in the intake statement we recorded for each (what the clinic says happens before
a first session), and 11 name G6PD, an enzyme test
for the condition described under G6PD deficiency (/glossary/#g6pd-deficiency) [19]. Few say who pays. One Texas
clinic requires CBC, CMP, and G6PD results from the month before the appointment and offers to draw them for $20 [5].
Another folds its required labs into a $250 evaluation [7]. An Oregon clinic says a separate G6PD test is required
before a protocol can be scheduled [6], a clinic near Austin lists G6PD, CMP, PT, PTT, and INR among its required
labs [10], and a San Diego clinic says it may waive its lab requirement for CBC, CMP, and G6PD results from the past
three months [2].

Add-ons

As of October 4, 2026, 22 of the 174 readable clinics list an add-on to EBO2, from 20 websites [19]. Two kinds
recur:

A light step, at 7 clinics: a Hemealumen light device named at 4, UV light at 2, and "extracorporeal
  photobiomodulation" at 1.
An IV infusion, at 13 clinics on 11 websites: NAD+ at 4, glutathione at 7, methylene blue at 3, a Myers'
  cocktail at 4, IV hydration at 2, and mentions of vitamin C, procaine, chelation, and an exosome
  infusion. As with prices, these are counts of listings: a business with several listings that name the same infusions
  counts once for each.

Single clinics also list PEMF and lymphatic drainage, PRP or stem-cell injections, other ozone therapies,
before-and-after toxin testing, and supplements. Three clinics publish an add-on price: $90 for a Hemealumen light [5], $150 for UV light [4], and $300
for HemeaLumen added to any of four protocols [6]. Two more price the combination instead. A San Diego clinic's EBO2
with the light device costs $200 more than its EBOO [2], and an Arizona clinic's EBOO with NAD costs
$201 more than EBOO alone, with EBOO plus procaine at $151 more [3]. Where a light step is priced, then, it adds $90
to $300 a session. A quote that includes a light device or an IV can be compared with other clinics only after the
EBO2 price without it is known.

A deposit

Deposits carry their own terms. One Texas clinic takes a $700 deposit that is non-refundable if the appointment is
cancelled within 3 business days [5]. A South Carolina clinic asks for a small deposit to reserve the day; on
September 28, 2026, its page put it at $297 against a $1,297 package [13].
Another Texas clinic takes a $45 deposit toward its $250 evaluation, and its page says "All sales final" [7].

How do packages work, and when do they save money?

As of October 4, 2026, 17 of the 174 readable clinics publish a package price, from 15 websites, and together
they list 21 packages [19]. Sixteen of the clinics sell a 3-session package, four a 5-session package, and one a
4-session package. Against the same clinic's single-session price, the packages save a median of 10% per session,
with a range of 0% to 17% and a middle half of 8% to 12%. Across a whole package that is $0 to $1,000, a median of
about $500. Package totals run from $2,700 to $6,750.

The test that matters is what happens if a course stops early. In all 21 packages, the package total is more than the
same clinic's single price times one fewer session [19]. A 3-session package at $3,750 from a clinic that charges
$1,500 a session comes to $1,250 a session if all three are used [1]. Stop after two, and those two cost $1,875
each, $750 more in total than two single sessions. The saving exists only for the buyer who uses every session.

Do the division rather than trusting the per-session figure printed beside a package. One Wisconsin clinic's page
lists "Three EBOO Sessions" at $3,750, described as $1,250 per session, and a second "Three EBOO Sessions" line at
$5,000, described as $1,000 per session [1]. Divided by three, $5,000 is about $1,667 a session; it matches $1,000 per
session only if that line means five sessions.

Refund terms are rarely published. Of the 17 listings with a package price, one page says "All sales final" [7], and
none of the 17 pages we saved says whether unused sessions can be refunded, transferred, or will expire [19]. The
answer, and whether the clinic will put it in writing, is worth having before any money changes hands. The
how many sessions guide (/guides/how-many-sessions/) covers the separate question of what course length clinics
recommend and what the studies used.

Why do prices differ between clinics?

The pages point to what is in the price more than to the procedure itself. Clinics with tiers charge more for
protocols that add a light device or an infusion [2][3][6]. Clinics with memberships publish a lower member rate,
$300 to $350 below the non-member price at the three that list both [12][19]. Bundles fold in consultations, lab
orders, or other therapies [5][13]; our guide to what else clinics sell (/guides/clinic-bundles/) covers those services. A price with more inside it is not comparable, number for number, with a bare
session price.

Every session also carries fixed costs. Two clinics cited here state that the filter (and, at one, the tubing) is
single-use [6][7], and an FDA warning letter describes one maker's "100 Pack EBOO Full Spectrum Kit" as including disposable
hemodialyzer filters bought from a supplier [16]. The technique's developers describe a session as about an hour of extracorporeal
circulation treating up to 4,800 ml of heparinized blood [17], and as of October 4, 2026, the 101 clinics that
state a session length give a median of about 75 minutes [19]. A lower-dose ozone method costs
far less at clinics that offer both: one Wisconsin clinic lists a single major autohemotherapy (/glossary/#mah)
session at $175 and a single EBOO session at $1,500 on the same page [1]. Our
comparison with 10-pass ozone and MAH (/guides/ebo2-vs-10-pass-ozone/) explains how the procedures differ.

None of this says whether a higher price buys a safer or better session. We have no data on outcomes by clinic, and
none of the studies in our research library (/research/) compares them.

Questions to ask about a quote

Is the price for one session, and what does that session include?
Is there a separate consultation, evaluation, or first-visit fee, and is it credited toward treatment?
Which lab tests are required before the first session, who orders them, and who bills for them?
Does the price include a light device, an IV infusion, or anything else, and what is the price without it?
Is this the member or the non-member price, and what does membership cost?
If the clinic sells several protocols, which one is this quote for, and what does each add?
Is a deposit required, and when does it stop being refundable?
For a package: what is the total, what happens to sessions not used, and can the clinic put that in writing?
How long is the quoted price good for?

The price check (/tools/price-check/) places a quote against every published price, and the
session cost planner (/tools/session-cost/) adds fees, add-ons, and travel into an all-in total. Our
guide to choosing a clinic (/guides/how-to-choose-a-clinic/) covers the questions that are not about money,
how to read a clinic's EBO2 page (/guides/how-to-read-a-clinic-ebo2-page/) decodes the FDA and benefit wording on
pricing pages, and the clinic directory (/clinics/) shows what each listed clinic states about its own service.

Does insurance, an HSA, or an FSA pay for it?

Ozone therapy is not FDA-approved for any condition, and the FDA's device rules describe ozone as a toxic gas with no
known useful medical application [18]. EBO2 is sold as an elective, cash-pay service; one Oregon clinic's page, for example, says it does not bill
insurance or provide superbills for it [6]. Our
insurance guide (/guides/insurance-coverage/) sets out what clinics say about paying, what Medicare's rules and the
IRS publications on HSA and FSA spending say, and what we could not verify about insurers' policies. For budgeting, the safe assumption is that the whole cost is out of pocket; an HSA or FSA changes how it
is paid only if the plan administrator accepts the expense.

What we could not verify

What the other 134 clinics charge. Clinics that publish no price quote it privately, and the 40 published
  prices may not represent them.
Whether a published price is still current. Pages were read on the dates given below. Prices change: one clinic
  that showed a sale price ("was $1,500") on September 28, 2026 shows no price at all now [13].
What a membership costs. Three clinics publish member rates, but we did not capture membership fees, so we
  cannot say when a membership pays for itself.
Packages outside the 21. Some pages state a discount without a total ("$500 off a three-session package") [6]
  or price a program only in a sentence. Those are not in our package figures.
Who pays for labs. Few pages say whether lab tests are billed by the clinic, by an outside lab, or through
  insurance.
Refund and expiry terms. Almost none of the saved pages state them. A clinic may publish terms on a page we did
  not save.
The Wisconsin package line. We could not tell from the page whether $5,000 buys three sessions or five [1].
Whether price tracks quality or safety. We have no data that could show it.

How this guide was made

This guide rests on 21 sources: 17 clinic pages, cited only for what each clinic states about its own prices and
fees; two FDA documents; one peer-reviewed review by the technique's developers; and our own clinic dataset, which
anyone can download (/data/). Every figure marked "As of October 4, 2026" was computed by a script from that
dataset: 177 directory listings from 152 websites, all read between September 28, 2026 and October 4, 2026, of which 174 had EBO2 pages we
could read with confidence. The qualifier, consultation-fee, add-on, and refund
counts were classified by reading each saved clinic page. The figures in this guide and under "From our data" are
computed from the same records whenever the site is built.
Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.
A price on this
page is not a recommendation of any clinic.

FAQ:
Q: How much does one EBO2 session cost?
A: As of October 4, 2026, 40 of the 174 clinics whose EBO2 pages we could read published a single-session price. The prices ran from $750 to $2,500, the median was $1,500, and the middle half fell between $1,274 and $1,550. Most clinics publish no price at all: 134 of the 174 whose EBO2 pages we could read did not, and some say the price is set at a consultation.

Q: Why do EBO2 prices vary so much between clinics?
A: Much of the spread is what the price includes. On clinics' own pages, some prices are starting-price figures, some are non-member rates with a lower member price, some are the base of several protocol tiers, and some bundle a consultation, lab orders, or light therapy. Where clinics price a light step separately, it adds $90 to $300 a session. We found no stated fact, such as session length or a named device, that separated higher prices from lower ones.

Q: What should an EBO2 quote include?
A: The per-session price and what it covers; any consultation or evaluation fee and whether it is credited toward treatment; which lab tests are required and who bills for them; any add-on built into the price; the deposit and when it stops being refundable; and for a package, the total, the number of sessions, and what happens to sessions that are not used.

Q: Are EBO2 packages worth it?
A: Only if every session is used. As of October 4, 2026, the 21 packages clinics published saved a median of 10% per session against the same clinic's single price, with a range of 0% to 17%. In all 21, the package total was more than paying the single price for one fewer session, so stopping early costs more than paying as you go.

Q: Does insurance pay for EBO2?
A: We found no sign that it does. Ozone therapy is not FDA-approved for any condition, and EBO2 is sold as an elective, out-of-pocket service. Whether an HSA or FSA can pay is a question for the plan administrator. Our insurance guide sets out what clinics say about paying, what Medicare's rules and the IRS publications on HSA and FSA spending say, and what we could not verify about insurers' policies.

Q: Is a cheaper EBO2 session a worse one?
A: Price tells us nothing we can measure about safety or effect. None of the studies in our research library compares outcomes by clinic or by price. A lower published price can also reflect a smaller bundle, a starting-price label, or a member rate, so comparing what each price includes says more than comparing the numbers.

Sources:
[1] Ozone. Eden Healing Oasis (Green Bay, WI), 2026. https://edenhealingoasis.com/ozone/
[2] EBOO Ozone Therapy and EBO2 Therapy. San Diego Center for Restorative Medicine, 2026. https://www.restorativemedicinecenter.com/eboo-ozone-therapy
[3] Extracorporeal Oxygenation & Ozoniation. Advanced IV Health (Tucson, AZ), 2026. https://advancedivhealth.com/services/eboo-ozone/extracorporeal-oxygenation-ozoniation-150327901
[4] EBOO session pricing. SynergyO3 Medical (Encinitas, CA), 2026. https://synergyo3.com/eboo-ozone-therapy-encinitas/pricing/
[5] Extracorporeal Blood Oxygenation and Ozonation (EBOO) in San Antonio. O3 Plus Tx (San Antonio, TX), 2026. https://o3plustx.com/treatments/ozone-therapy/extracorporeal-blood-oxygenation-and-ozonation-eboo/
[6] Full-Spectrum EBOO Therapy in Lake Oswego, Oregon. Evergreen Factor (Lake Oswego, OR), 2026. https://evergreenfactor.com/eboo-therapy
[7] EBOO Therapy in The Woodlands, TX. Detoxity Holistic MediSpa (The Woodlands, TX), 2026. https://www.detoxityspa.com/eboo-therapy
[8] EBOO Therapy. Progressive Medical Center (Atlanta, GA), 2026. https://www.progressivemedicalcenter.com/therapies/eboo-therapy-in-atlanta/
[9] EBOO (Extracorporeal Blood Oxygenation and Ozonation). Burick Center (Mechanicsburg, PA), 2026. https://burickcenter.com/eboo-extracorporeal-blood-oxygenation-and-ozonation/
[10] EBOO IV Therapy in Marble Falls, Texas. Roots Integrative Medicine (Marble Falls, TX), 2026. https://www.rootsintegrativemedicine.com/eboo-austin/
[11] Ozone Therapy Specialist. Valley Spinal Care (Phoenix and Scottsdale, AZ), 2026. https://www.valleyspinalcare.com/services/ozone-therapy
[12] EBOO Therapy. Vigeo Care Center & Aesthetics (Algonquin, IL), 2026. https://vigeocare.com/services/eboo-therapy/
[13] EBOO Therapy in North Charleston. Charleston Pain Relief Center (North Charleston, SC), 2026. https://charlestonpainreliefcenter.com/eboo-therapy/
[14] EBOO Therapy. Infinity Hydration & Wellness (Muncy, PA), 2026. https://www.infinityhydrationwellness.com/eboo
[15] Innate Healthcare Institute home page (consultation fee). Innate Healthcare Institute (Scottsdale, AZ), 2026. https://innatehealthcare.org
[16] Warning letter to O3UV, LLC (CBER 25-668840). U.S. Food and Drug Administration, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/o3uv-llc-668840-07072025
[17] Extracorporeal blood oxygenation and ozonation: clinical and biological implications of ozone therapy. Redox Report (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16156950/
[18] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[19] EBO2 clinic dataset and the clinic pages it lists, read between September 28, 2026 and October 4, 2026. EBO2.com, 2026. https://ebo2.com/data/
[20] EBOO Therapy. True Health DPC (Silverton, OR), 2026. https://truehealthdpc.com/eboo
[21] EBOO / EBO2 Therapy. Institute for Human Optimization (Hanover, MD), 2026. https://ifho.org/services/eboo-ebo2

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# EBO2 (EBOO) vs 10-Pass Ozone: A Side-by-Side From the Primary Sources

Source: https://ebo2.com/guides/ebo2-vs-10-pass-ozone/
Updated: 2026-10-04

Key takeaways:
- 10-pass ozone draws 200 mL of blood into a pressurized flask, ozonates it and returns it, ten times in about an hour. EBO2 (EBOO) pumps blood continuously through a gas exchanger or dialysis filter for about an hour. Ozone therapy is not FDA-approved for any condition.
- By the published parameters the two move similar amounts of blood: 2 liters in ten batches for 10-pass, and 1.8 to 2.4 liters in an hour in the 2023 California EBOO paper (our arithmetic).
- The claim that EBOO delivers three or more times the ozone of 10-pass sets a figure calculated from gas measurements in 12 patients against a theoretical maximum for 10-pass that counts all the ozone put in.
- No trial has compared the two. 10-pass has one published study: six patients, no control group, a laboratory measure of blood-cell energy, co-authored by the method's pioneer.
- As of October 4, 2026, 11 of the 174 clinic EBO2 pages we could read repeat the three-times comparison or its figures, and none says that the figures for the other methods are theoretical.

EBO2 (also called EBOO) and 10-pass ozone are the two methods US clinics market
as the highest-dose ways of ozonating blood. In 10-pass,
200 mL of blood is drawn into a vacuum flask, mixed with ozone gas under
pressure and returned, ten times in about an hour [1]. In EBOO, blood
is pumped continuously from one arm, through a gas exchanger or dialysis filter
where it meets the gas, and back into the other arm, for about an hour
[2][3]. Ozone therapy is not FDA-approved for any condition
[4].

This page sets the two side by side from the papers that describe them, then
takes apart the dose comparison that several clinic pages quote, which says EBOO delivers
"three or more times" the ozone of 10-pass [2]. The short version:
the two move similar amounts of blood, the dose comparison mixes calculated and
theoretical figures, and no study has compared what either does for patients.

The two procedures side by side

Figures are as each source states them; where we combined them, we say so.

| | 10-pass (ozone high-dose therapy) | EBOO, US practice | EBOO, Siena papers |
|---|---|---|---|
| Source | Six-patient study from the pioneer's practice in Austria [1] | 12-patient measurement study from a California clinic [2] | Developers' review and trial [5][6] |
| How blood meets ozone | 200 mL drawn into a vacuum flask; 200 mL of gas pumped in under pressure; blood returned under positive pressure | Pumped continuously past hollow fibers, with gas flowing the opposite way, in a dialysis chamber | Continuous circuit through a purpose-built gas exchanger [7] |
| Ozone concentration | 70 µg/mL | 10 to 60 µg/mL, mostly 30 to 40 | 0.5 to 1 µg/mL |
| Blood per session | 2,000 mL in ten batches of 200 mL (our arithmetic) | 30 to 40 mL a minute for one hour, so 1.8 to 2.4 liters (our arithmetic) | Up to 4,800 mL in one hour |
| Time | About one hour for ten passes | Exactly one hour | One hour |
| Anticoagulant | 7,500 units of heparin in the flask | Heparin drip, 15,000 units in a liter of saline, about 300 mL reaching the patient | Heparinized blood |
| Pressure | Up to 2 atmospheres in the flask, by the California paper's description [2] | None described | None described |
| Filter | None | Dialysis chamber (cellulose triacetate) | Gas exchanger, not a dialysis filter [8] |
| Device named | Hyper Medozon comfort (Herrmann Apparatebau, Germany) | Zotzmann Ozone 2000 generator; Renak CTA 1500 chamber | L001 gas exchanger (2007) |
| Sessions in the study | Two, within one week | Not stated; routine repeated sessions | 14 over 7 weeks as the standard cycle |

Two things stand out. First, the blood volumes are close. Ten passes of 200 mL
come to 2 liters, and the California EBOO pump speeds move 1.8 to 2.4 liters in
an hour; only the Siena description, at about 80 mL a minute, reaches 4.8
liters [1][2][5]. Second, the ozone
concentrations run the other way from what volume pitches imply: 10-pass uses
the highest concentration of the three, and the Siena version of EBOO the
lowest.

Each liter of blood also meets ozone differently. In 10-pass, a batch of blood
is mixed with an equal volume of gas in a bottle and shaken [1]. In
EBOO, flowing blood takes up ozone across a membrane, and the California group
found that how much it took up rose with pump speed, by up to 30 percent at 40
mL a minute compared with 30 [2]. Why US EBOO uses a dialysis filter, and
how that compares with hemodialysis, is in EBO2 vs dialysis (/guides/eboo-vs-dialysis/);
the heparin in both methods is covered in
blood thinners and other medicines (/guides/eboo-blood-thinners-and-medications/).

The dose comparison: what was measured and what was assumed

The "three or more times" figure comes from the title and conclusion of the
2023 California paper [2]. The paper is careful about its own method,
but the comparison it draws mixes figures of different kinds.

| Figure | Method | How the paper gets it | Kind of figure |
|---|---|---|---|
| 37 percent average uptake (range 25 to 50) | EBOO, 85 measurements in 12 patients | Ozone concentration measured at the generator and in the exhaust gas, corrected for a 23 percent loss measured in an empty, dry dialyzer | Calculated from gas measurements; uptake by blood is inferred, not measured in blood |
| About 460,000 µg | EBOO at 30 µg/mL for one hour | (30 µg/mL minus 7 lost in the equipment) × 0.9 L of gas a minute × 60 minutes × 37 percent | Calculated |
| About 558,900 µg | EBOO at a higher blood flow | The same sum at a 45 percent uptake | Calculated |
| Up to 140,000 µg | 10-pass | Ten passes of 200 mL of gas at 70 µg/mL | Theoretical maximum: all the ozone put in, counted as delivered |
| 14,000 µg | One hyperbaric pass | 200 mL × 70 µg/mL | Theoretical maximum |
| 10,000 µg (6,000 to 14,000) | Gravity MAH | 200 mL of gas at 50 (30 to 70) µg/mL, which the paper notes the plastic bag may absorb | Theoretical maximum |
| 3.28 times | EBOO against 10-pass | 460,000 ÷ 140,000 | A calculated figure divided by a theoretical one |

The paper's own wording marks the difference: for the other methods it gives
the "maximum theoretical delivery of ozone", and for 10-pass "a total of up to
140,000 μg" [2]. The 10-pass paper uses the same arithmetic and says
each pass "delivers 14,000 μg" [1]; neither paper measured how much
ozone 10-pass blood actually took up.

So the EBOO figure counts only the ozone that did not come back out in the
exhaust, while the 10-pass figure counts all the ozone put into the flask. The
two numbers answer different questions, and the ratio between them is not a
measured difference. The California authors also note limits of their own: they
did not check whether unabsorbed ozone was destroyed after leaving the chamber,
they do not know whether other dialysis chambers lose ozone the same way, and
they did not study clinical benefits or risks [2]. Whether more ozone
is better is a separate question the paper does not address, and its authors
note that "little is reported on the efficacy of higher doses of ozone vs.
lower dose" [2].

The one 10-pass study

The only peer-reviewed study of 10-pass in our library is König and Lahodny's
2022 pilot [1]. Its parameters, as the full text gives them:

Patients. Six consecutive patients aged 55 to 74 who came to Dr.
  Lahodny's private practice in St. Pölten, Austria, for preventive treatment;
  four had no current disease, and none took medication.
Treatment. Two sessions of ten passes within one week, on a Hyper Medozon
  comfort device. Each pass drew 200 mL of blood into a vacuum flask holding
  7,500 units of heparin, added 200 mL of gas at 70 µg/mL under pressure, and
  returned the blood using positive pressure of 0.9 atmosphere. Ten passes took
  about an hour. The paper does not say whether the heparin is added once or
  with every pass.
What was measured. A bioenergetic health index, a laboratory measure of
  energy use in white blood cells, before treatment, after the first session
  and after the second.
What it found. The index rose by the second session, driven by maximum
  respiration and reserve capacity. Against the starting value, the change was
  statistically significant after the second session (p = 0.045) but not after
  the first (p = 0.198).
Limits. Six patients, no comparison group, one week of follow-up, and a
  laboratory marker rather than any symptom or illness. The authors write that
  more patients should be included in further studies.
Interests. Lahodny "has pioneered the 10-pass OHT method" and uses it at
  his private clinic; the paper says he does not hold a patent on it.

The paper also dates the method's use at that practice to 2015 [1].
The California paper reports a survey of 10-pass therapists, presented at a
professional meeting, that found no significant toxicity in more than 4,000
treatments apart from rust-colored urine in a small minority of patients; we
have not read that survey [2].

The EBOO studies, briefly

EBOO has more papers, but not better ones for this question. As of October 2,
2026, our library lists six studies of EBOO as given to people, the California paper
among them, shown with their procedures in the table under "From our data". The only randomized trial compared EBOO with
intravenous prostacyclin in 28 patients with peripheral artery disease and
found greater regression of skin lesions with EBOO, with no change in leg
circulation in either group [6]. The California paper measured gas
and reports no outcomes [2]. Its authors write that patients who had
received both methods showed a "near universal preference" for EBOO, an
observation, not a measured result [2]. For the batch method that both
grew from, a controlled crossover study in 12 hemodialysis patients found that
nine sessions of ozonated autohemotherapy, 250 mL of blood at 50 µg/mL, did not
change two inflammation markers compared with nine oxygen-only sessions
[9]. More on all of these is in does EBO2 work? (/guides/does-ebo2-work/)
and what EBO2 is (/what-is-ebo2/).

What clinic pages say about the two

As of October 4, 2026, we could read the EBO2 pages of 174 of the
177 clinics in our directory (/clinics/). Of those 174:

Thirty-six mention 10-pass ozone.
Eleven repeat the three-times comparison or the figures behind
  it. None says that the 10-pass and MAH figures are theoretical maximums.
Five carry nearly the same sentence, saying traditional or 10-pass ozone "treats
  only a small portion" of the blood while EBO2 "treats the majority", at 4 to 6
  or 5 to 7 liters.

A few pages come closer to the papers. One sets out 10-pass as 200 mL "drawn,
ozonated, and returned 10 times" and puts its blood volume at 1.5 to 2 liters
[10]. Another clinic that offers EBOO says ozone dosing is "measured as
mcg/ml, not volume of blood treated or filtered" [11].

Prices for the two are not comparable from our data, which records EBO2 prices
only; see the price report (/reports/ebo2-prices/) and the
cost guide (/guides/ebo2-cost/).

What a fair comparison would need

We found none of these in the published record:

The same measurement for both: ozone taken up by blood, measured the same
   way in 10-pass and in EBOO, instead of a calculation for one and a maximum
   for the other.
A head-to-head trial in people with a defined condition, with a comparison
   group that gets neither, and outcomes that matter to patients.
Safety recorded the same way for both, with adverse events counted by people
   other than the practitioners.
Both versions of EBOO, the Siena gas exchanger and the US dialysis filter,
   since their settings differ many times over.

What we could not verify

The survey of 10-pass therapists that the California paper cites. It was
  presented at a meeting, and we have not found it published.
When 10-pass began. The 2022 paper dates its use at the pioneer's practice to
  2015; other accounts of the method's origin are not peer-reviewed.
Whether the heparin in the 10-pass flask is given once or with each pass.
How much ozone 10-pass blood actually takes up. No paper we found measured
  it.
Whether the dialysis chambers used in US EBOO behave like the one in the
  California paper.
Anything about 10-pass prices or session counts from our data, which covers
  EBO2 only.

How this guide was made

This guide draws on 11 sources: the 2022 10-pass paper and the
2023 California paper read in full on PubMed Central, Siena papers read as
abstracts and one in full, a federal regulation, and clinic pages saved by our
research pass. Where we combined published figures, such as liters of blood per
session, we say "our arithmetic". The clinic counts come from our dataset of
177 clinics, read between September 28, 2026 and October 4, 2026, and were counted from the saved
pages. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: Is EBO2 better than 10-pass ozone?
A: No study has compared them on any health outcome, so neither can be called better. The comparison clinics quote is about ozone dose, and it sets a calculated figure for EBOO against a theoretical maximum for 10-pass, so it is not like for like.

Q: How much ozone does 10-pass deliver?
A: The only 10-pass paper says each pass delivers 14,000 micrograms and ten passes 140,000. That is the amount of ozone put into the flask, 200 mL of gas at 70 micrograms per milliliter each time, not an amount measured in blood.

Q: Does EBO2 treat more blood than 10-pass?
A: Not by much, going by the published parameters. Ten passes of 200 mL move 2 liters of blood in batches; the 2023 California EBOO paper's pump speeds move 1.8 to 2.4 liters in an hour. The original Siena papers describe up to 4,800 mL an hour. Clinic pages that say 10-pass treats only a small portion of the blood do not match these figures.

Q: Is 10-pass the same as hyperbaric oxygen therapy?
A: No. In 10-pass the pressure is inside the glass flask holding 200 mL of blood and gas, up to 2 atmospheres by one paper's description. Hyperbaric oxygen therapy puts the whole person in a pressurized chamber. The 'hyperbaric' in hyperbaric ozone refers only to the flask.

Q: Does 10-pass use a filter?
A: No. Blood is mixed with ozone in the flask and returned. EBOO passes blood through a gas exchanger or, in US practice, a dialysis filter, which is where the filtering that clinic pages describe comes in.

Sources:
[1] Ozone high dose therapy (OHT) improves mitochondrial bioenergetics in peripheral blood mononuclear cells. Translational Medicine Communications (PubMed Central), 2022. https://pmc.ncbi.nlm.nih.gov/articles/PMC9301618/
[2] Ozone dialysis delivers three or more times the ozone than other forms of ozone blood treatment. Medical Gas Research (PubMed Central), 2023. https://pmc.ncbi.nlm.nih.gov/articles/PMC9555023/
[3] Oxygen/ozone as a medical gas mixture. A critical evaluation of the various methods clarifies positive and negative aspects. Medical Gas Research (PubMed Central), 2011. https://pmc.ncbi.nlm.nih.gov/articles/PMC3231820/
[4] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[5] Extracorporeal blood oxygenation and ozonation: clinical and biological implications of ozone therapy. Redox Report (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16156950/
[6] Extracorporeal blood oxygenation and ozonation (EBOO): a controlled trial in patients with peripheral artery disease. International Journal of Artificial Organs (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16288443/
[7] Oxygenation-ozonation of blood during extracorporeal circulation: in vitro efficiency of a new gas exchange device. Artificial Organs (PubMed), 2007. https://pubmed.ncbi.nlm.nih.gov/17725702/
[8] Ozonation of blood during extracorporeal circulation. I. Rationale, methodology and preliminary studies. International Journal of Artificial Organs (PubMed), 1999. https://pubmed.ncbi.nlm.nih.gov/10532435/
[9] No effects of ozonated autohemotherapy on inflammation response in hemodialyzed patients. Mediators of Inflammation (PubMed), 2004. https://pubmed.ncbi.nlm.nih.gov/15770057/
[10] EBOO Therapy. NOVA IV Therapy, 2026. https://www.novaivtherapy.com/eboo-therapy/
[11] EBOO/EBO2 Ozone Therapy. San Diego Center for Restorative Medicine, 2026. https://www.restorativemedicinecenter.com/eboo-ozone-therapy

---

# EBO2 (EBOO) vs Dialysis: How Ozone Dialysis Compares With Hemodialysis

Source: https://ebo2.com/guides/eboo-vs-dialysis/
Updated: 2026-10-04

Key takeaways:
- In a dialysis center, hemodialysis runs blood past a membrane with dialysis solution on the other side, for about 4 hours, usually three times a week. EBOO runs blood past a membrane with oxygen-ozone gas on the other side, for about an hour.
- The Italian group that developed EBOO rejected dialysis membranes as unsuitable for ozone and later wrote that dialysis filters should be used only for dialysis. A 2023 US series and an FDA warning letter show dialyzers in use for EBOO.
- Dialysis equipment is Class II and generally reaches the market through FDA 510(k) clearance. A device-name search for ozone in FDA's classification database returns no records, and in 2025 FDA told a maker of EBOO kits its devices lacked premarket approval.
- Dialysis removes material through dialysis solution and ultrafiltration, and FDA requires clearance and sieving tests for one class of dialyzer. No EBOO paper we read reports either measure for any substance.

EBO2 (also called EBOO) is sometimes sold as "ozone dialysis," and at least some US practices run it through the same kind of cartridge a kidney dialysis unit uses [16][17]. Both pump blood out of the body, past a membrane, and back. What sits on the other side of that membrane, for how long, and why, is different. Hemodialysis pumps blood past a membrane with prescribed dialysis solution on the other side, for about four hours, usually three times a week at a dialysis center, to take over part of the work of failed kidneys [1][4]. EBOO puts oxygen-ozone gas on the other side of the membrane, typically for one hour, to put ozone into the blood [8][13][16]. This guide sets the two side by side from federal regulations, a National Institutes of Health page, and the EBOO papers themselves; shows where the EBOO literature disagrees with itself about dialysis filters; and lists what evidence would be needed before EBOO could fairly be described in dialysis terms. Ozone therapy is not FDA-approved for any condition, and federal regulation calls ozone "a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [18].

Is EBOO a form of dialysis?

Not as the FDA's regulations describe dialysis. Its regulation for conventional systems describes hemodialysis as "an artificial kidney system for the treatment of patients with renal failure or toxemic conditions," in which "undesirable substances in the blood pass through the semipermeable membrane into the dialysate" [2]. The regulation for high permeability systems adds fluid overload and says they remove "toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate)" [1]. The National Institute of Diabetes and Digestive and Kidney Diseases describes hemodialysis as a treatment "to filter wastes and water from your blood, as your kidneys did when they were healthy," and says it "can replace part, but not all, of your kidney function" [4].

EBOO was built for a different job. The Siena group that developed it described its aim as "amplifying the results observed with ozone autohemotherapy" [9], and its 2005 review described treating up to 4,800 ml of blood with an oxygen-ozone mixture in one hour [8]. The US practitioners who use the dialysis label set out "solely to quantify the amount of ozone uptake" during their sessions, and called "ozone dialysis" "a simpler more descriptive term" for "countercurrent administration of ozone gas using semi-permeable dialysis membranes" [16]. Clinics disagree about the name. One clinic page says the method is "often called ozone dialysis because the blood is passed through a dialysis membrane where the ozone is" [20]. Another says "Using terms like 'ozone dialysis' is misleading," because dialysis "uses large volumes of dialysate fluid to osmotically remove toxins" and EBOO "does not use dialysate fluid" [19].

Same filter, or a different one?

The EBOO literature splits on this, and the split runs between the developers and later US practice.

The developers tried dialysis equipment first and turned it down. In 1999 they reported that they "first evaluated the classical dialysis-type technique" and "soon realized that semipermeable membranes are unsuitable because they are hydrophilic and vulnerable to O3," and moved to hydrophobic, ozone-resistant hollow fibers [11]. In 2001 they wrote that semipermeable membranes, except for one, "were gas-transfer inefficient, allowed ultrafiltration and were more or less vulnerable to O3" [12]. Their 2007 device used microporous, ozone-resistant polypropylene fibers with a membrane area of 0.22 m², coated on the side that touches blood, with the gas flowing inside the fibers [13]. In 2010 the same group compared four dialysis filters with that kind of gas exchanger. The filters' gas-exchange yield ranged "from 0 up to 70%," their fibers were "somewhat altered by ozone," and their materials "may release toxic compounds harmful for the patients"; the authors wrote that dialysis filters "should be specifically used only for dialysis" and that "some clinicians incautiously use them as GEDs" (gas exchange devices) [14].

Four US sources we read name a dialyzer as the cartridge. The 2023 ozone dialysis series circulated blood "through a Renak CTA (cellulose triacetate) 1500 dialysis chamber" [16]. An FDA warning letter in 2025 records that a Michigan maker of EBOO equipment bought "ABLE® H-200 High Flux Polyethersulfone Disposable Haemodialysers" sold as part of its EBOO kits, without evaluating the supplier [17]. A clinic that published a water test of its circuit says a "Renak CTA-1500 dialyzer was used for filtration and ozonation" [25]. In our own clinic data (/clinics/), as of October 4, 2026, 21 of the 174 clinics whose EBO2 page we could read name the device they use, and one of those names a hemodialyzer model. The authors of the 2023 series noted that they "do not know whether other dialyzing chambers and materials will show a similar loss" of ozone to the one they measured, an average of 23% absorbed or broken down by their own equipment [16].

Side by side

The table uses each source's own units. The middle column is EBOO as its developers described it; the right column is "ozone dialysis" as one US clinic's published series and the FDA's 2025 letter describe it. How long clinics say a session takes is in the "From our data" section below.

| | Hemodialysis | EBOO, Siena developers | US "ozone dialysis" |
|---|---|---|---|
| Stated purpose | "Artificial kidney system" for renal failure, fluid overload, or toxemic conditions [1] | "Amplifying the results observed with ozone autohemotherapy" [9] | To deliver ozone; the 2023 series measured "ozone uptake" [16] |
| Cartridge | Dialyzer with a semipermeable membrane; "high permeability" means an ultrafiltration coefficient above 8 mL per hour per mmHg [1][2] | Hydrophobic, ozone-resistant polypropylene hollow fibers, 0.22 m² in the 2007 device [13] | A cellulose triacetate "dialysis chamber" [16]; high-flux polyethersulfone hemodialyzers in one maker's kits [17] |
| On the other side of the membrane | Dialysis solution, flowing in the opposite direction [1][4] | Gas "composed of medical oxygen and ozone (about 99 and 1%, respectively)," flowing in the opposite direction [13] | Oxygen-ozone gas at 0.9 L/min, in the opposite direction [16] |
| Where the blood runs | "Inside hollow fibers" [4] | On the outside of the fibers [13] | "Around tiny tubules," with gas inside them [16] |
| How material leaves the blood | Diffusion into dialysate and convection by ultrafiltration, with fluid removal controlled by the machine [1] | Membranes that "allowed ultrafiltration" were rejected [12] | A 2 L canister "used to collect dialysis chamber drainage" [16]; we found no measurement of its volume or contents |
| Blood flow | "Almost a pint of blood" withdrawn and returned "every minute" [4] | Up to 4,800 ml in 1 hour [8], which the 2023 authors read as 80 mL/min [16] | 30, 35, and 40 mL/min [16] |
| Access | Arteriovenous fistula, graft, or venous catheter [4] | "Two contralateral veins" [15] | One 20-gauge catheter in each arm [16] |
| Anticoagulant | A heparin pump in the circuit [4] | "Heparinized blood" [8]; early tests with pig blood found heparin "not an ideal anticoagulant," and sheep work used sodium citrate [11] | 15,000 units of heparin in 1 L of saline, as a slow drip [16] |
| Session and course | In a center, about 4 hours, usually three times a week; at home, 2 to 10 hours, three to seven times a week [4] | 1 hour; a standard course of 14 sessions over 7 weeks [8] | "Exactly 1 hour" [16] |
| Ozone | None | 0.5 to 1 μg/ml [8] | 10 to 60 μg/mL, mostly 30 to 40 μg/mL [16] |
| FDA status | Class II; dialysis equipment generally reaches the market through 510(k) clearance [2][6] | Developed in Italy; we found no FDA record for its device | One maker's EBOO devices adulterated for lack of premarket approval and misbranded for lack of a 510(k) notice [17] |
| Evidence base | A graded practice guideline built on trials and observational studies [5] | One 28-patient randomized trial [9] | One ozone-uptake series in 12 patients, with no patient outcomes [16] |

Two rows deserve a second look. The same name covers very different doses: 0.5 to 1 μg/ml in the Siena human studies [8], against mostly 30 to 40 μg/mL in the US series [16], whose authors call the Siena figure "a very low concentration of ozone" [16]. And the 2023 authors wrote that the Siena studies "reported gas flow as a pressure but not volume," so "there is no way to know how much ozone gas is provided for uptake" in them [16].

What dialysis is held to, and how removal is measured

Dialysis equipment is regulated as Class II [2][6]. The FDA's consumer page on approval says moderate-risk devices, "for example dialysis equipment," generally reach the market through "510(k) clearance," by showing they are substantially equivalent to a device already on the market [6]. Conventional systems fall under performance standards [2], and high permeability systems under special controls that include FDA guidance on the content of 510(k)s for hemodialyzers [1].

The newest dialyzer regulation shows what a claim of removal is tested with. Since 2024, a hemodialyzer "with expanded solute removal profile," which removes more of the "middle" molecular weight range (0.5 kDa to 60 kDa) than standard high-flux dialyzers, must be tested for ultrafiltration, "clearance rates," "sieving coefficients," "mechanical hemolysis," and "structural integrity," among other things, and its clinical testing "must evaluate the solute removal profile and document all adverse events" [3]. Its labeling must state membrane surface area, priming volume, maximum transmembrane pressure, and maximum blood and dialysate flow [3]. A nephrology review from 2026 describes the trade-off behind such membranes: larger pores clear larger molecules, and there is "ongoing debate about the appropriate balance between large solute clearance and albumin loss" [7].

How much dialysis a patient gets is itself governed by evidence. The 2015 KDOQI hemodialysis adequacy guideline reviewed trials and observational studies published between 2000 and March 2014 and graded its recommendations using the GRADE approach, covering treatment time, frequency, and ultrafiltration rate [5]. Nothing comparable exists for EBOO; on October 2, 2026, ClinicalTrials.gov listed no registered study under "ozone dialysis" [24].

What the EBOO papers say about dialysis patients

The developers saw a place for EBOO alongside dialysis. Their 2005 review said "the EBOO technique can be easily adapted for use in hemodialysis also" [8], and their 2002 case report described EBOO in one dialysis patient with necrotizing fasciitis, whose condition "improved radically" [10]. That is one patient, reported in a four-sentence abstract.

The one controlled study in our library done in people on hemodialysis tested a different procedure. In a single-blind crossover in 12 hemodialysis patients, nine sessions of ozonated autohemotherapy, which mixes about 250 ml of blood with ozone outside the body, changed neither C-reactive protein nor interleukin-6 compared with nine oxygen-only sessions [21]. A 2017 case report describes a woman with chronic kidney disease who developed high potassium and sinus arrest after ozone autohemotherapy; the arrhythmia resolved when the ozone was stopped and the potassium treated [22]. We found no study of EBOO as a treatment for kidney failure itself. Our ozone therapy adverse events guide (/guides/ozone-therapy-adverse-events/) lists other reported harms.

For readers with kidney disease, the questions worth taking to a nephrologist follow from the table: whether the circuit's cartridge is a hemodialyzer and which model, how much heparin the session uses, whether anything controls fluid loss across the membrane the way dialysis machines must [1], and how the session would fit around dialysis days. Our contraindications guide (/guides/contraindications/) and the doctor questions tool (/tools/doctor-questions/) list more.

What would have to be true

Clinic pages describe EBOO in dialysis-like terms. One calls it ozone dialysis [20], and as of October 4, 2026, 151 of the 174 clinics whose EBO2 page we could read claim a detoxification benefit. For terms like filtering and removing to mean what they mean in dialysis, evidence of these kinds would be needed. We list them without saying whether any is true.

The cartridge would have to tolerate ozone. The developers' own tests found dialysis fibers "somewhat altered by ozone" and warned of possible toxic compounds [14]. For the newest class of dialyzer, FDA requires structural integrity testing and "a chemical analysis of the dialyzer membrane" [3]. The same tests, run with ozone gas where the dialysate would be, would answer the question.
Removal would have to be measured substance by substance. Dialyzers are characterized by clearance rates and sieving coefficients [3]. No EBOO paper we read reports either for any substance.
Something would have to carry the removed material out of the circuit. In dialysis, the dialysate does [1][2]. EBOO circuits put gas there instead [13][16], and one clinic states that EBOO "does not use dialysate fluid" [19]. The only route the sources describe is fluid draining from the cartridge into a canister [16], the ultrafiltration the developers saw as a flaw [12]. Its volume and laboratory contents, compared with a sham circuit, have not been published in anything we found.
Blood levels would have to change more than they do without the procedure. That needs measurements before and after in people who had EBOO and people who did not.
Patients would have to do better than a comparison group in a trial with a prespecified outcome, with adverse events recorded the way the dialyzer rule requires [3].
The dose would have to be defined. The 2023 authors could not reconstruct the ozone dose of the original studies [16], and the two traditions report very different concentrations [8][16].
The device would need FDA authorization for this use. FDA's classification database returned "No records were found" for a device-name search on "ozone" on October 2, 2026 [23], and FDA's 2025 letter treated one maker's EBOO devices as lacking premarket approval [17].

What we could not verify

Whether the dialyzer models named in the 2023 series and the FDA letter are labeled, cleared, or tested for use with ozone gas. We found no labeling or FDA record that says so, and we did not search each model's 510(k) file.
How many US clinics use a hemodialyzer rather than a purpose-built gas exchanger. As of October 4, 2026, only 21 of the 174 clinics whose EBO2 pages we could read name a device at all, and some describe a gas exchange unit without naming it.
Two statements in the 2023 paper rest on sources we could not check: that ozone dialysis has run "at least 22 years in Malaysia alone, with no significant toxicity observed in over 200,000 treatments," and that EBOO "clearly has clinical efficacy," a statement the paper supports by citing the Siena group's work [16].
We read only the abstracts of the Siena papers, so device names, test fluids, and numbers in their full texts are unknown to us [8][11][12][13][14].
Whether any EBOO circuit in use returns ultrafiltered fluid to the patient or discards it, and how much. The 2023 series mentions a drainage canister but gives no volume [16].

How this guide was made

This guide rests on 25 sources: four federal regulations, two FDA pages and an FDA database search, an NIH page, a ClinicalTrials.gov search, 13 papers listed on PubMed, and three clinic pages, which are cited only for what those clinics state. The device and claim figures come from our dataset of clinic pages, as of October 4, 2026. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources. No clinical reviewer has signed off on this guide yet.

FAQ:
Q: Is EBOO a form of dialysis?
A: Not in the sense the FDA uses. Its regulations describe a hemodialysis system as an artificial kidney in which waste passes across a membrane into dialysis solution. EBOO circuits put oxygen-ozone gas on the other side of the membrane instead, and the US practitioners who call it ozone dialysis describe it as a way to deliver ozone.

Q: Do EBOO clinics use real dialysis filters?
A: Some do. A 2023 US paper on ozone dialysis used a cellulose triacetate dialysis chamber, an FDA warning letter records high-flux polyethersulfone hemodialyzers sold in a maker's EBOO kits, and one clinic in our data names a hemodialyzer model as its device. The Italian developers used a purpose-built polypropylene gas exchanger instead.

Q: Can EBO2 replace dialysis for kidney disease?
A: No study we found tested EBOO as a treatment for kidney failure, and no source we read describes it as one. Hemodialysis is a regulated, guideline-governed treatment for kidney failure. The questions in this guide are written for people on dialysis or with kidney disease to take to a nephrologist.

Q: Why do some clinics call EBO2 ozone dialysis?
A: Because the blood passes through a dialysis-type membrane. A US practitioner called ozone dialysis a simpler and more descriptive name for the method, while another clinic calls the term misleading because EBOO uses none of the dialysis solution that lets dialysis clear wastes.

Q: How long is an EBOO session compared with dialysis?
A: The sources we read describe EBOO sessions of about one hour; the 2023 US series timed them at exactly one hour. A standard in-center hemodialysis session lasts about four hours, usually three times a week, according to the National Institute of Diabetes and Digestive and Kidney Diseases.

Sources:
[1] 21 CFR 876.5860 High permeability hemodialysis system. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-876/subpart-F/section-876.5860
[2] 21 CFR 876.5820 Hemodialysis system and accessories. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-876/subpart-F/section-876.5820
[3] 21 CFR 876.5862 Hemodialyzer with expanded solute removal profile. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-876/subpart-F/section-876.5862
[4] Hemodialysis. National Institute of Diabetes and Digestive and Kidney Diseases (NIH), 2018. https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/hemodialysis
[5] KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 update. American Journal of Kidney Diseases (PubMed), 2015. https://pubmed.ncbi.nlm.nih.gov/26498416/
[6] Is It Really 'FDA Approved'?. US Food and Drug Administration, 2026. https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved
[7] Dialysis membranes and hemodialyzers. Contributions to Nephrology (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42721103/
[8] Extracorporeal blood oxygenation and ozonation: clinical and biological implications of ozone therapy. Redox Report (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16156950/
[9] Extracorporeal blood oxygenation and ozonation (EBOO): a controlled trial in patients with peripheral artery disease. International Journal of Artificial Organs (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16288443/
[10] Necrotizing fasciitis successfully treated with extracorporeal blood oxygenation and ozonization (EBOO). International Journal of Artificial Organs (PubMed), 2002. https://pubmed.ncbi.nlm.nih.gov/12518965/
[11] Ozonation of blood during extracorporeal circulation. I. Rationale, methodology and preliminary studies. International Journal of Artificial Organs (PubMed), 1999. https://pubmed.ncbi.nlm.nih.gov/10532435/
[12] Ozonation of blood during extracorporeal circulation. II. Comparative analysis of several oxygenator-ozonators and selection of one type. International Journal of Artificial Organs (PubMed), 2001. https://pubmed.ncbi.nlm.nih.gov/11831595/
[13] Oxygenation-ozonation of blood during extracorporeal circulation: in vitro efficiency of a new gas exchange device. Artificial Organs (PubMed), 2007. https://pubmed.ncbi.nlm.nih.gov/17725702/
[14] Are dialysis devices usable as ozone gas exchangers?. Artificial Organs (PubMed), 2010. https://pubmed.ncbi.nlm.nih.gov/19817737/
[15] Oxygen/ozone as a medical gas mixture. A critical evaluation of the various methods clarifies positive and negative aspects. Medical Gas Research (PubMed), 2011. https://pubmed.ncbi.nlm.nih.gov/22146387/
[16] Ozone dialysis delivers three or more times the ozone than other forms of ozone blood treatment. Medical Gas Research (PubMed), 2023. https://pubmed.ncbi.nlm.nih.gov/36204785/
[17] Warning Letter: O3UV, LLC - 668840 - 07/07/2025. US Food and Drug Administration (CBER), 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/o3uv-llc-668840-07072025
[18] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[19] EBOO/EBO2 Ozone Therapy. San Diego Center for Restorative Medicine, 2026. https://www.restorativemedicinecenter.com/eboo-ozone-therapy
[20] Ozone Dialysis. Dr. Laura Enfield, 2026. https://drlauraenfield.com/ozone-dialysis/
[21] No effects of ozonated autohemotherapy on inflammation response in hemodialyzed patients. Mediators of Inflammation (PubMed), 2004. https://pubmed.ncbi.nlm.nih.gov/15770057/
[22] Ozone therapy induced sinus arrest in a hypertensive patient with chronic kidney disease: A case report. Medicine, Baltimore (PubMed), 2017. https://pubmed.ncbi.nlm.nih.gov/29390373/
[23] Product Classification database search: device name ozone. US Food and Drug Administration, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&devicename=ozone
[24] ClinicalTrials.gov search: ozone dialysis. U.S. National Library of Medicine, 2026. https://clinicaltrials.gov/search?term=ozone%20dialysis
[25] EBOO Ozone Dialysis. USA Medical Research Institute, 2026. https://usamedresearchinstitute.com/eboo-ozone-dialysis/

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# EBO2 (EBOO) vs Plasmapheresis: What Each Procedure Does to Blood

Source: https://ebo2.com/guides/ebo2-vs-plasmapheresis/
Updated: 2026-10-04

Key takeaways:
- Therapeutic plasma exchange removes the patient's plasma and replaces it, most often with 5% human albumin. EBOO returns the same blood after exposing it to oxygen-ozone gas, and no study we found has measured anything it removes.
- The American Society for Apheresis's 2026 guidelines, its tenth edition, hold 93 fact sheets with 183 graded and categorized indications for apheresis. No comparable grading exists for EBOO.
- FDA's classification database lists therapeutic plasma separators as two device types, one marketed through 510(k) and one through premarket approval. A device-name search there for ozone returns no records.
- 21 CFR 864.9245, which is sometimes cited for plasmapheresis machines, covers separators that collect blood components from donors for transfusion or manufacturing.
- An average plasma exchange lasts about 2 hours with citrate anticoagulation, according to a patient fact sheet published by the American Society for Apheresis. EBOO sessions in the papers last about 1 hour with heparin.

EBO2 (also called EBOO) and plasmapheresis both draw blood into a machine and return it through a vein, which is why the two get compared. They do different things to that blood. In therapeutic plasma exchange, in the words of a patient fact sheet published by the American Society for Apheresis, "a machine separates and removes the patient's plasma, replacing it with another fluid," most often "5% human albumin" [1]. In EBOO, whole blood flows past a membrane carrying a gas "composed of medical oxygen and ozone (about 99 and 1%, respectively)," and the blood goes back to the patient [10][11]. This guide sets the two side by side from FDA records, the Society's guidelines, its patient fact sheet, and the EBOO papers, so a reader can see what each procedure does, how each is run, and how each is regulated. It makes no claim that either is better for anything. Ozone therapy is not FDA-approved for any condition, and federal regulation calls ozone "a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [15].

What plasma exchange does

Plasma, in the patient fact sheet, is the "liquid" part of blood, which "contains proteins, electrolytes, vitamins, hormones, etc." but not the blood cells or platelets [1]. Plasma exchange "is used when it is necessary to remove disease-causing proteins, called antibodies," and because "it is often not possible to remove only the protein that is causing the disease," the plasma itself is removed [1]. Most machines "use a centrifuge to separate the blood into its different parts," and "a solution containing citrate" keeps blood from clotting [1]. Blood can be drawn from one arm and returned to the other, or through a central venous catheter in people with small or fragile veins [1]. An average procedure "lasts about 2 hours," and the number of procedures "depends on the disease that is being treated" [1].

One ASFA registry gives a sense of the amount. In 26 patients with recurrent focal segmental glomerulosclerosis after kidney transplant, treated at seven US centers, most procedures used albumin and citrate and exchanged 1 to 1.5 plasma volumes [4]. The fact sheet also warns that plasma exchange "can remove large amounts of some medications" and advises patients to talk to their physicians about medication changes before the procedure [1].

What EBOO does

EBOO adds something to blood rather than taking a component out. The Siena group that developed it described treating up to 4,800 ml of heparinized blood with an oxygen-ozone mixture "(0.5-1 microg/ml oxygen)" in one hour, and a standard course of 14 one-hour sessions over 7 weeks [8]. Its gas exchanger used ozone-resistant polypropylene fibers, with blood on the outside and gas flowing inside [10]. A later Siena paper describes blood drawn from and returned to "two contralateral veins" and says about 5 L of blood can be treated in an hour [12]. A 2023 US series ran blood through a dialysis chamber at 30 to 40 mL/min for "exactly 1 hour," with ozone at 10 to 60 μg/mL and heparin given as a slow drip [11].

What the papers measured is the change in the blood, not removal from it. After a session, the developers reported thiobarbituric acid reactants rising four- to fivefold and plasma protein thiols falling "without any appreciable erythrocyte haemolysis" [8]. The 2023 series measured an average ozone uptake of 37% of the generator's output [11]. No EBOO paper we found reports a plasma component, antibody, or other substance removed and measured. Our guide to what the filter removes (/guides/what-the-filter-removes/) goes through what has and has not been measured.

Side by side

Figures are in each source's own units.

| | Therapeutic plasma exchange | EBOO |
|---|---|---|
| What happens to the blood | Plasma separated and removed, then replaced [1] | Whole blood exposed to oxygen-ozone gas across a membrane and returned [10][11] |
| What is taken out | Plasma, including antibodies [1] | Nothing measured in any study we found |
| What goes back | The blood cells with "another fluid," most often 5% human albumin, sometimes donated plasma [1] | The same blood, after taking up ozone: an average of 37% of the generator's output in one series [11] |
| How the machine works | Most use a centrifuge; FDA also lists membrane separators [1][6] | A gas exchanger [10] or a dialysis chamber [11] |
| Anticoagulant | Citrate [1] | Heparin [8][11] |
| Access | A needle in each arm, or a central venous catheter [1] | Two veins [12]; a 20-gauge catheter in each arm in one series [11] |
| Session length | "About 2 hours" on average [1] | 1 hour [8][11] |
| Amount handled | 1 to 1.5 plasma volumes in one registry [4] | Up to 4,800 ml of blood in an hour [8] |
| Number of sessions | Depends on the disease [1] | 14 sessions over 7 weeks in the developers' standard course [8] |
| Setting | Hospital for urgent first treatment; often an outpatient clinic for maintenance [1] | Integrative and wellness clinics; our clinic directory (/clinics/) lists them |
| Graded indications | 93 fact sheets with 183 graded and categorized indications, tenth edition [22] | None; one 28-patient randomized trial [9] |
| FDA device status | Centrifugal therapeutic separators: unclassified, pre-amendment, 510(k) [5]; membrane separators: Class III, premarket approval [6] | A device-name search for "ozone" finds no records [14]; one maker's EBOO devices adulterated for lack of premarket approval [13] |

How each is regulated

FDA's product classification database lists therapeutic plasma separators under two product codes. "Separator, automated, blood cell and plasma, therapeutic" is unclassified with the reason "Pre-Amendment" and reaches the market through a 510(k) submission [5]. "Separator for therapeutic purposes, membrane automated blood cell/plasma" is a Class 3 device that needs premarket approval, and FDA recognizes a consensus standard for it, ISO 8637-3 on plasmafilters [6]. Both are reviewed by FDA's renal, gastrointestinal, obesity and transplant devices team [5][6].

One regulation often cited for plasmapheresis machines covers something else. 21 CFR 864.9245 identifies an automated blood cell separator that draws whole blood "from a donor" and is "intended for routine collection of blood and blood components for transfusion or further manufacturing use"; it is Class II with special controls [7]. That is donor collection, not therapeutic plasma exchange. An earlier version of this guide cited it for plasma exchange devices, and we have corrected it.

We found no product code for EBOO equipment. A device-name search for "ozone" in FDA's classification database returned "No records were found" on October 2, 2026 [14]. In July 2025, FDA told a Michigan maker of EBOO equipment that its devices were adulterated because no premarket approval application was in effect and misbranded because it had not filed a 510(k) notification [13]. The same letter records that the maker's EBOO kits included purchased "High Flux Polyethersulfone Disposable Haemodialysers" from a supplier it had not evaluated [13]. As of October 4, 2026, 148 of the 174 clinics whose EBO2 page we could read do not say there whether EBO2 or its equipment is FDA-approved; the "From our data" section below shows how the rest word it.

Apheresis as a family has other members with FDA-approved uses. An American Heart Association statement says lipoprotein apheresis, which lowers LDL cholesterol and lipoprotein(a), is used in the United States for only "a fraction of its Food and Drug Administration-approved indications" [20].

How the evidence is organized

The American Society for Apheresis grades therapeutic apheresis disease by disease. Since its fourth edition in 2007, its writing committee has used systematic review and evidence-based approaches to grade the evidence and categorize each indication in a fact sheet [3]. The eighth edition, in 2019, held 84 fact sheets with 157 graded and categorized indications [3]. The ninth, in 2023, held 91 fact sheets and 166 graded and categorized indications, including seven new fact sheets and eight changes of category [2]. The tenth, in 2026, holds 93 fact sheets and 183 graded and categorized indications, including two new fact sheets [22]. The patient fact sheet names Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, myasthenia gravis, hyperviscosity, and thrombotic thrombocytopenic purpura among conditions "commonly treated with plasma exchange" [1].

EBOO has no such framework. Its controlled evidence is one randomized trial of 28 patients with peripheral artery disease, comparing EBOO with intravenous prostacyclin at the developers' hospital [9]. On October 2, 2026, ClinicalTrials.gov listed no registered study under "extracorporeal blood oxygenation and ozonation," "EBOO," or "EBO2" [19]. The fuller list of what has been studied is in our guide to whether EBO2 works (/guides/does-ebo2-work/).

Why the two get compared

Some clinic language invites the comparison. One clinic's EBOO page describes the procedure as "EBOO (Apheresis)" [17]. Another clinic that offers EBOO draws the line the other way: "The closest medical intervention we have to true 'filtering' the blood is called therapeutic plasma exchange (TPE) or plasmapheresis," which it says can "remove up to 3 liters of your plasma and replace it with new proteins and colloid solution" [16]. The same page says no validated US research shows what an EBOO collection canister contains [16]. The two have also been combined. A 2011 study in the journal Vestnik Oftalmologii described plasmapheresis with ozonation of the cell mass in 179 patients (209 eyes) with uveitis and reported an advantage for the method; its abstract gives no figures and does not say what the comparison groups received [21]. The comparison with kidney dialysis, the other machine EBOO is likened to, is in our EBOO vs dialysis guide (/guides/eboo-vs-dialysis/).

Risks as each source describes them

The patient fact sheet lists common side effects of plasma exchange as "fatigue, nausea, dizziness, feeling cold and tingling in the fingers and around the mouth, allergic reaction, and lowered blood pressure," and says serious complications such as "abnormal heart beat, seizures, electrolyte abnormalities, and unexplained bleeding are extremely rare" [1].

For EBOO, the safety record is the developers' and practitioners' own reports. The 2005 trial recorded "no side effects or complications" in 210 EBOO treatments [9]; the 2023 US series reports "at least 400 sessions of ozone dialysis with no untoward effects observed" at the authors' clinic [11]. Neither is a systematic adverse-event study. Other ozone routes have case reports of harm, including a woman with chronic kidney disease who developed high potassium and sinus arrest after ozone autohemotherapy [18]. Our ozone therapy adverse events guide (/guides/ozone-therapy-adverse-events/) and side effects and safety guide (/guides/side-effects-and-safety/) cover the wider record.

Questions to ask if EBOO is offered in place of plasma exchange

These follow from the table and can be put to the clinic and to the physician treating the condition.

What does the procedure take out of the blood, how much, and has anyone measured it? For plasma exchange the answer is plasma, by the volume prescribed [1][4]. For EBOO no study we found gives one.
What does the fact sheet for this diagnosis in the American Society for Apheresis's guidelines say about plasma exchange [2]?
Which device is used, and what is its FDA status for this use [5][6][13][14]?
Which anticoagulant is used, and how much? Plasma exchange usually uses citrate [1]; the EBOO papers describe heparin [8][11].
Who manages a reaction during the session, and where is the nearest hospital if one is needed? The patient fact sheet says urgent plasma exchange is done in the hospital [1].
What happens to current medicines? Plasma exchange can remove large amounts of some of them [1].

What we could not verify

The patient fact sheet carries a disclaimer: its publication "does not constitute an endorsement by ASFA," ASFA "has not reviewed these materials," and its views "represent the opinion of the authors" [1]. It prints no date; we date it 2021 from its file.
The definitions of the Society's categories and grades, and which category each condition holds. We could read only the abstracts of the ninth and tenth editions; the full text of the ninth sat behind the publisher [2][22].
Typical plasma volumes exchanged across all indications. The one figure we cite comes from a registry of a single condition [4].
Whether any EBOO circuit in use removes plasma, antibodies, or other proteins in measurable amounts. We found no study that tested it.
The clinic statement that plasma exchange can remove "up to 3 liters" of plasma [16], which we could not match to a primary source.
How many US clinics use a dialyzer, a purpose-built gas exchanger, or another cartridge for EBOO.

How this guide was made

This guide rests on 22 sources: a patient fact sheet published by the American Society for Apheresis, three editions of its guidelines, and one of its registry reports; three FDA database records, two federal regulations, and an FDA warning letter; eight other papers listed on PubMed; a ClinicalTrials.gov search; and two clinic pages, which are cited only for what those clinics state. The FDA-wording and course figures in the "From our data" section come from our dataset of clinic pages, as of October 4, 2026. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources. No clinical reviewer has signed off on this guide yet.

FAQ:
Q: Is EBO2 a type of plasmapheresis or apheresis?
A: No. Apheresis separates blood into its parts and removes one of them; plasma exchange removes plasma and replaces it. EBOO circulates whole blood past a gas exchange membrane carrying oxygen and ozone and returns it. One clinic page nonetheless labels EBOO as apheresis.

Q: Does EBO2 remove plasma or antibodies?
A: No source we found says it does, and no study we found has measured antibodies or any other plasma component removed by an EBOO circuit. Plasma exchange is used when, in the words of a patient fact sheet published by the American Society for Apheresis, it is necessary to remove disease-causing proteins called antibodies.

Q: Can EBO2 replace plasma exchange for an autoimmune or neurologic disease?
A: No study we found has compared them, and no EBOO study we found has tested an autoimmune or neurologic condition. Plasma exchange is a standard treatment for conditions such as Guillain-Barré syndrome and myasthenia gravis. A neurologist or the apheresis team treating the condition can say what a substitution would risk.

Q: How is plasmapheresis regulated compared with EBO2?
A: FDA lists centrifugal therapeutic plasma separators as an unclassified, pre-amendment device type marketed through 510(k), and membrane separators as Class III devices that need premarket approval. A device-name search for ozone in FDA's classification database returns no records, and in 2025 FDA told a maker of EBOO equipment its devices lacked premarket approval.

Q: Which takes longer, plasma exchange or EBO2?
A: A patient fact sheet published by the American Society for Apheresis says an average plasma exchange lasts about 2 hours. The EBOO papers describe 1-hour sessions, and clinics' own stated session lengths are summarized in the From our data section of our dialysis comparison.

Sources:
[1] Procedure: Therapeutic Plasma Exchange (also referred to as therapeutic plasmapheresis). American Society for Apheresis, 2021. https://cdn.ymaws.com/www.apheresis.org/resource/resmgr/fact_sheets_file/therapeutic_plasma_exchange.pdf
[2] Guidelines on the Use of Therapeutic Apheresis in Clinical Practice, Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Ninth Special Issue. Journal of Clinical Apheresis (PubMed), 2023. https://pubmed.ncbi.nlm.nih.gov/37017433/
[3] Guidelines on the Use of Therapeutic Apheresis in Clinical Practice, Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Eighth Special Issue. Journal of Clinical Apheresis (PubMed), 2019. https://pubmed.ncbi.nlm.nih.gov/31180581/
[4] Report of the ASFA Apheresis Registry Study on Focal Segmental Glomerulosclerosis. Journal of Clinical Apheresis (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/40641429/
[5] Product Classification: separator, automated, blood cell and plasma, therapeutic (LKN). US Food and Drug Administration, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=2412
[6] Product Classification: separator for therapeutic purposes, membrane automated blood cell/plasma (MDP). US Food and Drug Administration, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=2424
[7] 21 CFR 864.9245 Automated blood cell separator. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-864/subpart-J/section-864.9245
[8] Extracorporeal blood oxygenation and ozonation: clinical and biological implications of ozone therapy. Redox Report (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16156950/
[9] Extracorporeal blood oxygenation and ozonation (EBOO): a controlled trial in patients with peripheral artery disease. International Journal of Artificial Organs (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16288443/
[10] Oxygenation-ozonation of blood during extracorporeal circulation: in vitro efficiency of a new gas exchange device. Artificial Organs (PubMed), 2007. https://pubmed.ncbi.nlm.nih.gov/17725702/
[11] Ozone dialysis delivers three or more times the ozone than other forms of ozone blood treatment. Medical Gas Research (PubMed), 2023. https://pubmed.ncbi.nlm.nih.gov/36204785/
[12] Oxygen/ozone as a medical gas mixture. A critical evaluation of the various methods clarifies positive and negative aspects. Medical Gas Research (PubMed), 2011. https://pubmed.ncbi.nlm.nih.gov/22146387/
[13] Warning Letter: O3UV, LLC - 668840 - 07/07/2025. US Food and Drug Administration (CBER), 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/o3uv-llc-668840-07072025
[14] Product Classification database search: device name ozone. US Food and Drug Administration, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?start_search=1&devicename=ozone
[15] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[16] EBOO/EBO2 Ozone Therapy. San Diego Center for Restorative Medicine, 2026. https://www.restorativemedicinecenter.com/eboo-ozone-therapy
[17] EBOO Ozone Dialysis. USA Medical Research Institute, 2026. https://usamedresearchinstitute.com/eboo-ozone-dialysis/
[18] Ozone therapy induced sinus arrest in a hypertensive patient with chronic kidney disease: A case report. Medicine, Baltimore (PubMed), 2017. https://pubmed.ncbi.nlm.nih.gov/29390373/
[19] ClinicalTrials.gov search: extracorporeal blood oxygenation and ozonation. U.S. National Library of Medicine, 2026. https://clinicaltrials.gov/search?term=extracorporeal%20blood%20oxygenation%20and%20ozonation
[20] Lipoprotein apheresis: utility, outcomes, and implementation in clinical practice: a scientific statement from the American Heart Association. Arteriosclerosis, Thrombosis, and Vascular Biology (PubMed), 2024. https://pubmed.ncbi.nlm.nih.gov/39370995/
[21] Plasmapheresis combined with cell mass ozonation in endogenous uveitis treatment. Vestnik Oftalmologii (PubMed), 2011. https://pubmed.ncbi.nlm.nih.gov/22442992/
[22] Guidelines on the Use of Therapeutic Apheresis in Clinical Practice-Evidence-Based Approach From the Writing Committee of the American Society for Apheresis: The Tenth Special Issue. Journal of Clinical Apheresis (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42747330/

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# EBO2 (EBOO), Blood Thinners, and Other Medicines: What the Sources Say and What to Ask

Source: https://ebo2.com/guides/eboo-blood-thinners-and-medications/
Updated: 2026-10-04

Key takeaways:
- Published descriptions of EBOO in people, and of similar continuous circuits, use heparin to keep blood from clotting; most autohemotherapy papers use sodium citrate instead, and few papers say how much reaches the patient.
- We found no study of EBO2 (EBOO) in people who take blood thinners, and an autohemotherapy trial that reported no complications excluded people with clotting problems.
- The FDA-approved label of a heparin product warns that bleeding, including fatal bleeding, has occurred and that drugs affecting clotting or platelets may add to it; those warnings concern heparin in general, not EBO2.
- Clinic pages disagree: some say people on anticoagulants cannot be treated, some say blood thinners need discussion first, and several list heparin allergy as a reason not to treat.
- Whether to change or hold any medicine is a decision for the clinician who prescribes it; none of the sources here answers that question for EBO2.

No study has tested EBO2 (also called EBOO) in people who take blood thinners, and no source we found sets out which medicines interact with it. What the sources do give is narrower: how the circuits are kept from clotting, what the label of heparin, the anticoagulant the EBOO papers describe, warns about, what one researcher reported with blood pressure medicines, and what clinics say on their own pages. This guide collects those, then lists the questions they leave for the doctor who prescribes your medicines, and everything the sources do not cover.

Ozone therapy is not FDA-approved for any condition; federal regulation calls ozone "a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [29]. Nothing here is a reason to start, stop, or change a medicine.

How the circuit is kept from clotting

Blood drawn into a bag or circuit is mixed with an anticoagulant (/glossary/#anticoagulation) so it does not clot there, as clinics describe it [16][17]. The papers in our library report the anticoagulant this way:

| Procedure | Source | Anticoagulant as reported |
|---|---|---|
| EBOO | Siena review, 2005 [1] | Blood described as heparinized; up to 4,800 mL treated in an hour; no amount in the abstract |
| EBOO | Siena trial, 2005 [11]; New York case report, 2025 [10] | Not stated |
| EBOO development, with pig blood and sheep | Bocci, 1999 [32] | Tests with pig blood found heparin not an ideal anticoagulant for the system; the sheep experiments used sodium citrate (ACD) at a dose the authors defined |
| Ozone dialysis, a similar circuit | Rowen, 2023 [2] | A slow IV drip of 1 L of saline with 15,000 units of heparin; the authors say about 300 mL of it reaches the patient in the 1-hour treatment, with more used to prime and flush the lines |
| 10-pass ozone | König, 2022 [3] | 200 mL of blood drawn into a vacuum flask containing 7,500 units of heparin; repeated for ten passes; whether heparin is added for each pass is not stated |
| Major autohemotherapy, as Bocci describes it | Bocci, 2011 [4] | Either 3.8% sodium citrate (1 mL per 9 mL of blood) or heparin (20 IU per mL of blood) |
| Major autohemotherapy studies | [5][6][7][8] | Sodium citrate in each, from 10 to 25 mL of solution per bag or bottle |
| Intravenous ozone session (case report) | Wong, 2025 [9] | 500 IU of heparin with 150 mL of ozone-infused blood |

The pattern is heparin in the continuous circuits and in 10-pass ozone, and citrate in most single-bag autohemotherapy. The Siena group's first paper on the method preferred citrate in sheep [32], while its later description of human treatment calls the blood heparinized [1]. Only the ozone dialysis paper says how much of the heparin solution reaches the patient [2], and none of the texts we read reports checking clotting times during a session.

The volumes differ widely. The Siena review describes treating up to 4,800 mL of heparinized blood in an hour [1]; the 2025 New York case report gives about 2 liters per treatment under that clinic's protocol [10]; a Texas clinic says about 2 liters of blood are filtered in its one-hour session [25]; and the ozone dialysis paper ran its pump at 30 to 40 mL per minute for an hour [2]. The autohemotherapy papers above treated 100 to 225 mL of blood at a time [5][6][7][8]. The table under "From our data" shows the blood volume each EBOO paper reports.

Clinics describe the same choice. A South Carolina clinic says it uses a heparin protocol during EBOO to prevent clots in the circuit [16]. A Miami Beach clinic calls heparin a short-acting blood thinner used during EBOO, and its description of a glass-jar ozone procedure adds that its heparin comes from a porcine source [17].

What heparin's label warns about

FDA-approved prescribing information for one heparin product, Hospira's heparin sodium in sodium chloride injection, sets out these points [12]. They describe heparin in general; the label does not mention EBO2.

Strengths. Heparin is supplied in several strengths. The label reports fatal hemorrhages from medication errors and says to confirm the correct strength before giving it.
Who should not receive it. People with a history of heparin-induced thrombocytopenia (HIT), a serious immune reaction to heparin; people with a known hypersensitivity to heparin or pork products (the label also notes that the drug is derived from porcine intestinal mucosa); people with uncontrollable active bleeding; and, for full-dose heparin, people whose blood clotting cannot be tested at suitable intervals.
Bleeding. Hemorrhage, including fatal events, has occurred, and can happen at almost any site. The label lists conditions with higher bleeding risk, among them severe high blood pressure, hemophilia, low platelet counts, stomach or intestinal ulcers, liver disease with impaired clotting, and the period during and right after a spinal tap or major surgery. It reports more bleeding in women over 60.
HIT. HIT can cause clots in veins and arteries, and can appear up to several weeks after heparin is stopped. The label calls for monitoring the platelet count in everyone who receives heparin.
Other drugs. Drugs that interfere with clotting or platelet function may induce bleeding. The label names aspirin, ibuprofen, indomethacin, dipyridamole, hydroxychloroquine, dextran, and phenylbutazone among platelet inhibitors to use with caution. Heparin can also prolong the prothrombin time used to manage warfarin, and some drugs, including digitalis, tetracyclines, antihistamines, and intravenous nitroglycerin, may partly counteract it.
Potassium. The label advises measuring potassium before heparin in people at risk of high potassium.

How much heparin a given EBO2 session gives a patient is not published, so these warnings cannot be scaled to the procedure. That is a question for the clinic, and the answer is one to share with the prescribing doctor.

Who the studies included

A finding about harms applies only to the kinds of people studied. The 2022 autohemotherapy trial that reported no complications excluded people with severe disorders including hematologic disorders and coagulation dysfunction, people allergic to anticoagulants such as sodium citrate, and pregnant or breastfeeding women, and it checked coagulation in everyone it admitted [5]. The ozone dialysis measurements came from consecutive patients at the authors' clinic with no exclusion criteria, but the paper reports no bleeding outcomes [2]. A 2026 case series excluded patients with contraindications to the treatment without listing them [7]. The EBOO abstracts we read do not say whether anyone taking a blood thinner was included [1][11].

Other medicines the sources mention

ACE inhibitors. Bocci's book chapter reports a sudden, marked fall in blood pressure when ozonated blood was reinfused quickly into patients taking ACE inhibitors, an unpublished observation by other clinicians that he says he confirmed in two patients, during autohemotherapy [13]. He lists treatment with ACE inhibitors among the situations that preclude or limit ozone therapy [13]. No EBOO paper addresses it.
Citrate. In the same chapter, tingling of the lips and tongue near the end of reinfusion is attributed to excess citrate returned too quickly, a temporary drop in calcium [13].
Heparin with other ozone treatment. An evidence map of ozone therapy for COVID-19 lists nosebleeds associated with concomitant heparin use among the few adverse events in the studies it reviewed [14].
High-dose vitamin C. A 2022 letter is titled as a report of new methemoglobinemia after ozone autohemotherapy given with a high-dose vitamin C injection; we could read only its title [15].
Vitamin K. A Dallas clinic lists high-dose vitamin K use among reasons a person is not eligible for EBO2, without giving a reason [27].

What clinics say about blood thinners and heparin

| Clinic | What its page says |
|---|---|
| Enovative Wellness, Phoenix [18] | Lists patients currently on anticoagulant therapy among those for whom EBOO is contraindicated; elsewhere the page says certain anticoagulants |
| Avena Natural Health, Solana Beach, California [19] | Lists severe anticoagulation without physician oversight among conditions for which EBOO is not recommended |
| Bliss MD, Hanover Park, Illinois [20] | Says EBOO is compatible with most prescription medications, and that chemotherapy agents and certain anticoagulants require additional assessment |
| Synergistiq Wellness, Clearwater, Florida [21] | Says certain medications, particularly blood thinners, may need to be discussed, and that the physician reviews the full medication and supplement list |
| LIVation, Madison, Connecticut [22] | Says clients prescribed blood thinners, blood pressure medications, insulin, or hormone therapy need to go over their treatments with its team |
| Venturis Clinic, Oklahoma City [28] | Asks for current medications, particularly anything affecting clotting |
| BionwoRx, Carmel, Indiana [23] | Lists people who cannot safely tolerate the anticoagulants needed to run the circuit as not eligible |
| in2GREAT, Overland Park, Kansas [24]; Roots Integrative Medicine, Marble Falls, Texas [25] | List heparin allergy among contraindications |
| My Concierge MD, Beverly Hills [26] | Lists bleeding in patients taking blood thinners among the risks of EBOO, on a page that offers consultations about it |

Heparin is prescription-only in New South Wales, where the Health Care Complaints Commission found that a non-registered practitioner at an ozone clinic had obtained heparin "from an unknown source" and "is not authorised to be in possession of, or to administer" it [31].

These are examples from pages we saved on September 28, 2026, not a count. As of October 4, 2026, 132 of the 174 clinics whose EBO2 page we could read have an intake statement in our published dataset, the one quoted statement per clinic about what happens before a first session; 9 of those 132 mention medications, and none names blood thinners. A clinic's intake page can be short and its screening thorough, so the questions below are worth asking either way. The clinic directory (/clinics/) lists what each clinic states.

Questions for the doctor who prescribes your medicines

The clinic says its circuit uses heparin (or citrate). With the blood thinner I take, what would that add to my bleeding risk?
Is there anything in my history, such as a reaction to heparin, low platelets, or an allergy to pork products, that the clinic needs to know?
Which of my medicines and supplements affect bleeding, clotting, or platelets?
Would any of my medicines need to change around a procedure like this, and who would manage that?
Do I need blood tests first, such as a platelet count?
I take an ACE inhibitor. Is the report of low blood pressure with fast reinfusion of ozonated blood relevant to me?

Questions for the clinic

Which anticoagulant does the circuit use, how much, and how is it given: as a single dose, a drip, or added to the line?
Who prescribes the heparin, who gives it, and which product and strength is used?
Who sets the dose, and does it change for someone who takes a blood thinner?
Is clotting or the platelet count checked before or during the session?
What happens if a needle site keeps bleeding after the session, and how do I reach the clinic after hours?
Will the clinic speak with my prescribing doctor?

Our doctor questions tool (/tools/doctor-questions/) builds a printable list of questions from our guides, including the contraindications guide (/guides/contraindications/). A bleeding problem or reaction after any ozone procedure can be reported to FDA through MedWatch [30]; our adverse events guide (/guides/ozone-therapy-adverse-events/) explains how.

What we could not verify

Any study of EBO2 in people on anticoagulants. We found none, for warfarin, the newer oral anticoagulants such as apixaban or rivaroxaban, clopidogrel, or aspirin.
Results for the people trials left out. The trial that reported no complications excluded people with coagulation dysfunction [5], so its result says nothing about them, and the EBOO abstracts do not state their exclusions.
Heparin doses in EBO2 practice. No EBOO paper we read states the amount, and clinic pages do not publish theirs.
Clotting checks during sessions. None of the papers reports them.
Whether the circuit's heparin raises bleeding at the IV sites afterward. The ozone dialysis paper states how much heparin solution reaches the patient but reports no bleeding outcomes [2].
The 10-pass heparin total. The paper does not say whether the flask's 7,500 units are replaced for each pass [3], so we give no total.
Supplements. No source we found addresses fish oil, vitamin E, ginkgo, or other supplements with EBO2.
The vitamin K rule and the ACE inhibitor report. The first has no stated reason; the second rests on an unpublished observation and two patients during a different procedure.
Clinics' claims about compatibility with most medicines. We found no study behind them.

How this guide was made

We used 32 sources: fourteen papers from our research library and NCBI, a book chapter, an FDA-approved heparin label from DailyMed, a federal regulation, an Australian commission's order, FDA's MedWatch form, and thirteen clinic pages saved on September 28, 2026, labeled clinic-stated. The intake count comes from our clinic dataset as of October 4, 2026, and the two tables under "From our data" are computed from it and from our study cards when the site is built. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: Can I get EBO2 if I take a blood thinner?
A: The published sources do not answer this. No EBOO study we found reports on people taking anticoagulants or antiplatelet drugs, and clinics' own pages range from listing anticoagulant therapy as a reason not to treat to saying blood thinners need discussion. It is a question to take to the doctor who prescribes the blood thinner, along with the clinic's answer about which anticoagulant its circuit uses and how much.

Q: What anticoagulant does an EBO2 circuit use?
A: The published descriptions of EBOO in people and of ozone dialysis use heparin. A 2023 ozone dialysis paper describes a slow drip of 1 liter of saline containing 15,000 units of heparin and says about 300 mL of that solution reaches the patient during a one-hour treatment. Clinics' doses are not published, so the amount used in a given clinic is something to ask.

Q: Is the heparin used in these procedures made from pigs?
A: The FDA-approved heparin label we read describes the drug as derived from porcine intestinal mucosa and lists known hypersensitivity to heparin or pork products as a reason not to use it. One Miami Beach clinic says the heparin in one of its ozone blood procedures is derived from a porcine source.

Q: Do blood pressure medicines matter?
A: A book chapter by the Siena physiologist Velio Bocci reports sudden, marked drops in blood pressure when ozonated blood was returned quickly to patients taking ACE inhibitors, based on an unpublished observation and two patients of his own, during autohemotherapy rather than EBOO. Any change to a blood pressure medicine is a decision for the clinician who prescribes it.

Q: Why do some clinics ask about vitamin K?
A: One Dallas clinic lists high-dose vitamin K use among the reasons a person is not eligible for EBO2. Its page gives no reason, and we found no published source that explains the rule.

Sources:
[1] Extracorporeal blood oxygenation and ozonation: clinical and biological implications of ozone therapy. Redox Report (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16156950/
[2] Ozone dialysis delivers three or more times the ozone than other forms of ozone blood treatment. Medical Gas Research (PubMed), 2023. https://pubmed.ncbi.nlm.nih.gov/36204785/
[3] Ozone high dose therapy (OHT) improves mitochondrial bioenergetics in peripheral blood mononuclear cells. Translational Medicine Communications (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/35880042/
[4] Oxygen/ozone as a medical gas mixture. A critical evaluation of the various methods clarifies positive and negative aspects. Medical Gas Research (PubMed), 2011. https://pubmed.ncbi.nlm.nih.gov/22146387/
[5] Combining Ozonated Autohemotherapy with Pharmacological Therapy for Comorbid Insomnia and Myofascial Pain Syndrome: A Prospective Randomized Controlled Study. Pain Research and Management (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/37214227/
[6] Effects of major ozonated autohemotherapy in the treatment of dry age related macular degeneration: a randomized controlled clinical study. International Journal of Ophthalmology (PubMed), 2012. https://pubmed.ncbi.nlm.nih.gov/23275905/
[7] Efficacy of major ozone autohemotherapy in patients with post-COVID syndrome. Frontiers in Medicine (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/41767530/
[8] Sjögren syndrome successfully treated with oxygen-ozone auto-hemotherapy (O2-O3-AHT). A case report. European Review for Medical and Pharmacological Sciences (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/36066166/
[9] Neurological Crisis Following Intravenous Ozone Therapy; a Case Report. Archives of Academic Emergency Medicine (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/40027218/
[10] Observed Reduction in Urinary Toxin Excretion With Extracorporeal Blood Oxygenation and Ozonation (EBOO) Treatment in an 88-Year-Old With Chronic Anemia: A Case Report. Cureus (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/41583215/
[11] Extracorporeal blood oxygenation and ozonation (EBOO): a controlled trial in patients with peripheral artery disease. International Journal of Artificial Organs (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16288443/
[12] Heparin Sodium in Sodium Chloride Injection: prescribing information (Hospira). DailyMed (NIH National Library of Medicine), 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0413f511-6b34-4c15-e48b-3fad08baacbe
[13] The Potential Toxicity of Ozone: Side Effects and Contraindications of Ozonetherapy. Ozone: A New Medical Drug, 2nd ed. (Springer), via PMC, 2011. https://pmc.ncbi.nlm.nih.gov/articles/PMC7498876/
[14] Clinical effectiveness of medical ozone therapy in COVID-19: the evidence and gaps map. Medical Gas Research (PubMed), 2023. https://pubmed.ncbi.nlm.nih.gov/37077114/
[15] New-Onset Methemoglobinemia After Receiving Ozone Autohemotherapy and High-Dose Vitamin C Injection. Transfusion Medicine Reviews (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/34815107/
[16] EBOO Therapy in North Charleston. Charleston Pain Relief Center (North Charleston, SC), 2026. https://charlestonpainreliefcenter.com/eboo-therapy/
[17] Ozone Therapy. Miami Beach Comprehensive Wellness Center (Miami Beach, FL), 2026. https://www.miamibeachcwc.com/ozone-therapy
[18] EBOO IV Therapy in Phoenix. Enovative Wellness (Phoenix, AZ), 2026. https://enovativewellness.com/eboo-iv-therapy/
[19] Extracorporeal Blood Ozone & Oxygenation at Avena Natural Health. Avena Natural Health (Solana Beach, CA), 2026. https://avenanaturalhealth.com/treatments/eboo-san-diego/
[20] EBOO Therapy in Naperville. Bliss MD (Hanover Park, IL), 2026. https://www.blissmedicines.com/eboo-therapy-naperville/
[21] What Is EBOO Therapy? Benefits, How It Works & What to Expect. Synergistiq Wellness (Clearwater, FL), 2026. https://synergistiqhealth.com/blog/what-is-eboo-therapy/
[22] Ozone Therapy in Connecticut. LIVation (Madison, CT), 2026. https://www.livationct.com/ozone
[23] EBO2 Ozone in Carmel, IN. BionwoRx (Carmel, IN), 2026. https://bionworx.com/services/ebo2-ozone-therapy-carmel-in/
[24] EBOO Therapy. in2GREAT (Overland Park, KS), 2026. https://in2greatkc.com/integrative-therapies-kansascity/eboo-therapy/
[25] EBOO IV Therapy in Marble Falls, Texas. Roots Integrative Medicine (Marble Falls, TX), 2026. https://www.rootsintegrativemedicine.com/eboo-austin/
[26] EBOO: Evidence, Risks, and Medical Consultation in Beverly Hills. My Concierge MD (Beverly Hills, CA), 2026. https://www.myconciergemd.com/extracorporeal-blood-oxygenation-ozonation/
[27] EB02 Therapy. Alive and Well (Dallas, TX), 2026. https://aliveandwell.health/dallas-ebo2/
[28] EBOO Ozone Therapy, Oklahoma City, OK. Venturis Clinic (Oklahoma City, OK), 2026. https://venturisclinic.com/services-oklahoma-city-ok/alternative-medicine/eboo-ozone-therapy/
[29] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[30] MedWatch Online Voluntary Reporting Form. U.S. Food and Drug Administration, 2026. https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
[31] Ozone Healing Clinic, Penrith: Time-bound Prohibition Order. NSW Health Care Complaints Commission, 2025. https://www.hccc.nsw.gov.au/decisions-orders/prohibition-orders/ozone-healing-clinic-penrith-nsw
[32] Ozonation of blood during extracorporeal circulation. I. Rationale, methodology and preliminary studies. International Journal of Artificial Organs (PubMed), 1999. https://pubmed.ncbi.nlm.nih.gov/10532435/

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# How Many EBO2 (EBOO) Sessions Do You Need? What Clinics Recommend and What Studies Used

Source: https://ebo2.com/guides/how-many-sessions/
Updated: 2026-10-04

Key takeaways:
- As of October 4, 2026, 48 of the 174 clinics whose EBO2 pages we could read gave a number of sessions for a first course. The numbers ran from 1 to 15; the median of the smallest number each clinic named was 3, and of the largest was 6. Thirty of the 48 started at 3.
- A clinic's recommended course is its own advice, not a research finding: none of the EBOO studies in our research library compared one number of sessions with another.
- The technique's developers described a standard cycle of 14 one-hour sessions over 7 weeks. Of the 48 clinics that give a number, 1 recommends a course that long.
- Clinics most often space sessions about a week apart (31 of the 69 that state a course), while 7 of the 8 ozone-blood studies in our library that state a rhythm used two or more sessions a week.
- By our arithmetic, a course of 3 to 6 sessions at the median published price of $1,500 comes to $4,500 to $9,000 before any package discount, consultation fee, labs, or add-ons.

EBO2 (also called EBOO) has no agreed course length. Clinics publish their own numbers, and the handful of published
EBOO studies used schedules of their own without testing one number against another. This guide puts the two side by
side so a reader can tell a clinic's scheduling habit from a research result. For what happens in a single session,
see what to expect (/guides/what-to-expect/); for the procedure itself, the pillar guide (/what-is-ebo2/).

The short answer: as of October 4, 2026, 69 of the 174 clinics whose EBO2 pages we could read state a recommended
course, and 48 of them give a number of sessions. The numbers run from 1 to 15; the median of the smallest number each
clinic names is 3, and of the largest is 6 [17]. None of the
EBOO studies in our research library (/research/) compared one number of sessions with another, so none of those
numbers rests on a dose-finding result. A clinic's recommended course is its own advice, not a finding.

What do clinics recommend?

The 48 clinics that give a number usually give a range, such as "3 to 6 sessions." As of October 4, 2026, the
smallest and largest numbers they name fall like this [17]:

| Sessions named | Clinics naming it as the smallest number | Clinics naming it as the largest number |
|---|---|---|
| 1 | 2 | 0 |
| 2 | 1 | 0 |
| 3 | 30 | 10 |
| 4 | 10 | 6 |
| 5 | 3 | 3 |
| 6 | 0 | 14 |
| 8 | 1 | 2 |
| 10 | 0 | 7 |
| 12 | 1 | 1 |
| 15 | 0 | 1 |

Three is the usual start: 30 of the 48 begin there, and 9 give exactly "3 to 6." Thirty-three of the 48 name 6 or
fewer as their largest number, and 9 name 10 or more [17]. The other 21 clinics that state a course give only a rhythm,
such as weekly sessions for a month, with no count. The 69 listings come from 61 websites, because some clinics list
more than one location with the same wording.

The common starting number matches the most common package. As of October 4, 2026, 16 of the 17 clinics that
publish a package price sell a 3-session package [17]. That does not show which came first, but it is a reason to ask
how a recommended number was chosen.

Many clinics tie the number to a reason. As of October 4, 2026, 28 of the 69 that state a course tie the number or
the rhythm to a condition or to how severe a case is, 14 of them using the word "chronic," and 5 tie it to general
wellness or longevity goals [17]. A recommendation tied to a condition is still the clinic's advice: our guide to
what the research shows (/guides/does-ebo2-work/) covers what is known about EBOO for any condition.

A few clinics describe a step before the first full session. As of October 4, 2026, 3 of the 174 readable clinics
say so in what they list as intake: a session of IV ozone or of UV blood irradiation first, to check tolerance, or a
separate visit to assess veins [17].

How do clinics word the rhythm?

As of October 4, 2026, the 69 course statements word the spacing and any follow-up this way. A statement can say
more than one of these [17]:

| What the course statement says | Clinics |
|---|---|
| About a week apart: "weekly," "once a week," "one week apart," "seven to ten days apart" | 31 |
| One to two weeks apart | 8 |
| Twice a week, offered as an option | 2 |
| Monthly, or a range that reaches monthly ("weekly to monthly") | 6 |
| A limit rather than a plan: "up to once per week," "as often as once a week" | 3 |
| Maintenance sessions after the first course: monthly, quarterly, or every 3 to 4 months | 13 |
| The whole course repeated on a schedule: twice a year, or every 3 to 4 months | 5 |
| A review point: how a patient feels after the first sessions decides how many more | 2 |

Two patterns stand out. Weekly spacing dominates, and few statements build in a point where the clinic reviews whether
to continue (2 of the 69) [17]. Maintenance and repeat courses turn a first course into an open-ended schedule,
which matters for cost (see below). How long each session runs is a separate question: the session-length figures at
the end of this page show what clinics state.

What did the EBOO studies use?

Our research library holds six papers on EBOO as given to people. The developers' 2007 test of a gas-exchange
device in the laboratory (Bocci et al., 2007 (/research/bocci-2007-eboo-device-invitro/)) [19] is filed with the
background science. The course details of the six, exactly as our study cards record them from each paper, are
below; each title links to the card.

| Study | Design and size, as the paper reports them | Course as reported | Session length | Blood treated per session |
|---|---|---|---|---|
| Di Paolo et al., 2000 (/research/di-paolo-2000-eboo-preliminary-report/) [3] | Preliminary report of EBOO used in man; total number of patients not given | Six treatments for the volunteer author; not stated for the patients | Not reported | Not reported |
| Di Paolo et al., 2002 (/research/di-paolo-2002-eboo-fasciitis-case/) [18] | Case report of one dialysis patient with necrotizing fasciitis | Not stated in the abstract | Not reported | Not reported |
| Di Paolo et al., 2005, trial (/research/di-paolo-2005-pad-trial/) [1] | Randomized controlled trial of 28 patients with peripheral artery disease, EBOO against intravenous prostacyclin | 210 EBOO treatments in total; the per-patient schedule is not stated in the abstract | Not reported | Not reported |
| Di Paolo et al., 2005, review (/research/di-paolo-2005-eboo-review/) [4] | Review by the technique's developers | "14 treatment sessions of 1 h" over 7 weeks, called the standard therapeutic cycle | 1 hour | Up to 4,800 ml of heparinized blood in 1 hour |
| Rowen et al., 2023 (/research/rowen-2023-ozone-dialysis-uptake/) [14] | Case series of ozone dialysis, which the paper says is commonly referred to as EBOO; 85 measurements in 12 patients during routine treatment | Not reported | Exactly 1 hour | Not reported; pump speeds of 30 to 40 mL a minute |
| Bennett et al., 2025 (/research/bennett-2025-eboo-toxin-case/) [2] | Case report of one patient | Two series of three sequential EBOO treatments, with tests at baseline, day 70, and day 131 | Not reported | Around 2 liters per treatment, "as per clinic protocol" |

The same review reports "more than 1200 treatments performed in 82 patients" [4], an average of at least 14 per
patient, in line with the 14-session cycle it calls standard. That is the developers' own convention. The review does
not describe a trial of 14 sessions against fewer or more, and it is a review read from its abstract, with
no controlled outcome data in that abstract [4].

The limits of the other five matter for anything drawn from them. The 2000 report is an uncontrolled preliminary
series by the device's inventors, including self-experimentation, and does not give its total sample size [3]. The
2002 report concerns one patient, by the same group, with no control and no long-term follow-up reported [18]. The 2005 trial is small, from a single center, and its abstract does not describe how patients were randomized or whether
outcome assessment was blinded; we could read only the abstract [1]. The 2023 series measured how much ozone blood took up
during routine treatment and reports no course or outcomes [14]. The 2025 case report concerns one patient and
cannot separate any effect of EBOO from changes in her exposures between tests [2]. None compared course lengths.

What did studies of other ozone blood treatments use?

The wider ozone literature uses different procedures, mostly major autohemotherapy (a single bag of blood mixed with
ozone and returned) and its "10-pass" variant. Their schedules are not evidence about EBOO, but they show how
researchers have set courses when they did state them. As our cards record them:

| Study | Procedure and size | Course as reported | Session length |
|---|---|---|---|
| Borrelli et al., 2012 (/research/borrelli-2012-ozone-amd-rct/) [5] | Major ozonated autohemotherapy; randomized trial, 70 treated and 70 controls | Twice weekly for the first 7 weeks, twice monthly for 3 more months, then monthly until month 12 | About 40 minutes |
| Tylicki et al., 2004 (/research/tylicki-2004-ozone-inflammation-controlled-trial/) [6] | Ozonated autohemotherapy; single-blind crossover in 12 dialysis patients | Nine oxygen-only control sessions, then nine ozonated sessions | Not reported |
| Shen et al., 2022 (/research/shen-2022-ozone-autohemotherapy-safety-rct/) [7] | Ozonated autohemotherapy; randomized, 53 treated and 50 controls completing follow-up | Three times a week for 3 weeks | Not reported |
| Izadi et al., 2020 (/research/izadi-2020-ozone-ms-th17-cohort/) [8] | Ozone autohemotherapy; 20 patients, described by its authors as non-controlled | Twice per week for 6 months | Not reported |
| Tahmasebi et al., 2021 (/research/tahmasebi-2021-ozone-ms-treg-cohort/) [9] | Ozone autohemotherapy; 20 patients, before-and-after | Twice weekly for 6 months | Not reported |
| Tirelli et al., 2021 (/research/tirelli-2021-ozone-pasc-fatigue-cohort/) [10] | Oxygen-ozone autohemotherapy; 100 patients, no comparison group | Usually 2 to 3 treatments a week for 2 to 3 weeks | Not reported |
| Kuculmez, 2026 (/research/kuculmez-2026-ozone-post-covid-cohort/) [11] | Major ozone autohemotherapy; 40 patients, retrospective chart review | 10 sessions, 2 to 3 times a week | Reinfusion within 15 minutes |
| König et al., 2022 (/research/konig-lahodny-2022-oht-mitochondrial-case-series/) [12] | 10-pass high-dose ozone therapy; 6 patients | 2 applications over 1 week | About 1 hour for 10 passes |
| Valdenassi et al., 2022 (/research/valdenassi-2022-ozone-sjogrens-case/) [13] | Oxygen-ozone autohemotherapy; case report of one patient | One session a week, "for a total of six discontinued weeks into two routes, with 10 days lag" | Not reported |

Of the 8 rows that state how often sessions were given, 7 used two or more a week; only the single case report used
one a week. EBOO's developers also used about two a week (14 in 7 weeks) [4]. Clinics mostly describe one a week. No
row in either table tested one schedule against another, and most are small or uncontrolled; each card lists that
study's limits. The Italian Scientific Society of Oxygen-Ozone Therapy's 2025 recommendations say the field's "widespread adoption is
hindered by inconsistent protocols and a lack of standardized guidelines" [15], which fits what the tables show.

Single session or a series: what each can show

A single session can show how a person tolerates the procedure: the two IV lines, the time in the chair, and how they
feel over the next day. What one session cannot show is whether more sessions would change anything, because
no study in our library compared outcomes after one session with outcomes after several. A few clinics say some of
their patients have a single session [17], and most recommend a series from the start. Neither approach rests on a
comparison. A clinic that will not sell a single session, or that recommends a package at the first contact, is
making a choice it can explain if asked.

What a course costs

Course length drives cost more than any other choice. As of October 4, 2026, the median published single-session
price was $1,500, from 40 of the 174 clinics whose EBO2 pages we could read [17]. At that price, a course of 3 to 6
sessions, the medians of the smallest and largest numbers clinics name, comes to $4,500 to $9,000 by our arithmetic,
and the developers' 14-session cycle would come to $21,000, before any package discount,
consultation fee, labs, add-ons, or travel. Monthly maintenance at the same price adds $18,000 a year. Those are
arithmetic on medians, not quotes; the cost guide (/guides/ebo2-cost/) shows what clinics charge and what their
prices leave out, and the session cost planner (/tools/session-cost/) totals a course from a real quote.

Packages change the arithmetic only for the buyer who finishes them: in every package clinics published, the package
cost more than paying the single price for one fewer session [17].

Questions to ask about a recommended course

Where does this number come from: the clinic's own experience, a published study, or a written protocol?
What would lead the clinic to recommend stopping, continuing, or changing the course?
Is there a planned review after the first sessions, and who makes that decision?
Is a single session available before any package is bought?
How was the spacing between sessions chosen?
Does the plan include maintenance sessions or a repeat course, and what would those cost in a year?
What happens to prepaid sessions if the course stops early?

Ozone therapy is not FDA-approved for any condition, and federal device rules describe ozone as a toxic gas with no
known useful medical application [16], so there is no FDA-approved labeling that sets a course length for EBO2. Our
guide to choosing a clinic (/guides/how-to-choose-a-clinic/) covers the questions that are not about the schedule,
and the clinic directory (/clinics/) shows what each listed clinic states about its own course.

What we could not verify

Whether any number of sessions is better than another. No study in our library compared course lengths for
  EBOO or for the other ozone blood treatments listed here.
How clinics chose their numbers. The course statements we collected give a number or a rhythm, and sometimes
  a condition. One clinic's page, shared by two listings, says its number is what research shows, without naming a
  study; no study in our library compared course lengths.
The 2005 trial's per-patient schedule. The abstract gives only the total of 210 treatments, and we could not
  read the full paper [1].
Whether the developers' cycle carries over. The 14-session cycle was described for the developers' apparatus
  and their patients in Italy [4]; today's US clinics use other machines and their own protocols.
Maintenance. None of the studies in our library tested maintenance sessions against stopping.
What clinics say in person. We read what clinics publish; the course a clinic proposes at a consultation may
  differ.

How this guide was made

This guide rests on 19 sources: 17 peer-reviewed papers, each linked to its card in our research library; one federal
regulation; and our own clinic dataset, which anyone can download (/data/). Study figures are copied from the study
cards, which quote each paper, and are not converted or combined. Every clinic figure marked "As of October 4, 2026"
was computed by a script from the dataset: 177 directory listings from 152 websites, all read between September 28, 2026 and October 4, 2026, of which 174 had EBO2 pages we could read with confidence. The rhythm and
reason categories were assigned by reading each clinic's course statement. The figures in this guide and under "From
our data" are computed from the same records whenever the site is built.
Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: How many EBO2 sessions do clinics recommend?
A: As of October 4, 2026, 69 of the 174 clinics whose EBO2 pages we could read stated a recommended course, and 48 of them gave a number. The numbers ran from 1 to 15 sessions; the median of the smallest number each clinic named was 3, and of the largest was 6. Three was the most common starting number (30 of the 48), and 3 to 6 was the most common range. These are clinics' own recommendations, not results from a study.

Q: Is one EBO2 session enough?
A: No study in our research library compared one EBOO session with several, so there is no research answer. A few clinics say some patients have a single session, and most recommend a series. One session can show how a person tolerates the procedure, including the two IV lines and how they feel afterward; it cannot show whether more sessions would make a difference.

Q: How far apart are EBO2 sessions?
A: Of the 69 clinics that stated a course as of October 4, 2026, 31 described sessions about a week apart, 8 said one to two weeks apart, 2 offered twice a week as an option, and 6 described monthly sessions or a range that reaches monthly. The developers' published cycle was 14 sessions in 7 weeks, about two a week.

Q: Do clinics recommend maintenance sessions after the first course?
A: Some do. As of October 4, 2026, 13 of the 69 clinics that stated a course described maintenance sessions after the first course, monthly, quarterly, or every 3 to 4 months, and 5 described repeating the whole course on a schedule, such as twice a year. None of the studies in our research library tested maintenance sessions against stopping.

Q: Why do clinics recommend fewer sessions than the studies used?
A: Nearly all clinic course statements give no reason for their number; one clinic, on two listings, says its 3 or 4 sessions are what research shows, without naming a study. The developers' standard cycle was 14 sessions, and their review reports more than 1,200 treatments in 82 patients. Clinic courses cluster at 3 to 6 sessions. Nothing we read explains the gap.

Q: Should I buy a package of sessions up front?
A: That is a money question, and the arithmetic is clear: in every package clinics published as of October 4, 2026, the package cost more than paying the single price for one fewer session, so a package saves money only if every session is used. Our cost guide and session cost planner show the math.

Sources:
[1] Extracorporeal blood oxygenation and ozonation (EBOO): a controlled trial in patients with peripheral artery disease. International Journal of Artificial Organs (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16288443/
[2] Observed Reduction in Urinary Toxin Excretion With Extracorporeal Blood Oxygenation and Ozonation (EBOO) Treatment in an 88-Year-Old With Chronic Anemia: A Case Report. Cureus (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/41583215/
[3] Extracorporeal blood oxygenation and ozonation (EBOO) in man. Preliminary report. International Journal of Artificial Organs (PubMed), 2000. https://pubmed.ncbi.nlm.nih.gov/10741810/
[4] Extracorporeal blood oxygenation and ozonation: clinical and biological implications of ozone therapy. Redox Report (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16156950/
[5] Effects of major ozonated autohemotherapy in the treatment of dry age related macular degeneration: a randomized controlled clinical study. International Journal of Ophthalmology (PubMed), 2012. https://pubmed.ncbi.nlm.nih.gov/23275905/
[6] No effects of ozonated autohemotherapy on inflammation response in hemodialyzed patients. Mediators of Inflammation (PubMed), 2004. https://pubmed.ncbi.nlm.nih.gov/15770057/
[7] Combining Ozonated Autohemotherapy with Pharmacological Therapy for Comorbid Insomnia and Myofascial Pain Syndrome: A Prospective Randomized Controlled Study. Pain Research & Management (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/37214227/
[8] Changes in Th17 cells frequency and function after ozone therapy used to treat multiple sclerosis patients. Multiple Sclerosis and Related Disorders (PubMed), 2020. https://pubmed.ncbi.nlm.nih.gov/32862036/
[9] The effects of oxygen-ozone therapy on regulatory T-cell responses in multiple sclerosis patients. Cell Biology International (PubMed), 2021. https://pubmed.ncbi.nlm.nih.gov/33724614/
[10] Fatigue in post-acute sequelae of SARS-CoV2 (PASC) treated with oxygen-ozone autohemotherapy, preliminary results on 100 patients. European Review for Medical and Pharmacological Sciences (PubMed), 2021. https://pubmed.ncbi.nlm.nih.gov/34604980/
[11] Efficacy of major ozone autohemotherapy in patients with post-COVID syndrome. Frontiers in Medicine (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/41767530/
[12] Ozone high dose therapy (OHT) improves mitochondrial bioenergetics in peripheral blood mononuclear cells. Translational Medicine Communications (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/35880042/
[13] Sjögren syndrome successfully treated with oxygen-ozone auto-hemotherapy (O2-O3-AHT). A case report. European Review for Medical and Pharmacological Sciences (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/36066166/
[14] Ozone dialysis delivers three or more times the ozone than other forms of ozone blood treatment. Medical Gas Research (PubMed), 2023. https://pubmed.ncbi.nlm.nih.gov/36204785/
[15] SIOOT recommendations for the optimal application of the oxygen-ozone therapy in clinical medicine. International Immunopharmacology (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/39657536/
[16] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[17] EBO2 clinic dataset and the clinic pages it lists, read between September 28, 2026 and October 4, 2026. EBO2.com, 2026. https://ebo2.com/data/
[18] Necrotizing fasciitis successfully treated with extracorporeal blood oxygenation and ozonization (EBOO). International Journal of Artificial Organs (PubMed), 2002. https://pubmed.ncbi.nlm.nih.gov/12518965/
[19] Oxygenation-ozonation of blood during extracorporeal circulation: in vitro efficiency of a new gas exchange device. Artificial Organs (PubMed), 2007. https://pubmed.ncbi.nlm.nih.gov/17725702/

---

# How to Choose an EBO2 (EBOO) Clinic: Checks You Can Run Before You Book

Source: https://ebo2.com/guides/how-to-choose-a-clinic/
Updated: 2026-10-08

Key takeaways:
- As of October 4, 2026, the median clinic EBO2 page we could read stated 3 of the 8 basic facts we track; 75 of the 174 named a clinician and 40 published a price.
- Of the 100 pages that say who supervises sessions, 56 use general wording such as "performed under medical supervision" without naming a role or a person.
- A license is checked with the state, not the clinic: Florida's and California's lookups, for example, search by name, and Florida's also searches disciplinary actions.
- Device claims can be checked in the FDA's own databases. Registration is not approval, and a 510(k) clearance covers only the use it was granted for.
- A "Verified" label in our directory means the clinic's own website offered EBO2 or EBOO on the date shown. It says nothing about licensure, safety, or results.

EBO2 (also called EBOO) draws blood from one arm, runs it through a filter and a gas-exchange device, and returns it
through the other. Because it involves an extracorporeal circuit (/glossary/#extracorporeal), who runs it and how
carefully matters more than for most elective wellness services, and ozone therapy is not FDA-approved for any
condition, so there is no FDA-approved labeling that tells a clinic how to do it. This guide is a set of checks a
reader can run before booking: what clinic pages disclose, from our own dataset; how to look up a license, a board
record, and a device; what to get in writing; and twelve questions to ask. To find listed clinics near you and see what
each one publishes, use the clinic finder (/tools/clinic-finder/) or the clinic directory (/clinics/).

What do clinics tell you before you book?

Often less than a reader needs. We track 8 basic facts on each clinic's EBO2 page: a price, a package price, session
length, the device, who supervises, what happens before a first session, a recommended course, and named clinicians.
As of October 4, 2026, of the 174 clinics whose pages we could read, the median page stated 3 of the 8; 12 pages
stated none, and the most any page stated was 7 [12]. The full breakdown is under "From our data" at the end of this page.

Three gaps matter most for vetting [12]:

Who is in charge. 100 of the 174 pages say who supervises sessions, but 56 of those 100 use general wording, such
  as "performed under medical supervision" or "trained professionals," without naming a role or a person. 48 pages
  neither name a clinician nor say who supervises.
Who the named people are. 75 pages name at least one clinician, 137 people in all. Their listed credentials, with how many
  people list each: MD 31; DO 10; physician with no degree given 2; nurse practitioner or advanced
  practice nurse 24; registered or licensed practical nurse 13; naturopathic doctor 13 (ND 7, NMD
  6); chiropractor 5; acupuncturist 5; massage therapist 2; dietitian 1; midwife
  1; listed only as "Dr." 2; no credential given 28. A named person is not necessarily the
  one who runs the circuit.
What it costs. 40 of the 174 publish a single-session price, and 68 publish none of a price, a device, or a
  clinician's name.

A page that leaves these out is not necessarily hiding them, but each gap is a question to ask before booking.

Check the license yourself

State license lookups are public. Florida's Department of Health portal "provides direct
access to the division's online License Verification tool, which allows users to search the Division's database by
licensee name or license number," and also lets users "search disciplinary actions" and "view practitioner profiles"
[1]. California's Department of Consumer Affairs search is a single tool to "verify a license issued by the Department
of Consumer Affairs" across boards that include the Medical Board, the Osteopathic Medical Board, the Board of
Registered Nursing, and naturopathic doctors [2]. For another state, search for that state's medical, osteopathic, and
nursing boards by name.

The federal NPI Registry is a second check: a free, "query-only database which is updated daily," searchable by
provider name or number [3]. The NPI itself is "a unique identification number for covered health care providers,"
used in insurance transactions, and the number carries no other information about the provider [13]. It is not a
license, so the state lookup comes first.

Board records also show what a board has done. In 2024 the Medical Board of California placed a physician on five years'
probation and ordered that "During probation, Respondent is prohibited from performing intravenous ozone therapy
treatment" [8]. The case concerned intravenous ozone, not EBOO [8]; it shows the kind of entry a disciplinary search
can turn up.

Who runs the circuit, and how were they trained?

A license confirms a credential, not experience with this procedure. Ask how long the clinic has offered EBO2, how many
sessions the team has run, and whether the person operating the circuit has training in extracorporeal blood handling
rather than only IV placement. Ask where that training came from: the equipment maker, another clinic, or a course.
Machines differ. As of October 4, 2026, 21 of the 174 readable pages named the device or system they use [12];
training on one system does not automatically carry over to another. A clinic confident in its protocol usually
answers these questions directly.

Single-use equipment and infection control

EBO2 shares the infection-control basics of any procedure that draws and returns blood through
IV access (/glossary/#venous-access). CDC's core practices for every healthcare setting say to "Use needles and syringes
for one patient only," to "Use fluid infusion or administration sets (e.g., intravenous tubing) for one patient only,"
and to "Clean and reprocess (disinfect or sterilize) reusable medical equipment ... prior to use on another patient or
when soiled," following manufacturers' instructions [4]. They also call for "one or more qualified individuals with
training in infection prevention and control" to manage a facility's program [4].

As of October 4, 2026, 14 of the 174 readable pages stated that the circuit, filter, or tubing is single-use [12].
The rest do not say either way. Ask directly whether the filter, the tubing, and every part that touches blood or ozone
is discarded after each patient, and how anything reusable is reprocessed.

Screening before a first session

A careful clinic asks before the first session. As of October 4, 2026, 132 of the 174 readable pages described some step
before a first session. In the intake statement we recorded for each, 83 describe a consultation, 33 mention lab tests
or bloodwork, and 11 name a G6PD test [12].
What matters is whether a clinician reviews your history and medicines before the session is booked, not only whether
a form exists. Our guide to contraindications (/guides/contraindications/) covers what clinics screen for, and the
questions for your doctor (/tools/doctor-questions/) tool turns a reader's situation into questions to take to their
own clinician before deciding.

Monitoring and emergencies

Ask what is monitored during the session, what happens if a patient feels unwell partway through, what emergency
equipment is on site, and who can be called after leaving. As of October 4, 2026, 15 of the 174 readable pages said
vital signs are taken or monitored at a session, 11 of them during the treatment itself, and we found no saved page that described an emergency plan or the
resuscitation equipment on hand [12]. That is not proof a clinic has none, only that the page does not say, so the
question has to be asked. Our side effects guide (/guides/side-effects-and-safety/) covers what has been reported.

The protocol, in writing

A documented protocol states how much blood is processed, at what
ozone concentration (/glossary/#ozone-concentration), for how long, and what is monitored. Published studies show what
that level of detail looks like: the controlled trial from the technique's developers randomized 28 patients with
peripheral artery disease to EBOO or intravenous prostacyclin and named its primary measures: skin lesions, pain,
quality of life, and blood flow in the legs [6]. A reader is not expected to judge the science in a clinic lobby,
but a clinic that can state its protocol in those terms has one. Our research library (/research/) records what each
study used.

Claims and FDA wording

Ozone therapy is not FDA-approved, and the FDA's rule calls ozone "a toxic gas with no known useful medical application
in specific, adjunctive, or preventive therapy" [7]. A page that calls the treatment FDA-approved is wrong. Registration
with the FDA is not approval, and the FDA issues no device registration certificates [9]; to check whether a named
device was cleared or approved, search Devices@FDA by device or company name [10]. The FDA has acted on such equipment: in
2025 it warned an EBOO equipment maker that its devices lacked premarket approval and that it had not notified the
agency before selling them [5]. Our guide to reading a clinic's EBO2 page (/guides/how-to-read-a-clinic-ebo2-page/)
takes each common phrase in turn, from "FDA-cleared equipment" to "supports detox pathways," with the regulators' own
words and a one-page checklist.

Price, packages, and terms

A clinic should be able to give the price of one session, every fee around it, and its package and refund terms before
anyone pays. Our cost guide (/guides/ebo2-cost/) shows what clinics publish and what a published price can leave out,
and the price check (/tools/price-check/) places a quote against every published price. Because we found no evidence
that health insurance pays for EBO2, the terms are in practice between the patient and the clinic, which is why they
belong in writing; our
insurance guide (/guides/insurance-coverage/) covers HSA and FSA rules.

What our directory checks, and what it does not

A clinic is listed in our directory (/clinics/) when public sources or the clinic itself indicate that it offers EBO2
or EBOO. "Verified" means that on the date shown we confirmed, on the clinic's own website, that it offers EBO2 or
EBOO, and the listing links to that page; the editorial policy shows how many listings are verified today [11]. That is
the whole of the verification: it does not cover licensure, safety, or results, and a listing is not a recommendation.
Clinics are listed free, and nothing a clinic does or pays changes where its listing appears or which badges it shows
[11].

What to get in writing before the first session

The single-session price, every other fee, and what each covers.
Package terms: the total, the number of sessions, and what happens to sessions not used.
The names and license types of the people who will supervise and run the session.
The device's maker and model, and the 510(k) number of anything the clinic says is FDA-cleared.
The protocol: blood volume, ozone concentration, session length, and what is monitored.
What screening happens first, including any required lab tests and who bills for them.
The plan if something goes wrong during a session, and a number to call afterward.
A copy of the consent form, to read before the day of the session.

Twelve questions to ask

Who is licensed, with which license, and who runs my session?
How many EBO2 sessions has this team performed?
Which device do you use, and where did the operator train on it?
Are the filter, the tubing, and every part that touches blood single-use?
What health history and screening do you require, and who reviews it?
What do you monitor during the session?
What is your plan if I have a reaction during the session?
What blood volume, ozone concentration, and session length does your protocol use?
Can I have your price list, package terms, and refund policy in writing?
Do you describe EBO2 as FDA-approved? (The correct answer is no.)
What do you tell patients about the evidence for EBO2?
Can I speak with the supervising clinician before I book?

What we could not verify

Who actually performs sessions. Pages name clinicians, but not always the person who runs the circuit; we cannot
  tell from a page who is in the room.
Licenses. We did not look up the licenses of the 137 people named on clinic pages.
What clinics do but do not publish. Monitoring, emergency equipment, single-use parts, and screening may exist at
  clinics whose pages do not mention them.
State rules. We did not survey which license types each state allows to run an extracorporeal circuit.
Credentials as written. We recorded credentials as clinics list them and did not check them against any board.

How this guide was made

This guide rests on 14 sources: two state license portals, two federal pages on the NPI Registry and the NPI, CDC's core
infection-control practices, two medical board decisions, three FDA documents and databases, one federal regulation,
one peer-reviewed trial, our editorial policy, and our own clinic dataset, which anyone can download (/data/). Every
figure marked "As of October 4, 2026" was computed from that dataset: 177 directory listings, read between September 28, 2026 and October 4, 2026,
of which 174 had EBO2 pages we could read with confidence. The supervision, single-use, and monitoring counts were
classified by reading each saved page.
Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: Who is qualified to perform EBO2?
A: That depends on state rules, which this guide does not survey. The useful questions are who holds which license, who places the two IV lines, and who stays in the room for the whole session; each license can be checked with the state's own lookup.

Q: What should a clinic ask me before treatment?
A: Health history, current medicines, and the conditions its own protocol excludes, reviewed by a clinician before the session is booked. As of October 4, 2026, 132 of the 174 clinic EBO2 pages we could read described some step before a first session, and 33 mentioned lab tests or bloodwork.

Q: What are the red flags on a clinic's page?
A: A claim that the treatment is FDA-approved or that equipment registration means approval, promises of results, no named clinician, no written price or package terms, and pressure to prepay for many sessions before the first one. Our guide to reading a clinic's EBO2 page explains each phrase and how to check it.

Q: How do I check a clinician's license?
A: Use the licensing board's public search for the state where the clinic operates. Florida's Department of Health portal searches licenses and disciplinary actions; California's Department of Consumer Affairs search covers physicians, nurses, nurse practitioners, and naturopathic doctors. The federal NPI Registry is a second, free search, but an NPI is an identification number used in insurance transactions, not a license.

Q: Does a listing on EBO2.com mean a clinic is recommended?
A: No. A clinic is listed when its own website or other public sources indicate it offers EBO2 or EBOO. "Verified" means we confirmed that on the clinic's own website on the date shown. We do not verify licensure, outcomes, or safety records, and no clinic can pay for placement or a badge.

Sources:
[1] FL HealthSource: Division of Medical Quality Assurance online services. Florida Department of Health, 2026. https://flhealthsource.gov/
[2] DCA License Search. California Department of Consumer Affairs, 2026. https://search.dca.ca.gov/
[3] Data Dissemination (NPPES and the NPI Registry). Centers for Medicare & Medicaid Services, 2026. https://www.cms.gov/medicare/regulations-guidance/administrative-simplification/data-dissemination
[4] CDC's Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings. Centers for Disease Control and Prevention, 2024. https://www.cdc.gov/infection-control/hcp/core-practices/index.html
[5] Warning letter to O3UV, LLC (CBER 25-668840). U.S. Food and Drug Administration, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/o3uv-llc-668840-07072025
[6] Extracorporeal blood oxygenation and ozonation (EBOO): a controlled trial in patients with peripheral artery disease. International Journal of Artificial Organs (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16288443/
[7] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[8] Decision and stipulated settlement, Case No. 800-2022-088393 (intravenous ozone therapy). Medical Board of California, 2024. https://www2.mbc.ca.gov/BreezePDL/document.aspx?path=%5CDIDOCS%5C20240621%5CDMRAAAJD2%5C&did=AAAJD240621215614354.DID
[9] Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved?. U.S. Food and Drug Administration, 2021. https://www.fda.gov/medical-devices/consumers-medical-devices/are-there-fda-registered-or-fda-certified-medical-devices-how-do-i-know-what-fda-approved
[10] Devices@FDA (database). U.S. Food and Drug Administration, 2026. https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm
[11] Editorial policy: how clinics are listed and verified. EBO2.com, 2026. https://ebo2.com/editorial-policy/
[12] EBO2 clinic dataset and the clinic pages it lists, read between September 28, 2026 and October 4, 2026. EBO2.com, 2026. https://ebo2.com/data/
[13] National Provider Identifier Standard (NPI). Centers for Medicare & Medicaid Services, 2026. https://www.cms.gov/regulations-and-guidance/administrative-simplification/nationalprovidentstand

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# How to Read a Clinic's EBO2 (EBOO) Page: What "FDA-Cleared," "Detox," and Branded Names Mean

Source: https://ebo2.com/guides/how-to-read-a-clinic-ebo2-page/
Updated: 2026-10-04

Key takeaways:
- Registering with the FDA or listing a device is not approval, and a page that implies otherwise is misbranding under 21 CFR 807.39; a 510(k) clearance is not approval either, under 21 CFR 807.97.
- As of October 4, 2026, of the 174 clinic EBO2 pages we could read, 148 did not say whether EBO2 or its equipment is FDA-approved, 23 said EBO2 is not FDA-approved, 3 said their equipment is FDA-cleared, registered, or approved, and none said the treatment is cleared or approved.
- As of the same date, 163 of those 174 pages named a health benefit, most often detoxification (151). The FTC says health claims need competent and reliable scientific evidence, and that words like "may" or "helps" do not fix a weak one.
- A clearance covers a device's intended use. A hemodialyzer is cleared as an artificial kidney, so "FDA-cleared equipment" says nothing about EBO2 itself.
- Every check in the checklist at the end can be run with public FDA databases, a state license lookup, and the clinic's own answers in writing.

EBO2 (also called EBOO) is sold mostly through clinic web pages, and those pages use a small set of phrases over and
over: "FDA-registered," "FDA-cleared equipment," "medical-grade ozone," "supports the body's natural detox pathways,"
a trademarked name for the clinic's version, "studies show," and patient stories. This guide takes each one in turn:
what it means, what the FDA or the Federal Trade Commission (FTC) says about it, and how a reader can check it. It ends
with a one-page checklist that can be used on any clinic page, including the pages linked from our
clinic directory (/clinics/).

One fact frames everything below: ozone therapy is not FDA-approved for any condition, and the FDA's ozone rule calls
ozone "a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [10]. A
clinic page can be accurate, careful, and well sourced, and that sentence will still be true. For the regulatory
background, see whether EBO2 is FDA approved (/guides/is-ebo2-fda-approved/); the
regulatory tracker (/reports/regulatory-tracker/) lists every FDA, FTC, and board record we hold, with its exact
language.

What do clinic pages say, in the aggregate?

We read the EBO2 pages of every clinic in our directory and saved them. As of October 4, 2026, 174 of the 177
listings had pages we could read with confidence [14]. On those pages:

| What the page says | Pages, of 174 |
|---|---|
| Names at least one health benefit | 163 |
| Says nothing about whether EBO2 or its equipment is FDA-approved | 148 |
| Says EBO2 is not FDA-approved | 23 |
| Says its equipment is FDA-cleared, registered, or approved | 3 |
| Says the treatment itself is FDA-cleared or approved | 0 |
| Uses the phrase "medical-grade" | 103 |
| Names the device or system it uses | 21 |
| Uses "full spectrum" for a light step, a device, or a protocol | 15 |
| Gives its version a coined name or sells it in numbered tiers | at least 13 |
| Says studies or research show or suggest something about EBOO or ozone | 21 |
| Links to a specific published paper (a PubMed, PubMed Central, DOI, or journal-article record) | 29 |
| Carries patient testimonials | 26 |
| Lists "no side effects" or "no long-term risks" as a benefit | 2 |
| Uses "FDA-registered" or "FDA-compliant" for its equipment | 2 |

The FDA-status and health-benefit rows are recomputed from our dataset each time the site is built, under "From our
data" at the end of this page; the others were counted by reading the saved pages, which can include a clinic's home
page and pages about its other services [14]. We publish these readings only as totals and never attach them to a
named clinic. A page that says one of these things is not, by that fact alone, breaking a rule; the sections below say
what each phrase can and cannot mean.

"FDA-registered" or "FDA-compliant"

What it means. Companies that make or distribute medical devices for the US market generally must register their
establishment with the FDA each year and list their devices [3]. Registration is paperwork, not a review.

What regulators say. The regulation is direct: "Registration of a device establishment or assignment of a
registration number does not in any way denote approval of the establishment or its products. Any representation that
creates an impression of official approval because of registration or possession of a registration number is
misleading and constitutes misbranding" [1]. The FDA's consumer page adds that the registration entry "does not denote
approval, clearance, or authorization of that facility or its medical devices," and that "The FDA does not issue any
type of device registration certificates to medical device facilities" [3]. The same page names the three statuses that
do reflect an FDA review: approved, cleared, and authorized; "FDA-compliant" is not one of them [3]. The FDA also notes
that it does not "approve" health care providers, "including physician offices or laboratories" [4].

How to check. Ask the clinic for the maker and model of each device in the circuit. The FDA's Establishment
Registration and Device Listing database shows whether a company is registered, and it carries its own note that
registration or listing "does not in any way denote approval of the establishment or its products by FDA" [5]. To see
whether a device was actually cleared or approved, search Devices@FDA by device or company name, as the FDA's own
instructions describe [3][7]. A certificate with an FDA logo on it is a warning sign, since the FDA issues none [3].

"FDA-cleared equipment"

What it means. A 510(k) clearance means the FDA found that a device is "substantially equivalent" to a device
already legally on the market [6]. Moderate-risk devices, including dialysis equipment, are generally marketed this way
[4]. A clearance is for a stated intended use [11].

What regulators say. A clearance "does not in any way denote official approval of the device," and "Any
representation that creates an impression of official approval of a device because of complying with the premarket
notification regulations is misleading and constitutes misbranding" [2]. The intended use matters: a high permeability
hemodialysis system is defined as "a device intended for use as an artificial kidney system for the treatment of
patients with renal failure, fluid overload, or toxemic conditions" [8]. The FDA's 2025 warning letter to one EBOO
equipment maker describes its EBOO kits as including disposable hemodialyzer filters bought from a supplier. It says
the company's devices were intended for treating conditions such as autoimmune diseases and cardiovascular disorders,
and that the company had neither premarket approval for them nor had it notified the agency before selling them, as
the law requires [9]. The FTC gives a parallel example: a device cleared for one purpose and
advertised as "FDA Approved" next to claims for a different effect is deceptive, because the pairing implies the FDA
found it effective for that effect [11].

How to check. Ask which component is cleared, its 510(k) number, and its intended use. Search the 510(k) database
by that number or the maker's name, then read the record for what the device was cleared for [6]. If the cleared use
is hemodialysis, the clearance says nothing about ozone exposure or about EBO2 as a treatment [2][8]. Our comparison of
EBOO and dialysis (/guides/eboo-vs-dialysis/) covers the filter question in detail. As of October 4, 2026, 3 of the
174 readable pages said their equipment is FDA-cleared, registered, or approved, and none said the treatment is [14].

"Medical-grade ozone"

What it means. The phrase is the clinic's own description of its gas or equipment, not an FDA status. As of
October 4, 2026, 103 of the 174 readable pages used "medical-grade," 86 of them for the ozone or the oxygen [14].

What regulators say. The FDA's rule on ozone does not distinguish grades. It calls ozone "a toxic gas with no known
useful medical application," and says a device that generates ozone "will be considered adulterated and/or misbranded"
if it is used "In any medical condition for which there is no proof of safety and effectiveness" [10].

How to check. Ask for the make and model of the ozone generator and search Devices@FDA for it [7]. Ask what ozone
concentration the clinic uses and how it is measured; the published EBOO studies give concentrations in their own
units, which our research library (/research/) records study by study.

"Supports the body's natural detox pathways" and other benefit wording

What it means. A claim that the procedure has an effect on the body. Clinic pages often soften it with "may,"
"helps," or "supports." As of October 4, 2026, 163 of the 174 readable pages named at least one health benefit, and
detoxification was the most common, on 151 [14].

What regulators say. The FTC's health products guidance says claims about the health benefits or safety of
health-related products require "competent and reliable scientific evidence" [11]. It addresses softening words
directly: "Vague qualifying terms are inadequate. For example, it's not enough to say that the product 'may' have the
claimed benefit or 'helps' achieve the claimed benefit" [11]. As a general matter, it says, substantiation "will need
to be in the form of randomized, controlled human clinical testing" [11]. The FTC has written to ozone therapy
marketers before; in 2020 it said some of its COVID-19 warning letters targeted treatments it had warned companies
about previously, "including intravenous (IV) Vitamin C infusions, ozone therapy, and supplements" [13].

How to check. Ask which study measured that effect in people having EBO2, how many people it included, and what it
compared them with. Then look the study up in our research library (/research/). For detox claims in particular, see
what the filter removes (/guides/what-the-filter-removes/); for any condition, see
what the research shows (/guides/does-ebo2-work/); for cancer, see EBOO and cancer claims (/guides/eboo-cancer-claims/).

A branded or coined name for the procedure

What it means. The clinic's own name for its version: a "full spectrum" label, which usually means a UV or other
light step is added to the circuit; a trademarked protocol name; or numbered tiers. As of October 4, 2026, at least
13 of the 174 readable pages gave their version a name of its own or sold it in tiers, and 15 used "full spectrum" for
a light step or as the name of a device or protocol [14].

What regulators say. The FDA's statuses for a device are approved, cleared, and authorized [3]; a protocol name is
none of these. The same words can belong to a device: the FDA's 2025 warning letter concerned devices sold under names that include "Full
Spectrum," which it said lacked approval or clearance [9]. A clinic using those words does not tell a reader which
machine it uses.

How to check. Ask what the name adds compared with plain EBOO: a light device, an IV infusion, a different filter,
a different ozone concentration, or a longer session. Ask what the version without it costs. Our
cost guide (/guides/ebo2-cost/) shows that clinics selling tiers charge more for versions that add a light device or
an infusion, and the guide to what else clinics sell (/guides/clinic-bundles/) covers bundled services.

"Studies show" and links to research

What it means. A page pointing to research. As of October 4, 2026, 21 of the 174 readable pages said that studies or
research show or suggest something about EBOO or ozone, and 29 linked to a specific published paper, meaning a PubMed,
PubMed Central, DOI, or journal-article record, somewhere on the pages we saved [14]. A link shows which paper a page
points to, not that the paper supports the page's claim.

What regulators say. The FTC says "Claims that don't match the research results, no matter how sound that research
is, are likely to be deceptive" [11]. It also says that "Animal and in vitro studies may provide useful supporting or
background information, but, without confirmation by human RCTs, they aren't sufficient to substantiate health-related
claims" [11].

How to check. Open the study. Four questions settle most of it: Did it test EBOO, or another ozone method such as
major autohemotherapy? Was it in people, animals, or a test tube? How many people, and was there a comparison group?
Does its result match the sentence on the clinic page? Our research library (/research/) answers the first three for
every paper it holds, with each paper's limits.

Patient testimonials

What it means. One person's report of how they felt. As of October 4, 2026, 26 of the 174 readable pages carried
testimonials [14].

What regulators say. Under the FTC's endorsement rules, a testimonial about a key result "will likely be
interpreted as representing that the endorser's experience is representative of what consumers will generally achieve"
[12], so the advertiser needs evidence that typical patients get it. The FTC's guidance adds that testimonials do not
substitute for scientific evidence of the claimed effect [11].

How to check. Read a testimonial as one person's account, not as a result. Ask the clinic whether it tracks
outcomes for its patients and what the typical result is; a clinic that can answer has data to show.

"No side effects"

What it means. A safety claim. As of October 4, 2026, 2 of the 174 readable pages listed "no side effects" or
"no long-term risks" among the benefits, while others describe mild, short-lived effects [14].

What regulators say. The FTC's evidence standard applies to safety claims as well as benefit claims [11], and the
FDA's rule calls ozone a toxic gas [10]. Our side effects guide (/guides/side-effects-and-safety/) and our review of
ozone therapy adverse events (/guides/ozone-therapy-adverse-events/) set out what has been reported.

How to check. Ask what side effects the clinic's own patients have had, what the clinic does if one occurs during
a session, and who to call afterward.

"Physician-supervised"

What it means. A statement about staffing. As of October 4, 2026, 100 of the 174 readable pages said who
supervises sessions, and 75 named at least one clinician [14].

What regulators say. The FDA does not "approve" health care providers, "including physician offices or
laboratories" [4], so a supervision statement is not something the FDA reviews.

How to check. Look up each named clinician's license, and ask who is physically in the room during a session. Our
guide to choosing a clinic (/guides/how-to-choose-a-clinic/) lists the license lookups.

A one-page checklist for any clinic page

Does the page say plainly that ozone therapy, or EBO2, is not FDA-approved? If it says "FDA-approved," that is
   wrong for the treatment [10].
If it says "FDA-registered" or "FDA-compliant," treat that as a statement about paperwork, not review [1][3].
If it says "FDA-cleared," find out which component, its 510(k) number, and its cleared intended use [2][6].
Search Devices@FDA for every device the page names [7].
Note every condition the page names, and ask which study measured that effect in people having EBO2 [11].
Discount "may," "helps," and "supports"; the claim underneath still needs evidence [11].
Open every linked study and check the procedure, the subjects, and the comparison group.
Read testimonials as single accounts, not results [12].
If the procedure has a coined name, ask what it adds and what the plain version costs.
Check that the page names the clinicians who supervise, then look up their licenses.
Look for a price, what it includes, and the package terms; our cost guide (/guides/ebo2-cost/) lists what a
    quote can leave out.
Save a copy of the page and the date, and get the clinic's answers to these questions in writing.

The price check (/tools/price-check/) places a quote against published prices, and
questions for your doctor (/tools/doctor-questions/) builds a list of medical questions to take to a clinician. The
FTC takes reports of "fraud, scams, and bad business practices" at ReportFraud.ftc.gov [13].

What we could not verify

The 3 "FDA-cleared, registered, or approved" claims. We did not look up the devices behind the three pages that make this claim,
  and we publish FDA wording only as totals.
The devices clinics name. Whether each named machine, filter, or light device holds a clearance needs a
  device-by-device search, which this guide does not report.
Counts from saved pages. The phrase counts come from the pages we saved, which can include a clinic's other
  services; we read the smaller counts hit by hit, but the "medical-grade" count is a count of the phrase.
Legal questions. The FTC guidance is staff guidance, and whether any page breaks a rule is for regulators and
  courts. We do not judge any page.
Whether testimonials are typical. No clinic publishes outcome data we could compare them with.

How this guide was made

This guide rests on 14 sources: five FDA regulations and FTC rules from the eCFR, two FDA consumer pages, three FDA public
databases, the FDA's 2025 warning letter to an EBOO equipment maker, two FTC documents, and our own clinic dataset,
which anyone can download (/data/). The FDA-status and health-benefit figures come from the dataset, read between September 28, 2026 and October 4, 2026, for the 174 of 177 listings whose EBO2 pages we could read with confidence. The other counts come from
reading those saved pages, and every figure is published only as a total. We did not read any clinic site for this
guide beyond the pages saved on those dates.
Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.
Nothing here is legal advice.

FAQ:
Q: What does "FDA-registered" mean on a clinic or device page?
A: Only that a company has registered its establishment with the FDA and listed its devices. The FDA says that entry does not denote approval, clearance, or authorization, and federal rules call any representation that registration means official approval misleading. The FDA issues no device registration certificates.

Q: Is "FDA-cleared equipment" the same as an FDA-approved treatment?
A: No. A 510(k) clearance means the FDA found a device substantially equivalent to one already on the market, for a stated intended use; the regulation says it does not denote official approval. A filter cleared for hemodialysis is cleared as an artificial kidney. Ozone therapy is not FDA-approved for any condition.

Q: What does "medical-grade ozone" mean?
A: It describes the gas, not its regulatory status. The FDA's rule on ozone calls it a toxic gas with no known useful medical application, and says an ozone-generating device is adulterated or misbranded if used in any medical condition for which there is no proof of safety and effectiveness.

Q: Are patient testimonials evidence for a health claim?
A: No. Under the FTC's endorsement rules, a testimonial about a key result is likely to be read as a claim that the result is what people generally get, and the advertiser needs evidence for it. FTC guidance says testimonials do not constitute substantiation. As of October 4, 2026, 26 of the 174 clinic pages we could read carried testimonials.

Q: Why doesn't this guide name the clinics that make these claims?
A: We publish how clinics word FDA status and health benefits only as totals, so that no named business is characterized by our reading of its page. Plain facts such as prices, session length, and named clinicians appear on each clinic's page in our directory, with a link to the page each fact came from.

Sources:
[1] 21 CFR 807.39 Misbranding by reference to establishment registration or to registration number. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807/subpart-B/section-807.39
[2] 21 CFR 807.97 Misbranding by reference to premarket notification. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807/subpart-E/section-807.97
[3] Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved?. U.S. Food and Drug Administration, 2021. https://www.fda.gov/medical-devices/consumers-medical-devices/are-there-fda-registered-or-fda-certified-medical-devices-how-do-i-know-what-fda-approved
[4] Is It Really 'FDA Approved'?. U.S. Food and Drug Administration, 2026. https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved
[5] Establishment Registration & Device Listing (database). U.S. Food and Drug Administration, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm
[6] 510(k) Premarket Notification (database). U.S. Food and Drug Administration, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
[7] Devices@FDA (database). U.S. Food and Drug Administration, 2026. https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm
[8] 21 CFR 876.5860 High permeability hemodialysis system. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-876/subpart-F/section-876.5860
[9] Warning letter to O3UV, LLC (CBER 25-668840). U.S. Food and Drug Administration, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/o3uv-llc-668840-07072025
[10] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[11] Health Products Compliance Guidance. Federal Trade Commission, 2022. https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance
[12] 16 CFR 255.2 Consumer endorsements. eCFR (Federal Trade Commission), 2026. https://www.ecfr.gov/current/title-16/chapter-I/subchapter-B/part-255/section-255.2
[13] FTC Sends Letters Warning 20 More Marketers to Stop Making Unsupported Claims That Their Products and Therapies Can Effectively Prevent or Treat COVID-19. Federal Trade Commission, 2020. https://www.ftc.gov/news-events/news/press-releases/2020/11/ftc-sends-letters-warning-20-more-marketers-stop-making-unsupported-claims-their-products-therapies
[14] EBO2 clinic dataset and the clinic pages it lists, read between September 28, 2026 and October 4, 2026. EBO2.com, 2026. https://ebo2.com/data/

---

# Is EBO2 (EBOO) Covered by Insurance? What Medicare, the IRS, and Clinics Say About Paying

Source: https://ebo2.com/guides/insurance-coverage/
Updated: 2026-10-04

Key takeaways:
- As of October 4, 2026, none of the 174 clinic EBO2 pages we could read said health insurance covers EBO2, and 23 said it is not covered or that the clinic does not accept or bill insurance.
- Medicare excludes any service that is not reasonable and necessary for diagnosing or treating illness or injury. Our plain-text read of Medicare's coverage database listed no document on ozone therapy, though we could not confirm that none exists.
- With an HSA, the account holder carries the risk: the IRS says records must show each withdrawal paid a qualified medical expense, and other withdrawals are taxed and may draw an additional 20% tax.
- With a health FSA, the plan decides which expenses qualify, needs a written statement from an independent third party, and cannot reimburse future sessions in advance.
- An HSA card accepted at a clinic's front desk is not a ruling that the expense qualifies. As of October 4, 2026, 14 of the 174 readable clinics mentioned HSA or FSA payment, and 15 mentioned financing.

EBO2 (also called EBOO) is sold as an out-of-pocket service, and we found no evidence that health insurance or Medicare
pays for it. The harder question is whether pre-tax money in a health savings account (HSA) or a health flexible
spending arrangement (FSA) can, and there the answer turns on federal tax rules that put most of the risk on the
person paying. This guide sets out what the primary sources say for each way of paying, what clinics say on their own
pages, and the questions to ask a health plan and an account administrator before money changes hands. For what a
course costs, see the cost guide (/guides/ebo2-cost/).

The short answer: ozone therapy is not FDA-approved for any condition, and federal device rules describe ozone as a
toxic gas with no known useful medical application [4]. As of October 4, 2026, none of the 174 clinic EBO2 pages we
could read said insurance covers EBO2 [18]. An HSA or FSA can pay only for "medical care" as the IRS defines it, and
the IRS publications that define it do not mention ozone therapy [1][2].

Does health insurance pay for EBO2?

Nothing we could verify says it does. As of October 4, 2026, 23 of the 174 clinics whose EBO2 pages we could read
say that EBO2 is not covered by insurance or that the clinic does not accept or bill insurance, and none says
insurance covers it [18]. One clinic answers "Do you take insurance?" with "Coverage varies by plan and service,"
without saying whether EBO2 is ever covered [15]. A typical statement: "These are elective wellness services and are
typically not covered by insurance in the United States. We do not bill insurance directly" [9]. Another clinic
writes that it "does not accept medical insurance for EBOO treatments" [16].

Some clinics offer a way to try anyway. Five of the 174 say they give patients a superbill or an itemized receipt to
submit for reimbursement, four of them to an insurer and one for HSA or FSA claims [12][13][18], and at least one says it does
not provide superbills for EBOO at all [11]. One practice describes
the arrangement this way: "I provide a superbill receipt for you to mail to your insurance company for any potential
reimbursement," adding that the patient is "responsible for handling any follow up process" [10]. A superbill shifts
the claim to the patient; it does not change what the plan covers.

Private insurers publish their own medical policies. We do not read insurers' websites directly for this guide, so
their current wording on ozone therapy is listed under "What we could not verify" below.

Does Medicare or Medicaid pay for it?

Medicare's rules exclude "any services that are not reasonable and necessary" for "the diagnosis or treatment of
illness or injury or to improve the functioning of a malformed body member" [3]. Medicare decides what meets that test
through national and local coverage determinations, published in the Medicare Coverage Database [6]. Our plain-text read of
that database's search for "ozone" listed no results, but its results load in a browser, so we could not confirm that
no document addresses ozone therapy [6]. One
clinic's page states that it does not accept insurance, "including Medicare and Medicaid" [14].

Medicaid is run by each state. "States establish and administer their own Medicaid programs and determine the type,
amount, duration, and scope of services within broad federal guidelines," in the words of the federal Medicaid agency
[5]. This guide does not survey state Medicaid policies.

Can an HSA pay for EBO2?

The test is whether the expense is medical care. IRS Publication 969 says an HSA's "qualified medical expenses" are
amounts paid for medical care as defined in the tax code, "but only to the extent the amounts are not compensated for by
insurance or otherwise" [2]. Publication 502 defines medical expenses as the costs of diagnosing, treating, mitigating,
or preventing disease, or of affecting a part or function of the body, and adds: "Medical care expenses must be
primarily to alleviate or prevent a physical or mental disability or illness. They don't include expenses that are
merely beneficial to general health, such as vitamins or a vacation" [1]. Neither publication mentions ozone therapy or
EBO2 [1][2]. Whether a given EBO2 session qualifies therefore depends on why the person is having it.

The account holder carries the risk. Paying with an HSA debit card counts as a distribution: Publication 969 says total
distributions "include amounts paid with a debit card," and the trustee reports them to the IRS [2]. The account holder
"must keep records sufficient to show that" each distribution was "exclusively to pay or reimburse qualified medical
expenses" [2]. If it was not, "the amount you withdraw will be subject to income tax and may be subject to an
additional 20% tax" [2]. Nothing in Publication 969 says the HSA trustee approves an expense before it is paid [2],
so a card accepted at the clinic's front desk is not a ruling that the expense qualifies.

Can an FSA pay for EBO2?

An FSA has a gatekeeper. Publication 969 says an FSA's qualified medical expenses "are those specified in the plan that
would generally qualify for the medical and dental expenses deduction" [2], so the plan's own rules decide. Before
reimbursing, the plan needs "a written statement from an independent third party stating that the medical expense has
been incurred and the amount of the expense," plus a statement that no other plan has paid it [2].

Two FSA rules matter for EBO2 in particular [2]:

No advance payment. "The FSA can't make advance reimbursements of future or projected expenses." A prepaid
  package of sessions not yet received is a future expense.
Use it or lose it. FSAs "are generally 'use-it-or-lose-it' plans," although a plan may allow a grace period of
  up to 2 1/2 months or a carryover, which for 2025 was capped at $660.

Does a doctor's letter change the answer?

It can document the purpose, but it is not a pass. Publication 502 says lessons such as swimming "even if they are
recommended by a doctor" do not count "if they are only for the improvement of general health" [1]. Neither IRS
publication uses the phrase "letter of medical necessity" [1][2]. A clinician's letter that names a diagnosed condition
and explains why the treatment is for it speaks to the IRS test, primarily to alleviate or prevent an illness. An FSA
plan still decides whether to reimburse, and for an HSA the account holder still answers to the IRS if it disagrees.

What do clinics say about paying?

As of October 4, 2026, 35 of the 174 clinics whose EBO2 pages we could read say something about insurance,
tax-advantaged accounts, or financing [18]:

| What the clinic's saved pages say | Clinics |
|---|---|
| EBO2 is not covered by insurance, or the clinic does not accept or bill insurance | 23 |
| Insurance covers EBO2 | 0 |
| A superbill or itemized receipt for the patient to submit for reimbursement | 5 |
| HSA or FSA payment is accepted or possible | 14 |
| Financing, through a lender such as CareCredit, Cherry, Affirm, or Klarna, or a payment plan | 15 |
| A 0% promotional financing offer | 4 |

Five of the 14 that mention HSA or FSA payment hedge it, as in "Some clients use HSA or FSA funds where their plan
allows" [9]. The rest state it plainly, such as "Insurance is not accepted, but HSA/FSA superbills are provided" [13]
or "we do take HSA/FSA, cash and credit cards" [14].
The counts are per listing: the 35 come from 30 websites, because some clinics list several locations with the same
pages. Acceptance at the front desk tells a reader how a clinic takes payment, not whether the IRS or a plan will treat
the expense as qualified.

What should a reader check before financing?

Financing spreads the cost; it does not lower it. The Consumer Financial Protection Bureau reported in 2023 that medical
credit cards and loans "often have deferred interest plans, with all accrued interest potentially becoming due at the
end of a defined period, which can prove especially expensive and unaffordable for patients" [8]. Its report also notes
that these products are marketed to healthcare providers, who are encouraged to promote them to patients [7]. One
clinic advertises "0% interest for 12 months to 24 months on eligible plans" [17]; the terms after that period, and
whether interest is deferred rather than waived, are the questions to ask. Financing a package also raises the question
of what happens to the loan if sessions are not used, which our cost guide (/guides/ebo2-cost/) covers.

Step by step: questions to ask before paying

The health plan

Does the plan cover EBO2, or "extracorporeal blood oxygenation and ozonation," under any circumstances? Ask for the
   plan's medical policy on ozone therapy in writing.
If not, does the plan have out-of-network benefits, and would it consider a claim from a superbill?
Which billing codes would the clinic put on the superbill, and does the plan cover those codes? (Ask the clinic for
   the codes first.)
Is prior authorization required, and if a claim is denied, what is the appeal process and the deadline?
Are a consultation or lab tests billed separately, and are those treated differently from the procedure?

The HSA

Is this expense medical care for me under Publication 502, that is, primarily to alleviate or prevent a specific
   illness? A tax professional, not the clinic, is the right person to ask.
What records will I keep: the itemized receipt, the diagnosis, and any clinician's statement of purpose?
Has any part of the expense been paid or reimbursed by insurance? That part cannot also come from the HSA.
Was the HSA open before the session took place? Expenses incurred before an HSA is established are not qualified
   medical expenses [2].

The FSA

Does the plan's list of qualified expenses include EBO2 or ozone therapy? Ask for the answer in writing before buying.
What does the plan need to substantiate the claim: the independent third-party statement, a letter from a clinician,
   or both?
What are the plan year's deadlines, and does the plan have a grace period or a carryover?
Will the plan reimburse a package only as each session is received?

The session cost planner (/tools/session-cost/) totals a course, and the price check (/tools/price-check/) places a
quote against published prices. For the regulatory background, see whether
EBO2 is FDA approved (/guides/is-ebo2-fda-approved/); the clinic directory (/clinics/) lists what each clinic states.

What we could not verify

Private insurers' current policies. An earlier version of this guide cited an Aetna clinical policy bulletin
  and an Oregon coordinated-care organization's ozone policy. Both sit on private websites we do not read directly, so
  we could not re-check them for this update.
Whether any Medicare coverage document addresses ozone therapy. The Medicare Coverage Database's search results
  load in a browser, and our plain-text read listed none [6].
State Medicaid policies. We did not survey them, so we cannot say whether any state names ozone therapy.
Billing codes. We could not check which procedure codes, if any, clinics put on superbills, or whether any plan
  has paid on one.
Plan decisions. We found no public record of an HSA trustee, an FSA plan, or the IRS ruling on an EBO2 expense.
Prepaid packages and HSAs. The publications do not say when a prepaid package counts as incurred for HSA
  purposes.

How this guide was made

This guide rests on 18 sources: two IRS publications for tax year 2025, two federal regulations, four other federal
pages (Medicaid.gov, the Medicare Coverage Database, and the Consumer Financial Protection Bureau's 2023 report and its
announcement), nine clinic pages cited only for what each clinic says about payment, and our own clinic dataset, which
anyone can download (/data/). The clinic counts marked "As of October 4, 2026" come from reading the saved EBO2 pages
of the 174 clinics we could read with confidence, out of 177 directory listings, all read between September 28, 2026 and October 4, 2026. Each payment statement was classified by reading it in context, and
patient reviews quoted on clinic pages were not counted. We did not read private insurers' or clinics' sites for this
update; all clinic text comes from pages saved on those dates.
Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.
This guide is not
tax, legal, or medical advice.

FAQ:
Q: Does health insurance cover EBO2?
A: We found no sign that it does. Ozone therapy is not FDA-approved for any condition. As of October 4, 2026, none of the 174 clinic EBO2 pages we could read said insurance covers EBO2, and 23 said it is not covered or that the clinic does not accept or bill insurance. A few clinics give patients an itemized receipt (a superbill) to send to their insurer themselves; whether a plan pays anything on it depends on the plan.

Q: Will Medicare pay for EBO2?
A: Federal rules exclude from Medicare coverage any service that is not reasonable and necessary for the diagnosis or treatment of illness or injury. We could not find a national or local Medicare coverage document that addresses ozone therapy, so we cannot point to a written Medicare decision either way. One clinic's page says it does not accept Medicare or Medicaid.

Q: Can I use my HSA for EBO2?
A: Only if the expense is medical care under the IRS definition, which turns on whether it is primarily to alleviate or prevent an illness rather than for general health. Neither IRS Publication 502 nor 969 mentions ozone therapy. The account holder must keep records showing the withdrawal paid a qualified expense; if it did not, the amount is taxed and may draw an additional 20% tax.

Q: Can I use an FSA for EBO2?
A: It depends on the plan. The IRS says an FSA's qualified expenses are those specified in the plan that would generally qualify for the medical expense deduction, and the plan needs a written statement from an independent third party showing the expense was incurred. An FSA cannot reimburse sessions in advance, which matters for prepaid packages.

Q: Does a doctor's letter make EBO2 eligible?
A: Not by itself. IRS Publication 502 says lessons recommended by a doctor still do not count if they are only for general health. A letter can document that a treatment is for a specific diagnosed condition, which is what the IRS test asks about, but an FSA plan still decides, and for an HSA the account holder still carries the risk if the IRS disagrees.

Q: Is clinic financing a good way to pay?
A: Read the terms first. The Consumer Financial Protection Bureau has reported that medical credit cards and loans often carry deferred interest, with all accrued interest potentially due at the end of a promotional period. As of October 4, 2026, 15 of the 174 readable clinics mentioned financing, 4 of them a 0% promotional offer.

Sources:
[1] Publication 502 (2025), Medical and Dental Expenses. Internal Revenue Service, 2025. https://www.irs.gov/publications/p502
[2] Publication 969 (2025), Health Savings Accounts and Other Tax-Favored Health Plans. Internal Revenue Service, 2025. https://www.irs.gov/publications/p969
[3] 42 CFR 411.15 Particular services excluded from coverage. eCFR (Centers for Medicare & Medicaid Services), 2026. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-411/subpart-A/section-411.15
[4] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[5] Benefits. Medicaid.gov (Centers for Medicare & Medicaid Services), 2026. https://www.medicaid.gov/medicaid/benefits
[6] Medicare Coverage Database search results for "ozone". Centers for Medicare & Medicaid Services, 2026. https://www.cms.gov/medicare-coverage-database/search-results.aspx?keyword=ozone&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P
[7] Medical Credit Cards and Financing Plans. Consumer Financial Protection Bureau, 2023. https://www.consumerfinance.gov/data-research/research-reports/medical-credit-cards-and-financing-plans/
[8] CFPB Report Highlights Costly Credit Cards and Loans Pushed on Patients. Consumer Financial Protection Bureau, 2023. https://www.consumerfinance.gov/archive/newsroom/cfpb-report-highlights-costly-credit-cards-and-loans-pushed-on-patients/
[9] Pricing. EBO2 Therapy & Wellness, 2026. https://ebo2therapy.com/pricing
[10] Frequently Asked Questions. Dr. Laura Enfield, 2026. https://drlauraenfield.com/faq/
[11] Full-Spectrum EBOO Therapy in Lake Oswego, Oregon. Evergreen Factor (Lake Oswego, OR), 2026. https://evergreenfactor.com/eboo-therapy
[12] EBOO Therapy. Progressive Medical Center (Atlanta, GA), 2026. https://www.progressivemedicalcenter.com/therapies/eboo-therapy-in-atlanta/
[13] SynergyO3 Medical home page. SynergyO3 Medical (Encinitas, CA), 2026. https://synergyo3.com/
[14] EBOO in Philadelphia. Meeting Point Health, 2026. https://www.meetingpointhealth.com/eboo/
[15] Grand Rapids location. Michigan Health and Wellness, 2026. https://www.mihwcenter.com/locations/grand-rapids
[16] What Is EBOO Therapy?. Synergistiq Wellness (Tampa and Clearwater, FL), 2026. https://synergistiqhealth.com/blog/what-is-eboo-therapy/
[17] Wellness Reboot home page. Wellness Reboot, 2026. https://www.wellness-reboot.com/
[18] EBO2 clinic dataset and the clinic pages it lists, read between September 28, 2026 and October 4, 2026. EBO2.com, 2026. https://ebo2.com/data/

---

# Is EBO2 (EBOO) FDA Approved? What the FDA Has Said and How to Check a Claim

Source: https://ebo2.com/guides/is-ebo2-fda-approved/
Updated: 2026-10-08

Key takeaways:
- No form of ozone therapy, EBO2 included, is FDA-approved for any condition; the FDA's device rule calls ozone a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy.
- In July 2025 the FDA told the maker of two devices sold for EBOO and ultraviolet blood irradiation that both were adulterated and misbranded because they had no premarket approval or clearance.
- FDA registration, a registration number, or a 510(k) clearance for a part such as a dialysis filter is not FDA approval of EBO2, and federal rules call a representation otherwise misleading.
- As of October 4, 2026, of 174 clinics whose EBO2 page we could read, 148 did not say whether EBO2 or its equipment is FDA-approved, 23 said EBO2 is not FDA-approved, 3 used an FDA term for their equipment, and none said the treatment itself was cleared or approved.
- Any FDA claim can be checked in the agency's own databases; this guide gives the steps, the addresses, and what each result would and would not mean.

EBO2 (also called EBOO) is not FDA-approved, and neither is any other form of ozone therapy [1][2]. This guide sets out what the FDA itself has written about ozone and about EBOO equipment, what the words "approved", "cleared", and "registered" mean when a clinic uses them, and how to check any FDA claim in the agency's own databases, with what each result would and would not tell you. A description of the procedure itself is in our pillar guide on what EBO2 is (/what-is-ebo2/).

The short answer

No FDA approval exists for ozone therapy for any condition [1]. The FDA's device rule on ozone opens with the sentence "Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [1]. In July 2025 the FDA told the maker of two devices sold for EBOO and ultraviolet blood irradiation that both were adulterated and misbranded because neither had premarket approval or clearance [2]. A registration number is not approval either: a federal regulation says that registering a device establishment "does not in any way denote approval of the establishment or its products" [3], and another says the same of a 510(k) clearance [4]. The FDA also does not approve health care providers, so no clinic is FDA-approved as a clinic [5].

What the FDA's ozone rule says

The rule is 21 CFR 801.415, part of the FDA's device labeling regulations, which the eCFR dates to a Federal Register notice of February 13, 1976 [1]. Its first paragraph calls ozone a toxic gas with no known useful medical application, and adds that to work as a germicide ozone "must be present in a concentration far greater than that which can be safely tolerated by man and animals" [1]. The second paragraph describes irritation of the mucous membranes and lungs and warns that pulmonary edema from inhaled ozone "is usually delayed for some hours after exposure", so that neither symptoms nor smell is a reliable warning [1].

The third paragraph bears on medical use: any device that generates ozone "will be considered adulterated and/or misbranded" if it is used or intended for use under any of five conditions, and one of them is use "in any medical condition for which there is no proof of safety and effectiveness" [1]. The section's numbers, 0.05 parts per million for indoor air and a 0.10 parts per million industrial threshold that it attributes to the American Conference of Governmental Industrial Hygienists, concern air that people breathe, and the rule sets no dose for ozone in blood [1].

What the FDA said about EBOO devices in July 2025

On July 7, 2025, the FDA's Center for Biologics Evaluation and Research sent a warning letter to O3UV, LLC of Grand Ledge, Michigan, after inspecting the firm from August 23 to August 31, 2023 [2]. The letter covers two products, Champion Full Spectrum and EBOO Full Spectrum UV, which it says are meant to expose a patient's blood to ozone and ultraviolet light before the blood is returned intravenously, during UV blood irradiation or EBOO [2]. According to the letter, the products were intended for diseases including autoimmune, cardiovascular, and respiratory conditions and were distributed to physicians, nurses, and other practitioners across the United States [2].

| What the letter found | The letter's words or our summary |
| --- | --- |
| No marketing authorization | Adulterated "because you do not for these devices have approved applications for premarket approval (PMA) in effect", or an investigational device exemption, and misbranded because the firm did not file the 510(k) notice before selling them [2] |
| Device identifiers | No information submitted to the FDA's Global Unique Device Identification Database for either product [2] |
| Registration and listing | Not completed for fiscal year 2025 [2] |
| Manufacturing quality | Eight quality-system findings from the 2023 inspection, among them no design controls, no complaint procedure, and no corrective and preventive action procedure, plus no written adverse-event reporting procedures [2] |
| Purchased parts | Hemodialyzer filters sold in the firm's EBOO kits, and infusion pumps sold in bundles, bought without evaluating the suppliers [2] |

The letter asked for a written answer within 15 working days and said that failing to address the matters "may result in legal action being initiated by FDA without further notice", such as seizure or an injunction [2]. When we checked the FDA's warning letter list on October 2, 2026, the row for this letter showed no response letter and no close-out letter [6]. The FDA notes on that list that matters in a warning letter may have been the subject of later interaction with the recipient "that may have changed the regulatory status of issues discussed in the letter" [6]. It issues a close-out letter only after it has verified the corrections, usually by a follow-up inspection [7].

A warning letter is the FDA's notice of what it believes are significant violations, and it gives the recipient a chance to respond or to disagree [7]. This one concerns one manufacturer and two products. It does not name or describe any clinic [2].

What "approved", "cleared", and "registered" mean

| Wording | What it is | What it would not mean |
| --- | --- | --- |
| FDA-approved device | Premarket approval (PMA), based on the FDA's finding of "sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s)"; required for the highest-risk class of devices [8] | Approval of any other device, use, or procedure |
| FDA-cleared device | A 510(k) order finding a device substantially equivalent to one already legally marketed; the FDA says this order "clears" the device for commercial distribution [9] | Official approval, which a regulation says a 510(k) does not denote [4] |
| De Novo authorization | Marketing authorization for a new type of low- to moderate-risk device [10] | Authorization of other devices or uses |
| FDA-registered or listed | The yearly registration of a place that makes or handles devices, and the list of devices made there [11] | Approval, clearance, or authorization, in the FDA's words [10] |
| FDA registration certificate | Nothing the FDA issues: it "does not issue any type of device registration certificates" [10] | Any FDA review; a firm that shows such a certificate to imply FDA review misbrands the device [10] |
| FDA-approved drug | A drug the FDA has found safe and effective for its intended use [5] | Approval of other uses |
| Warning letter | The FDA's notice of what it believes are significant violations, with a request for a response [7] | A court ruling; later events may change the status [6] |

The FDA places dialysis equipment among the moderate-risk devices that reach the market through 510(k) clearance [5]. The filters in the EBOO kits the FDA inspected were hemodialyzers [2], and the classification rule for high-permeability hemodialysis systems describes such filters as intended "for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions" [12]. A cleared filter is therefore cleared for the uses written in its 510(k) [9]. Our guide to EBOO devices and FDA status (/guides/eboo-devices-and-fda-status/) applies this to each part of the circuit, and our comparison of EBOO and dialysis (/guides/eboo-vs-dialysis/) covers the filter itself.

How clinics word FDA status

Of the 177 clinics in our directory (/clinics/), we could read the EBO2 page of 174 as of October 4, 2026. Of those 174, 148 do not say whether EBO2 or its equipment is FDA-approved, 23 say EBO2 or ozone therapy is not FDA-approved, 3 use an FDA term for their equipment, and none says the treatment itself is FDA-cleared or approved. The three equipment statements between them use the words registered, cleared, and approved, which the table above shows are different things. We publish this wording only as totals, never clinic by clinic. The "From our data" section at the end of this guide recomputes the figures each time the site is built, and the clinic transparency report (/reports/clinic-transparency/) shows what else clinics state. Our guide on how to read a clinic's EBO2 page (/guides/how-to-read-a-clinic-ebo2-page/) takes this wording phrase by phrase.

How to check an FDA claim yourself

Write down the claim exactly. Note what it attaches to: the treatment, a device, the ozone, or the clinic. If a device is named, ask the clinic in writing for the manufacturer, the brand and model, and any FDA number it relies on. A 510(k) number looks like K043207 [13].
Search Devices@FDA (accessdata.fda.gov/scripts/cdrh/devicesatfda (https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm)) by device name and then by company name. The FDA describes it as a catalog of cleared and approved devices that searches both the 510(k) and the PMA databases [10][14].
Search the three marketing databases directly if you have a number or want more control: the 510(k) database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm), searchable by 510(k) number, applicant, device name, or product code; the PMA database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm); and the De Novo database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm), all at accessdata.fda.gov [14][15]. Try one distinctive word of a brand name at a time, because the same word often belongs to unrelated products.
Read what the record covers. A 510(k) decision letter finds the device substantially equivalent "for the indications for use stated in the enclosure", and the Indications for Use page in the PDF is where the cleared uses are written [13]. Compare those uses with what the clinic says the device does. The FDA's 510(k) page says a new 510(k) is required when a device is to be marketed for a new or different intended use [9].
Search Registration and Listing (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm) by company or device name. If a listed device needs premarket authorization, the owner is expected to give the FDA its 510(k), De Novo, or PMA number, so a listing that shows one points to the record to read [14][11].
Search the warning letter list (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters) on fda.gov for the company and the product names, and check the response and close-out columns for any letter found [6]. An empty result here is weak evidence, for the reasons below.
For a claim about ozone as a drug, search Drugs@FDA (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm), which covers most drug products approved since 1939 [16]. A National Drug Code listing is not an approval: the FDA describes that directory as one of "approved and unapproved finished drugs" [5].
For a claim about safety, the MAUDE adverse event database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM) and the device recall database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm) hold reports and recalls [14]. The FDA warns that a report "does not necessarily demonstrate that the device caused or contributed to the adverse outcome or event", and that these reports cannot show how often events happen [17]. Our guide to ozone therapy adverse events (/guides/ozone-therapy-adverse-events/) sets out a MAUDE search for ozone reports.

Two of our own test searches, run on October 2, 2026, show why an empty or noisy result settles nothing. A search of the warning letter list for "Connealy", part of the name of the Irvine, California clinic that received a joint FDA and FTC letter in May 2020, returned no results, although that letter is still on the FDA's website [6][18]. A search for "EBOO" returned the 2025 O3UV letter and also a 2021 letter about apricot-seed products whose text contains the word "eBook" [6].

| What a search finds | What it would mean | What it would not mean |
| --- | --- | --- |
| A 510(k) for the named device | The FDA found that device substantially equivalent for the indications in that 510(k) [9] | Official approval [4]; clearance for other uses; anything about the procedure |
| A PMA | The FDA approved that device for its approved uses [8] | Approval of other devices or uses |
| A De Novo authorization | The FDA authorized that new type of device for marketing [10] | Authorization of other uses |
| A registration and listing entry | A firm registered a facility and listed devices there [11] | Approval, clearance, or authorization [10] |
| A "registration certificate" | Nothing from the FDA, which issues none [10] | Any FDA review |
| A warning letter | The FDA believed, at that date, that there were significant violations [7] | A court ruling; the status may have changed since [6] |
| A close-out letter | The FDA verified the firm's corrections [7] | Approval or clearance |
| No result | Nothing either way | That no record exists under another spelling, company, or model name |

What our own searches found

We ran these checks for EBOO and ozone terms on October 2, 2026. The 510(k), PMA, and registration search forms answered our automated requests with either a blank form or an automated check, which we did not try to get around, so we searched those three databases, and the FDA's unique device identifier and classification data, through openFDA, a public data service that is an initiative of the FDA's Office of Health Informatics [19][20]. The De Novo database, the AccessGUDID device identifier search, and the warning letter list answered our searches directly [15][14][6].

"EBOO" and "EBO2" returned no 510(k), PMA, De Novo, registration and listing, or unique device identifier record [20][15].
"Ozone" in a 510(k) device name returned 11 records: six sterilizers or sterilization wraps and indicators, four systems that disinfect the water or solution systems used for dialysis, and one test strip for detecting ozone in water used for hemodialysis [20][21]. The only one named simply "Ozone Generator", K043207, cleared on November 4, 2005, is an accessory for disinfecting a dialysis solution mixing and distribution system, which is then rinsed "until the system is residual free of ozone" [13]. None of the 11 is for exposing a patient or a patient's blood to ozone.
The FDA's device classification data had no device type with "ozone" in its name or its definition [19].
Drugs@FDA had no application with ozone as an active ingredient, while the same search for oxygen returned 20 applications [16].
The warning letter list returned seven letters for "ozone": the O3UV letter, three about devices sold to clean CPAP equipment with ozone, two about products marketed as drugs, and one about a manufacturer's own ozone sanitizing step [6]. Only the O3UV letter concerns equipment for treating blood.

Our guide to EBOO devices and FDA status (/guides/eboo-devices-and-fda-status/) gives the results for each device name that clinics in our data use.

Who oversees ozone therapy if the FDA has not approved it

The FDA regulates products, and it says it does not approve health care providers, including physician offices [5]. Its ozone rule is written about devices used or intended for use in medical conditions without proof of safety and effectiveness [1], and its 2025 action on EBOO equipment was addressed to a manufacturer [2]. Federal prosecutors have also charged a physician over ozone devices: in June 2025 a Richmond, Virginia pain physician was indicted on counts that include receiving adulterated and misbranded devices, and the indictment alleges that he used three FDA-unapproved devices that produced medical ozone gas and billed ozone injections as nerve blocks [22]. The Justice Department's release notes that charges are only allegations [22].

State medical boards license physicians and act on how they practice, and their records on ozone differ:

Alabama, 2011. Asked by a physician for permission to use ozone, the state Board of Medical Examiners said it does not regulate specific practice procedures and declined to make a recommendation. It added that, "due to the experimental and investigational nature of the non-FDA approved therapy, the Board would be extremely concerned should any patient complaints be received related to the use of Ozone therapy" [23].
California, 2024. The Medical Board placed a physician on five years' probation, during which he "is prohibited from performing intravenous ozone therapy treatment". The accusation behind the case says a patient lost consciousness during an intravenous ozone treatment in December 2020 and was later diagnosed with an air embolism and a stroke [24].

None of these is an approval of ozone therapy, and none speaks for other states. We have not surveyed every state's rules, and nothing in this guide is a legal opinion on whether a given clinic's practice is lawful.

What federal agencies have done about ozone claims

| Date | Agency | Action |
| --- | --- | --- |
| 2014 | FDA recall database | A dentist's professional corporation recalled 16 ozone generators it had distributed, "because it is not approved or cleared by the FDA for medical use" [25] |
| April 10, 2020 | FTC | Warning letter to a Santa Rosa, California clinic whose website called ozone therapy a "Cost[] Effective Treatment for Corona Virus"; the letter said no study was known to support such COVID-19 claims and asked for a reply within 48 hours [26] |
| April 23, 2020 | FTC | Announced 21 warning letters over COVID-19 claims, with three recipients listed under an "Ozone Therapy" heading and a fourth whose claims included ozone therapy [27] |
| April 24, 2020 | Justice Department | A federal court in Dallas entered an agreed permanent injunction barring an ozone therapy center and one of its principals from claiming that ozone can treat COVID-19; court filings alleged the center called its treatments 95 percent effective [28] |
| May 2020 | FDA and FTC | Joint letter to an Irvine, California clinic; the FTC's part listed posts claiming that "Ozone destroys viruses!" among claims it said lack competent and reliable scientific evidence [18] |
| November 12, 2020 | FTC | Announced 20 more letters, bringing the total to more than 330 recipients, and said "currently there is no scientific evidence that these products or services can prevent or treat the disease" [29] |
| July 7, 2025 | FDA | Warning letter to the maker of two EBOO and ultraviolet blood irradiation devices [2] |

Each of these actions concerned specific products or specific claims. None of them is a general ruling on ozone therapy as a practice.

Outside the United States

None of the regulatory documents we hold from other countries approves EBOO. Brazil's 2023 law allows ozone therapy only as a complementary procedure, performed by a university-level health professional registered with a professional council and with an ozone generator regularized by the national health regulator [30]. In 2005 Italy's Health Ministry relayed its Superior Health Council's view that no controlled clinical studies were available to support the efficacy of oxygen-ozone therapy and that it can cause serious and potentially fatal side effects [31]. Our guide to what regulators abroad have said (/guides/eboo-around-the-world/) compares those documents country by country, including Germany's exclusion of ozone therapy from statutory health insurance, and our regulatory tracker (/reports/regulatory-tracker/) lists every record we hold with its exact language.

What we could not verify

The full database search forms. The FDA's 510(k), PMA, and Registration and Listing search pages return a blank form to plain requests and show an automated check to a form submission, which we did not try to pass. We used openFDA's copies of those databases instead; openFDA updates its 510(k) data monthly and says not to rely on it for decisions about medical care [20]. A reader's own search on the FDA's pages may show records added since.
Absence. A search can show that a record exists. It cannot show that none exists under another name, a parent company, a distributor, or a model number.
The O3UV letter's outcome. We do not know whether the firm answered the FDA or changed its products after July 2025. The FDA's list showed no response or close-out letter on October 2, 2026 [6].
The procedure as practiced. No FDA document we found addresses EBOO as performed in clinics. The agency's statements we found concern ozone devices and named products [1][2].
Clinics' equipment. As of October 4, 2026, 21 of the 174 clinics whose page we could read named a device or system, and a brand name on a web page does not identify a maker or model, so we cannot match any clinic's machine to an FDA record.
State law. We have not surveyed the rules of all 50 states on ozone therapy.
Earlier claims about other countries. An earlier version of this guide summarized ozone therapy rules in Germany, Spain, several Italian regions, and Cuba, drawing on practitioner associations and a Cuban newspaper. Our sourcing rules now allow direct reading only of public institutions' own documents. Our guide to regulators abroad (/guides/eboo-around-the-world/) now covers Germany and Italy from the regulators' own documents; we hold no primary documents for Spain or Cuba, so we make no claim about them.

How this guide was made

This guide rests on 32 sources, nearly all of them the FDA's, the FTC's, the Justice Department's, and state boards' own documents and databases, each read for this update. The counts of how clinics word FDA status come from our clinic dataset as read between September 28, 2026 and October 4, 2026 (174 readable pages among 177 listed clinics). The database results come from searches we ran on October 2, 2026, and we keep the queries and results on file. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: Is EBO2 or EBOO FDA approved?
A: No. No form of ozone therapy is FDA-approved for any condition. The FDA's device rule on ozone describes it as a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy, and in July 2025 the FDA told the maker of two devices sold for EBOO that they had no premarket approval or clearance.

Q: Is the filter used in EBOO FDA approved?
A: Some EBOO circuits use hemodialysis filters, including the kits in the FDA's 2025 warning letter. The FDA classifies high-permeability hemodialysis systems as Class II devices intended as artificial kidney systems, and individual filters are cleared through 510(k) for the uses written in their submissions, such as kidney failure. A filter's clearance covers those uses. It is not approval of EBOO, and federal rules say a 510(k) does not denote official approval.

Q: What does it mean when a clinic says its equipment is FDA-registered?
A: It means a company that makes or handles the equipment registered its facility with the FDA and listed its devices. The FDA says that entry does not denote approval, clearance, or authorization, and the FDA does not issue registration certificates.

Q: How can I check a clinic's FDA claim myself?
A: Ask the clinic for the manufacturer, the model, and any FDA number it relies on. Then search Devices@FDA, the 510(k), PMA, and De Novo databases, the Registration and Listing database, and the FDA's warning letter list, and read the indications for use in any record you find. The steps, with addresses and what each result means, are in this guide.

Q: Where can a misleading FDA claim about a device be reported?
A: The FDA takes allegations about device makers and marketers, including marketing without clearance or approval and promotion outside cleared uses, through its Allegations of Regulatory Misconduct form or by email, and anyone may file one. State medical boards handle complaints about a licensed physician's practice.

Sources:
[1] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[2] Warning letter to O3UV, LLC (CBER 25-668840). U.S. Food and Drug Administration, 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/o3uv-llc-668840-07072025
[3] 21 CFR 807.39 Misbranding by reference to establishment registration or to registration number. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807/subpart-B/section-807.39
[4] 21 CFR 807.97 Misbranding by reference to premarket notification. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807/subpart-E/section-807.97
[5] Is It Really 'FDA Approved'?. U.S. Food and Drug Administration, 2026. https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved
[6] Warning Letters (list and search). U.S. Food and Drug Administration, 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
[7] About Warning and Close-Out Letters. U.S. Food and Drug Administration, 2024. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/about-warning-and-close-out-letters
[8] Premarket Approval (PMA). U.S. Food and Drug Administration, 2019. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma
[9] Premarket Notification 510(k). U.S. Food and Drug Administration, 2024. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
[10] Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved?. U.S. Food and Drug Administration, 2021. https://www.fda.gov/medical-devices/consumers-medical-devices/are-there-fda-registered-or-fda-certified-medical-devices-how-do-i-know-what-fda-approved
[11] Device Registration and Listing. U.S. Food and Drug Administration, 2025. https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
[12] 21 CFR 876.5860 High permeability hemodialysis system. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-876/subpart-F/section-876.5860
[13] 510(k) K043207, Ozone Generator: summary, decision letter, and indications for use. U.S. Food and Drug Administration, 2005. https://www.accessdata.fda.gov/cdrh_docs/pdf4/K043207.pdf
[14] Medical Device Databases. U.S. Food and Drug Administration, 2022. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
[15] Device Classification Under Section 513(f)(2) (De Novo) database. U.S. Food and Drug Administration, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm
[16] Drugs@FDA Overview (openFDA). U.S. Food and Drug Administration (openFDA), 2026. https://open.fda.gov/apis/drug/drugsfda/
[17] About Manufacturer and User Facility Device Experience (MAUDE). U.S. Food and Drug Administration, 2025. https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude-database
[18] Warning letter to Center for New Medicine/Perfectly Healthy by Connealy MD (MARCS-CMS 605804). U.S. Food and Drug Administration and Federal Trade Commission, 2020. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/center-new-medicineperfectly-healthy-connealy-md-605804-05112020
[19] What is openFDA?. U.S. Food and Drug Administration (openFDA), 2026. https://open.fda.gov/about/
[20] Device 510(k) Overview (openFDA). U.S. Food and Drug Administration (openFDA), 2026. https://open.fda.gov/apis/device/510k/
[21] 510(k) K132344, E-Z Check Ozone Test Strips: summary and indications for use. U.S. Food and Drug Administration, 2014. https://www.accessdata.fda.gov/cdrh_docs/pdf13/K132344.pdf
[22] U.S. Attorney Erik S. Siebert announces charges as part of DOJ's national health care fraud enforcement action. U.S. Attorney's Office, Eastern District of Virginia, 2025. https://www.justice.gov/usao-edva/pr/us-attorney-erik-s-siebert-announces-charges-part-dojs-national-health-care-fraud
[23] Ozone Therapy correspondence, August 2011. Alabama State Board of Medical Examiners, 2011. https://www.albme.gov/uploads/files/ozone%20therapy.pdf
[24] In the Matter of the Accusation Against German Zermeno, M.D., Case No. 800-2022-088393: Decision and Stipulated Settlement. Medical Board of California, 2024. https://www2.mbc.ca.gov/BreezePDL/document.aspx?path=%5CDIDOCS%5C20240621%5CDMRAAAJD2%5C&did=AAAJD240621215614354.DID
[25] Class 2 Device Recall Enaly 1000 BT12 Ozone Generator (Z-1576-2014). U.S. Food and Drug Administration, 2014. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127001
[26] Warning Letter to RowenSu Clinic: Unsubstantiated Claims for Coronavirus Treatment. Federal Trade Commission, 2020. https://www.ftc.gov/system/files/warning-letters/covid-19-letter_to_rowensu.pdf
[27] FTC Sends 21 Letters Warning Marketers to Stop Making Unsupported Claims That Their Products and Therapies Can Effectively Treat Coronavirus. Federal Trade Commission, 2020. https://www.ftc.gov/news-events/news/press-releases/2020/04/ftc-sends-21-letters-warning-marketers-stop-making-unsupported-claims-their-products-therapies-can
[28] Court Prohibits Dallas Health Center from Touting "Ozone Therapy" as a COVID-19 Treatment. U.S. Department of Justice, 2020. https://www.justice.gov/archives/opa/pr/court-prohibits-dallas-health-center-touting-ozone-therapy-covid-19-treatment
[29] FTC Sends Letters Warning 20 More Marketers to Stop Making Unsupported Claims That Their Products and Therapies Can Effectively Prevent or Treat COVID-19. Federal Trade Commission, 2020. https://www.ftc.gov/news-events/news/press-releases/2020/11/ftc-sends-letters-warning-20-more-marketers-stop-making-unsupported-claims-their-products-therapies
[30] Lei nº 14.648, de 4 de agosto de 2023: Autoriza a ozonioterapia no território nacional. Presidência da República (Brazil), 2023. https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2023/lei/L14648.htm
[31] Ossigeno-ozono terapia (nota DGFDM.III/P/1752/I.4.C.C.), circular of 20 January 2005, published as an annex by Regione Toscana. Ministero della Salute (Italy), 2005. https://www.regione.toscana.it/documents/10180/12096595/Allegato+3+Parere+n.+10-2007+%28Autore+Bailo+09-03-2007%29.pdf/f1bb981c-98e3-4ca9-8c8a-e111f32713fa?version=1.0&t=1416999155247&download=true

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# Ozone Therapy Adverse Events by Route: What Case Reports Show, and Where EBO2 (EBOO) Fits

Source: https://ebo2.com/guides/ozone-therapy-adverse-events/
Updated: 2026-10-03

Key takeaways:
- As of October 2, 2026, we found no published case report of a serious adverse event during EBO2 (EBOO) itself; the documented events come from other blood-based ozone methods and from injections.
- The most common serious events in these reports are strokes, vision loss, and spinal cord injury that began during or minutes after a procedure, which most of their authors attribute to gas entering the bloodstream.
- Infections are the other large group: a hepatitis C cluster among patients given ozonated blood, and spine, joint, and brain-lining infections after injections.
- A case report shows that an event followed a procedure; it cannot show how often that happens, and two 2026 reviews say the overall rate of serious events cannot be reliably estimated.
- On October 2, 2026, FDA's device adverse-event data held 10 reports whose narratives mention ozone therapy and none mentioning EBOO; anyone can search it and anyone can file a MedWatch report.

We could not find a published case report of a serious adverse event during EBO2 (also called EBOO), as of October 2, 2026. The adverse events in the medical literature come from other ways of giving ozone (/glossary/#ozone): mixing it into a bag of blood and returning the blood, injecting the gas into a vein, and injecting it into or beside the spine, a joint, a wound, or the skin. This page lists every such report we could read, grouped by route, with what each says happened, the outcome, and how its authors explain it. It ends with how to search FDA's adverse-event database and how to report a problem to FDA.

Ozone therapy is not FDA-approved to treat any condition, and federal regulation calls ozone "a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [55]. For what the EBOO studies record and the warning signs after a session, see our side effects and safety guide (/guides/side-effects-and-safety/); for who the sources say should not be treated, see contraindications (/guides/contraindications/).

What a case report can and cannot show

A case report describes one patient, or a few, as the treating doctors saw them. It shows that an event followed a procedure and how those doctors explained it. It cannot show how often the event happens, who is most at risk, or on its own that ozone caused it. Authors word causation differently, from "most likely" to "probable" to a plain statement that a report establishes only a link in time, and we keep their wording below.

No registry counts how many ozone treatments are given or what follows them. A 2026 scoping review of autohemotherapy safety concluded that the overall rate of serious adverse events cannot be reliably estimated, because there are no prospective registries and no reliable figures for how many treatments are given [1]. A 2026 umbrella review of randomized trials found safety outcomes too inconsistently reported to support firm conclusions [2]. Velio Bocci, a Siena physiologist whose group reported about 800 EBOO sessions, wrote that he had proposed six times that health authorities require ozone therapists to keep a register of adverse events [3].

The low complication rates quoted in practitioner reviews, 0.0007% or 0.7 per 100,000 treatments, trace back to a 1982 survey by Jacobs [3][4]. Bocci notes that the survey's data included four deaths from direct intravenous injection of the gas [3], and the 2026 scoping review says the frequently cited low estimate rests on uncertain methods [1].

Blood-based methods

These reports involve ozone mixed into withdrawn blood that is then returned (autohemotherapy (/glossary/#autohemotherapy)), or gas given into a vein. Reports marked "abstract only" are ones whose full text we could not read.

| Report | Procedure | What happened | Outcome as reported |
|---|---|---|---|
| Marchetti 2000, Italy [6] | Oxygen-ozone autohemotransfusion for psoriasis | Gas embolism during the procedure (abstract only) | Death |
| Faustini 2005, Rome [7] | Ozone-enriched transfusion of the patient's own blood at a hospital outpatient clinic, 2001 | Hepatitis C cluster: 6 of the 31 exposed patients who were tested carried the virus, one known to be infected since 1986 and a possible source; all six had received the blood procedure, and spread probably happened at one of the three busiest sessions (abstract only) | 3 had symptoms of infection |
| Ureyen 2015, Turkey [10] | Ozonated autohemotherapy at a private clinic that morning | Heart attack with coronary artery spasm and a blocked artery in a 46-year-old man without the usual risk factors (abstract only) | Stent placed |
| Tang 2017, China [11] | Autohemotherapy for 9 days, 100 mL of blood, dose unknown (as the patient described it) | Sinus arrest from high potassium (6.8 mmol/L) in a woman with high blood pressure, diabetes, and kidney disease; the authors hypothesize a link to the therapy | Potassium and rhythm normal after treatment |
| Bingham 2020, US [12] | Blood drawn, ozone injected into it, and returned through an IV | Fainting and a heart attack (NSTEMI) right after; the authors associate it with oxidative stress from ozone (abstract only) | Admitted for cardiac evaluation |
| Wong 2025, Australia [13] | Private outpatient IV session: 150 mL of ozone-infused blood with 500 IU of heparin | Chest pain, fainting, and a seizure within minutes; MRI showed infarcts; small patent foramen ovale; the authors' main suspected diagnosis was cerebral air embolism | Intensive care; problems with attention, concentration, and migraines at 9 months |
| Singh 2026, US [14] | Intravenous ozone therapy | Leg weakness and loss of vision in both eyes, consistent with arterial gas embolism (abstract only) | Full recovery after hyperbaric oxygen |

Milder effects appear in Bocci's account of about 5,000 major autohemotherapy treatments in Siena from 1995 to 2000: tingling of the lips and tongue near the end of reinfusion, which he attributes to excess citrate; nausea, bloating, and a metallic taste in 10 to 15% of women, which he attributes to additives in PVC bags; a day of tiredness after the first treatments in 20 to 30% of patients; and four women who developed a rash, itching, nausea, flushing, and slightly low blood pressure. He writes that these stopped after his group switched to glass bottles and a calibrated amount of citrate [3]. A 2025 modeling paper by authors from the Italian society SIOOT argues the opposite about containers, that glass bottles cause more breakdown of red blood cells than plastic bags [56].

Three more reports in this group are letters we could read only by title: hepatitis C transmission by ozone enrichment of blood (1996) [8], hepatitis C and HIV infection after autohemotherapy (1997) [9], and methemoglobinemia after autohemotherapy given with high-dose vitamin C (2022) [15].

Injecting the gas itself into a vein is a different practice from autohemotherapy. Bocci's 2004 review notes four recorded deaths from pulmonary embolism during direct intravenous administration [17] and wrote that the gas mixture should never be injected into blood vessels because of the risk of oxygen embolism [16]. A 2018 document from Tuscany's regional clinical-governance body summarizes Italian ozone-society guidelines as saying the mixture "must not be used in direct intravenous administration" because of the danger of pulmonary gas embolism (our translation) [18].

Three official records describe harm after intravenous ozone. In New York, a medical examiner found gas emboli in a podiatrist's patient who went into cardiac arrest within 15 minutes of an intravenous ozone injection, attributed them to the ozone, and ruled the death a homicide due to extreme medical negligence; an appellate court held that determination was not arbitrary and capricious [19]. In California, a physician admitted an accusation that a patient's IV made gurgling sounds during intravenous ozone therapy in 2020, after which she lost consciousness and was diagnosed with air embolism and a stroke; he was placed on probation and barred from intravenous ozone therapy [20]. In New South Wales, the Health Care Complaints Commission found, on expert opinion, that treatment at an ozone clinic was the most likely reason a patient developed an infection that led to septic shock [21]. Our side effects guide (/guides/side-effects-and-safety/) gives the exact wording of each.

Injections into or beside the spine

These reports involve injections into a disc (intradiscal), around the nerve root (periganglionic or intraforaminal), into the back muscles (paravertebral), or into the epidural space, almost all for back or neck pain.

| Report | Procedure | What happened | Outcome as reported |
|---|---|---|---|
| Corea 2004, Italy [22] | Intradiscal and periganglionic ozone with a periganglionic steroid | Stroke in the vertebrobasilar circulation with Anton's syndrome (abstract only) | Not stated in the abstract |
| Lo Giudice 2004, Italy [23] | Intradiscal and periganglionic lumbar injection | Sudden loss of vision from bleeding inside both eyes (abstract only) | Laser drainage of one eye weeks later |
| Gazzeri 2007, Italy [24] | Earlier ozone treatment for lumbar disc herniation | Fulminant E. coli septicemia with infected back muscle and septic lung emboli (abstract only) | Death |
| Vaiano 2016, Italy [25] | 4 mL intradiscal and 11 mL periganglionic at L5-S1, 27 μg/mL | Blindness in both eyes about a minute later; strokes in both visual cortices; large patent foramen ovale; the authors favor air embolism as the most likely cause | Normal vision by day 9 |
| Beyaz 2018, Turkey [29] | Epidural ozone through a catheter; 20 mL given instead of the planned 8 mL | Cardiopulmonary arrest 2 minutes after the injection; air inside the skull | Resuscitated; discharged after the air resorbed |
| He 2019, China [28] | 8 mL intradiscal at L4-L5 | Paralysis of both legs (anterior spinal cord syndrome) and an ST-elevation heart attack; large patent foramen ovale; air embolism judged most likely | Standing with a cane at 9 months |
| Freund 2019, Canada [26] | Regular cervical paravertebral injections | Fainting, then ataxia, aphasia, and weakness; gas in a vertebral artery; multiple strokes (abstract only) | Not stated in the abstract |
| Chirchiglia 2019, Italy [27] | Oxygen-ozone for a lumbar disc protrusion | Suspected massive pulmonary embolism; the authors suspect the needle entered a vein (abstract only) | Sudden death |
| Khosravi 2024, Iran [30] | Lumbar intradiscal injection at a pain clinic | Speech and limb problems during the injection; gas bubbles in the brain and strokes in both hemispheres; small patent foramen ovale | No symptoms at 12 months |
| Haggiag 2021, Italy [31] | Cervical or lumbar ozone sessions, 3 patients | Loss of consciousness, cortical blindness, memory loss, speech trouble, or vertigo right after; the authors call it ozone-induced encephalopathy (abstract only) | All recovered within 48 hours |
| Salaria 2021, India [32] | 20 mL of intradiscal ozone with a steroid at two lumbar levels | Tuberculosis infection of the spine with abscesses, which the authors attribute most likely to direct inoculation | Improving on tuberculosis drugs at 6 months |
| Andrés-Cano 2016, Spain [35] | C6-C7 intradiscal oxygen-ozone at an outside hospital | Severe sepsis from a neck disc infection 10 days later, with an epidural abscess from C4 to T1 compressing the spinal cord; streptococcus grown; the authors suspect the needle passed through the esophagus | Emergency drainage, later spinal fusions; improved at 1 year |
| Shahi 2020, India [33] | Fluoroscopy-guided ozone at L4-L5 | Mycobacterium abscessus spine infection after 3 symptom-free months | Spinal fusion and antibiotics |
| Velluto 2026, Italy [34] | Intradiscal oxygen-ozone | Lactobacillus iners spine infection 3 months later; the authors' review found 8 such infections, one fatal | Full recovery after surgery and antibiotics |
| Elmas Dal 2026, Turkey [36] | Injections along the spine and the front of the neck at a private clinic | Meningitis and air inside the skull the next day; the author thinks a contaminated needle most likely passed from the epidural space into the spinal fluid space | Recovered on antibiotics |
| Vanni 2016, Italy [37] | Earlier intraforaminal ozone in 23 of 186 patients later operated on | Hard scar adhesions around nerve roots, found at surgery only in the ozone-injected patients (abstract only) | Found during later surgery |

Bocci's chapter also records a death in Naples in May 2001 that he attributes to intramuscular injection of the gas into the muscles beside the spine, and it describes how a large, painful injection can trigger a reflex slowing of the heart that may end in cardiac arrest [3].

Larger summaries put these reports in context without settling the rate. A 2010 meta-analysis of 12 studies and almost 8,000 patients gave a complication likelihood of 0.064% for disc treatment; its authors' listed affiliation is ActiveO, of Salt Lake City [38]. A 2025 analysis by authors from the Italian ozone society SIOOT, pooling seven studies of 120 patients, reported a relative risk of severe adverse events 6.57 times higher for intradiscal than for intramuscular injection [39].

Other routes

| Report | Procedure | What happened | Outcome as reported |
|---|---|---|---|
| Uzun 2012, Turkey [41] | Topical ozone and autohemotherapy, then injections into a diabetic foot ulcer | After the second injection, spreading redness and, within two days, a large area of dead tissue and infection | Surgery, antibiotics, and a flap; the wound healed |
| Gante 2025, Portugal [40] | Injection under the skin at facial acupuncture points, for allergies | Confusion, unsteadiness, and involuntary arm movements about 10 minutes later; called probable ozone-induced encephalopathy, causality not established | Ventilated 48 hours; full recovery |
| Shamohammadi 2025, Iran [43] | Second ozone session for a lumbar disc herniation, route not stated | Abdominal pain and swelling within 10 minutes; free air in and behind the abdomen | Intensive care without surgery; home after 5 days |
| Cortez 2026, Brazil [42] | One session with a physical therapist for shoulder pain, route not stated | Septic arthritis (Staphylococcus aureus); the authors say the link is only in time | Surgery and antibiotics; well at 6 months |

Two more are known to us only by title: posterior reversible encephalopathy syndrome after intramuscular injection (2020) [44] and massive emphysema with air in the chest after ozone therapy (2021) [45]. Breathing ozone is a separate hazard: FDA has received reports of asthma attacks, headaches, and breathlessness from people who used ozone devices sold to clean CPAP equipment [46].

What the reports have in common

Timing. Most neurological and heart events began during the procedure or within minutes of it [13][25][29][30][40].
Gas in the circulation. Many authors attribute the event to gas embolism. In five reports, echocardiography found a patent foramen ovale, an opening between the heart's upper chambers, which the authors describe as the route by which bubbles crossed from veins to arteries [13][25][28][30][31]. A case report cannot show how much such an opening adds to the risk.
Infection. Infections followed blood procedures and injections alike, and several authors tie them to lapses in sterile technique [7][32][34][36]. The New South Wales commission found a clinic trying to sterilize single-use items for reuse [21].
Errors and equipment. One arrest followed an injected volume more than twice the planned one [29], and the California accusation charged a failure to maintain the ozone machine [20].

Practitioners read the same reports differently. A 2020 review in a journal special issue on ozone therapy concluded that most safety problems in the case reports come from infections or traumatic injuries due to malpractice, not from ozone itself at therapeutic doses [57]. The 2026 scoping review, by contrast, groups the documented events by mechanism, including gas embolism, hemolysis at high concentrations, and reactions to equipment materials, and says their overall frequency cannot be estimated [1].

What has not been reported: EBO2 itself

A Europe PMC search on October 2, 2026, for "extracorporeal blood oxygenation and ozonation" or EBOO returned 88 records; none of the EBOO papers among them is an adverse-event report [50]. The largest controlled EBOO trial recorded no side effects or complications in 210 treatments [47], and a 2005 review by the same Siena group reports more than 1,200 treatments in 82 patients and describes treating up to 4,800 mL of heparinized blood in an hour without technical or clinical problems [48]. A California clinic's paper on ozone dialysis, which it says is commonly referred to as EBOO, reports at least 400 sessions with no untoward effects observed [49]. These come from the people who developed or offer the procedure, none was designed to detect rare events, and no registry exists. The EBOO studies side by side (/reports/studies-compared/) show how small they are.

How to search FDA's MAUDE database

MAUDE holds medical device reports sent to FDA by manufacturers, importers, and hospitals and other user facilities, which must report, and by clinicians, patients, and consumers, who may [51].

Open the simple search at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/TextSearch.cfm. FDA's instructions say to enter a single word, an exact phrase in quotes, or several words joined by "and" [51].
Choose a report year, or the option for all years. MAUDE covers the last ten years and is updated monthly; older reports are in FDA's MDR data files [5].
Try terms such as `ozone`, `"ozone therapy"`, the brand of an ozone generator, or the name of a device a clinic says it uses; our devices guide (/guides/eboo-devices-and-fda-status/) explains how to look a device up in FDA's other databases.
For more control, use the advanced search at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm to filter by brand name, manufacturer, product code, event type, or date; each search returns up to 500 reports [51].
Open a report and read the event description, the event type (death, injury, or malfunction), who reported it, and the date FDA received it.

What a result means: FDA says a report does not necessarily show that the device caused or contributed to the event, and that the report data "is not intended to be used either to evaluate rates of adverse events" or to compare devices; under-reporting, inaccuracies, and unverified details limit it [5]. A search that finds nothing does not mean nothing happened.

We ran these searches on October 2, 2026, through openFDA, FDA's public interface to the same reports (data last updated September 22, 2026). The phrase "ozone therapy" appeared in the narratives of 10 reports [52]. Eight concerned other products, such as breast implants, dermal fillers, a needle, and a spinal stimulator, with ozone therapy mentioned in passing. Two were voluntary reports about ozone treatment itself: one described loss of consciousness and days in a coma after ozone therapy, and one, coded as a death, described ozone treatment of the blood. Like any MAUDE report, neither establishes cause [5]. The term EBOO returned no reports.

How to report a problem to FDA

Use MedWatch, FDA's voluntary reporting program. The online form is at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm, with one version for health professionals (Form 3500) and one for consumers and patients (Form 3500B) [54].
PDF versions are at https://www.fda.gov/media/76299/download (Form 3500) and https://www.fda.gov/media/85598/download (Form 3500B). FDA also takes reports by phone at 1-888-INFO-FDA (1-888-463-6332), option 2 [53].
FDA encourages people to take the form to their doctor, who can add clinical details from the medical record; a health care provider is not required to report, and patients may file themselves [53].
The online form can be saved and finished within 3 days, contact details are optional, and a reporter can ask FDA not to share them with the manufacturer [54].
Include the product and a summary of what happened [54]. The details most often missing from the published reports above are the route, the ozone concentration and gas volume, any anticoagulant used (see our blood thinners and medicines guide (/guides/eboo-blood-thinners-and-medications/)), the generator or device name, and how soon symptoms began.

The form's page tells anyone with a medical emergency to call 911 [54]. MedWatch collects reports about medical products [53]; conduct by a practitioner is a matter for state licensing boards, such as the Medical Board of California in the case above [20], and our regulatory tracker (/reports/regulatory-tracker/) lists the records we hold. Our clinic directory (/clinics/) lists what each clinic states about its own service.

What we could not verify

Five reports we know only by title: the 1996 and 1997 hepatitis letters [8][9], the 2022 methemoglobinemia letter [15], the 2020 encephalopathy letter [44], and the 2021 emphysema report [45]. We list them so readers can find them, not as evidence of what happened.
Twelve reports read as abstracts only, marked in the tables. Their full texts may give doses, timing, or other causes we could not see. We also cite the 2010 disc meta-analysis and the 2026 scoping review from their abstracts [1][38].
The 1982 Jacobs survey behind the 0.0007% figure, which we have not read.
Doses. Most reports give no ozone concentration or gas volume, so no pattern by dose can be drawn.
Unpublished events. Mild reactions, and serious ones nobody wrote up, do not appear in journals, and MAUDE captures few ozone treatments.
Comment letters that journals published about several of these reports, which we did not read.

How this guide was made

We built this compilation from 57 sources: case reports, series, and reviews read through NCBI and Europe PMC, court and regulator records, and FDA's own pages and data. The study details come from our library's study cards where one exists (see our research library (/research/)) and otherwise from the papers' abstracts or full texts as marked. The MAUDE counts come from our own openFDA queries on October 2, 2026, which anyone can repeat with the links in the sources. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: Has anyone died from ozone therapy?
A: Yes, according to published reports and official records. A 2000 forensic report describes a death from gas embolism during ozone autohemotransfusion; a 2007 report describes fatal septicemia after ozone treatment for a herniated disc; a 2019 report describes a suspected pulmonary embolism and sudden death; and a New York medical examiner attributed gas emboli in a patient who died to an intravenous ozone injection. None of these involved EBO2.

Q: Has EBO2 (EBOO) itself been linked to a documented injury?
A: Not in anything we could find as of October 2, 2026. The EBOO papers in our library attribute no side effects to the procedure, but they are small and come mostly from the group that developed the technique, and no registry collects outcomes. An absence of published reports is not evidence that the procedure is safe.

Q: What is ozone-induced encephalopathy?
A: It is a name proposed by neurologists in Rome in 2021 for brain symptoms, such as confusion, vision loss, or memory problems, that begin right after an ozone procedure. Their three patients recovered within 48 hours, and a 2025 report from Lisbon used the same label for a patient injected under the skin of the face. The Rome authors describe its cause as complex and say it is probably under-reported.

Q: How do I report a bad reaction to ozone therapy to the FDA?
A: Through MedWatch, FDA's voluntary reporting program, at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm. Patients and consumers use Form 3500B and health professionals use Form 3500, online or as a PDF. FDA also takes calls at 1-888-INFO-FDA (1-888-463-6332), option 2. FDA encourages people to take the form to their doctor, who can add clinical details.

Q: Does a report in FDA's MAUDE database prove that a device caused harm?
A: No. FDA says a report does not necessarily show that a device caused or contributed to the event, that the reports cannot be used to measure how often events happen, and that under-reporting and unverified details limit what they show. A report is a signal that someone saw a problem.

Q: Where does the often-quoted 0.0007% complication rate come from?
A: Reviews by ozone practitioners trace it to a 1982 survey by Jacobs, which we have not been able to read. One of those reviews notes that the survey's data included four deaths from injecting the gas directly into a vein, and a 2026 scoping review says the frequently cited low estimate has uncertain methods and should be read with considerable caution.

Sources:
[1] Oxygen-ozone autohaemotherapy in fibromyalgia: safety profile and adverse events. A scoping review. Clinical and Experimental Rheumatology (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42328943/
[2] Effectiveness and Safety of Ozone Therapy in Humans: An Umbrella Review of Systematic Reviews with Meta-Analyses of Randomized Clinical Trials. Medical Sciences (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42346828/
[3] The Potential Toxicity of Ozone: Side Effects and Contraindications of Ozonetherapy. Ozone: A New Medical Drug, 2nd ed. (Springer), via PMC, 2011. https://pmc.ncbi.nlm.nih.gov/articles/PMC7498876/
[4] Ozone and oxidation therapies as a solution to the emerging crisis in infectious disease management: a review of current knowledge and experience. Medical Gas Research (PubMed), 2019. https://pubmed.ncbi.nlm.nih.gov/31898609/
[5] About Manufacturer and User Facility Device Experience (MAUDE) Database. U.S. Food and Drug Administration, 2025. https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude-database
[6] An unexpected death during oxygen-ozone therapy. American Journal of Forensic Medicine and Pathology (PubMed), 2000. https://pubmed.ncbi.nlm.nih.gov/10871129/
[7] A cluster of hepatitis C virus infections associated with ozone-enriched transfusion of autologous blood in Rome, Italy. Infection Control and Hospital Epidemiology (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16209382/
[8] Transmission of hepatitis C by ozone enrichment of autologous blood. The Lancet (PubMed), 1996. https://pubmed.ncbi.nlm.nih.gov/8596287/
[9] Hepatitis C and human immunodeficiency virus infection following ozone autohaemotherapy. European Journal of Clinical Microbiology and Infectious Diseases (PubMed), 1997. https://pubmed.ncbi.nlm.nih.gov/9323479/
[10] Myocardial Infarction after Ozone Therapy: Is Ozone Therapy Dr. Jekyll or Mr. Hyde?. Cardiology (PubMed), 2015. https://pubmed.ncbi.nlm.nih.gov/26139204/
[11] Ozone therapy induced sinus arrest in a hypertensive patient with chronic kidney disease: A case report. Medicine, Baltimore (PubMed), 2017. https://pubmed.ncbi.nlm.nih.gov/29390373/
[12] A Non-ST Elevation Myocardial Infarction Associated with Alternative Medicine Ozone Infusion. Journal of Emergency Medicine (PubMed), 2020. https://pubmed.ncbi.nlm.nih.gov/31708316/
[13] Neurological Crisis Following Intravenous Ozone Therapy; a Case Report. Archives of Academic Emergency Medicine (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/40027218/
[14] Hyperbaric Oxygen Treatment for Arterial Gas Embolism With Transient Cortical Blindness Following Intravenous Ozone Therapy: A Case Report. Undersea and Hyperbaric Medicine (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42365944/
[15] New-Onset Methemoglobinemia After Receiving Ozone Autohemotherapy and High-Dose Vitamin C Injection. Transfusion Medicine Reviews (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/34815107/
[16] Oxygen/ozone as a medical gas mixture. A critical evaluation of the various methods clarifies positive and negative aspects. Medical Gas Research (PubMed), 2011. https://pubmed.ncbi.nlm.nih.gov/22146387/
[17] Ozone as Janus: this controversial gas can be either toxic or medically useful. Mediators of Inflammation (PubMed), 2004. https://pubmed.ncbi.nlm.nih.gov/15203558/
[18] Allegato alla Decisione CTS n. 20 del 11/12/2018 (terapie ossidative). Regione Toscana, Organismo Toscano per il Governo Clinico, 2018. https://www.regione.toscana.it/documents/10180/16111184/Allegato+-+Decisione+20_2018.pdf/4edd57e6-44e0-4092-9f5e-d093691f6c36
[19] Matter of Robins v New York City Off. of Chief Med. Examiner, 2023 NY Slip Op 00286. New York Supreme Court, Appellate Division, First Department, 2023. https://www.nycourts.gov/reporter/3dseries/2023/2023_00286.htm
[20] In the Matter of the Accusation Against German Zermeno, M.D., Case No. 800-2022-088393: Decision and Stipulated Settlement. Medical Board of California, 2024. https://www2.mbc.ca.gov/BreezePDL/document.aspx?path=%5CDIDOCS%5C20240621%5CDMRAAAJD2%5C&did=AAAJD240621215614354.DID
[21] Ozone Healing Clinic, Penrith: Time-bound Prohibition Order. NSW Health Care Complaints Commission, 2025. https://www.hccc.nsw.gov.au/decisions-orders/prohibition-orders/ozone-healing-clinic-penrith-nsw
[22] A case of vertebrobasilar stroke during oxygen-ozone therapy. Journal of Stroke and Cerebrovascular Diseases (PubMed), 2004. https://pubmed.ncbi.nlm.nih.gov/17903984/
[23] Acute bilateral vitreo-retinal hemorrhages following oxygen-ozone therapy for lumbar disk herniation. American Journal of Ophthalmology (PubMed), 2004. https://pubmed.ncbi.nlm.nih.gov/15234314/
[24] Fulminating septicemia secondary to oxygen-ozone therapy for lumbar disc herniation: case report. Spine (PubMed), 2007. https://pubmed.ncbi.nlm.nih.gov/17268255/
[25] Transient cortical blindness after intradiscal oxygen-ozone therapy. Indian Journal of Ophthalmology (PubMed), 2016. https://pubmed.ncbi.nlm.nih.gov/28112142/
[26] Multifocal Stroke From Ozone Gas Emboli. Journal of Neuro-Ophthalmology (PubMed), 2019. https://pubmed.ncbi.nlm.nih.gov/30741783/
[27] Suspected Pulmonary Embolism after Oxygen-Ozone Therapy for Low Back Pain. Journal of Neurological Surgery Part A (PubMed), 2019. https://pubmed.ncbi.nlm.nih.gov/31430795/
[28] A Case of Paradoxical Embolism Causing Anterior Spinal Cord Syndrome and Acute Myocardial Infarction Following the Intradiscal Oxygen-Ozone Therapy. Frontiers in Neurology (PubMed), 2019. https://pubmed.ncbi.nlm.nih.gov/30853936/
[29] Cardiopulmonary Arrest and Pneumoencephaly Developing after Epidural Oxygen-ozone Mixture Therapy. Anesthesia, Essays and Researches (PubMed), 2018. https://pubmed.ncbi.nlm.nih.gov/29628600/
[30] Cerebral gas embolism and multifocal ischemic stroke during oxygen-ozone therapy: a case report. BMJ Neurology Open (PubMed), 2024. https://pubmed.ncbi.nlm.nih.gov/39720509/
[31] Ozone-induced encephalopathy: A novel iatrogenic entity. European Journal of Neurology (PubMed), 2021. https://pubmed.ncbi.nlm.nih.gov/33657263/
[32] Mycobacterium tuberculosis Infection of the Spine Secondary to Oxygen-Ozone Therapy for Prolapse Intervertebral Disc: A Scoping Review. Journal of Orthopaedic Case Reports (PubMed), 2021. https://pubmed.ncbi.nlm.nih.gov/35437492/
[33] Mycobacterium abscessus mimicking tubercular spondylodiscitis following ozone therapy: A case report and review of literature. Surgical Neurology International (PubMed), 2020. https://pubmed.ncbi.nlm.nih.gov/32363058/
[34] Spondylodiscitis Following Oxygen-Ozone Therapy: A Case Report of Lactobacillus iners Infection and a Systematic Literature Review. Diseases (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/41892016/
[35] Cervical Spondylodiscitis After Oxygen-Ozone Therapy for Treatment of a Cervical Disc Herniation: a Case Report and Review of the Literature. HSS Journal (PubMed), 2016. https://pubmed.ncbi.nlm.nih.gov/27703423/
[36] Simultaneous pneumocephalus and meningitis as a complication of ozone therapy. Northern Clinics of Istanbul (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42516792/
[37] Intraforaminal ozone therapy and particular side effects: preliminary results and early warning. Acta Neurochirurgica (PubMed), 2016. https://pubmed.ncbi.nlm.nih.gov/26293228/
[38] A metaanalysis of the effectiveness and safety of ozone treatments for herniated lumbar discs. Journal of Vascular and Interventional Radiology (PubMed), 2010. https://pubmed.ncbi.nlm.nih.gov/20188591/
[39] How Safe Are Oxygen-Ozone Therapy Procedures for Spine Disc Herniation? The SIOOT Protocols for Treating Spine Disorders. Journal of Imaging (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/41440568/
[40] Ozone-Induced Encephalopathy Following Subcutaneous Ozone Injection: A Case Report. Cureus (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/41492606/
[41] Pitfalls of Intralesional Ozone Injection in Diabetic Foot Ulcers: A Case Study. Journal of the American College of Clinical Wound Specialists (PubMed), 2012. https://pubmed.ncbi.nlm.nih.gov/26199878/
[42] Septic Arthritis of the Shoulder Following Ozone Therapy: A Case Report. Cureus (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/41728388/
[43] Ozone therapy-associated pneumoperitoneum in a patient with low back pain: A case report. International Journal of Surgery Case Reports (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/40233642/
[44] Posterior Reversible Encephalopathy Syndrome After Intramuscular Oxygen-Ozone Therapy. Canadian Journal of Neurological Sciences (PubMed), 2020. https://pubmed.ncbi.nlm.nih.gov/32077386/
[45] Novel complication of ozone therapy: Massive emphysema and pneumomediastinum. American Journal of Emergency Medicine (PubMed), 2021. https://pubmed.ncbi.nlm.nih.gov/32245704/
[46] Do You Need a Device That Claims to Clean a CPAP Machine?. U.S. Food and Drug Administration, 2024. https://www.fda.gov/consumers/consumer-updates/do-you-need-device-claims-clean-cpap-machine
[47] Extracorporeal blood oxygenation and ozonation (EBOO): a controlled trial in patients with peripheral artery disease. International Journal of Artificial Organs (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16288443/
[48] Extracorporeal blood oxygenation and ozonation: clinical and biological implications of ozone therapy. Redox Report (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16156950/
[49] Ozone dialysis delivers three or more times the ozone than other forms of ozone blood treatment. Medical Gas Research (PubMed), 2023. https://pubmed.ncbi.nlm.nih.gov/36204785/
[50] Europe PMC search: "extracorporeal blood oxygenation and ozonation" OR EBOO. Europe PMC (EMBL-EBI), 2026. https://europepmc.org/search?query=%22extracorporeal%20blood%20oxygenation%20and%20ozonation%22%20OR%20EBOO
[51] MAUDE simple search. U.S. Food and Drug Administration, 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/TextSearch.cfm
[52] openFDA device adverse event reports whose narrative mentions "ozone therapy". U.S. Food and Drug Administration (openFDA), 2026. https://api.fda.gov/device/event.json?search=mdr_text.text:%22ozone+therapy%22&limit=10
[53] Reporting Serious Problems to FDA. U.S. Food and Drug Administration, 2025. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda
[54] MedWatch Online Voluntary Reporting Form. U.S. Food and Drug Administration, 2026. https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
[55] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[56] Haemolysis Generated with the Use of Glass Bottles Instead of PVC, DEHP-Free Blood Collection Bags in the Oxygen-Ozone Therapy. Maedica (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/40880716/
[57] Safety, pitfalls, and misunderstandings about the use of ozone therapy as a regenerative medicine tool. A narrative review. Journal of Biological Regulators and Homeostatic Agents (PubMed), 2020. https://pubmed.ncbi.nlm.nih.gov/33176412/

---

# The History of EBO2 (EBOO): A Dated Timeline From Siena to US Clinics

Source: https://ebo2.com/guides/history-of-ebo2/
Updated: 2026-10-08

Key takeaways:
- EBO2 (EBOO) was built by a nephrology and physiology group in Siena, Italy, starting in 1990. Its first human report appeared in 2000 and its only randomized trial in 2005.
- The FDA rule calling ozone a toxic gas with no known useful medical application dates from 1976, more than two decades before the first EBOO paper. Ozone therapy is not FDA-approved for any condition.
- While the Siena papers appeared, Italy's Superior Health Council said in 2003 that no controlled studies supported oxygen-ozone therapy and that it could cause serious and potentially lethal side effects.
- The earliest dated sign of EBOO equipment in the US in our sources is an FDA finding that a Michigan firm distributed EBOO devices from January 2022. When US clinics began offering the procedure is not documented.
- As of September 28, 2026, of the 34 primary-source records in our regulatory database, 23 are dated 2020 or later, and none approves or clears EBOO or its equipment.

EBO2 (also called EBOO) was invented in a hospital. A group in Siena, Italy,
began ozonating blood in an extracorporeal circuit in 1990 [1],
described its method in 1999 [2], published its first report in
patients in 2000 [3], and ran the only randomized trial in 2005
[1]. How the procedure moved from there into US wellness clinics
is much less documented. The first dated sign of EBOO equipment in the US in
our sources is an FDA finding about devices distributed from January 2022
[4]. Ozone therapy is not FDA-approved for any condition, and the FDA
rule describing ozone as a toxic gas with no known useful medical application
dates from 1976 [5].

This page is a dated timeline in which every entry cites its source, followed
by what the record shows about the procedure's arrival in US clinics and what
it does not. Regulatory entries come from our database of 34
primary-source records as of September 28, 2026; the four newest are shown under "From our data".

Before EBOO

The background comes mostly from secondary sources, and they do not agree. A
2025 review by authors at a government naturopathy institute in India dates the
first recorded observation of ozone to 1785, its naming by Christian Friedrich
Schönbein to 1840, and medical use of ozonized oils to 1859 [6]. On
major autohemotherapy, the batch method EBOO was designed to scale up
[7], the sources differ by seven years: a 2022 paper co-authored by the physician who
pioneered 10-pass ozone says it was first described in 1954 by Wehrli and Steinbart [8], and
the 2025 review credits Hans Wolff with introducing it by 1961
[6]. The Siena group's own summary in 2000 was that ozone
autohemotherapy had been used "for four decades with encouraging results but,
owing to the lack of clinical studies, it has never been adopted by orthodox
medicine" [3].

| Date | What happened | Source |
|---|---|---|
| Feb 13, 1976 | The FDA's device labeling rule calls ozone "a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy", caps ozone in occupied spaces at 0.05 parts per million, and treats an ozone-generating device used in a medical condition without "proof of safety and effectiveness" as adulterated or misbranded | [5] |
| Aug 23, 1977 | FDA rules that registering a device establishment, or filing a 510(k) notification, does not denote approval, and that claiming otherwise is misbranding | [9][10] |

Siena builds EBOO, 1990 to 2011

| Date | What happened | Source |
|---|---|---|
| 1990 | The Siena group begins "using extracorporeal circulation to ozonate blood", aiming to amplify the results of ozone autohemotherapy | [1] |
| 1999 | First methods paper: dialysis membranes found "unsuitable because they are hydrophilic and vulnerable to O3"; hydrophobic, ozone-resistant hollow fibers adopted; tests in saline, pig blood and sheep; heparin "not an ideal anticoagulant" and sodium citrate used; the exchanger clogged with cells | [2] |
| 2000 | First report in patients: one author volunteers and reports two lipomas gone after six treatments; a patient with Madelung disease and several with atherosclerotic vascular disease follow; reported "without side-effects" | [3] |
| 2001 | Several oxygenator-ozonators compared; dialysis membranes again rejected; more biocompatible oxygenators can treat up to 5 liters in about an hour, "making the treatment of critical patients feasible" | [11] |
| 2002 | A case of necrotizing fasciitis in a dialysis patient; the authors write that EBOO "is no longer in the experimental stage and is used routinely in our hospital" | [12] |
| 2005 | Randomized trial in 28 patients with peripheral artery disease, EBOO against intravenous prostacyclin; no side effects recorded in 210 EBOO treatments | [1] |
| 2005 | Review: more than 1,200 treatments in 82 patients; up to 4,800 mL of blood an hour at 0.5 to 1 µg/mL of ozone; a standard cycle of 14 one-hour sessions over 7 weeks | [7] |
| 2007 | A purpose-built gas exchanger, L001, tested in saline | [13] |
| 2010 | A Siena team tests four dialysis filters as ozone gas exchangers, finds yields of 0 to 70 percent and fibers altered by ozone, warns they "may release toxic compounds harmful for the patients", and says "some clinicians incautiously use them" | [14] |
| 2011 | Bocci's group describes EBOO as "a procedure to be used in emergency conditions such as PAD stage 4", expensive, and to be run by "technicians specialized in extravascular blood circulation" | [15] |

Italian authorities while EBOO was being built

Siena is in Tuscany, and the national and regional health bodies took a
cautious line on oxygen-ozone therapy in the same years. The quotations from
Italian documents below are our translations.

| Date | What happened | Source |
|---|---|---|
| Jan to Jun 2001 | A cluster of hepatitis C infections among patients treated with ozone autohemotherapy or intramuscular ozone at a Rome hospital outpatient department; of 31 patients tested, 6 were infected. Reported in 2005 | [16] |
| Dec 31, 2002 | The Health Ministry relays the Superior Health Council's view that oxygen-ozone therapy should be tested only for disc herniation by intradiscal injection, only in public or accredited private hospitals, "expressly excluding private outpatient clinics, beauty or fitness centres or the like" | [17] |
| Nov 19, 2003 | The Council says no controlled clinical studies support the efficacy of oxygen-ozone therapy and that it "can cause serious and potentially lethal side effects", and that it should be given only in ethics-approved hospital trials | [17] |
| Jan 20, 2005 | The Ministry says its 2002 note is not legally binding, but warns that departing from the Council's view could expose a doctor to criminal or civil liability after an incident | [17] |
| Sep 5, 2006 | Tuscany's regional health council finds no top-grade evidence for intradiscal ozone and says "there is no indication for other conditions" | [18] |
| Mar 6, 2007 | Tuscany: in private outpatient facilities, oxygen-ozone therapy is possible "only in controlled clinical trials" | [19] |
| Nov 3, 2015 | Tuscany classes ozone therapy as an invasive procedure needing authorized premises and calls ozonated autohemotherapy "of doubtful clinical efficacy" | [20] |
| Dec 11, 2018 | Tuscany's clinical governance body, summarizing Italian ozone-therapy guidelines: the gas mixture "must not be used by direct intravenous administration because of the danger of pulmonary gas embolism" | [21] |
| Mar 26, 2020 | Italy's national public health institute says it did not authorize trials of ozone therapy for COVID-19 | [22] |

The field's own consensus document, the Madrid Declaration, first appeared on
June 4, 2010; its 2015 second edition lists EBOO among 24 recommended routes of
administration and direct intravenous injection of ozone among routes "not
recommended for not being safe" [23]. It is written by ozone
therapists, not by a regulator.

The United States, 2020 to 2026

The US record before 2020 says little about EBOO itself. Then the COVID-19
pandemic brought a wave of actions against ozone therapy claims, and EBOO
equipment appears in the record from 2022.

| Date | What happened | Source |
|---|---|---|
| Apr 10, 2020 | The FTC warns RowenSu Clinic of Santa Rosa, California, over website claims that ozone therapy treats COVID-19 | [24] |
| Apr 23, 2020 | The FTC announces 21 more COVID-19 warning letters, including several to marketers of ozone therapy, saying "there is currently no scientific evidence" these services treat the disease | [25] |
| Apr 24, 2020 | The FTC warns a San Diego seller whose marketing said "You can do ozone therapy yourself" with its machine and a tent | [26] |
| Apr 24, 2020 | A federal court enters an agreed permanent injunction barring a Dallas ozone center from claiming ozone treats COVID-19; the Justice Department notes the complaint's claims are allegations | [27] |
| May 6 and Jun 30, 2020 | Joint FDA and FTC warning letters to two California clinics list ozone claims among those not supported by competent and reliable scientific evidence | [28][29] |
| Jul 2020 | New York City's medical examiner rules the death of a patient injected intravenously with ozone gas a homicide due to extreme medical negligence; an appeals court upholds the challenge's dismissal in 2023 | [30] |
| Nov 12, 2020 | The FTC's ninth set of COVID-19 letters again includes ozone therapy, bringing the total to more than 330 recipients | [31] |
| 2022 | The Austrian physician who pioneered 10-pass ozone co-authors a six-patient laboratory study of the method | [8] |
| Jan 1, 2022, to Aug 21, 2023 | A Michigan firm, O3UV, distributes devices including "EBOO Full Spectrum UV" without design controls, according to the FDA's later findings | [4] |
| Aug 23 to 31, 2023 | The FDA inspects O3UV in Grand Ledge, Michigan | [4] |
| 2023 | Practitioners at a Santa Rosa, California clinic publish ozone measurements from 12 patients receiving "ozone dialysis", the dialysis-filter version of EBOO | [32] |
| Jun 21, 2024 | The Medical Board of California places a physician on five years' probation, barred from intravenous ozone, after a patient lost consciousness during IV ozone treatment in 2020 and was diagnosed with air embolism and stroke | [33] |
| Aug 26, 2024 | FDA consumer update: no device is cleared to clean CPAP machines, and ozone cleaners have drawn reports of asthma attacks, headaches and breathlessness | [34] |
| Jun 30, 2025 | Federal prosecutors charge a Richmond pain physician with offenses including using FDA-unapproved ozone generators and billing ozone treatments as nerve blocks; the charges are allegations | [35] |
| Jul 7, 2025 | FDA warning letter to O3UV: its blood-ozonation devices for UV blood irradiation or EBOO are adulterated and misbranded for lack of premarket approval or clearance | [4] |
| 2025 | A New York case report follows an 88-year-old woman through two series of EBOO | [36] |
| May 4, 2026 | FDA consumer update explains that registration and listing are not approval, and that dialysis equipment is marketed through 510(k) clearance | [37] |

Elsewhere, 2022 to 2026

| Date | What happened | Source |
|---|---|---|
| Mar 2, 2022 | The UK advertising regulator rules a clinic's IV ozone claims unsubstantiated and misleading | [38] |
| Nov 2, 2022 | Health Canada warns that no ozone sauna is licensed and that selling unlicensed medical devices is illegal | [39] |
| Aug 4, 2023 | Brazil's federal law authorizes ozone therapy as a complementary procedure, given by a registered health professional with a regulator-approved generator | [40] |
| Aug 1, 2024 | A New South Wales commission bars an ozone clinic in Castle Hill from providing health services while it investigates | [41] |
| Apr 8, 2025 | The same commission bars a Penrith ozone clinic for five years, finding unapproved equipment including a "Champion Full Spectrum UV" device, heparin obtained "from an unknown source" by a practitioner "not authorised to be in possession of, or to administer" it, and no infection control | [42] |
| Aug 21, 2025 | Brazil's Federal Council of Medicine authorizes ozone therapy as an add-on for four kinds of wound (topical only), knee osteoarthritis and disc-related back pain | [43] |
| Jun 16, 2026 | Brazil's health regulator lists the uses it recognizes for ozone-emitting devices and says they may be sold only for approved indications | [44] |

How EBOO reached US clinics: what the record shows

What is documented. By the FDA's account, a Michigan firm sold EBOO
equipment to "healthcare practitioners (e.g., physicians, nurses, etc.)
throughout the United States" between January 2022 and August 2023, and its
EBOO kits included purchased hemodialyzer filters [4]. A California clinic group reported at least
400 sessions of what it calls ozone dialysis in a 2023 paper; its authors write
that the method has run "for decades, at least 22 years in Malaysia alone",
citing a source we have not read [32]. Clinic pages give their own
start dates: one clinic says its physician has provided EBOO since 2022 [45],
one Kansas practice began offering it in July 2023 [46], one Bay Area
practice says it has offered EBOO for more than five years [47], and one
clinic says it has performed more than 2,000 EBOO treatments in the past three
years [48]. As of October 4, 2026, our directory (/clinics/) lists
177 US clinics.

What changed on the way. Three shifts show in the sources. The setting
moved from a hospital department, where the developers called EBOO routine by
2002 [12], to outpatient clinics [32]. The equipment moved
from a purpose-built gas exchanger to the dialysis filters its inventors had
warned against [2][14][4]. And the patients moved
from people with severe vascular disease, for whom Bocci's group reserved the
procedure as an emergency measure [15], to a wellness market: as of
October 4, 2026, 163 of the 174 clinic EBO2 pages we
could read state a health benefit, from detoxification to longevity. The what EBO2 is (/what-is-ebo2/) guide sets the two
procedures side by side, EBO2 vs dialysis (/guides/eboo-vs-dialysis/) compares
the dialysis-filter version with hemodialysis, and
EBO2 devices and FDA status (/guides/eboo-devices-and-fda-status/) covers the
equipment.

What is not documented. We found no source that says who first offered
EBOO in the United States or when, who adapted it to dialysis filters, or who
first called it EBO2. None of the Siena abstracts uses the name EBO2.

What regulators have and have not done

No regulator in our records has evaluated EBOO as a treatment. None of the
34 records in our database as of September 28, 2026, approves or clears it or its equipment,
and the FDA's 2025 letter found that two devices sold for EBOO and UV blood
irradiation had no approval in effect [4]. US action has followed two tracks: claims, as in
the FTC's COVID-19 letters of 2020 [25][31], and devices, as in
the 2025 warning letter [4]. State boards and courts have acted on harm
from intravenous ozone gas, a different procedure [33][30];
case reports from that and other routes are compiled in
ozone therapy adverse events (/guides/ozone-therapy-adverse-events/).
Abroad, Italy's health bodies confined ozone therapy to trials in their
opinions [17][19], Brazil authorized a short list of uses
that leaves out blood circuits [43], and Australian regulators have acted
against individual clinics [42]. Our
regulatory tracker (/reports/regulatory-tracker/) holds every record with its
exact language, and Is EBO2 FDA approved? (/guides/is-ebo2-fda-approved/)
explains the US rules.

What we could not verify

Biographies. Earlier versions of this page gave birth and career dates for
  Velio Bocci from ozone-therapy association websites. We could not check them
  against an institutional source, so we have left them out.
The origin of major autohemotherapy. Our two sources give 1954 and 1961, and
  we have not read the papers either one cites.
Earlier extracorporeal work. PubMed indexes a 1960 German paper titled "The
  development of extracorporeal therapy of blood with oxygen, UV rays and
  ozone" [49] and two 1995 Russian papers, on extracorporeal
  ozone-oxygen treatment of blood in dogs [50] and on ozone therapy
  with hemoperfusion [51]. We could read only their titles, so we
  cannot say how they relate to EBOO.
The California paper's statement about 22 years of ozone dialysis in Malaysia
  and more than 200,000 treatments, which cites a source we have not read
  [32].
The first use of EBOO, and of the name EBO2, in the United States.
A device maker's claim, linked from one clinic page, to have pioneered EBOO
  technology "since 2000". We could not read the maker's site under our rules
  for automated access.

How this guide was made

This guide draws on 52 sources: papers read through PubMed,
PubMed Central and Europe PMC; regulatory documents, court decisions and press
releases read on the issuing bodies' sites; and clinic pages saved by our
research pass. Dates are as each document states them. The clinic count comes
from our dataset, read between September 28, 2026 and October 4, 2026. Translations from Italian are
ours. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: Who invented EBOO?
A: A group at the University of Siena and the Siena hospital's nephrology and dialysis department, led in its clinical papers by the nephrologist Nicola Di Paolo, with the physiologist Velio Bocci as co-author of most of them. They began ozonating blood in an extracorporeal circuit in 1990, published their methods in 1999 and the first report in patients in 2000.

Q: When did EBO2 come to the United States?
A: No source we found dates it. The earliest dated marker in our sources is an FDA finding that a Michigan firm distributed EBOO devices to practitioners across the country between January 2022 and August 2023. A California clinic group reported at least 400 sessions in a 2023 paper, and clinic pages give their own start dates, from 2022 to more than five years ago.

Q: Where does the name EBO2 come from?
A: We could not find who first used it or when. The Siena papers use EBOO throughout. Today clinics use EBO2 in several ways: as another name for EBOO, as EBOO 2.0, or for EBOO with an added light device.

Q: Has EBOO ever been banned?
A: Not as such in any record we hold. In the US the FDA has found EBOO devices adulterated and misbranded for lack of approval. Italy's Health Ministry in 2002 relayed advice to confine oxygen-ozone therapy to hospital trials, later calling that advice not legally binding. Brazil's 2025 medical council rules list no blood-circuit use among the authorized ones, and Australian regulators have barred individual ozone clinics.

Sources:
[1] Extracorporeal blood oxygenation and ozonation (EBOO): a controlled trial in patients with peripheral artery disease. International Journal of Artificial Organs (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16288443/
[2] Ozonation of blood during extracorporeal circulation. I. Rationale, methodology and preliminary studies. International Journal of Artificial Organs (PubMed), 1999. https://pubmed.ncbi.nlm.nih.gov/10532435/
[3] Extracorporeal blood oxygenation and ozonation (EBOO) in man. Preliminary report. International Journal of Artificial Organs (PubMed), 2000. https://pubmed.ncbi.nlm.nih.gov/10741810/
[4] Warning Letter: O3UV, LLC (CBER 25-668840), July 7, 2025. US Food and Drug Administration (CBER), 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/o3uv-llc-668840-07072025
[5] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[6] Historical Highlights of Ozone Therapy. Journal of Pharmacy & Bioallied Sciences (PubMed Central), 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC12564041/
[7] Extracorporeal blood oxygenation and ozonation: clinical and biological implications of ozone therapy. Redox Report (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16156950/
[8] Ozone high dose therapy (OHT) improves mitochondrial bioenergetics in peripheral blood mononuclear cells. Translational Medicine Communications (PubMed Central), 2022. https://pmc.ncbi.nlm.nih.gov/articles/PMC9301618/
[9] 21 CFR 807.39 Misbranding by reference to establishment registration or to registration number. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807/subpart-B/section-807.39
[10] 21 CFR 807.97 Misbranding by reference to premarket notification. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807/subpart-E/section-807.97
[11] Ozonation of blood during extracorporeal circulation. II. Comparative analysis of several oxygenator-ozonators and selection of one type. International Journal of Artificial Organs (PubMed), 2001. https://pubmed.ncbi.nlm.nih.gov/11831595/
[12] Necrotizing fasciitis successfully treated with extracorporeal blood oxygenation and ozonization (EBOO). International Journal of Artificial Organs (PubMed), 2002. https://pubmed.ncbi.nlm.nih.gov/12518965/
[13] Oxygenation-ozonation of blood during extracorporeal circulation: in vitro efficiency of a new gas exchange device. Artificial Organs (PubMed), 2007. https://pubmed.ncbi.nlm.nih.gov/17725702/
[14] Are dialysis devices usable as ozone gas exchangers?. Artificial Organs (PubMed), 2010. https://pubmed.ncbi.nlm.nih.gov/19817737/
[15] Oxygen/ozone as a medical gas mixture. A critical evaluation of the various methods clarifies positive and negative aspects. Medical Gas Research (PubMed Central), 2011. https://pmc.ncbi.nlm.nih.gov/articles/PMC3231820/
[16] A cluster of hepatitis C virus infections associated with ozone-enriched transfusion of autologous blood in Rome, Italy. Infection Control and Hospital Epidemiology (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16209382/
[17] Ossigeno-ozono terapia (circular DGFDM.III/P/1752/I.4.C.C., 20 January 2005), annexed to Tuscany opinion 10/2007. Italian Ministry of Health, Directorate General of Medicines and Medical Devices, 2005. https://www.regione.toscana.it/documents/10180/12096595/Allegato+3+Parere+n.+10-2007+%28Autore+Bailo+09-03-2007%29.pdf/f1bb981c-98e3-4ca9-8c8a-e111f32713fa?version=1.0&t=1416999155247&download=true
[18] Parere 31/2006: Ossigeno ozonoterapia. Regione Toscana, Consiglio Sanitario Regionale, 2006. https://www.regione.toscana.it/documents/10180/12161851/Parere+n.+31-2006.pdf/92a34289-3623-4f30-89af-3c73b9f70e7a?version=1.1&t=1576228147561&download=true
[19] Parere 10/2007: Utilizzo ossigeno-ozono terapia in strutture ambulatoriali private. Regione Toscana, Consiglio Sanitario Regionale, 2007. https://www.regione.toscana.it/documents/10180/12096595/Parere+n.+10-2007+%28Autore+Bailo+09-03-2007%29.pdf/9d6b1360-af79-482e-b9a2-13619e31a1df?version=1.1&t=1576228313360&download=true
[20] Parere 67/2015: Prestazioni di idrocolonterapia, terapia chelante e ozonoterapia. Regione Toscana, Consiglio Sanitario Regionale, 2015. https://www.regione.toscana.it/documents/10180/13326460/Parere+67_15+Ozono+idrocolon+e+chelante.pdf/a1f11111-daac-4ae4-a7a9-437884a0d813?version=1.0&t=1460457106345&download=true
[21] Allegato alla Decisione CTS n. 20 del 11/12/2018. Regione Toscana, Organismo Toscano per il Governo Clinico, 2018. https://www.regione.toscana.it/documents/10180/16111184/Allegato+-+Decisione+20_2018.pdf/4edd57e6-44e0-4092-9f5e-d093691f6c36
[22] CS N° 25/2020 - Ozonoterapia, non rientra nei compiti dell'ISS autorizzare sperimentazioni. Istituto Superiore di Sanità (Italy), 2020. https://www.iss.it/en/coronavirus/-/asset_publisher/1SRKHcCJJQ7E/content/id/5313647
[23] Madrid Declaration on Ozone Therapy, 2nd edition (index of routes). ISCO3 (International Scientific Committee of Ozone Therapy), 2015. https://isco3.org/madrid-declaration-2nd-edition/
[24] Warning Letter to RowenSu Clinic: Unsubstantiated Claims for Coronavirus Treatment. Federal Trade Commission, Southwest Region, 2020. https://www.ftc.gov/system/files/warning-letters/covid-19-letter_to_rowensu.pdf
[25] FTC Sends 21 Letters Warning Marketers to Stop Making Unsupported Claims That Their Products and Therapies Can Effectively Treat Coronavirus. Federal Trade Commission, 2020. https://www.ftc.gov/news-events/news/press-releases/2020/04/ftc-sends-21-letters-warning-marketers-stop-making-unsupported-claims-their-products-therapies-can
[26] Warning Letter to Forever Ozone: Unsubstantiated Claims for Coronavirus Prevention or Treatment. Federal Trade Commission, Southwest Region, 2020. https://www.ftc.gov/system/files/warning-letters/covid-19-letter_to_swro_forever_ozone.pdf
[27] Court Prohibits Dallas Health Center from Touting "Ozone Therapy" as a COVID-19 Treatment. US Department of Justice, 2020. https://www.justice.gov/archives/opa/pr/court-prohibits-dallas-health-center-touting-ozone-therapy-covid-19-treatment
[28] Warning Letter to Center for New Medicine/Perfectly Healthy by Connealy MD (MARCS-CMS 605804). US Food and Drug Administration and Federal Trade Commission, 2020. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/center-new-medicineperfectly-healthy-connealy-md-605804-05112020
[29] Warning Letter to Center for Wellness and Integrative Medicine (MARCS-CMS 608693). US Food and Drug Administration and Federal Trade Commission, 2020. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/center-wellness-and-integrative-medicine-608693-06302020
[30] Matter of Robins v New York City Off. of Chief Med. Examiner, 2023 NY Slip Op 00286. New York Supreme Court, Appellate Division, First Department, 2023. https://www.nycourts.gov/reporter/3dseries/2023/2023_00286.htm
[31] FTC Sends Letters Warning 20 More Marketers to Stop Making Unsupported Claims That Their Products and Therapies Can Effectively Prevent or Treat COVID-19. Federal Trade Commission, 2020. https://www.ftc.gov/news-events/news/press-releases/2020/11/ftc-sends-letters-warning-20-more-marketers-stop-making-unsupported-claims-their-products-therapies
[32] Ozone dialysis delivers three or more times the ozone than other forms of ozone blood treatment. Medical Gas Research (PubMed Central), 2023. https://pmc.ncbi.nlm.nih.gov/articles/PMC9555023/
[33] In the Matter of the Accusation Against German Zermeno, M.D., Case No. 800-2022-088393: Decision and Stipulated Settlement. Medical Board of California, 2024. https://www2.mbc.ca.gov/BreezePDL/document.aspx?path=%5CDIDOCS%5C20240621%5CDMRAAAJD2%5C&did=AAAJD240621215614354.DID
[34] Do You Need a Device That Claims to Clean a CPAP Machine?. US Food and Drug Administration, 2024. https://www.fda.gov/consumers/consumer-updates/do-you-need-device-claims-clean-cpap-machine
[35] U.S. Attorney Erik S. Siebert announces charges as part of DOJ's national health care fraud enforcement action. US Attorney's Office, Eastern District of Virginia, 2025. https://www.justice.gov/usao-edva/pr/us-attorney-erik-s-siebert-announces-charges-part-dojs-national-health-care-fraud
[36] Observed Reduction in Urinary Toxin Excretion With Extracorporeal Blood Oxygenation and Ozonation (EBOO) Treatment in an 88-Year-Old With Chronic Anemia: A Case Report. Cureus (PubMed Central), 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC12826612/
[37] Is It Really 'FDA Approved'?. US Food and Drug Administration, 2026. https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved
[38] ASA Ruling on The Detox Clinic Ltd. Advertising Standards Authority (UK), 2022. https://www.asa.org.uk/rulings/the-detox-clinic-ltd-a21-1119332-the-detox-clinic-ltd.html
[39] Unlicensed ozone saunas may pose serious health risks to users and anyone in close proximity. Health Canada, 2022. https://recalls-rappels.canada.ca/en/alert-recall/unlicensed-ozone-saunas-may-pose-serious-health-risks-users-and-anyone-close-proximity
[40] Lei nº 14.648, de 4 de agosto de 2023: Autoriza a ozonioterapia no território nacional. Presidency of the Republic of Brazil, 2023. https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2023/lei/L14648.htm
[41] The Ozone Clinic, Castle Hill: Interim Prohibition Order. NSW Health Care Complaints Commission, 2024. https://www.hccc.nsw.gov.au/decisions-orders/prohibition-orders/the-ozone-clinic-castle-hill
[42] Ozone Healing Clinic, Penrith: Time-bound Prohibition Order. NSW Health Care Complaints Commission, 2025. https://www.hccc.nsw.gov.au/decisions-orders/prohibition-orders/ozone-healing-clinic-penrith-nsw
[43] Resolução CFM n° 2.445, de 21 de agosto de 2025. Conselho Federal de Medicina (Brazil), 2025. https://sistemas.cfm.org.br/normas/arquivos/resolucoes/BR/2025/2445_2025.pdf
[44] Nota Técnica nº 41/2026/SEI/GQUIP/GGTPS/DIRE3/ANVISA. Agência Nacional de Vigilância Sanitária (Anvisa), Brazil, 2026. https://www.gov.br/anvisa/pt-br/setorregulado/regularizacao/produtos-para-saude/notas-tecnicas/nota-tecnica-no-43-2022-sei-gquip-ggtps-dire3-anvisa/@@display-file/file
[45] Full-spectrum EBOO Therapy in Lake Oswego, Oregon. Evergreen Factor, 2026. https://evergreenfactor.com/eboo-therapy
[46] EBOO Therapy. in2GREAT (Overland Park, KS), 2026. https://in2greatkc.com/integrative-therapies-kansascity/eboo-therapy/
[47] EBOO Therapy (EBO2 service page). Biohackr Health, 2026. https://www.biohackr.health/services/ebo2/
[48] Extracorporeal Oxygenation & Ozoniation. Advanced IV Health, 2026. https://advancedivhealth.com/services/eboo-ozone/extracorporeal-oxygenation-ozoniation-150327901
[49] [The development of extracorporeal therapy of blood with oxygen, UV rays and ozone] (PubMed record, title only). Medizinische Klinik (PubMed), 1960. https://pubmed.ncbi.nlm.nih.gov/13834150/
[50] [The effect of extracorporeal treatment of blood with an ozone-oxygen mixture on lung function of dogs under normal conditions and in disease] (PubMed record, title only). Biulleten' Eksperimental'noi Biologii i Meditsiny (PubMed), 1995. https://pubmed.ncbi.nlm.nih.gov/7795192/
[51] [Ozone therapy and hemoperfusion in the treatment of diabetes mellitus in patients with pulmonary tuberculosis] (PubMed record, title only). Problemy Tuberkuleza (PubMed), 1995. https://pubmed.ncbi.nlm.nih.gov/7761384/

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# What Does the EBO2 (EBOO) Filter Actually Remove?

Source: https://ebo2.com/guides/what-the-filter-removes/
Updated: 2026-10-04

Key takeaways:
- No published study we found has measured what an EBO2 circuit removes from a patient's blood. The papers measured ozone uptake, oxidation markers, gas transfer, and one patient's urine.
- Dialysis moves material out of blood by diffusion into dialysis solution and by ultrafiltration. EBOO circuits carry gas, not dialysis solution, and no paper has analyzed the fluid that drains from them into a canister.
- The developers rejected dialysis membranes for ozone, saw their own exchanger clog with cells, and later wrote that dialysis filters exposed to ozone may release toxic compounds.
- Clinic statements that the filter removes heavy metals or microplastics rest on theory borrowed from dialysis or on one clinic's test of water, not blood.
- A lab report on filtrate means something only if it names the sample, the control, the units, and the volume collected. This guide lists the checks.

No published study we found has measured what an EBO2 (also called EBOO) circuit removes from a patient's blood. The papers we hold measured other things: how much ozone blood takes up [11], oxidation markers in blood after a session [10], how well a device moves gas into saline [8], how much ozone passes through dialysis filters [9], and toxins in one patient's urine [12]. Claims that the filter removes heavy metals, microplastics, cholesterol, or pathogens therefore rest either on theory borrowed from kidney dialysis or on what clinics say. This guide separates the three, using federal dialysis regulations, the EBOO papers' own descriptions of the circuit, and the clinics' words, and ends with the checks a lab report on filtrate would have to pass. Ozone therapy is not FDA-approved for any condition, and federal regulation describes ozone as "a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [18].

How a dialysis membrane moves material out of blood

Clinics compare EBOO with dialysis [14][16], so the dialysis rules are the place to start. In a hemodialysis system, blood flows through one compartment of the dialyzer and "undesirable substances in the blood pass through the semipermeable membrane into the dialysate" in the other [2]. The regulation for high permeability systems names two ways this happens: "convection (via a high ultrafiltration rate)" and "diffusion (via a concentration gradient in dialysate)," with the machine controlling "the rate at which fluid is removed from the patient" [1]. In the words of the National Institute of Diabetes and Digestive and Kidney Diseases, blood passes through "very thin, hollow fibers" while dialysis solution flows the other way outside them, and "waste products from your blood move into the dialysis solution" [4].

What can cross depends on the membrane. A high permeability dialyzer is defined by an ultrafiltration coefficient "greater than 8 milliliters per hour per conventional millimeter of mercury" [1]. A 2026 nephrology review describes newer medium cut-off membranes with "mean pore sizes substantially larger" than standard high-flux membranes, which clear larger molecules at a cost: there is "ongoing debate about the appropriate balance between large solute clearance and albumin loss" [5]. Since 2024, FDA's rule for dialyzers with an "expanded solute removal profile" defines the "middle" molecular weight range as 0.5 kDa to 60 kDa and requires each such device to be tested for "clearance rates," "sieving coefficients," and other measures [3].

Two points follow from the rules themselves. Removal in dialysis is measured, solute by solute, under stated conditions [3]. And removal needs a destination: the dialysate, or the fluid pulled across by ultrafiltration [1][2].

What sits in an EBO2 circuit

Two kinds of cartridge appear in the sources. The Siena group that developed EBOO tried dialysis membranes first and found them "unsuitable because they are hydrophilic and vulnerable to O3" [6]. By 2001 it had concluded that semipermeable membranes, except for one, "were gas-transfer inefficient, allowed ultrafiltration and were more or less vulnerable to O3" [7]. Its 2007 device used microporous, ozone-resistant polypropylene fibers with a membrane area of 0.22 m², blood on the outside and an oxygen-ozone gas mixture flowing inside [8]. When the group later tested four dialysis filters with ozone, it found fibers "somewhat altered by ozone" and warned that the filters "may release toxic compounds harmful for the patients" [9].

Several US sources describe dialyzers instead. A 2023 US paper circulated blood through "a Renak CTA (cellulose triacetate) 1500 dialysis chamber," with ozone gas running inside the fibers and blood around them [11]. An FDA warning letter records "ABLE® H-200 High Flux Polyethersulfone Disposable Haemodialysers" sold in one maker's EBOO kits [13]. One clinic that offers the procedure says EBOO "uses the same dialyzer filters, but in a very different arrangement" and "does not use dialysate fluid" [14]. Our EBOO vs dialysis guide (/guides/eboo-vs-dialysis/) sets the two procedures side by side.

With no dialysis solution in the circuit, the sources point to three places material from the blood can go. Fluid can cross the membrane: the developers counted ultrafiltration against dialysis membranes [7], and the 2023 paper describes a 2 L canister "used to collect dialysis chamber drainage" [11], which clinics call a "collection container" or "catch canister" [14] and a "collection cup" [15]. Gases can cross it: in tests of a sepsis prototype, one pass raised oxygen and lowered carbon dioxide in blood [19]. And blood components can stay on it: the developers' exchanger clogged progressively with cells [6]. None of these sources reports the volume of the drainage or its laboratory contents.

Measured, theorized, and said by clinics

Every figure here is in the units its source uses. "Measured" means a paper reports a measurement; it does not mean the measurement shows removal.

| Statement | Status | What the source reports |
|---|---|---|
| Blood takes up ozone in the circuit | Measured, 12 patients, one clinic | Average uptake of 37% of the generator's output, range 25 to 50%; about 460,000 μg in one hour at 30 μg/mL, by the authors' calculation [11] |
| The equipment itself consumes ozone | Measured, no blood | An average loss of 23% through a dry dialyzer and tubing [11] |
| Ozone changes the blood | Reported in the developers' review | Thiobarbituric acid reactants up four- to fivefold and plasma protein thiols down after a session, "without any appreciable erythrocyte haemolysis" [10] |
| Dialysis filters can serve as gas exchangers | Measured, bench | Gas-exchange yield "from 0 up to 70%"; fibers "somewhat altered by ozone" [9] |
| Toxins leave the body after EBOO | Measured in urine, one patient | Average declines of 64.8% for mycotoxins, 25.7% for heavy metals, and 55.1% for environmental toxins in urine ratios (µg/g creatinine); nickel rose overall [12] |
| Ozonated blood carries fewer live bacteria | Measured, different prototype, pigs and blood samples | One pass cut live E. coli by 27% [19] and live P. aeruginosa by 53% [20]; in pigs, bacteria in the bloodstream did not differ from untreated animals [19][20] |
| Middle molecules cross the membrane and collect in the canister | Theory | One clinic lists beta 2 microglobulin, "urea/uric acid, cytokines, adipokines and vitamin B12, and homocysteine," and says this "is elucidated from dialysis therapy and cannot be directly applied to EBOO therapy" [14] |
| Heavy metals cross the membrane | Theory | The same clinic: metals "freely circulating in your bloodstream could also theoretically pass through the tubules" [14] |
| The filtrate holds heavy metals, microplastics, and parasites | Clinic statement | Another clinic: "there are claims" to this effect, and "current research is still investigating the exact composition" [15] |
| The circuit removes microplastics | Clinic test of water | Distilled water run through a circuit with a Renak CTA-1500 dialyzer: microplastics at 0.006 Count/mL (1 to 5 µm) and 0.002 Count/mL (10 to 50 µm) in the control sample, none detected after the circuit [16] |

The urine row needs a caution of its own. The 2025 case measured what the patient excreted at three points over 131 days, not what the circuit took out, with no control for exposure in between [12]. The bacteria row comes from a different device, a prototype that cools blood and mixes it with oxygen-ozone gas, run for 30 minutes in one study and within a 4-hour experiment in the other, in pigs with sepsis [19][20]. And the water test sampled one liter of distilled water from plastic containers before and after the circuit [16]. It does not show what happens to particles in blood, or to particles in the body.

As of October 4, 2026, 151 of the 174 clinics whose EBO2 page we could read claim a detoxification benefit. The "From our data" section below breaks those claims down and shows how many clinics name the device they use.

What the canister holds, and why its look proves little

Clinics and patients often point to what collects during a session. One clinic captions a photo of its canister "Clear fluid collection and foam" [14]. Another says "the contents and appearance of the filtered materials can vary significantly between patients and even between different sessions for the same patient" [15]. A patient testimonial on a third clinic's page describes "less than 100 mL of inflammatory product dialyzed out" at one session and "almost 500 mL" at another [16].

None of these is an analysis. A volume of fluid says nothing about what is dissolved in it, and the sources give other explanations for what a cartridge can hold. The developers reported that their exchanger "became less effective (low pO2 values) due to progressive clogging with cells" in sheep [6], and that uncoated polypropylene fibers led to "platelet aggregation and blood coagulation," problems that "become prohibitive in the presence of ozone" [7]. That does not tell anyone what a given clinic's residue is. It shows that color, foam, or volume cannot settle the question without a laboratory.

What a filtrate lab report would have to show

A clinic that says it has tested its filtrate can be asked for the report. These checks come from how dialysis removal is tested [3] and from the gaps in the sources above.

The sample. Patient blood, canister fluid, or water? The one published clinic test used distilled water [16].
The laboratory and the method. Who ran the test, with what method, and whether the lab is accredited for it.
The amount, in units. A concentration, such as micrograms per liter, and the volume collected in milliliters, so the total removed can be worked out.
A control. The same circuit run with saline or without ozone, and the patient's blood before the session. Without one, a substance in the canister could have come from the tubing, the cartridge, or the water.
Blood levels before and after. Removal from blood should show in blood, measured at the same points in time.
Scale. The amount removed set against the amount in the blood and in the body, so the result can be judged.
Repeat runs and other patients. One sample is an anecdote, and dialyzer testing is done under stated conditions of use [3].
The membrane itself. Whether the cartridge was tested for what it releases under ozone, the concern the developers raised about dialysis filters [9].

Procedures that publish what they remove

Some extracorporeal procedures are built to remove one thing and report it. An American Heart Association statement calls lipoprotein apheresis "a valuable but underused adjunctive therapeutic option for low-density lipoprotein cholesterol and lipoprotein(a) lowering," with effects measured in blood lipids [17]. In therapeutic plasma exchange, a patient fact sheet published by the American Society for Apheresis describes a machine that "separates and removes the patient's plasma, replacing it with another fluid," most commonly "5% human albumin" [21]; our plasmapheresis comparison (/guides/ebo2-vs-plasmapheresis/) covers it. Both procedures are defined by what they take out of the blood. No EBOO source we found says what EBOO takes out. Our clinic directory (/clinics/) records what each clinic states about its own service, including the device where it names one.

What we could not verify

What any EBOO canister or cartridge contains. We found no published laboratory analysis, and the one clinic test we found used water [16].
How much fluid an EBOO circuit loses across the membrane in a session. The 2023 paper mentions the canister but no volume [11], and the only figures we found are in a patient testimonial [16].
Whether drainage is discarded or returned to the patient in each clinic's setup.
The laboratory, method, and replicate results behind the clinic's water test, which its page calls "a rough draft" [16].
The full texts of the Siena development papers, which we could read only as abstracts [6][7][9].
Whether the dialyzers used for EBOO in the US have been tested for what they release under ozone, the concern raised in 2010 [9].

How this guide was made

This guide rests on 21 sources: four federal regulations and an FDA warning letter, an NIH page, a patient fact sheet published by the American Society for Apheresis, 11 papers listed on PubMed, and three clinic pages, which are cited only for what those clinics state. The claim figure comes from our dataset of clinic pages, as of October 4, 2026. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources. No clinical reviewer has signed off on this guide yet.

FAQ:
Q: Does EBO2 remove heavy metals?
A: No study we found has measured metals in an EBO2 circuit or its drainage. One 2025 case report measured one patient's urine: heavy-metal ratios fell 25.7% on average across two series of treatments, but nickel rose overall. One clinic says freely circulating metals could theoretically cross the membrane and that no validated US research shows what the canister holds.

Q: What is in the canister or collection cup after a session?
A: No published study we found has analyzed it. One clinic captions a photo of its canister as clear fluid and foam, another says the contents vary between patients and between sessions, and a testimonial on a third clinic's page describes less than 100 mL at one session and almost 500 mL at another.

Q: Does EBO2 remove microplastics?
A: No study of blood that we found has tested it. One clinic published a test in which distilled water, not blood, was run through its circuit: microplastics were detected in the control water and not in the water after the circuit. A single water sample cannot show what happens to blood or to particles inside the body.

Q: Is the EBO2 filter the same as a dialysis filter?
A: Sometimes. The Italian developers used a purpose-built polypropylene gas exchanger, while a 2023 US paper used a cellulose triacetate dialysis chamber and an FDA warning letter records hemodialyzers sold in EBOO kits. Either way, EBOO puts gas, not dialysis solution, on the other side of the membrane.

Q: Does EBO2 remove cholesterol?
A: No EBOO study we found has measured cholesterol removal. Lipoprotein apheresis, a different procedure built to lower LDL cholesterol and lipoprotein(a), is described by the American Heart Association as a valuable but underused option for lowering LDL cholesterol and lipoprotein(a).

Sources:
[1] 21 CFR 876.5860 High permeability hemodialysis system. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-876/subpart-F/section-876.5860
[2] 21 CFR 876.5820 Hemodialysis system and accessories. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-876/subpart-F/section-876.5820
[3] 21 CFR 876.5862 Hemodialyzer with expanded solute removal profile. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-876/subpart-F/section-876.5862
[4] Hemodialysis. National Institute of Diabetes and Digestive and Kidney Diseases (NIH), 2018. https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/hemodialysis
[5] Dialysis membranes and hemodialyzers. Contributions to Nephrology (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42721103/
[6] Ozonation of blood during extracorporeal circulation. I. Rationale, methodology and preliminary studies. International Journal of Artificial Organs (PubMed), 1999. https://pubmed.ncbi.nlm.nih.gov/10532435/
[7] Ozonation of blood during extracorporeal circulation. II. Comparative analysis of several oxygenator-ozonators and selection of one type. International Journal of Artificial Organs (PubMed), 2001. https://pubmed.ncbi.nlm.nih.gov/11831595/
[8] Oxygenation-ozonation of blood during extracorporeal circulation: in vitro efficiency of a new gas exchange device. Artificial Organs (PubMed), 2007. https://pubmed.ncbi.nlm.nih.gov/17725702/
[9] Are dialysis devices usable as ozone gas exchangers?. Artificial Organs (PubMed), 2010. https://pubmed.ncbi.nlm.nih.gov/19817737/
[10] Extracorporeal blood oxygenation and ozonation: clinical and biological implications of ozone therapy. Redox Report (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16156950/
[11] Ozone dialysis delivers three or more times the ozone than other forms of ozone blood treatment. Medical Gas Research (PubMed), 2023. https://pubmed.ncbi.nlm.nih.gov/36204785/
[12] Observed Reduction in Urinary Toxin Excretion With Extracorporeal Blood Oxygenation and Ozonation (EBOO) Treatment in an 88-Year-Old With Chronic Anemia: A Case Report. Cureus (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/41583215/
[13] Warning Letter: O3UV, LLC - 668840 - 07/07/2025. US Food and Drug Administration (CBER), 2025. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/o3uv-llc-668840-07072025
[14] EBOO/EBO2 Ozone Therapy. San Diego Center for Restorative Medicine, 2026. https://www.restorativemedicinecenter.com/eboo-ozone-therapy
[15] EBOO Ozone Therapy. The James Clinic, 2026. https://jamesclinic.com/eboo-ozone-therapy/
[16] EBOO Ozone Dialysis. USA Medical Research Institute, 2026. https://usamedresearchinstitute.com/eboo-ozone-dialysis/
[17] Lipoprotein apheresis: utility, outcomes, and implementation in clinical practice: a scientific statement from the American Heart Association. Arteriosclerosis, Thrombosis, and Vascular Biology (PubMed), 2024. https://pubmed.ncbi.nlm.nih.gov/39370995/
[18] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[19] Evaluation of an extracorporeal ozone-based bactericide system for the treatment of Escherichia coli sepsis. Intensive Care Medicine Experimental (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/35467176/
[20] Immunomodulation by extracorporeal ozone-based bactericide system in porcine Pseudomonas aeruginosa septic shock. Scientific Reports (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/40562794/
[21] Procedure: Therapeutic Plasma Exchange (also referred to as therapeutic plasmapheresis). American Society for Apheresis, 2021. https://cdn.ymaws.com/www.apheresis.org/resource/resmgr/fact_sheets_file/therapeutic_plasma_exchange.pdf

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# What Else EBO2 (EBOO) Clinics Sell: HBOT, Chelation, IV Drips, Stem Cells

Source: https://ebo2.com/guides/clinic-bundles/
Updated: 2026-10-04

Key takeaways:
- As of October 4, 2026, 109 of the 177 US clinics in our directory list at least one service beside EBO2, and 52 list three or more. IV nutrient therapy is the most common, on 81 listings.
- Hyperbaric oxygen chambers are FDA-cleared Class II devices, and Medicare's national coverage determination lists 15 conditions it will pay for and states that all other indications are not covered.
- Medicare's determination on EDTA chelation for atherosclerosis calls it experimental and not covered, and the FDA says it has never approved any chelation product for over-the-counter use for any health condition.
- The only FDA-approved stem cell products are blood-forming stem cells from umbilical cord blood, there are no approved exosome products, and none is approved for orthopedic, neurological, cardiovascular, or fatigue indications.
- A bundle multiplies cost and, for anyone under an anti-doping code, multiplies the eligibility questions, because an intravenous infusion over 100 mL in 12 hours is itself a prohibited method outside hospital, surgical, and diagnostic settings.

Most places that sell EBO2 (also called EBOO) sell at least one other service too, and a second service can come up in the same conversation as the first. This guide counts what those other services actually are across every clinic in our directory, then sets out, for each of the common ones, what the service is, what the FDA has approved or cleared it for, what Medicare will and will not pay for, and the questions worth asking when it arrives bundled with an EBO2 session.

What the directory shows

Our directory records the services each clinic lists on its own website. As of October 4, 2026, across 177 listed US clinics:

| Service listed alongside EBO2 | Clinics | Share of 177 |
|---|---|---|
| IV nutrient therapy | 81 | 46% |
| Peptide therapy | 48 | 27% |
| Hyperbaric oxygen | 44 | 25% |
| NAD+ therapy | 42 | 24% |
| PRP | 24 | 14% |
| Chelation | 18 | 10% |
| Major autohemotherapy (MAH) | 17 | 10% |
| Other services | 15 | 8% |
| 10-pass ozone | 11 | 6% |

Two further counts describe the shape of this. Sixty-eight of the 177 listings record EBO2 with no other service, so a single-service clinic is common. At the other end, 52 listings record three or more other services, 14 record five or more, and 103 of the 177 list at least one of hyperbaric oxygen, chelation, IV nutrient therapy, PRP, peptides, or NAD+. Twenty-one list another ozone method, usually major autohemotherapy (/glossary/#mah) or 10-pass (/glossary/#ten-pass), which we compare in our guide to EBO2 against 10-pass ozone (/guides/ebo2-vs-10-pass-ozone/).

A service is recorded when the clinic's own site lists it, so these are floors rather than ceilings: a clinic may offer more than its website shows. The numbers are counts of listings, not of revenue, visits, or how hard any service is sold.

Hyperbaric oxygen therapy

What it is: breathing oxygen at a concentration far above air inside a chamber pressurized above normal atmospheric pressure.

Its status: hyperbaric chambers are regulated as devices rather than drugs. The FDA states that "HBOT devices are Class II medical devices and are cleared by the FDA through the 510(k) process", and that cleared devices can be identified by searching product code CBF in the agency's 510(k) database [2]. Clearance is a finding of substantial equivalence to a device already on the market, and the FDA's own regulation says that representing it as official approval "is misleading and constitutes misbranding" [9]; the agency's consumer page gives dialysis equipment as its example of this Class II route [10].

What it is paid for: Medicare's national coverage determination on hyperbaric oxygen lists the conditions it will reimburse, including acute carbon monoxide intoxication, decompression illness, gas embolism, gas gangrene, acute traumatic peripheral ischemia, crush injuries, progressive necrotizing infections, acute peripheral arterial insufficiency, preparation of compromised skin grafts, chronic refractory osteomyelitis, osteoradionecrosis, soft tissue radionecrosis, cyanide poisoning, actinomycosis, and diabetic lower-extremity wounds in patients meeting three stated criteria [1]. It then states: "All other indications not specified under §270.4(A) are not covered under the Medicare program" [1]. The same document lists conditions it will not pay for at all, among them cutaneous, decubitus, and stasis ulcers, chronic peripheral vascular insufficiency, senility, myocardial infarction, and cerebral vascular insufficiency [1].

One safety note from the FDA belongs here because it concerns the setting rather than the biology: the agency wrote to health care providers in 2025 that it "is aware of recent reports of fires that occurred with HBOT devices that resulted in serious injuries and deaths", that the root cause was not then known, and that providers should follow manufacturer instructions on grounding, clothing, training, and monitoring [2].

Ask: which of those listed conditions am I being treated for? If none, what is the chamber being used for, how many sessions, at what total cost, and what evidence is being offered? Who is trained to run it, and what are the fire-safety rules in this facility?

Chelation

What it is: giving a chemical, usually EDTA, that binds metals so they can be excreted. Its established use is metal poisoning.

Its status: the FDA states that "All FDA-approved chelation therapy products require a prescription because they can only be used safely under the supervision of a healthcare practitioner", and, asked whether any over-the-counter chelation product is approved, answers: "No. FDA has never approved any chelation product for OTC use for any health condition" [4]. The agency says it is concerned about serious side effects "such as dehydration, kidney failure, and death", and about people delaying necessary care while relying on unapproved products, which are commonly marketed to patients with serious conditions and for detoxification [4]. It also notes that companies selling these products often sell home metal-screening tests, which it says it has not cleared [4].

What it is paid for: Medicare's determination is blunt. It states that EDTA chelation therapy for atherosclerosis "is controversial", that "its clinical effectiveness has never been established by well designed, controlled clinical trials", that it "is considered experimental", and that "EDTA chelation therapy for the treatment or prevention of atherosclerosis is not covered" [3]. The same determination tells claims processors to deny claims that relabel the same therapy under other names [3].

Ask: is this a prescription product given under supervision, and for which diagnosis? What test established the metal burden being treated, who ran it, and is that test FDA-cleared? What is the monitoring plan for kidney function and electrolytes? If this is being sold for heart disease or for a general toxin burden, what evidence supports that use?

IV nutrient therapy and drips

What it is: vitamins, minerals, amino acids, or other substances infused into a vein, often sold under names such as Myers cocktail, immunity drip, or hangover drip, and increasingly bundled with EBO2 as a before-or-after add-on.

Its status: the ingredients vary, and so does the regulation. Where a clinic uses a compounded preparation rather than an FDA-approved product, the agency's position is explicit: "Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed", and compounded drugs "should only be used in patients whose medical needs cannot be met by an FDA-approved drug" [6]. Quality standards differ by setting: products made in registered outsourcing facilities are subject to current good manufacturing practice requirements, while those compounded by a pharmacist in a state-licensed pharmacy or by a physician under section 503A are not [6].

On the claims, the FTC brought what it called its first action against a marketer of intravenous cocktail therapy in 2018, charging that the company advertised its drips as treatments for serious diseases including cancer, congestive heart failure, multiple sclerosis, diabetes, and neurodegenerative disorders, and as more effective and better tolerated than conventional therapy. The settling order bars those claims unless supported by competent and reliable scientific evidence, and the Commission's chairman said at the time: "Health claims must be supported by competent and reliable scientific evidence" [5]. The release notes the drips cost $100 or more per session [5].

For anyone who competes under an anti-doping code, a bundled drip raises a separate question that has nothing to do with what is in it. USADA's note on infusions says that IV infusions or injections "are prohibited both in- and out-of-competition if the amount is over 100 mL within a 12-hour period", even when the substance itself is permitted, with exceptions for hospital and emergency treatment, surgery, and diagnostic procedures [12]. Our guide for athletes (/guides/ebo2-for-athletes/) sets out that rule and the blood-manipulation rules as anti-doping agencies word them.

Ask: exactly what is in the bag, at what dose, and is each component an FDA-approved product for this use or a compounded preparation? If compounded, by whom, in a 503A pharmacy or a 503B outsourcing facility? What is the total volume and over what period? What is this expected to do that an oral equivalent would not?

Stem cell, exosome, PRP, peptide, and NAD+ services

These are grouped here because clinics group them, usually under a heading such as regenerative or anti-aging. Their regulatory positions are not the same, and the differences are the useful part.

For stem cells and exosomes the FDA's consumer alert is unusually direct. It states that "generally, all stem cell products require FDA approval", that "Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood", approved for disorders of blood production and not for other uses, and that "There are currently no FDA-approved exosome products" [7]. The alert then lists what has not been approved, including treatment of "any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain", any neurological disorder, any cardiovascular or lung disease, and "autism, macular degeneration, blindness, chronic pain, or fatigue" [7]. It covers products described as coming from adipose tissue, umbilical cord blood, Wharton's jelly, or amniotic fluid [7].

Enforcement has followed the claims. In 2018 the FTC settled with a physician and two companies over advertising that amniotic stem cell therapy could treat Parkinson's disease, autism, macular degeneration, cerebral palsy, multiple sclerosis, and heart attacks; the order bars such claims without competent and reliable scientific evidence, imposes a partially suspended judgment of $3.31 million, and required the defendants to notify current and former patients within 30 days [8].

Peptides and NAD+ are usually drug products rather than devices or biologics, and the question that decides their status is whether the specific product is FDA-approved for the use proposed or is a compounded preparation, which brings the compounding position above into play [6]. We did not find an FDA consumer statement addressing platelet-rich plasma specifically, so we make no claim about its status here; it is listed in the table above because clinics list it.

Ask: which product is this exactly, what is it approved for, and in whom? If the answer is that it is not approved for this use, what is the basis for offering it? Is there a clinical trial I could join instead, and would having this affect my eligibility for one?

Why a bundle is harder to judge than a single treatment

The costs stack. Each service is a separate charge, often sold as a package before the first session. The price block below shows what clinics publish for EBO2 alone; a bundle sits on top of that, and our session cost planner (/tools/session-cost/) and price check tool (/tools/price-check/) take a quoted figure apart.
Attribution disappears. If three things are given in the same week, no one can say which produced an improvement, and, more importantly, which produced a side effect.
Contraindications multiply. Each service has its own cautions, and the combination has not been studied. Our contraindications guide (/guides/contraindications/) and our record of ozone adverse events by route (/guides/ozone-therapy-adverse-events/) cover the EBO2 side of that.
The sales logic runs one way. Bundles are built to raise the value of a visit. That does not make them wrong, but it does mean the reason a second service was proposed may not be clinical, and asking which problem it addresses is a fair question.
A cleared or registered device in the bundle does not validate the bundle. Ozone therapy is not FDA-approved for any medical use, and the federal rule states that ozone "is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [11]; separately, a 510(k) clearance for a machine is not approval of a treatment [9][10].

A checklist for a bundle conversation

Ask for an itemized price list, in writing, with each service priced separately and the package price shown next to the sum of its parts.
Ask which condition or finding each component addresses, and what measurement would show it had worked. The claims block below shows which conditions clinics most often attach to EBO2 itself, a useful comparison when a bundle is proposed for the same conditions.
Ask what is FDA-approved or cleared, for what, and request the product name so you can check it yourself.
Ask what happens if you stop after the first session: is the package refundable, transferable, or lost?
Ask who is physically present during each service, what their licence is, and what the emergency plan is.
Ask whether any component affects your eligibility for a clinical trial, or, if you compete, your anti-doping status.
Compare what the clinic tells you before you book against what clinics generally publish, in the transparency block below and in our clinic directory (/clinics/).

What we could not verify

Whether a clinic offers a service it does not list, or no longer offers one it does. Our counts come from listings recorded from clinic websites and checked between September 16, 2026 and September 28, 2026, and the directory (/clinics/) shows the date for each.
What any clinic charges for a bundle. Our price data covers published single-session EBO2 prices and packages; we did not record prices for the other services.
The regulatory status of platelet-rich plasma in the United States. We did not find an FDA consumer statement addressing it, and we make no claim about it here.
Whether the services listed are given in the same visit, in the same course, or separately. The listing records what is offered, not how it is sequenced.
Whether bundled services interact with EBO2. We found no study of any such combination, which means no evidence of harm and no evidence of safety.
How clinics describe these services, in their own words, beyond what we recorded for the EBO2 service itself. Our research pass read EBO2 pages, not every service page on every site.

How this guide was made

This guide draws on 12 primary sources: two Medicare national coverage determinations, five FDA publications and regulations, two FTC enforcement announcements, two further federal regulations, and one national anti-doping agency's note on the infusion rule in the WADA Prohibited List. The service counts were computed from our own directory of 177 listed US clinics with the site's own `servicesMix` function, on listings checked between September 16, 2026 and September 28, 2026, and every count is given against that denominator; the blocks below are computed from the same dataset when the page is built. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources. No clinical reviewer has signed off on this page yet.

FAQ:
Q: What else do EBO2 clinics usually offer?
A: Counting from the 177 US clinic listings in our directory on October 4, 2026: IV nutrient therapy appears on 81, peptide therapy on 48, hyperbaric oxygen on 44, NAD+ therapy on 42, PRP on 24, chelation on 18, major autohemotherapy on 17, and 10-pass ozone on 11. Sixty-eight listings record EBO2 with no other service, and 52 record three or more.

Q: Is hyperbaric oxygen therapy approved?
A: Hyperbaric chambers are regulated as Class II medical devices and reach the market through FDA 510(k) clearance, which is not the same as approval. For coverage, Medicare's national determination lists 15 conditions, among them carbon monoxide poisoning, decompression illness, gas gangrene, osteoradionecrosis, and certain diabetic lower-extremity wounds after standard care has failed, and then states that all other indications are not covered.

Q: Is chelation therapy covered or approved for heart disease or detoxification?
A: No. Medicare's national coverage determination says EDTA chelation therapy for atherosclerosis has never had its clinical effectiveness established by well designed controlled trials, calls it experimental, and does not cover it. The FDA says all approved chelation products require a prescription and that it has never approved any chelation product for over-the-counter use for any condition, and it lists dehydration, kidney failure, and death among the serious side effects.

Q: Why does it matter that services are bundled?
A: Three reasons. Cost: each added service is a separate charge, often in a package bought before the first session. Attribution: if several treatments are given in the same visit or week, no one can say which produced a change or a side effect. Interaction: a clinic that treats bundling as routine may not be assessing whether the combination suits you, and some services carry their own contraindications.

Q: What should I ask when a clinic proposes a bundle?
A: Ask for the itemized price of every component and whether it can be bought separately; ask which specific condition each component is intended for and whether it is FDA-approved or cleared for that use; ask what happens if you stop after one session; and ask who is present and monitoring during each. The questions at the end of this guide go service by service.

Sources:
[1] NCD 20.29 Hyperbaric Oxygen Therapy. Centers for Medicare & Medicaid Services (CMS), 2017. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=12
[2] Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices: Letter to Health Care Providers. FDA, Center for Devices and Radiological Health, 2025. https://www.fda.gov/medical-devices/letters-health-care-providers/follow-instructions-safe-use-hyperbaric-oxygen-therapy-devices-letter-health-care-providers
[3] NCD 20.21 Chelation Therapy for Treatment of Atherosclerosis. Centers for Medicare & Medicaid Services (CMS), 2026. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=86&ncdver=1
[4] Questions and Answers on Unapproved Chelation Products. FDA, Center for Drug Evaluation and Research, 2026. https://www.fda.gov/drugs/medication-health-fraud/questions-and-answers-unapproved-chelation-products
[5] FTC Brings First-ever Action Targeting iV Cocktail Therapy Marketer. Federal Trade Commission, 2018. https://www.ftc.gov/news-events/news/press-releases/2018/09/ftc-brings-first-ever-action-targeting-iv-cocktail-therapy-marketer
[6] Compounding and the FDA: Questions and Answers. FDA, Center for Drug Evaluation and Research, 2026. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
[7] Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. FDA, Center for Biologics Evaluation and Research, 2024. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes
[8] FTC Stops Deceptive Health Claims by a Stem Cell Therapy Clinic. Federal Trade Commission, 2018. https://www.ftc.gov/news-events/news/press-releases/2018/10/ftc-stops-deceptive-health-claims-stem-cell-therapy-clinic
[9] 21 CFR 807.97 Misbranding by reference to premarket notification. eCFR (FDA), 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807/subpart-E/section-807.97
[10] Is It Really 'FDA Approved'?. FDA, Office of the Commissioner, 2026. https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved
[11] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[12] IV Infusion: Explanatory Note. U.S. Anti-Doping Agency (USADA), 2026. https://www.usada.org/athlete-advisory/iv-infusions-explanatory-note/

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# What to Expect at an EBO2 (EBOO) Session: A Timeline From Clinic Pages and the Studies

Source: https://ebo2.com/guides/what-to-expect/
Updated: 2026-10-04

Key takeaways:
- A first EBO2 (EBOO) visit has four stages: an intake with screening, preparation on the day, about an hour on the circuit, and a short check before you leave. Ozone therapy is not FDA-approved for any condition.
- As of October 4, 2026, 132 of the 174 clinic EBO2 pages we could read describe what happens before a first session. In the intake statement we recorded for each, 35 mention lab work or other testing; anywhere on the saved pages, 18 describe a G6PD test.
- As of October 4, 2026, the 101 of 174 clinic pages we could read that state a session length give 25 to 120 minutes, with a median of about 75. The Siena papers that introduced EBOO and a 2023 US paper both describe one-hour treatments.
- As of October 4, 2026, of the 174 clinic pages we could read, 42 ask for hydration and 35 for a meal beforehand, which clinics tie to vein access and blood sugar. Aftercare advice is thinner: 16 say to keep drinking water afterward.
- The published papers say almost nothing about preparation or aftercare, so most of this timeline rests on what clinics write, not on studies.

EBO2 (also called EBOO) is a clinic procedure in which blood is pumped from one
arm, through a device where it meets an oxygen and ozone gas mixture, and back
into the other arm for about an hour [1][2]. A first visit has
four stages: an intake with screening, sometimes on an earlier day; preparation,
mostly hydration and a meal; the hour on the circuit; and a short check before
you leave. Ozone therapy is not FDA-approved for any condition [3].

This guide builds that timeline from two kinds of source. One is what clinic
pages say: as of October 4, 2026, we could read the EBO2 pages of
174 of the 177 clinics in our directory (/clinics/), and we
counted their statements from the saved pages. The other is the published papers, which
describe the procedure but say almost nothing about the patient's day. A few
chains repeat one page across locations, and each location counts once. The
guide ends with questions to ask at intake.

The timeline at a glance

| Stage | What the 174 clinic pages say | What the papers say |
|---|---|---|
| Intake, days or weeks before | 132 pages describe it; 35 of those statements mention lab work; five state a consultation fee | No screening protocol in the Siena abstracts; the 2023 California group took consecutive routine patients with "no exclusion criteria" [2] |
| The day before and the morning of | 42 pages ask for hydration, 35 for a meal, 12 for no alcohol | Not addressed |
| Arrival and setup | 16 pages mention vital signs; a line in each arm | Blood out of one vein and back through another [1]; a heparin drip [2] |
| The hour on the circuit | 101 pages state a length, 25 to 120 minutes, median about 75 | One hour in the Siena standard technique [4] and in the California paper [2] |
| After | 25 pages say normal activities resume the same day; 28 mention tiredness; 13 describe a check before you leave | No side effects recorded in 210 trial treatments [5]; none observed in at least 400 California sessions [2] |
| The course | See how many sessions (/guides/how-many-sessions/) | 14 one-hour sessions over 7 weeks in Siena [4]; two series of three in a 2025 case report [6] |

Before you book: the intake

Of the 174 pages we could read, 132 describe what happens
before a first session. We recorded one statement per clinic, so the counts
below are a floor. Of those 132 statements, 120 describe a
consultation, evaluation or screening, 45 mention a review of
health history, 35 mention lab work or other testing, and
nine mention medications. Five of those statements state a price
for the consultation, from $125 to $450, and a free consultation is stated in
one of the 132. Anywhere on the pages we saved, 10 clinics list a fee for a consultation,
evaluation, or first visit, from $50 to $600, as our cost guide (/guides/ebo2-cost/)
itemizes.

Labs. Anywhere on the saved pages, 31 of 174 mention G6PD, an
enzyme whose deficiency clinics treat as a reason not to proceed;
18 describe a G6PD test before treatment, and the rest list the
deficiency only as a reason to decline. In the intake statements alone, 11 name a
G6PD test. Nine pages, two of them
locations of one practice, name the same three tests: a complete blood count, a
metabolic panel and G6PD. One clinic says results from the past three months
may let it waive repeat testing [7].

Extra steps at some clinics. A few clinics ask for more before an EBO2
session. One requires a previous high-dose IV ozone treatment "to make sure you
can tolerate high dose ozone" [8]. Another lists "one well-tolerated IV
UVBI session" and "two compliant veins (one in each arm)" among its
prerequisites [9]. A third schedules a separate pre-therapy visit
"for vein assessment" [10]. At the other end, one clinic says treatment can
follow the intake on the same day [11], and four say a
clinical check comes before every session, not only the first.

Who you will see. Of the 174 pages, 100 say who
supervises or performs sessions. Of those, 57 name no profession,
saying only "medical supervision", "trained professionals" or similar; the rest
mention a physician, nurse practitioner, nurse or naturopathic doctor, and at two
locations of one practice, chiropractors. The technique's developers wrote that
EBOO "must be performed by technicians specialized in extravascular blood
circulation" [1]. Our guide to
who should not get EBO2 (/guides/contraindications/) lists the conditions
clinics screen for.

What the papers add. Little. The abstracts of the Siena papers describe no
screening protocol, and the California group's patients were consecutive
patients on routine treatment, with "no exclusion criteria" [2].

The day before and the morning of

Water. Of the 174 pages, 42 ask patients to arrive
hydrated, and the reasons they give are practical: "Well-hydrated veins make
catheter placement easier" [12], and one calls hydrating the day
before "essential for accessing the veins" [13]. One asks for 32 to 40
ounces of water in the two hours before the appointment [14].

Food. Thirty-five pages tell patients to eat beforehand, usually a light
meal one to two hours ahead. The reason given is blood sugar. One clinic warns
against arriving on an empty stomach so blood sugar stays stable through the
session [12]; another checks that blood glucose is at least 100 mg/dL
at the start "to avoid hypoglycemia" [9].

Alcohol and clothing. Twelve pages ask patients to avoid
alcohol beforehand. Several ask for loose or short sleeves, since both arms need
a line.

Medicines. The circuit is anticoagulated. The 2023 California paper dripped
in a liter of saline holding 15,000 units of heparin, of which about 300 mL
reached the patient during the hour, with more used to prime and flush the lines
before and after [2]. Anyone taking a blood thinner
or a supplement that affects bleeding has reason to raise it at intake; only
nine of the intake statements we read mention medications. Our guide to
blood thinners and other medicines (/guides/eboo-blood-thinners-and-medications/)
lists questions for the prescribing doctor and for the clinic.

No paper we read tested whether any of this preparation changes how a session
goes.

Arrival and setup

Check-in can include a short review and vital signs: anywhere on the saved
pages, 16 mention vital signs, 15 of them as taken or monitored at a session,
and one lists "an intake review, consent, vitals, and a
pre-procedure evaluation" before every session [15]. Then come two
lines, one in each arm. The published descriptions match: blood leaves through
one vein and returns through a vein in the other arm [1]. The
California group used a 20-gauge catheter in each arm and kept to that size,
although larger catheters allow faster flow, to protect patients' veins over
repeated sessions [2].

Setup is not counted in most stated session lengths. One clinic starts its hour
only after IV access is established [16]; another plans 75 to 90 minutes in all, "including
check-in, preparation, and a brief post-treatment monitoring period"
[12].

The hour on the circuit

How long. Of the 174 pages, 101 state how long a session
takes. The figures run from 25 to 120 minutes, with a
median of about 75, and 65 fall between 60 and 89 minutes
(taking the midpoint where a page gives a range). The chart under "From our
data" shows the spread. Ten pages say the whole
visit takes about two hours, including consultation and monitoring, and eight of
them are locations of one chain [17]. One clinic starts at 25 minutes
and works up to 60 "as tolerated" [18].

The papers are more uniform. Siena's standard technique was one hour, repeated
14 times over seven weeks [4], and the California treatments ran
"exactly 1 hour" [2]. In the developers' 1999 sheep experiments the
gas exchanger worked less well after 50 minutes because it clogged with cells
(Bocci 1999 (/research/bocci-1999-ozonation-gas-exchanger-sheep/))
[19]. By 2001 they reported more biocompatible oxygenators that could
treat up to 5 liters in about an hour [20].

Who watches what. One clinic says vitals, blood glucose and oxygenation are
monitored in real time throughout [15]. The Siena group monitored
blood chemistry: after a session it measured a 4- to 5-fold rise in a marker of
lipid oxidation and a fall in plasma protein thiols, and proposed those tests
for routine monitoring [4]. The California paper measured the gas
going in and out every 15 minutes, which tells you how much ozone the circuit
used, not how the patient was doing [2]. Monitoring matters when
something goes wrong: in 2025 a New South Wales commission found that an ozone
practitioner did not check a patient's vital signs when she reacted to treatment,
in a clinic where it also found he obtained heparin "from an unknown source" and
"is not authorised to be in possession of, or to administer" it, and that the
clinic had no infection control [21]. That order concerned ozone therapy with a
UV device, not a documented EBOO circuit.

What it feels like. The papers do not say. One clinic lists chills during
the session among the effects patients most commonly report [15].

After the session

Aftercare is the thinnest part of what clinic pages say. Of the 174
pages:

Twenty-five say normal activities can resume the same day or that there
  is no downtime; one says the following morning [14].
Twenty-eight mention tiredness afterward, and thirteen
  of those attribute it to "detox". We found no study that tested that
  explanation.
Sixteen say to keep drinking water afterward, and
  seven advise against strenuous exercise for the rest of the
  day.
Ten mention bruising or tenderness where the lines went in.
Thirteen describe a check or monitoring period before you leave.

One page tells patients that many "feel tired after their EBO2" and to "take rest
as you need" [22]. The papers record few problems: none in 210 treatments
in the Siena trial [5] and none in at least 400 California
sessions [2]. In a 2025 case report from New York, the patient said she
felt more tired after her second series of three treatments than after the
first, and her care turned to her anemia [6]. For symptoms that
warrant a call to the clinic or urgent care, see
side effects and safety (/guides/side-effects-and-safety/).

The course

Of the 174 pages, 69 state a recommended course or schedule.
In Siena the standard cycle was 14
sessions over seven weeks [4]. In the 2025 case report, three
treatments ran over two weeks, on February 13, 18 and 27, because the clinic's
protocol assumed that three treatments of about 2 liters would process "nearly
all of the patient's blood" [6]. A clinic that offers the procedure
calls that kind of reasoning "mostly a marketing gimmick" and says dose is
measured in micrograms per milliliter, not liters [7]. What clinics
recommend and sell is in how many sessions (/guides/how-many-sessions/), and the
session cost planner (/tools/session-cost/) totals a course.

Questions to ask at intake

Each question below comes from a gap in what clinic pages say.

Which device and filter do you use: a gas exchanger built for ozone, or a
   dialysis filter? Who makes it? See what EBO2 is (/what-is-ebo2/) for why
   this differs between clinics, and
   EBO2 devices and FDA status (/guides/eboo-devices-and-fda-status/) for how to
   look a device up.
What ozone concentration, blood flow and session length will you use? Only
   seven of the 174 pages we read state a concentration.
Which anticoagulant do you use, and how much? What do you need to know about
   my medicines and supplements?
Which labs do you need before the first session, how recent must they be,
   and is a G6PD test among them? Do they cost extra?
Who places the lines, who stays in the room for the whole session, and what
   are their licenses?
What do you monitor during the session, and what do you do if I feel faint,
   short of breath or unwell?
How long is the whole visit, not just the time on the circuit?
What does the quoted price include: consultation, labs, add-ons? See
   what else EBO2 clinics sell (/guides/clinic-bundles/).
What should I do afterward, what is normal, and whom do I call if something
   is not?

A printable list built from our contraindications guide is at
questions for your doctor (/tools/doctor-questions/).

What we could not verify

What happens in practice. Clinic pages describe what clinics say they do; we
  did not observe sessions.
Whether any preparation advice matters. No paper we read tested hydration,
  meals or fasting before EBOO.
The "detox" explanation for tiredness after a session. We found no study of
  it.
Aftercare and complication rates outside the practitioners' own series. The
  papers report few problems, but no independent monitoring or registry.
Whether stated session lengths include setup. Most pages do not say.
The full Siena protocols. We read the abstracts only, which do not describe
  screening, preparation or aftercare.
The dates in the 2025 case report: it places a check-in on April 14, 2025,
  "about a month after" the first series, and the second series on April 1, 10
  and 29 of the same year [6].

How this guide was made

This guide draws on 22 sources: papers read through PubMed
Central and Europe PMC, regulatory documents read on the issuing bodies' sites,
and clinic pages saved by our research pass. The clinic counts come from our dataset of 177
clinics, read between September 28, 2026 and October 4, 2026; we counted preparation, aftercare, monitoring and supervision statements
from the saved pages, checked every count against them, and kept the list of
pages behind each one. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: How long does an EBO2 session take?
A: As of October 4, 2026, the 101 of 174 clinic pages we could read that state a length give 25 to 120 minutes, with a median of about 75, and most fall between 60 and 90. Several say the whole visit, with consultation and monitoring, takes about two hours. The Siena papers that introduced EBOO and a 2023 US paper describe one-hour treatments.

Q: Do I need blood tests before EBO2?
A: Many clinics ask for them. As of October 4, 2026, of the 174 clinic pages we could read, 132 describe an intake, 35 of those statements mention lab work, and 18 pages name a G6PD test, which checks for an enzyme deficiency that clinics treat as a reason not to proceed. Ask which tests a clinic requires, how recent they must be, and whether they cost extra.

Q: Should I eat before an EBO2 session?
A: The clinic pages that address it say yes. As of October 4, 2026, 35 of the 174 clinic pages we could read tell patients to eat beforehand, usually a light meal one to two hours ahead, and several give stable blood sugar as the reason; one checks blood glucose before starting. No study we found has tested this advice.

Q: Can I go back to work after EBO2?
A: Most clinic pages that address recovery say normal activities can resume the same day, though some say patients may feel tired or lightheaded for a few hours, and a few advise avoiding strenuous exercise for the rest of the day. None of the clinic pages or papers we read describe sedation for EBO2. Ask the clinic what it advises after a first session.

Q: What should I ask at the intake visit?
A: Ask which device and filter the clinic uses, what ozone concentration, blood flow and session length it plans, which anticoagulant and how much, which labs it requires, who places the lines and stays in the room and what their license is, what the quoted price includes, and what it tells patients to do afterward and whom to call.

Sources:
[1] Oxygen/ozone as a medical gas mixture. A critical evaluation of the various methods clarifies positive and negative aspects. Medical Gas Research (PubMed Central), 2011. https://pmc.ncbi.nlm.nih.gov/articles/PMC3231820/
[2] Ozone dialysis delivers three or more times the ozone than other forms of ozone blood treatment. Medical Gas Research (PubMed Central), 2023. https://pmc.ncbi.nlm.nih.gov/articles/PMC9555023/
[3] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[4] Extracorporeal blood oxygenation and ozonation: clinical and biological implications of ozone therapy. Redox Report (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16156950/
[5] Extracorporeal blood oxygenation and ozonation (EBOO): a controlled trial in patients with peripheral artery disease. International Journal of Artificial Organs (PubMed), 2005. https://pubmed.ncbi.nlm.nih.gov/16288443/
[6] Observed Reduction in Urinary Toxin Excretion With Extracorporeal Blood Oxygenation and Ozonation (EBOO) Treatment in an 88-Year-Old With Chronic Anemia: A Case Report. Cureus (PubMed Central), 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC12826612/
[7] EBOO/EBO2 Ozone Therapy. San Diego Center for Restorative Medicine, 2026. https://www.restorativemedicinecenter.com/eboo-ozone-therapy
[8] EBOO (service page). Sandia IV & Wellness, 2026. https://www.sandiaivwellness.org/service-page/eboo
[9] Extracorporal Blood Oxygenation & Ozonation (EBOO) in Seattle. Mitch Marder DDS, 2026. https://mitchmarderdds.com/services/extracorporal-blood-oxygenation-ozonation-eboo/
[10] EBOO (IV Ozone) Therapy. Thryv Medical, 2026. https://www.thryvmedical.com/eboo
[11] Ozone Dialysis. Dr. Laura Enfield, 2026. https://drlauraenfield.com/ozone-dialysis/
[12] What Is EBOO Therapy? Benefits, How It Works & What to Expect. Synergistiq Wellness, 2026. https://synergistiqhealth.com/blog/what-is-eboo-therapy/
[13] Frequently Asked Questions. Dr. Laura Enfield, 2026. https://drlauraenfield.com/faq/
[14] EBOO IV Therapy in Phoenix. Enovative Wellness, 2026. https://enovativewellness.com/eboo-iv-therapy/
[15] EBOO Therapy. Forbidden Well, 2026. https://forbiddenwell.com/eboo-therapy/
[16] EBOO Therapy in The Woodlands, TX. Detoxity Holistic MediSpa, 2026. https://www.detoxityspa.com/eboo-therapy
[17] EBOO Ozone Therapy in Bellevue. Next Health, 2026. https://www.next-health.com/pages/eboo-ozone-therapy-in-bellevue
[18] Ozone Therapy: EBOO, High Dose Therapy and Insufflations. Renewed Vitality and Wellness, 2026. https://renewedvitalityandwellness.com/ozone-therapy%3A-eboo-%26-hd
[19] Ozonation of blood during extracorporeal circulation. I. Rationale, methodology and preliminary studies. International Journal of Artificial Organs (PubMed), 1999. https://pubmed.ncbi.nlm.nih.gov/10532435/
[20] Ozonation of blood during extracorporeal circulation. II. Comparative analysis of several oxygenator-ozonators and selection of one type. International Journal of Artificial Organs (PubMed), 2001. https://pubmed.ncbi.nlm.nih.gov/11831595/
[21] Ozone Healing Clinic, Penrith: Time-bound Prohibition Order. NSW Health Care Complaints Commission, 2025. https://www.hccc.nsw.gov.au/decisions-orders/prohibition-orders/ozone-healing-clinic-penrith-nsw
[22] EBO2 Ozone Therapy. Omni Life Med + Wellness, 2026. https://omnilifemed.com/ebo2

---

# Who Should Not Get EBO2 (EBOO)? Contraindications Compared Across Sources

Source: https://ebo2.com/guides/contraindications/
Updated: 2026-10-04

Key takeaways:
- No regulator publishes contraindications for EBO2 (EBOO); the lists come from ozone practitioners, an Italian consensus on spinal injections, a trial's exclusion rules, and clinics' own pages.
- In the eleven itemized clinic lists we compared, all include bleeding or clotting disorders, ten include pregnancy, eight include G6PD deficiency, and seven include an unstable heart or a recent heart attack.
- Beyond that core the lists diverge, from heparin allergy and leukemia to sulfa drugs and high-dose vitamin K, and none of them rests on a study of who is harmed by EBO2.
- The G6PD exclusion traces to a 1977 theoretical model of breathing polluted air and to practitioners' advice, not to a documented case after EBO2.
- As of October 4, 2026, 132 of the 174 clinics whose EBO2 page we could read describe what happens before a first session, and 11 of those statements name a G6PD test.

No regulator publishes a list of who should not have EBO2 (also called EBOO). Ozone therapy is not FDA-approved for any condition, and federal regulation calls ozone "a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy" [17], so there is no approved labeling with contraindications. The lists that exist come from four kinds of source: an ozone physiologist's book chapter, an Italian national consensus on one kind of spinal injection, the exclusion rules of a randomized trial, and clinics' own pages. This guide compares them condition by condition, gives each source's reasoning, and shows what clinics say about screening.

They agree on a short core: bleeding or clotting problems, pregnancy, G6PD deficiency, an unstable heart, and uncontrolled hyperthyroidism. Beyond that they diverge, and none of them rests on a study of who has been harmed by EBO2. Whether an item matters for a particular person is a question for that person's own doctor; our doctor questions tool (/tools/doctor-questions/) turns these items into questions to take along. The clinic directory (/clinics/) shows what each clinic publishes.

How the lists compare

The three non-clinic sources each cover a different procedure. Bocci's chapter addresses ozone therapy in general and especially autohemotherapy [1]. The 2008 consensus from Italy's national health institute covers intramuscular injections beside the spine for disc herniation [2]. The 2022 trial excluded certain patients from autohemotherapy [3]. The eleven clinic pages are ones we chose because each gives an itemized list for its EBO2 or EBOO service; other clinic pages mention contraindications more briefly, so the counts describe this set, not all clinics. They are cited by number in the table [4][5][6][7][8][9][10][11][12][13][14].

| Condition | Book, consensus, and trial | Clinic pages that list it (of 11) |
|---|---|---|
| Bleeding or clotting disorders | Trial excluded hematologic disorders and coagulation dysfunction [3] | 11: all |
| Pregnancy | Bocci, especially early [1]; consensus [2]; trial [3] | 10: all but Enovative; in2GREAT and Mitch Marder list the first trimester |
| G6PD deficiency or favism | Bocci, a significant deficit [1]; consensus, favism [2] | 8: in2GREAT, Charleston, BionwoRx, Roots, Mitch Marder, Avena, Michigan, Enovative |
| Unstable heart, heart failure, or recent heart attack | Bocci, serious instability [1]; consensus, decompensation [2]; trial, heart failure [3] | 7: in2GREAT, BionwoRx, Mitch Marder, Avena, Renew, Michigan, Omni |
| Hyperthyroidism, active or uncontrolled | Bocci [1]; consensus, clinically evident [2] | 5: in2GREAT, Charleston, Roots, Mitch Marder, Enovative |
| Cancer or leukemia | None | 5: BionwoRx (during active treatment), Alive and Well, in2GREAT, Roots, Mitch Marder |
| Breastfeeding | Trial [3] | 4: BionwoRx, Renew, Michigan, Omni |
| Severe or uncontrolled anemia | None | 4: BionwoRx, Avena, Renew, Omni |
| Heparin allergy or intolerance | Trial excluded allergy to anticoagulants such as sodium citrate [3] | 4: in2GREAT, Roots, Mitch Marder, BionwoRx |
| Low platelets (thrombocytopenia) | Bocci [1] | 3: in2GREAT, Roots, Mitch Marder |
| Stroke | None | 3: Charleston (recent), in2GREAT and Mitch Marder (hemorrhagic) |
| Alcohol intoxication | None | 3: in2GREAT, Roots, Mitch Marder |
| Taking anticoagulants | None | 2: Enovative; Avena (severe, without physician oversight) |
| Kidney or liver failure | Trial, renal injury and liver dysfunction [3] | 1: Omni |
| ACE inhibitors | Bocci [1] | 0 |
| Other items on one list each | Consensus: surgery that cannot wait [2] | Low blood pressure (Avena); uncontrolled high blood pressure and porphyria (Roots); sensitivity to ozone (Renew); active infection (BionwoRx); seizures and iron overload or iron infusions (in2GREAT); acute hemolytic anemia, photosensitivity, and sulfa drugs (Mitch Marder); high-dose vitamin K (Alive and Well) |

The clinics also rank items differently. in2GREAT calls only favism and G6PD deficiency absolute and weighs everything else case by case [4], while Charleston calls active hyperthyroidism, severe G6PD deficiency, pregnancy, an active bleeding disorder, and a recent stroke absolute [5]. A list on one clinic's page tells a reader what that clinic says it screens for, not what another clinic does.

Contraindications most sources share

G6PD deficiency

Glucose-6-phosphate dehydrogenase helps red blood cells handle oxidation, and ozone is an oxidant. The warning has two roots. A 1977 paper, available to us only as a one-sentence abstract, modeled ozone exposure at levels reached in some cities and predicted that people with the deficiency may experience acute hemolysis, the breakdown of red blood cells [15]. It describes breathing polluted air, not any ozone therapy. Bocci lists a significant G6PD deficit among the situations that preclude or limit ozone therapy and says patients should be checked for it [1], and a 2026 scoping review of autohemotherapy safety lists G6PD screening as mandatory among its key safety measures [16]. We found no published case of hemolysis after EBO2 in a person with the deficiency. See G6PD deficiency (/glossary/#g6pd-deficiency) and hemolysis (/glossary/#hemolysis).

Pregnancy

Bocci lists pregnancy, particularly its early phase, to exclude any mutagenic risk, which he calls unlikely [1]. The Italian consensus excludes pregnancy from paravertebral injection [2], and the 2022 trial excluded pregnant and breastfeeding women [3]. Ten of the eleven clinic pages list pregnancy; two limit it to the first trimester, and one of those cites medical and legal reasons [8]. We found no study of EBO2 in pregnancy.

Uncontrolled hyperthyroidism

Bocci groups hyperthyroidism with low platelets and serious cardiovascular instability as abnormal situations that preclude or limit ozone therapy [1], and the consensus excludes clinically evident hyperthyroidism [2]. Neither source explains the reasoning further. Five clinic pages list it, as active, uncontrolled, or Graves disease [4][5][7][8][13].

Active bleeding or severe thrombocytopenia

Every clinic page in the comparison lists bleeding or clotting problems in some form, from a history of severe clotting failure to an active bleeding disorder [4][5][6][7][8][9][10][11][12][13][14], and the 2022 trial excluded people with coagulation dysfunction [3]. EBO2 adds two needle sites and an anticoagulated circuit. The FDA-approved label of a heparin product, the anticoagulant the EBOO papers describe, lists low platelet counts and hemophilia among conditions with a higher risk of bleeding, and an uncontrollable active bleeding state as a reason not to use heparin [24]. Our blood thinners and medicines guide (/guides/eboo-blood-thinners-and-medications/) covers the circuit's anticoagulant in detail.

Recent heart attack or stroke

Bocci lists serious cardiovascular instability [1], the consensus lists cardiovascular decompensation [2], and the trial excluded heart failure [3]. Clinic pages word it as a recent heart attack, an unstable cardiovascular status, or severe cardiovascular instability; one Indiana clinic adds that such patients "cannot handle systemic fluid shifts" [6]. Three list stroke, recent or hemorrhagic [4][5][8].

Ozone allergy

Bocci notes that an allergy to ozone has been claimed and asks what it would be, suggesting that asthma patients' reactions to polluted air have caused confusion and that plastic bags can release allergenic material [1]. One clinic lists a known sensitivity to ozone [10]. A past reaction to any ozone treatment is worth describing to both the clinic and one's own doctor.

Relative precautions

These items appear on fewer lists, or as conditions clinics weigh rather than rule out.

Anemia. Four clinic pages list severe or uncontrolled anemia [6][9][10][12]. A 2025 case report describes two series of three EBOO treatments in an 88-year-old woman with chronic anemia whose hemoglobin was 7.4 g/dL at baseline, 6.8 after the first series, and 7.5 after the second; after the second series she reported feeling worse, more tired than after the first. The paper has no adverse-events section and attributes neither change to EBOO [20].
Veins. EBO2 needs a working line in each arm for the whole session. One clinic lists two compliant veins, one in each arm, as a prerequisite [8], and another says it places its own sterile lines and does not use existing PICC lines or ports [23]. The authors of an ozone dialysis paper chose smaller catheters because of concern that larger ones would damage patients' veins over repeated treatments [22].
Blood pressure. One clinic lists severe hypotension [9] and another uncontrolled high blood pressure [7]; the heparin label lists severe hypertension among conditions with higher bleeding risk [24].
Kidney disease. The trial excluded renal injury [3]. A 2017 case report describes sinus arrest from high potassium in a woman with chronic kidney disease after nine days of autohemotherapy, which its authors hypothesize was linked to the therapy [21].
Infection. One clinic excludes active, severe blood-borne infections [6].
Blood sugar. One clinic tells patients to eat a proper meal before treatment because, it says, ozone and ultraviolet blood treatment affect blood sugar; it cites no source [4].
Cancer. One clinic excludes people in active cancer treatment [6], another lists cancer without qualification [14], and three list leukemia [4][7][8]. Our cancer claims guide (/guides/eboo-cancer-claims/) covers what clinics say EBO2 does for cancer.

Medication interactions clinics ask about

Only one medicine class appears in a non-clinic source: Bocci reports sudden, marked drops in blood pressure when ozonated blood was reinfused quickly into patients taking ACE inhibitors, from an unpublished observation and two of his own patients, and lists ACE inhibitor treatment among situations that preclude or limit ozone therapy [1]. Clinic pages add others without giving reasons: anticoagulants [9][13], heparin allergy [4][7][8], iron infusions [4], sulfa drugs [8], high-dose vitamin K [14], and chemotherapy agents, which one clinic says need additional assessment alongside certain anticoagulants [25]. Heparin's label lists a known hypersensitivity to heparin or pork products as a reason not to use it, and notes that the drug is derived from pig intestinal mucosa [24]. The blood thinners and medicines guide (/guides/eboo-blood-thinners-and-medications/) covers what the label says about other drugs. A complete list of medicines and supplements is what lets a clinician check any of this.

What clinics say about intake screening

As of October 4, 2026, 132 of the 174 clinics whose EBO2 page we could read describe what happens before a first session, in the intake statement we recorded for each. Of those 132 statements, 33 mention lab tests, bloodwork, or biomarkers, 11 name a G6PD test, and 9 mention medications; two of the G6PD statements, from two locations of one business, call the test helpful rather than required. The intake statement is one quoted sentence or two per clinic, so a clinic may screen more than its statement shows. The block under "From our data" at the end of this page shows the full transparency figures.

The specific requirements vary. A Kansas clinic reviews a metabolic panel, a complete blood count, a G6PD test, fasting insulin, C-reactive protein, and D-dimer before the first treatment [4]. A South Carolina clinic requires a blood count, a metabolic panel, and a G6PD test, and calls the G6PD screen and a consultation non-negotiable [5]. A Seattle practice requires one well-tolerated session of intravenous ultraviolet blood irradiation, two compliant veins, and lab values in the normal range [8]. A New Mexico clinic requires a high-dose intravenous ozone treatment first, to check that a patient tolerates high-dose ozone [26].

Two practitioner bodies have called for common standards. The Madrid Declaration on Ozone Therapy has sections on contraindications, interactions, and graded adverse effects in its table of contents [18], and a 2025 paper from the Italian society SIOOT argues that standardized protocols are needed for safety [19].

Questions to expect at intake

Bocci writes that before ozone therapy the physician must know the patient's full medical history and current drugs [1]. Questions a careful intake would cover, drawn from the lists above:

Any bleeding or clotting problem, low platelets, or past reaction to heparin.
Pregnancy or breastfeeding.
A known G6PD deficiency or favism, or whether a G6PD test has been done.
Thyroid disease, heart disease, a recent heart attack or stroke, and blood pressure.
Kidney or liver disease, anemia, an active infection, or cancer treatment.
Every medicine and supplement, including blood thinners, ACE inhibitors, and iron.
Past reactions to any ozone treatment, and how good the veins in both arms are.

Every source above assumes that these questions are asked before a first session. It is reasonable to ask a clinic what it screens for, which labs it requires, what it does when a result raises one of these concerns, and whether it will talk with the patient's own doctor.

What we could not verify

Evidence behind any list. No source we found tested who is harmed by EBO2; the lists are precautions, practice rules, or trial design choices.
A documented G6PD case. We found no published report of hemolysis after EBO2 in a person with G6PD deficiency, and the 1977 model behind the warning is available to us only as a one-sentence abstract [15].
The Madrid Declaration's contraindications. Its text is sold by its publisher; we read only the table of contents [18].
Reasons for many clinic items, including sulfa drugs, photosensitivity, porphyria, alcohol, iron, and vitamin K, which the pages list without explanation.
What clinics actually screen. Our figures count what intake statements say, not what happens in the room.
The reasoning for hyperthyroidism and heart conditions, which the book and the consensus list without further explanation.

How this guide was made

We compared 26 sources: a book chapter, an Italian national consensus, a randomized trial, five other papers read through NCBI, an FDA-approved heparin label, a federal regulation, two practitioner documents, and fourteen clinic pages saved on September 28, 2026, labeled clinic-stated. The intake figures come from our clinic dataset as of October 4, 2026, and the transparency block below is computed from it when the site is built. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.

FAQ:
Q: Can you get EBO2 while pregnant?
A: Ten of the eleven clinic pages we compared list pregnancy as a reason not to treat, two of them only the first trimester, and an Italian consensus and a randomized trial both excluded pregnant women. The ozone physiologist Velio Bocci lists early pregnancy to exclude any mutagenic risk, which he calls unlikely. We found no study of EBO2 in pregnancy.

Q: Why is G6PD deficiency a contraindication?
A: G6PD deficiency leaves red blood cells less able to handle oxidation, and ozone is an oxidant. A 1977 model predicted that people with the deficiency may develop hemolysis from breathing ozone at levels found in some cities, and Bocci lists a significant G6PD deficit among the situations that preclude or limit ozone therapy. We found no published case of hemolysis after EBO2 in someone with the deficiency.

Q: Can I get EBO2 on blood thinners?
A: The sources do not settle it. Two clinic pages we read list anticoagulant treatment among reasons not to treat, others say blood thinners need discussion first, and no study has looked at EBO2 in people taking them. Our blood thinners and medicines guide sets out what the sources say about the circuit's heparin and what to ask the prescribing doctor.

Q: Does age matter?
A: None of the sources we compared sets an upper age limit, and the 2022 trial enrolled only adults. A heparin label we read reports more bleeding in women over 60, and heart disease, kidney disease, and anemia appear on clinic lists. A 2025 case report describes EBOO in an 88-year-old woman with chronic anemia.

Q: Who decides whether I can have EBO2?
A: The clinic decides whether it will treat someone, and clinics describe very different screening. Whether a condition or medicine matters for a particular person is a question for that person's own doctor; our doctor questions tool turns the items on this page into questions to take to an appointment.

Sources:
[1] The Potential Toxicity of Ozone: Side Effects and Contraindications of Ozonetherapy. Ozone: A New Medical Drug, 2nd ed. (Springer), via PMC, 2011. https://pmc.ncbi.nlm.nih.gov/articles/PMC7498876/
[2] Conferenza di consenso. Ossigeno-ozono terapia nel trattamento delle lombosciatalgie da ernia discale con tecnica iniettiva intramuscolare paravertebrale (Rapporti ISTISAN 08/9). Istituto Superiore di Sanità (Italy), 2008. https://www.iss.it/documents/20126/45616/08-9+web.1208510331.pdf/3ef442c5-3897-763b-9bc1-5588793b0fd0?t=1581098533176
[3] Combining Ozonated Autohemotherapy with Pharmacological Therapy for Comorbid Insomnia and Myofascial Pain Syndrome: A Prospective Randomized Controlled Study. Pain Research and Management (PubMed), 2022. https://pubmed.ncbi.nlm.nih.gov/37214227/
[4] EBOO Therapy. in2GREAT (Overland Park, KS), 2026. https://in2greatkc.com/integrative-therapies-kansascity/eboo-therapy/
[5] EBOO Therapy in North Charleston. Charleston Pain Relief Center (North Charleston, SC), 2026. https://charlestonpainreliefcenter.com/eboo-therapy/
[6] EBO2 Ozone in Carmel, IN. BionwoRx: Center for Functional and Regenerative Medicine, 2026. https://bionworx.com/services/ebo2-ozone-therapy-carmel-in/
[7] EBOO IV Therapy in Marble Falls, Texas. Roots Integrative Medicine (Marble Falls, TX), 2026. https://www.rootsintegrativemedicine.com/eboo-austin/
[8] Extracorporeal Blood Oxygenation Ozonation (EBOO). Mitch Marder DDS (Seattle, WA), 2026. https://mitchmarderdds.com/services/extracorporal-blood-oxygenation-ozonation-eboo/
[9] Extracorporeal Blood Ozone & Oxygenation at Avena Natural Health. Avena Natural Health (Solana Beach, CA), 2026. https://avenanaturalhealth.com/treatments/eboo-san-diego/
[10] EBO2: Extracorporeal Blood Oxygenation & Ozonation. Renew Specialty Group (Cornelius, NC), 2026. https://www.renewhealthwellnessnc.com/services/eboo/
[11] EBOO (Extracorporeal Blood Oxygenation and Ozonation) Therapy. Michigan Health & Wellness (Grand Rapids, MI), 2026. https://www.mihwcenter.com/services/eboo-therapy
[12] EBO2 at Omni Life Med + Wellness. Omni Life Med + Wellness (Tampa, FL), 2026. https://omnilifemed.com/ebo2
[13] EBOO IV Therapy in Phoenix. Enovative Wellness (Phoenix, AZ), 2026. https://enovativewellness.com/eboo-iv-therapy/
[14] EB02 Therapy. Alive and Well (Dallas, TX), 2026. https://aliveandwell.health/dallas-ebo2/
[15] Ozone: a possible cause of hemolytic anemia in glucose-6-phosphate dehydrogenase deficient individuals. Journal of Toxicology and Environmental Health (PubMed), 1977. https://pubmed.ncbi.nlm.nih.gov/846014/
[16] Oxygen-ozone autohaemotherapy in fibromyalgia: safety profile and adverse events. A scoping review. Clinical and Experimental Rheumatology (PubMed), 2026. https://pubmed.ncbi.nlm.nih.gov/42328943/
[17] 21 CFR 801.415 Maximum acceptable level of ozone. eCFR (FDA), 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415
[18] Madrid Declaration on Ozone Therapy (2nd edition). ISCO3 (International Scientific Committee of Ozone Therapy), 2015. https://isco3.org/madrid-declaration-2nd-edition/
[19] SIOOT recommendations for the optimal application of the oxygen-ozone therapy in clinical medicine. International Immunopharmacology (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/39657536/
[20] Observed Reduction in Urinary Toxin Excretion With Extracorporeal Blood Oxygenation and Ozonation (EBOO) Treatment in an 88-Year-Old With Chronic Anemia: A Case Report. Cureus (PubMed), 2025. https://pubmed.ncbi.nlm.nih.gov/41583215/
[21] Ozone therapy induced sinus arrest in a hypertensive patient with chronic kidney disease: A case report. Medicine, Baltimore (PubMed), 2017. https://pubmed.ncbi.nlm.nih.gov/29390373/
[22] Ozone dialysis delivers three or more times the ozone than other forms of ozone blood treatment. Medical Gas Research (PubMed), 2023. https://pubmed.ncbi.nlm.nih.gov/36204785/
[23] EBOO Therapy Across NJ, NYC and the Tri-State Area. IV Elements (Hoboken, NJ), 2026. https://ivelements.net/eboo-ozone-therapy
[24] Heparin Sodium in Sodium Chloride Injection: prescribing information (Hospira). DailyMed (NIH National Library of Medicine), 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0413f511-6b34-4c15-e48b-3fad08baacbe
[25] EBOO Therapy in Naperville. Bliss MD (Hanover Park, IL), 2026. https://www.blissmedicines.com/eboo-therapy-naperville/
[26] EBOO service description. Sandia IV & Wellness (Albuquerque, NM), 2026. https://www.sandiaivwellness.org/service-page/eboo

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# Frequently asked questions

Source: https://ebo2.com/faq/

Q: Is EBO2 the same as EBOO?
A: Usually. Both names are short for extracorporeal blood oxygenation and ozonation, but some clinics use EBO2 for a different version, one of them for EBOO plus a light device at a higher price, so it is worth asking what a clinic's version includes. The Siena papers that introduced the method use only EBOO, and as of October 4, 2026, 36 of the 174 clinic pages about the procedure that we could read use the term EBO2 at all.

Q: What does EBOO stand for?
A: Extracorporeal blood oxygenation and ozonation: blood is exposed to oxygen and ozone outside the body and then returned. It is pumped from a vein in one arm through a device where it meets an oxygen and ozone gas mixture, then back into a vein in the other arm, continuously, for about an hour. The Siena group that built the method used a purpose-built gas exchanger; as of October 4, 2026, 31 of the 174 clinic pages we could read say their circuit uses a dialysis filter, dialyzer, or dialysis membrane instead. Clinics also sell the procedure as EBO2.

Q: Where and when was EBOO developed?
A: In Siena, Italy, by a hospital nephrology and physiology group. It started circulating blood through an ozone circuit in 1990, described its method in 1999, published its first patient report in 2000, and ran the method's only randomized trial in 2005. How EBOO reached US clinics is not documented: the earliest dated sign of its equipment in the US that we found is an FDA finding that a Michigan firm distributed EBOO devices to practitioners from January 2022. In the same years Italy's Superior Health Council said, in 2003, that no controlled studies supported oxygen-ozone therapy, and Tuscany, the region around Siena, later said the therapy belongs in controlled trials apart from a doctor acting on his or her own responsibility.

Q: What is the theory behind putting ozone in blood?
A: That a small, measured dose of ozone, a strong oxidant, acts as a controlled stress that prompts the body's own antioxidant defenses to respond. A 2009 review led by Velio Bocci, a physiologist in the Siena group that developed EBOO, describes a calibrated dose as reactivating the blood's antioxidant system. Biologists call this kind of response hormesis and usually illustrate it with exercise or calorie restriction. The Siena group measured a four- to fivefold rise in a blood marker of lipid oxidation after a session, but no study we found has linked that response to a health outcome in patients, and a plausible mechanism is a reason to run a trial, not a result from one. The FDA's device rule calls ozone a toxic gas with no known useful medical application.

Q: How is EBO2 different from ozone injections?
A: An ozone injection puts the gas itself into a joint, a spinal disc, a muscle, or the skin through a needle. EBO2 does not inject gas: blood is pumped out of one arm, exposed to oxygen and ozone across a membrane outside the body, and returned through the other arm. The research record differs too. Many of the larger ozone trials in our library tested injections, and most of the serious case reports we found, such as strokes, vision loss, and spine infections, followed injections into or beside the spine. Injecting ozone gas straight into a vein is a third practice, which the field's own consensus document lists among routes not recommended because they are not safe.

Q: Does EBO2 do the same job as kidney dialysis?
A: No. Hemodialysis runs blood past a membrane with dialysis solution on the other side, which carries wastes and fluid away; in a dialysis center a session takes about four hours, usually three times a week. EBOO puts oxygen and ozone gas on the other side of the membrane instead, for about an hour, to get ozone into the blood. Some US clinics do use a dialysis filter as that membrane: as of October 4, 2026, 31 of the 174 clinic pages we could read say so, and 14 call the procedure ozone dialysis or say it goes by that name. EBOO's developers rejected dialysis membranes for ozone and in 2010 warned that dialysis filters used this way may release toxic compounds. No study we found has tested EBOO as a substitute for dialysis.

Q: Is EBO2 the same as 10-pass ozone or major autohemotherapy?
A: No, though all three expose blood to ozone outside the body. Major autohemotherapy mixes one batch of about 100 to 225 mL of blood with ozone in a bottle or bag and returns it. 10-pass draws 200 mL into a pressurized flask, ozonates it, and returns it, ten times in about an hour, about 2 liters in all. EBO2 pumps blood continuously through a gas exchanger or dialysis filter for about an hour; the pump speeds in a 2023 US paper, 30 to 40 mL a minute, come to 1.8 to 2.4 liters an hour by our arithmetic. The claim on some clinic pages that EBOO delivers three or more times the ozone of 10-pass divides a figure calculated from gas measurements by a theoretical maximum for 10-pass. No trial has compared these methods on patient outcomes.

Q: How is EBO2 different from plasmapheresis?
A: Plasmapheresis, or therapeutic plasma exchange, takes something out: according to a patient fact sheet published by the American Society for Apheresis, a machine separates the patient's plasma, removes it, and replaces it, most often with 5% human albumin, over about 2 hours with citrate to stop clotting. EBO2 returns the same whole blood after exposing it to oxygen and ozone, typically for about an hour with heparin, and we found no study that measured anything it takes out. Apheresis has a professional body that rates its evidence condition by condition: the American Society for Apheresis's 2026 guidelines hold 93 fact sheets with 183 graded indications. Nothing comparable exists for EBO2, whose controlled evidence is one 28-patient trial.

Q: How is EBO2 different from hyperbaric oxygen therapy?
A: In hyperbaric oxygen therapy the whole person breathes concentrated oxygen inside a pressurized chamber, and no blood leaves the body. EBO2 runs blood through an external circuit where it meets oxygen and ozone gas. Their regulatory standing differs as well: the FDA clears hyperbaric chambers as Class II devices through the 510(k) process, and Medicare's national coverage determination lists 15 conditions it pays for, while we found no FDA approval or clearance for any EBOO system. As of October 4, 2026, 44 of the 177 clinics in our directory list hyperbaric oxygen alongside EBO2. The word hyperbaric in hyperbaric ozone, or 10-pass, refers only to pressure inside a flask of blood.

Q: What is "full spectrum" EBOO, or EBO2 with a light device?
A: Usually EBOO with a light step added to the blood circuit, such as an ultraviolet or multi-wavelength light unit. As of October 4, 2026, 15 of the 174 clinic pages we could read use "full spectrum" for a light step, a device, or a protocol, and 7 of the 21 pages that name a device name the same branded light unit. At the 3 clinics that price a light step on its own, it costs $90 to $300 more per session. We found no FDA record under the light-unit names clinics give, though no match does not show that a device is unregistered or uncleared under some other name. In July 2025 the FDA found two devices that expose blood to ozone and ultraviolet light adulterated for lack of premarket approval. Asking what the name adds to plain EBOO, and what the plain version costs, separates the parts.

Q: Where is EBO2 offered?
A: In the United States, at outpatient clinics, often described as integrative or wellness practices, that sell it as an elective, self-pay service. As of October 4, 2026, our directory lists 177 US clinics in 43 states, from 152 websites, and 109 of them list at least one other service, most often IV nutrient therapy (81 listings). We do not count clinics outside the US. The method began in a hospital nephrology department in Siena, Italy, but Italy's health bodies have said oxygen-ozone therapy belongs in controlled trials, apart from a doctor acting on his or her own responsibility, and no regulator whose documents we hold has approved EBOO.

Q: What happens to blood during an EBO2 session?
A: It is pumped out of a vein in one arm, mixed with an anticoagulant so it does not clot in the tubing, run past a membrane carrying an oxygen and ozone gas mixture, and returned to a vein in the other arm, continuously, for about an hour. In a 2023 US paper the pump ran at 30 to 40 mL a minute with a heparin drip, and the ozone generator was set at 10 to 60 micrograms per milliliter, mostly 30 to 40; the Siena group's 2005 review gives 0.5 to 1. The spent gas went through a unit that destroys ozone before it reaches room air. As of October 4, 2026, only 7 of the 174 clinic pages we could read state an ozone concentration.

Q: How long does an EBO2 session take?
A: About an hour on the circuit, by the published papers; clinics state anything from 25 to 120 minutes. As of October 4, 2026, the most common statement among the 101 of 174 readable clinic pages that give a length is 60 to 90 minutes, on 43 pages. Most do not say whether that includes placing the lines or a check before leaving, so the whole visit can run longer.

Q: How much blood is processed?
A: Roughly 2 to 5 liters a session, depending on the source. The developers in Siena reported treating as much as 4.8 liters in an hour, while a 2023 US paper's pump speeds of 30 to 40 mL a minute come, by our arithmetic, to 1.8 to 2.4 liters in its one-hour sessions. Clinic figures spread wider: as of October 4, 2026, 53 of the 174 clinic pages we could read state a volume, from 1 to 7 liters, with 37 giving an upper figure of 3 liters or less and 13 giving 5 liters or more. Volume is not dose: one clinic that offers the procedure calls volume pitches a marketing gimmick and says ozone dose is measured in micrograms per milliliter.

Q: What does the filter in an EBO2 circuit do?
A: It is where blood meets the ozone: blood flows along one side of a bundle of hollow fibers while oxygen and ozone gas flows along the other. The Siena developers built an ozone-resistant gas exchanger for this and rejected dialysis membranes as unsuitable. Some US circuits use a hemodialysis filter instead, as a 2023 US paper and an FDA warning letter record, and in 2010 the developers warned that dialysis filters exposed to ozone may release toxic compounds. Dialysis clears wastes into dialysis solution; an EBOO circuit carries gas on that side of the membrane. No published study we found has measured what an EBOO circuit removes from a patient's blood.

Q: What is in the filter afterward?
A: No one has published a laboratory analysis of it. Fluid that crosses the membrane can drain into a canister, which a 2023 US paper describes as holding 2 liters, but no study we found reports its volume or contents. Clinic descriptions vary: one shows its canister holding clear fluid and foam, and another says the contents differ between patients and sessions. The developers saw their own gas exchanger clog with blood cells, a reminder that color, foam, or volume cannot show what was removed without a laboratory. As of October 4, 2026, 14 of the 174 clinic pages we could read say the circuit, filter, or tubing is single-use.

Q: Does EBO2 hurt?
A: The papers do not describe how it feels. It needs a needle line in each arm for about an hour; one 2023 US group used 20-gauge catheters and kept to that size to protect veins over repeated sessions. Clinic pages describe mild, short-lived effects: as of October 4, 2026, of the 174 we could read, 28 mention tiredness afterward and 10 mention bruising or tenderness where the lines went in, and one lists chills during the session among the effects patients most often report. We found no clinic page or paper that describes sedation.

Q: What happens at the consultation before a first EBO2 session?
A: Usually a consultation or screening for conditions a clinic counts as reasons not to proceed, sometimes with a review of health history or lab tests. As of October 4, 2026, 132 of the 174 clinic pages we could read describe a step before a first session. In the intake statement we recorded for each, 120 describe a consultation, evaluation, or screening, 45 a review of health history, 35 lab work or other testing, and 9 medications. Anywhere on the pages we saved, 18 describe a G6PD test before the first session, 9 name the same three tests (a blood count, a metabolic panel, and G6PD), and 10 of the 174 list a fee for a consultation, evaluation, or first visit, from $50 to $600.

Q: Can I eat before a session?
A: Yes, according to the clinic pages that mention food; the papers do not address it. As of October 4, 2026, 35 of the 174 clinic pages we could read ask patients to eat beforehand, typically a light meal an hour or two ahead, and several give steady blood sugar as the reason. Preparation advice also covers water and alcohol: 42 ask patients to arrive hydrated, which clinics link to easier placement of the lines, and 12 ask them to avoid alcohol. No study has tested any of this; the published papers give no preparation advice, and clinics' instructions differ.

Q: How soon can I exercise after?
A: Few clinic pages address exercise, and no study has tested it. As of October 4, 2026, of the 174 clinic pages we could read, 25 say normal activities can resume the same day or that there is no downtime, and 7 advise against strenuous exercise for the rest of the day. Twenty-eight mention tiredness afterward, and 16 say to keep drinking water. The published papers say almost nothing about aftercare, and clinics' advice differs; what a clinic advises after a first session, and whom to call if something feels wrong, are questions it can answer.

Q: Is there a standard number of EBO2 sessions?
A: No. Clinics set their own courses, and no EBOO study compared one number of sessions with another. As of October 4, 2026, 69 of the 174 clinic pages we could read state a recommended course, and 48 give a number: from 1 to 15 sessions. The median of the smallest number each clinic names is 3, and of the largest is 6, and 30 of the 48 start at 3. The most common spacing is about a week apart (31 of the 69), and 13 describe maintenance sessions after the first course. The method's developers described a standard cycle of 14 one-hour sessions over 7 weeks, and only 1 of the 48 clinics recommends a course that long.

Q: How much does EBO2 cost?
A: Around $1,500 a session at the clinics that publish a price, before any extra fees. As of October 4, 2026, 40 of the 174 clinics whose EBO2 page we could read published a single-session price: $750 to $2,500, with a median of $1,500 and a middle half of $1,274 to $1,550, and 13 of the 40 were exactly $1,500. The other 134 publish no price. Of the 40 prices, 26 came with a condition on the clinic's own pages, such as a starting-price label, a member rate, or a separate consultation fee. We found no sign that health insurance pays for it.

Q: What does a full course of EBO2 cost?
A: Thousands of dollars at published prices, because clinics usually recommend a series. As of October 4, 2026, the median single-session price among the 40 of 174 readable clinics that publish one was $1,500, and among the 48 clinics that give a number of sessions, the median of the smallest number each names was 3 and of the largest was 6. By our arithmetic, 3 to 6 sessions at $1,500 come to $4,500 to $9,000 before any package discount, consultation fee, labs, or add-ons. Published package totals run from $2,700 to $6,750. At the median price, the developers' 14-session cycle would come to $21,000, and monthly maintenance sessions would add $18,000 a year. These are arithmetic on medians, not quotes.

Q: Are there fees on top of the session price?
A: Sometimes, and a quote may not show them. As of October 4, 2026, 10 of the 174 clinics whose EBO2 page we could read list a separate consultation, evaluation, or first-visit fee on the pages we saved, from $50 to $600, and one folds its required lab tests into a $250 evaluation. Twenty-two list an add-on to the session; where a light step is priced separately (3 clinics) it adds $90 to $300, and one clinic's EBOO with NAD costs $201 more than EBOO alone. Some take deposits with their own terms, such as $700 that becomes non-refundable if the appointment is cancelled within 3 business days. A quote that does not mention these has not necessarily ruled them out.

Q: What is the cheapest way to pay for EBO2?
A: Comparing published single-session prices is the plainest route; a package lowers the price per session only for the buyer who uses every session. As of October 4, 2026, the lowest single-session price published by the 174 clinics whose EBO2 page we could read was $750, and 17 of them published package prices, 21 packages in all. Per session, packages came to a median of 10% below the same clinic's single price, with a middle half of 8% to 12% and a range of 0% to 17%. Every one of the 21 cost more than the single price for one fewer session, so a package abandoned partway costs more than single sessions would have. The price check tool on this site places a quote against every published price.

Q: Do clinics offer refunds on packages?
A: Clinics rarely publish refund terms. As of October 4, 2026, 17 of the 174 clinics whose EBO2 page we could read published a package price; one of those pages says "All sales final," and none says whether unused sessions can be refunded, transferred, or will expire. Deposits carry their own terms: one clinic's $700 deposit becomes non-refundable if the appointment is cancelled within 3 business days. In all 21 published packages, the total was more than the single price for one fewer session, so the refund terms, in writing, matter before paying. An FSA cannot reimburse sessions in advance.

Q: Is EBO2 cheaper in some states?
A: Our data cannot say. As of October 4, 2026, the 40 single-session prices published by the 174 clinics whose EBO2 page we could read came from 17 of the 43 states with a listed clinic, and no state had more than 6, too few to compare states. Price also did not track what clinics state about the session: the median price for clinics that state a session length, name a device, or name clinicians stayed within about $100 of $1,500. Clinics' pages point instead to what a price includes, such as a consultation, a member rate, or a light device.

Q: Does insurance or Medicare pay anything toward EBO2?
A: We found no sign that health insurance or Medicare pays for it. As of October 4, 2026, none of the 174 clinic EBO2 pages we could read said insurance covers it, and 23 said it is not covered or that the clinic does not accept or bill insurance. Five offer a superbill or itemized receipt for patients to submit themselves, which moves the claim to the patient without changing what a plan covers. Medicare excludes services that are not reasonable and necessary for diagnosing or treating illness or injury. Our plain-text read of Medicare's coverage database listed no document on ozone therapy, but its results load in a browser, so we could not confirm that none exists. We did not survey state Medicaid programs or read private insurers' current policies.

Q: Can I use an HSA?
A: Only if the session counts as medical care under IRS rules, and with an HSA the account holder carries the risk. IRS Publication 502 says medical care must be primarily to alleviate or prevent an illness, not merely beneficial to general health, and neither it nor Publication 969 mentions ozone therapy. Publication 969 describes no advance approval by the HSA trustee: the account holder keeps the records showing that a withdrawal paid a qualified expense, and a withdrawal that did not is taxed as income and can carry an extra 20% tax. A card accepted at the front desk is not a ruling that the expense qualifies. A health FSA differs: the plan decides which expenses qualify, needs a third-party statement, and cannot pay for sessions in advance.

Q: Is EBO2 FDA approved?
A: No. The FDA has approved no form of ozone therapy for any condition, and we found no FDA approval, clearance, or De Novo authorization for any EBOO system; in July 2025 the FDA told the maker of two devices sold for EBOO that they were adulterated and misbranded. As of October 4, 2026, of the 174 clinic EBO2 pages we could read, 148 did not say whether EBO2 or its equipment is FDA-approved, 23 said EBO2 is not FDA-approved, and none said the procedure itself was cleared or approved.

Q: What do "FDA registered" and "FDA cleared" mean on a clinic page?
A: Neither means the FDA has approved EBO2. Registered means a company has told the FDA where it makes or handles devices and which devices those are; a federal rule says registration does not denote approval, and the FDA issues no registration certificates. Cleared means a specific device, such as a hemodialysis filter, was cleared through a 510(k) for the uses written in its own submission, such as kidney failure, and another rule says a clearance does not denote official approval either. As of October 4, 2026, 3 of the 174 clinic EBO2 pages we could read used an FDA term for their equipment. A device's maker, model, and 510(k) number are what let anyone check it in the FDA's databases.

Q: Has the FDA acted against EBOO equipment?
A: Yes. On July 7, 2025, the FDA sent a warning letter to O3UV, LLC of Grand Ledge, Michigan, after a 2023 inspection. It said two devices meant to expose blood to ozone and ultraviolet light, during UV blood irradiation or EBOO, were adulterated because no premarket approval was in effect, and misbranded because the firm had not filed a 510(k) notice. It also found no complaint procedure, and hemodialyzer filters in the firm's EBOO kits bought without evaluating the supplier. On October 2, 2026, the FDA's list showed no response or close-out letter. A warning letter states the agency's position; it is not a court ruling, and it names no clinic.

Q: Who regulates EBO2 if the FDA has not approved it?
A: The FDA regulates the devices, state boards license the people who use them, and the FTC polices health claims. The FDA does not approve health care providers, and its ozone rule counts an ozone device used in a medical condition without proof of safety and effectiveness as adulterated or misbranded. State medical boards act on how licensed clinicians practice: Oregon's board revoked a physician's license in 1994, in part over ozone therapy it called unproved and unnecessary, and California's board in 2024 barred a physician on probation from intravenous ozone therapy. We have not surveyed every state's rules, and nothing here is a legal opinion.

Q: Has any country outside the US approved EBOO?
A: None that we found. We hold regulators' documents from Italy, Germany, Brazil, the UK, Canada, and Australia, and none approves EBOO. The only one that names it, a 2001 German insurance review, judged the first EBOO study in patients unsuitable as evidence of efficacy, and Germany has excluded ozone therapy, including ozone autohemotherapy, from statutory health insurance since March 2001. Brazil allows ozone therapy as a complementary procedure, and its medical council lists wound, knee, and spine uses for physicians, none of them a blood circuit. Italy's health bodies said no controlled studies supported oxygen-ozone therapy. The UK, Canadian, and Australian records concern one advertiser, ozone saunas, and two clinics.

Q: How much safety data exists for EBO2?
A: Very little. As of October 2, 2026, our library classes six papers as studies of EBOO as given to people, four of them from the Siena group that developed it. None attributes an adverse event to the procedure, and none was designed to detect uncommon ones. The developers' trial recorded no side effects in 210 EBOO treatments, their review reports more than 1,200 treatments in 82 patients without technical or clinical problems, and a California clinic reports at least 400 sessions with no untoward effects observed. A 2025 case report, which has no adverse-events section, notes a fall in hemoglobin and that the patient felt worse after her second series, without attributing either to EBOO. These are the practitioners' own accounts. No registry collects EBO2 outcomes, so how often problems occur is unknown, and the absence of reports is not evidence of safety.

Q: What are the side effects?
A: Clinic pages describe mild, short-lived effects, such as tiredness, dizziness, bruising, or discomfort where the lines go in, and none gives counts of patients or events. The handful of EBOO papers attribute no side effects to the procedure, but most come from the group that developed the method and none was built to catch rare events. One practice's EBOO page goes further, listing infection, clotting, bleeding, and fainting among reported and potential risks. With other ways of giving ozone, published case reports describe strokes, blindness, heart attacks, infections, and deaths; their authors most often blame gas reaching the bloodstream.

Q: What serious problems have been reported after ozone therapy?
A: Strokes, vision loss, spinal cord injury, heart attacks, serious infections, and deaths, though as of October 2, 2026 we found no published report of a serious event during EBO2 itself. Most of the serious events followed injections into or beside the spine, or ozonated blood or gas given into a vein, and began during the procedure or within minutes; most of their authors attribute them to gas entering the bloodstream. Infections, including a hepatitis C cluster among patients given ozone-enriched transfusions of their own blood in Rome, are the other large group. A case report shows that an event followed a procedure, not how often it happens, and a 2026 review says the overall rate cannot be reliably estimated.

Q: Can EBO2 cause a blood clot or embolism?
A: Neither has been reported in the EBOO papers, which are too small to rule either out. The concern comes from other procedures that return ozonated blood or gas to a vein: authors of several case reports attribute strokes and other sudden events to gas bubbles reaching the circulation, and a California patient was diagnosed with an air embolism and stroke after her IV line appeared to leak air during intravenous ozone. Published EBOO circuits use heparin to keep clots from forming in the tubing, and heparin's label warns of bleeding and of heparin-induced thrombocytopenia, a reaction that can itself cause clots. No study has measured either risk for EBO2's equipment.

Q: Who should not get EBO2?
A: No regulator publishes a list, but the lists that exist share a core: bleeding or clotting problems, pregnancy, G6PD deficiency, an unstable heart or recent heart attack, and uncontrolled hyperthyroidism. In the eleven itemized clinic lists we compared, saved on September 28, 2026, all include bleeding or clotting disorders, ten pregnancy, eight G6PD deficiency, and seven an unstable heart. Beyond that core they diverge, from heparin allergy to anemia, and none rests on a study of who has been harmed by EBO2. Whether an item applies to a particular person is a question for that person's own doctor.

Q: Is EBO2 safe with medications?
A: No study has tested EBO2 alongside any medicine, so the sources cannot say. Two kinds come up most. Blood thinners, because the circuit is kept from clotting with heparin, whose label warns that drugs affecting clotting or platelets may add to bleeding; clinic pages range from listing anticoagulant use as a reason to decline to saying it needs discussion. Blood pressure medicines, because the ozone physiologist Velio Bocci reported a sudden fall in blood pressure when ozonated blood was reinfused fast into patients on ACE inhibitors, from an unpublished observation and two patients, during autohemotherapy rather than EBOO. Any change to a medicine is a decision for the clinician who prescribes it.

Q: Is it safe during pregnancy?
A: That is unknown. We found no study of EBO2 in pregnancy, and almost every list of exclusions we compared names it, including 10 of the 11 itemized clinic lists we saved on September 28, 2026, an Italian national consensus on ozone injections, and a 2022 autohemotherapy trial. Two of those clinic lists exclude only the first trimester. Breastfeeding appears on four of the clinic lists and in the trial's exclusions. The question belongs with the clinician caring for the pregnancy, and our contraindications guide gives each source's reasoning.

Q: Where can a problem after EBO2 be reported?
A: To the FDA through MedWatch and, for a clinician's conduct, to the state licensing board. MedWatch, the FDA's voluntary reporting program, is at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm, where patients and consumers use Form 3500B and health professionals Form 3500; the FDA also takes reports by phone at 1-888-INFO-FDA (1-888-463-6332), option 2, and a patient's own doctor can add clinical details to a report. On October 2, 2026, the FDA's device report database held 10 reports whose narratives mention ozone therapy and none mentioning EBOO. For a medical emergency, the MedWatch page says to call 911.

Q: What health benefits do clinics claim for EBO2?
A: Almost every clinic page claims at least one. As of October 4, 2026, 163 of the 174 clinics whose EBO2 page we could read (94%) state a health benefit. By kind: detoxification 151, energy or fatigue 133, infections or pathogens 119, autoimmune conditions 104, Lyme disease or mold illness 90, heart and circulation 87, longevity 56, long COVID 48, and cancer 22, with 94 naming other conditions. For autoimmune disease, fatigue, long COVID, Lyme or mold illness, longevity, and cancer, no study of EBOO itself in our library measured the outcome in patients. We publish these claims only as counts, never for a named clinic.

Q: Has EBO2 been shown to help any condition?
A: No. Its research record is too small to show a benefit for any condition. As of October 2, 2026, of the 78 studies in our library, six are about EBOO as given to people: one 28-patient randomized trial at the developers' hospital, two single-patient case reports, a preliminary report with no patient count, a review by the developers, and ozone-uptake measurements in 12 patients at a California clinic. None is large or independent, and ClinicalTrials.gov listed no registered EBOO trial on that date. The larger ozone trials in our library tested injections or major autohemotherapy, and a result for one route does not carry over to another. Ozone therapy is not FDA-approved for any condition.

Q: Is there evidence for EBO2 in heart or circulation problems?
A: A little, and it is the only area with a controlled EBOO trial. In 2005 the Siena developers randomized 28 patients with peripheral artery disease to EBOO or intravenous prostacyclin and reported greater regression of skin lesions and differences in pain and well-being with EBOO, but no significant change in blood supply to the legs in either group. The trial ran at the developers' own hospital, and its abstract gives no arm sizes, randomization method, or blinding. Bocci's group later described EBOO as a procedure for emergencies such as stage 4 peripheral artery disease. As of October 4, 2026, 87 of the 174 clinic EBO2 pages we could read claim a heart or circulation benefit.

Q: Does EBO2 detox the body?
A: No study has shown that it does, though it is the most common claim: as of October 4, 2026, 151 of the 174 clinic EBO2 pages we could read claim a detoxification benefit. No published study we found has measured what an EBOO circuit removes from a patient's blood. The one case report on toxins followed a single 88-year-old woman's urine over two series of sessions: average ratios fell for mycotoxins, heavy metals, and environmental toxins, but nine of the 29 mycotoxins measured ended higher, nickel rose overall, and there was no comparison. Claims about heavy metals and microplastics rest on theory borrowed from dialysis or on one clinic's test of water, not blood.

Q: Does EBO2 help fatigue or low energy?
A: No study has tested it. As of October 4, 2026, 133 of the 174 clinic EBO2 pages we could read claim a benefit for energy or fatigue, the second most common claim, yet no study of EBOO itself in our library measured fatigue in patients. The nearest evidence comes from major autohemotherapy, a different method: a 2021 series reported a 67% fall in mean fatigue scores among 100 people with post-COVID fatigue, with no comparison group to show what would have happened anyway. Tiredness is also reported after sessions: 28 clinic pages mention it, and the one recent EBOO case report describes a patient who felt worse, more tired, after her second series, which the paper does not attribute to EBOO.

Q: Does EBO2 kill viruses or bacteria in the blood?
A: No study has shown that it does in people. As of October 4, 2026, 119 of the 174 clinic EBO2 pages we could read claim a benefit against infections or pathogens, and the recorded wording of 29 says the procedure kills, destroys, inactivates, or neutralizes microbes. The closest tests used a different extracorporeal ozone prototype in pigs with sepsis: one pass lowered live bacteria in the blood flowing through the device, but bacteria in the animals' circulation did not differ from untreated pigs. The only EBOO report on an infection is a single dialysis patient with necrotizing fasciitis. In 2020 the FTC told ozone marketers their COVID-19 claims lacked competent and reliable scientific evidence.

Q: Does EBO2 help autoimmune disease?
A: No study has tested EBO2 in any autoimmune disease. As of October 4, 2026, 104 of the 174 clinic EBO2 pages we could read claim an autoimmune benefit, though the wording we recorded names a specific disease for only 23 of them. The ozone studies that exist used other methods. Two multiple sclerosis case series, each of 20 patients and possibly the same 20, gave ozone autohemotherapy twice a week for six months and measured immune-cell markers, not relapses or disability; the one Sjögren's report is a single case; and a 2016 rheumatoid arthritis trial added rectal ozone to methotrexate for 20 days, with no sham described. The treatments NIH lists for lupus, Sjögren's, and rheumatoid arthritis do not include ozone.

Q: Does EBO2 help long COVID?
A: No published study has given EBO2 to people with long COVID. As of October 4, 2026, 48 of the 174 clinic EBO2 pages we could read claim a long COVID benefit. The post-COVID studies in our library used major ozone autohemotherapy, a batch method. The only randomized one, a 73-patient pilot, reported a symptom response in 25 of 35 people given ozone with usual care against 17 of 38 on usual care alone, with no sham procedure described, and its authors say the findings need validation; the other two had no comparison group. CDC and NIH say there are no approved treatments for long COVID, and NIH's RECOVER trials have not involved ozone.

Q: Does EBO2 help Lyme disease?
A: No study has tested it. We found no study, in the laboratory, in animals, or in people, that tested ozone or EBO2 against Borrelia burgdorferi, the bacterium that causes Lyme disease, and ClinicalTrials.gov listed no such trial on October 2, 2026. Even so, as of October 4, 2026, the claim wording we recorded from 76 of the 174 clinic EBO2 pages we could read names Lyme disease, 64 of them in a list with other conditions. Reviews of alternative Lyme treatments in 2015 and 2026 found no trial evidence for oxygen-based therapies such as ozone. CDC lists antibiotic courses for every form of the disease and says more antibiotics are unlikely to help symptoms that last after treatment.

Q: Does EBO2 help mold illness or CIRS?
A: No study has tested EBO2, or any ozone therapy, in people with mold-related illness or CIRS. As of October 4, 2026, the claim wording we recorded from 51 of the 174 clinic EBO2 pages we could read names mold, mycotoxins, biotoxins, or CIRS. The only EBOO report that measured mycotoxins followed one 88-year-old woman with chronic anemia: some urine levels fell, but 9 of the 29 mycotoxins tested were higher at the end, and she kept living in the building she blamed. CDC says there is no FDA-approved test for mycotoxins in human urine and that they turn up in healthy people's urine, and its advice for a moldy building is to fix the moisture problem and remove the mold.

Q: What do clinics claim about EBO2 and cancer?
A: As of October 4, 2026, 22 of the 174 clinic EBO2 pages we could read state a cancer-related benefit, more often as support alongside conventional care than as a cancer treatment. No study we found has given EBO2 to people with cancer: an exact-phrase Europe PMC search for the procedure's full name on October 2, 2026 returned 14 records, none a cancer study. A supportive-care claim would still need a controlled trial behind it. Brazil's Federal Council of Medicine bars ozone therapy for neoplastic wounds outside approved research, and the American Cancer Society recommended in 1993 that people with cancer not seek treatment from anyone promoting hyperoxygenation therapy, a family that includes ozone, as an alternative.

Q: Does EBO2 help with longevity or aging?
A: No study has tested it against any aging outcome. As of October 4, 2026, 56 of the 174 clinic EBO2 pages we could read claim a longevity or anti-aging benefit, yet no study in our library, of EBO2 or any other ozone therapy, measured lifespan, a validated aging clock, or the rate of age-related disease. The case rests on a mechanism argument: the most cited ozone-and-aging review pooled biomarker studies with very high heterogeneity and described itself as a rationale for future trials. The trial its authors announced used rectal ozone, not blood filtration, was completed in November 2023, and had no published results when we checked on October 2, 2026.

Q: Can athletes who are drug-tested have EBO2?
A: Only the athlete's own anti-doping organization can say; some athletes ask it in writing before a session. None of the anti-doping agency pages we read names EBO2 or EBOO. As those agencies summarise the WADA Prohibited List, it bans removing blood (except for testing or donation), putting blood back into the circulation, manipulating blood inside the circulation by physical or chemical means, and IV infusions above 100 mL in 12 hours outside hospital, surgical, or diagnostic care. USADA's guidance calls ozone autohemotherapy prohibited at all times and says wellness clinics do not count as hospitals, and a UFC athlete accepted a six-month sanction in 2018 after his physician's records showed his ozone treatment involved a blood transfusion. As of October 4, 2026, 26 of the 174 clinic pages we could read mention athletes alongside the procedure; no study has tested EBO2 in athletes.

Q: How do I find an EBO2 clinic near me?
A: Through our clinic directory, which as of October 4, 2026 lists 177 US clinics in 43 states, or the clinic finder on this site, which sorts them by straight-line distance from a ZIP code or your location. Each listing shows what the clinic states about its own service, such as a price, session length, and named clinicians, each linked to the clinic page it came from. Verified means we confirmed on the clinic's own website, on the date shown, that it offers EBO2 or EBOO; it says nothing about licensure, safety, or results, and a listing is not a recommendation. No clinic can pay for its position or a badge.

Q: What do clinic EBO2 pages usually leave out?
A: Most of what a reader needs to compare clinics. We track eight basic facts, and as of October 4, 2026, the median page among the 174 clinic EBO2 pages we could read stated 3 of them. Of those 174, 40 published a price, 17 a package price, 21 the device, 69 a recommended course, and 75 named a clinician; 100 said who supervises, 56 of them in general words such as "medical supervision." Sixty-eight published none of a price, a device, or a clinician's name, and 148 did not say whether EBO2 or its equipment is FDA-approved. A missing fact is not proof of a problem, only a question to ask before booking.

Q: What should I ask an EBO2 clinic before booking?
A: The questions clinic pages rarely answer. Ask who places the lines, who stays in the room for the whole session, and what license each holds. Ask which device and filter are used, and whether every part that touches blood is single-use; as of October 4, 2026, 14 of the 174 clinic pages we could read say the circuit, filter, or tubing is single-use. Ask what screening and lab tests come first, what is monitored during the session, and what happens if a patient feels unwell: 15 pages say vital signs are taken or monitored at a session, and none we saved describes an emergency plan. Then ask for the full price, every fee, and the package and refund terms, in writing.

Q: Who performs EBO2, and how can I check their license?
A: Clinic pages often do not say, and which licenses may run the circuit depends on state rules we have not surveyed. As of October 4, 2026, 100 of the 174 clinic EBO2 pages we could read say who supervises sessions, but 56 of those use general wording without a role or a name; 75 name at least one clinician, and the 137 people named include 31 MDs, 10 DOs, 24 nurse practitioners, 13 registered or practical nurses, 13 naturopathic doctors (7 NDs and 6 NMDs), and 5 chiropractors. A license is checked in the state licensing board's own lookup. The federal NPI Registry is a second search, but an NPI is an identification number, not a license. We do not check licenses ourselves.

Q: Which other services do EBO2 clinics sell alongside it?
A: Most often IV drips, followed by peptides, hyperbaric oxygen, and NAD+. As of October 4, 2026, 109 of the 177 US clinics in our directory list at least one service besides EBO2: IV nutrient therapy on 81 listings, peptide therapy on 48, hyperbaric oxygen on 44, NAD+ therapy on 42, PRP on 24, chelation on 18, major autohemotherapy on 17, and 10-pass ozone on 11. Separately, 22 of the 174 clinics whose EBO2 page we could read list an add-on to the session itself, such as a light device or an IV infusion. Each part of a bundle is a separate cost, and when several are given together no one can tell which produced a change or a side effect.

Q: How does EBO2.com verify clinics?
A: A clinic is listed when public sources or the clinic itself indicate that it offers EBO2 or EBOO, and Verified means we confirmed on the clinic's own website, on the date shown, that it offers the service; that page is recorded as the listing's source. Our procedure rechecks each listing at 90 days, our automated tests fail at 150, and the site cannot be rebuilt while any listing is more than 180 days past its last check. A separate research pass reads each clinic's EBO2 page and saves the exact words behind every fact it records, and a script checks each quote against the saved text. We do not check licenses, safety records, complaints, or results.

Q: Does EBO2.com sell Featured or sponsored placements?
A: No. Every listing is free, and no clinic can pay for position, a badge, or a mention in an article. Within each state, directory pages show verified clinics first and then sort alphabetically. A listing shows "Verified" only once we confirm EBO2 on the clinic's own website, and a listing that has not been confirmed says so plainly instead.

Q: Where does the clinic data on EBO2.com come from?
A: From the clinics' own websites. Our directory lists 177 US clinics from 152 websites. A research pass read each clinic's EBO2 page, saving the exact words and the page behind every fact it recorded, and a script checks each quote against the saved text. Every share of what the research pass recorded counts only the clinics whose EBO2 page we could read, so a page we could not read never counts as saying nothing. How clinics word FDA status and health benefits is published only as counts. The data can be downloaded as CSV or JSON under a CC BY 4.0 license, with our 78 study cards and 34 regulatory records as of October 2, 2026.

Q: How do I report a clinic making false claims?
A: To us through the contact page if the problem is in our listing, and to regulators for the clinic's own marketing. Our listing text may describe services and prices but may not claim that EBO2 can treat or prevent disease, and reports are checked against that rule; it does not govern what a clinic says on its own website. The FDA accepts complaints about how device makers and sellers market their products, including selling without clearance or beyond a cleared use, through its Allegations of Regulatory Misconduct form. State medical boards handle complaints about a licensed clinician's practice, and the FTC takes reports of bad business practices at ReportFraud.ftc.gov.

Q: Can my clinic be listed?
A: Yes, for free, if EBO2 or EBOO appears as a service on the clinic's own website, which becomes the verification source, and sessions are delivered by or under the supervision of a licensed clinician in your state. Listing text may describe services and prices but may not make disease claims. The form on the For clinics page claims an existing listing or requests a new one. A listing shows facts from the clinic's own pages with links to them; how a clinic words FDA status or health benefits is never shown on its listing.

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# Glossary

Source: https://ebo2.com/glossary/

10-pass ozone: A higher-dose form of major autohemotherapy. As described in a 2022 paper co-written by the method's pioneer, 200 mL of blood is drawn into a vacuum bottle containing heparin, 200 mL of oxygen/ozone gas at 70 µg/mL is pumped in under pressure, and the blood is returned using positive pressure. That is one pass; nine more follow, and the ten passes take about an hour.

21 CFR 801.415: The FDA device regulation stating that ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. It sets a maximum acceptable ozone level of 0.05 parts per million in air for devices that generate ozone, and treats such a device as adulterated or misbranded if it is used for any medical condition for which there is no proof of safety and effectiveness.

510(k) clearance: The FDA's finding, after a manufacturer files a premarket notification known as a 510(k), that a new device is substantially equivalent to a device already on the US market, which allows it to be sold. FDA regulation 21 CFR 807.97 states that this finding does not in any way denote official approval of the device, and that any claim giving the impression of official approval because of it is misleading and counts as misbranding.

Adverse event: Any harmful or unwanted medical occurrence in a person after a treatment, whether or not the treatment caused it. FDA's drug-trial rules define it this way, call an event serious if it causes death, is life-threatening, requires or prolongs a hospital stay, causes lasting incapacity, or causes a birth defect, and reserve the term adverse reaction for an event the treatment caused.

Anticoagulation during EBO2: Adding an anticoagulant, a drug that reduces the blood's ability to clot, to blood that is being treated outside the body. A 2005 review by the Siena group that developed EBOO describes an apparatus that can treat up to 4,800 mL of heparinized blood with an oxygen/ozone mixture during one hour of extracorporeal circulation.

Apheresis: A process in which a machine takes blood from a person through a catheter, separates out and removes one part, such as plasma, platelets, white or red blood cells, or blood stem cells, and returns the rest to the body. It may be done to collect blood stem cells before a transplant or to remove abnormal blood cells or proteins, and it is used to treat some blood disorders, blood cancers, autoimmune disorders, and other conditions.

Autohemotherapy: Treating a patient's own blood with an oxygen/ozone gas mixture outside the body and giving it back. A 2011 paper by ozone-therapy researchers Bocci, Zanardi, and Travagli divides ozonated autohemotherapy by blood volume into major autohemotherapy, which treats 100 to 225 mL of blood and reinfuses it into a vein, and minor autohemotherapy, which treats about 5 mL and injects it into a buttock muscle, and lists EBOO alongside them.

Biomarker: A characteristic that is measured as an indicator of normal biological processes, disease processes, or responses to an exposure or treatment, such as a molecular, imaging, or physiologic measurement. FDA notes that a biomarker is not an assessment of how a person feels, functions, or survives, so a change in one is not, on its own, evidence that patients are better off.

Blinding (masking): Keeping trial participants, and sometimes the research team, from knowing who is receiving which treatment, so that this knowledge does not bias what is reported. In a single-blind study the participants are not told but the research team knows; in a double-blind study neither knows, though the treatment can always be revealed if medically necessary.

Case report: A published, detailed account of the clinical course of an individual patient. Case reports are often the first notice of a new disease, a rare condition, or an unexpected adverse effect, but with so few patients they cannot show that a treatment caused an outcome or how often something happens, which places them low on the evidence hierarchy.

Case series: A study that describes a series of patients, usually all given the same treatment, with observations before and after it but no control group. Because case series are uncontrolled, many systematic reviews of non-randomized studies leave them out. The line between case series and cohort studies is blurry: one study found that about 72% of cohort studies had been mislabeled as case series.

Chelation therapy: Giving, through a vein, a substance that binds metals or minerals so they can be removed from the body in urine. As a complementary treatment for coronary heart disease, EDTA chelation is not FDA-approved, and a second large NIH-funded trial, TACT2, reported in 2024 that it lowered blood lead but did not reduce cardiovascular events. Its most important serious side effects are low blood calcium and kidney damage.

Chronic inflammatory response syndrome (CIRS): A diagnosis that its supporters describe as a dysregulation of the innate immune system after breathing the air of water-damaged buildings, with symptoms in several organ systems at once. The authors of a 2024 review that supports the diagnosis call it under-recognized and often misdiagnosed as chronic fatigue syndrome; they found 13 published articles on treating it, 11 of them describing one approach, the Shoemaker Protocol.

Class II medical device: The middle of the FDA's three risk-based device classes. Class I devices are low risk and subject to general controls only. Class II devices, such as dialysis equipment and many catheters, are moderate risk, can carry special controls such as testing or labeling rules, and are generally marketed through 510(k) clearance. Class III devices are the highest risk and generally need premarket approval. The class applies to the device; FDA says it does not approve health care providers.

Cohort study: An observational study in which a defined group of people is followed over time to examine how the treatments or exposures they received relate to later outcomes. Unlike a case series, a cohort study compares groups, such as people who did and did not receive a treatment; unlike a randomized trial, it is a non-randomized design.

Confidence interval (CI): A range of values around a study's result that describes the uncertainty in the estimate, often read as the range in which the true effect probably lies. Strictly, if a study were repeated many times, 95% of the 95% confidence intervals calculated would contain the true effect. A narrow interval means the effect is known precisely; a very wide one, often from a small study, means little is known.

Conflict of interest: A situation that creates a risk that a person's professional judgment or actions on a primary interest, such as giving an unbiased estimate of a treatment's effect, will be unduly swayed by a secondary interest, which can be financial or non-financial. Cochrane notes that conflicts of interest are probably one of several important reasons trials with negative findings go unpublished.

Diabetic foot ulcer: An open sore on the foot of a person with diabetes. High blood sugar can damage the nerves and blood vessels of the feet, so a wound may go unnoticed and heal poorly because of reduced blood flow; infection plus poor circulation can lead to gangrene and sometimes amputation. Controlling blood sugar and caring for the feet every day are the main ways to prevent serious problems.

EBO2 (EBOO): Extracorporeal blood oxygenation and ozonation: an ozone therapy in which heparinized blood is exposed to an oxygen/ozone mixture as it circulates outside the body and back. A 2005 review by the Siena group that developed the technique describes an apparatus that can treat up to 4,800 mL of blood in one hour, and a standard course of 14 one-hour sessions over 7 weeks. FDA regulation 21 CFR 801.415 calls ozone a toxic gas with no known useful medical application.

Effect size: A number that expresses how large a difference an intervention made between groups, such as a risk ratio or odds ratio, or a mean difference or standardized mean difference for measured outcomes. For ratio measures, a value of 1 means no difference between the groups; for difference measures, a value of 0 does.

Erratum (correction): A notice a journal publishes to correct or add information in an article it has already published. The National Library of Medicine treats corrections, corrigenda, addenda, and partial retractions all as errata, does not distinguish errors made in publishing from errors in the science itself, and links each erratum notice to the original article in PubMed with the phrase "Erratum in".

Extracorporeal circuit: The tubing and devices that carry a patient's blood outside the body and back. In FDA's description of a hemodialysis system, blood flows through the tubing of the extracorporeal blood system to the dialyzer and returns through more tubing to the patient, and that system includes pumps, pressure monitors, air foam or bubble detectors, and alarms to keep the blood moving safely.

FDA establishment registration and device listing: The yearly registration that businesses making or distributing medical devices for the US are generally required to file with the FDA, along with a list of their devices. FDA says the resulting entry in its database does not mean the business or its devices are approved, cleared, or authorized, and that it issues no registration certificates, so "FDA registered" or "FDA certified" on a website is not a sign of FDA review.

FDA warning letter: A letter in which the FDA notifies a company or person of what it believes are significant violations of federal requirements, such as problems with claims for what a product can do, poor manufacturing practices, or incorrect directions for use. The recipient is asked to respond within a set time, either with plans for correction or with its own reasoning if it disagrees. FDA posts warning letters on its website, and later responses or actions can change the status of the issues a letter raises.

Fibromyalgia: A chronic condition that causes pain and stiffness all over the body, fatigue, and trouble sleeping, often with problems in thinking and memory. Its exact cause is unknown, though studies suggest people with it process pain differently. There is no specific test, so other causes have to be ruled out first, and treatment, which combines medicines, lifestyle changes, talk therapy, and complementary therapies, focuses on relieving symptoms.

G6PD deficiency: An inherited enzyme deficiency that leaves red blood cells poorly defended against reactive oxygen species, so infections, certain drugs, and fava beans can trigger red blood cell breakdown, called hemolysis. Many people with it never have symptoms and do not know they have it.

Gas embolism: Gas, such as air, entering the bloodstream and blocking blood flow. Bubbles in a vein travel to the lungs and can obstruct the pulmonary circulation; bubbles in an artery, or ones that cross to the left side of the heart through a patent foramen ovale, can block flow to organs such as the brain. It is rare but can be fatal, most cases follow medical procedures, especially those involving access to blood vessels, and treatment can include hyperbaric oxygen.

Hemodialyzer: The filter of a dialysis system, in which blood flows through one compartment and dialysis fluid through another, separated by a semipermeable membrane that toxins and excess fluid cross. FDA classifies high-permeability hemodialysis systems as Class II devices intended as artificial kidney systems for kidney failure, fluid overload, or toxemic conditions; the regulation does not mention ozone therapy.

Hemofilter (dialysis-type filter): A dialysis filter cartridge used in some versions of EBOO. In a 2023 paper on what it calls ozone dialysis, a California clinic describes a pump drawing blood from a vein in one arm into a cellulose triacetate dialysis chamber, where blood flows around tiny tubes while ozone gas flows the opposite way inside them, and then returning it through a vein in the other arm.

Hemoglobin: The iron-rich protein in red blood cells that carries oxygen from the lungs to the rest of the body. A hemoglobin test, usually measured as part of a complete blood count, is often used to check for anemia, a shortage of healthy red blood cells. It is a different test from hemoglobin A1C, which tracks average blood sugar.

Hemolysis: The premature breakdown of red blood cells. When red cells are destroyed faster than the body can replace them, the result is hemolytic anemia. In G6PD deficiency, for example, infections, certain drugs, or fava beans can raise levels of reactive oxygen species until they damage red cells and trigger hemolysis.

Heparin: An anticoagulant, or blood thinner, that works by reducing the blood's ability to clot. It is used to prevent clots in people with certain medical conditions or during certain medical procedures, to stop clots that have already formed from growing, and to keep catheters from clotting. It is given into a vein or deep under the skin, not into a muscle.

Hollow-fiber membrane: A membrane made as very thin hollow fibers, used as the gas-exchange surface of membrane oxygenators. Oxygenator fibers described in a 2024 review include ones 200 micrometers across inside, made of silicone rubber, porous polypropylene, or polymethylpentene, and in most current oxygenators blood flows around the outside of the fibers. Clotting in the blood path or plasma leaking through the membrane can reduce gas exchange and make the device fail.

Hormesis: An adaptive response in which a moderate challenge, such as exercise, fasting, or a low dose of a chemical or radiation, leaves a cell or organism functioning better or better able to tolerate a later, more severe challenge. Researchers also call such effects a biphasic or U-shaped dose response, or preconditioning, the term behind oxidative preconditioning.

Hyperbaric oxygen therapy (HBOT): A treatment in which a person breathes pure oxygen inside a special chamber where the air pressure is raised above normal, which helps the lungs take in more oxygen. FDA classifies HBOT chambers as Class II devices cleared through the 510(k) process and has warned providers about reports of serious injuries and deaths with their use. It involves breathing oxygen, not ozone, so it is a different treatment from EBO2 and from the 10-pass method some clinics call hyperbaric ozone.

In vitro: Describes research done in the laboratory, outside a living body, for example on cells or a blood sample in a dish or tube. The opposite is in vivo, meaning in a living body. An in vitro result shows what happened under laboratory conditions, not what happens in a patient.

Informed consent: The process in which a health care provider explains a patient's condition and a proposed treatment, including what happens during it, its risks and how likely they are, how likely it is to work, whether it can wait, and the other options, before the patient decides. Signing a form is one way to record consent, and a patient who understands the choices may refuse.

Investigational device exemption (IDE): FDA permission to use an investigational device, or a marketed device for a new intended use, in a clinical study that collects safety and effectiveness data. The study needs an investigational plan approved by an institutional review board, and FDA must also approve the IDE when the device poses a significant risk. An IDE lets a device be shipped for research without meeting the rules that apply to devices in commercial distribution.

Lipoprotein apheresis: A form of apheresis that lowers low-density lipoprotein (LDL) cholesterol and lipoprotein(a) in the blood. A 2024 American Heart Association scientific statement describes it as an underused add-on option for high-risk patients whose cholesterol stays high despite medication, particularly children and adults with familial hypercholesterolemia, and notes that US use covers only a fraction of its FDA-approved indications.

Long COVID: A chronic condition that follows infection with SARS-CoV-2, the virus that causes COVID-19, and is present for at least 3 months. It includes a wide range of symptoms and conditions that may improve, worsen, or persist for months or years. CDC notes that it is not one illness, that no approved laboratory test can show symptoms are due to it, and that there are no approved treatments.

Lyme disease: A bacterial infection spread to people by the bite of infected blacklegged ticks, caused in the United States by Borrelia burgdorferi and, rarely, Borrelia mayonii. Typical symptoms are fever, headache, fatigue, and a characteristic rash called erythema migrans; if untreated, the infection can spread to the joints, heart, and nervous system. It is most common in the Northeast, mid-Atlantic, and upper Midwest.

MAH treatment cycle: One round of major autohemotherapy, in which a batch of about 200 mL of the patient's blood is mixed with an oxygen/ozone gas mixture outside the body and returned. In the 10-pass method, as described in a 2022 paper co-written by its pioneer, each round is called a pass: one pass with 200 mL of gas at 70 µg/mL delivers 14,000 µg of ozone, and ten passes take about an hour.

Major autohemotherapy (MAH): A form of ozone therapy in which, as described in a 2022 paper co-written by the pioneer of the 10-pass method, around 200 mL of a patient's blood is mixed with ozone and then returned to the same patient by gravity. The paper says it was first described in 1954. A higher-dose version that draws, ozonates, and returns blood ten times in one session is known as 10-pass ozone.

MAUDE database: The FDA's public database of medical device reports (MDRs) of adverse events, filed by manufacturers, importers, and device user facilities, which are required to report, and by voluntary reporters. FDA cautions that a report does not by itself show the device caused the event, and that the data cannot establish how often events happen, because events are under-reported, reports can be inaccurate, and causes often go unverified.

Medical ozone generator: A device that makes ozone from medical oxygen at the point of use, since ozone made this way has to be used immediately; ozone is about 3% of the resulting gas mixture. Ozone-therapy researchers write that ozonated autohemotherapy was done empirically from 1970 to 2000, partly because generators were imprecise, and that generators with photometers able to measure the ozone concentration accurately became available by 1998.

MedWatch: The FDA's medical product safety reporting program for health professionals, patients, and consumers. It takes reports from the public about problems with FDA-regulated products, including prescription and over-the-counter medicines, biologics such as blood components, and medical devices, and FDA uses it to publish safety alerts when appropriate.

Meta-analysis: The statistical combination of results from two or more separate studies. It can make an estimate more precise, answer questions single studies did not pose, and help settle conflicting findings, but variation between studies, called heterogeneity, has to be considered, and the result can be very misleading if the review behind it neglects steps such as selecting studies carefully and considering their risk of bias.

Methemoglobinemia: A blood disorder in which too much of the blood's hemoglobin takes an altered form, methemoglobin, that still picks up oxygen but does not hand it on well to the tissues. Some people inherit it, but it is more often acquired after exposure to certain medicines, chemicals, or foods, such as some anesthetics and antibiotics and the nitrites used to preserve meat. Bluish skin, called cyanosis, is a common sign.

Minor autohemotherapy: A small-volume form of ozonated autohemotherapy. As described by ozone-therapy researchers Bocci, Zanardi, and Travagli (2011), usually 5 mL of the patient's blood is mixed vigorously with an equal volume of oxygen/ozone gas for about a minute and immediately injected, with the gas foam, into a buttock muscle, rather than the 100 to 225 mL reinfused into a vein in major autohemotherapy.

Misbranding: A violation of the Federal Food, Drug, and Cosmetic Act in which a drug's or device's labeling is false or misleading, leaves out required information or adequate directions for use, or recommends a use that is dangerous to health. A device is also misbranded if it is sold without FDA concurrence on a required 510(k) submission.

Multiple sclerosis (MS): A disease of the brain and spinal cord in which damage to myelin, the protective coating around nerve cells, slows or blocks messages between the brain and body. Its exact cause is unknown; many believe it is an autoimmune disease in which the immune system attacks myelin. Symptoms vary and can include vision problems, weakness, numbness, fatigue, and trouble with balance; in the most common type, flare-ups alternate with periods of recovery.

Mycotoxins: Toxins made by certain molds and fungi that can grow on crops such as grains, dried beans, dried fruits, and coffee, generally during production and storage. Eating food with high levels can make people sick, and regularly eating foods with aflatoxins, one group of mycotoxins, can raise the risk of liver cancer. FDA monitors the food supply for several mycotoxins.

Narrative review: A review article in which authors summarize and interpret research on a topic without the predefined protocol, thorough search, and transparent selection criteria of a systematic review. Narrative reviews can offer an expert's perspective, but their choice of studies can be selective: in one comparison, narrative reviews of the same studies reached different conclusions, and such reviews are not considered rigorous evidence.

Nrf2 pathway: A cell signaling pathway centered on the protein Nrf2 that regulates cells' protective response to stress caused by reactive oxygen species. Normally a partner protein, Keap1, marks Nrf2 for breakdown; when Nrf2 is active, it binds to antioxidant response elements in DNA and switches on protective genes. Raising Nrf2 activity can protect cells from oxidative stress, but it can also help cancer cells survive and multiply.

Off-label practice: Using an FDA-approved or FDA-cleared drug, biologic, or device for a use that is not included in its FDA-required labeling, which FDA calls an unapproved use. FDA says health care providers generally prescribe and use such products for unapproved uses when they judge the use medically appropriate for a particular patient. The idea applies only to products that have satisfied FDA's premarket requirements, such as a device with premarket approval, 510(k) clearance, or De Novo authorization.

Oxidative preconditioning: The idea that a moderate, controlled oxidative stress makes cells develop an adaptive response, switching on their antioxidant defenses. In a 2011 review, ozone-therapy researchers Sagai and Bocci proposed that ozone therapy may work this way: moderate oxidative stress from ozone would activate Nrf2 and the production of antioxidant enzymes, while severe oxidative stress instead drives inflammation and tissue injury.

Oxidative stress: An imbalance between oxidants and antioxidants in favor of the oxidants, which disrupts redox signaling and control in cells or damages molecules. A 2015 review of the concept notes that the body's main antioxidant defense comes from antioxidant enzymes rather than small-molecule antioxidant compounds, and warns that the term is sometimes used loosely, without a clear link to the underlying chemistry.

Ozonated saline: Saline treated with ozone and given as an intravenous infusion. Ozone-therapy researchers Bocci, Zanardi, and Travagli (2011) wrote that no comparative clinical studies had tested claims that it works like major autohemotherapy, noted that oxidative DNA damage had been found in patients' white blood cells after such infusions, and concluded that its use remains a constant danger.

Ozone (O3): A gas that the FDA regulation 21 CFR 801.415 describes as toxic, with no known useful medical application in specific, adjunctive, or preventive therapy. The regulation says its main effect on the body is irritation of the mucous membranes, that breathing it in can irritate the lungs enough to cause pulmonary edema, and that to kill germs it must be far more concentrated than people can safely tolerate.

Ozone concentration, µg/mL: The amount of ozone in each milliliter of the oxygen/ozone gas mixture, usually reported in micrograms per milliliter. The mixture is mostly oxygen with a small fraction of ozone, and ozone-therapy papers state the doses used to treat blood in these units.

Ozonides: Compounds formed when ozone reacts with unsaturated fatty acids; the form made in the absence of water is called a Criegee ozonide. Ozone-therapy researchers list ozonides among the lipid ozonation products, along with hydroperoxides and aldehydes, that form as ozone reacts with fats, and propose that these products and hydrogen peroxide, rather than ozone itself, carry its effects in the body.

P value: The probability of getting a result at least as large as the one observed if there were really no effect, the so-called null hypothesis. A very small P value means the result is unlikely to be due to chance alone, and values below 0.05 are often called statistically significant. A P value does not show whether an effect is large enough to matter, and a lack of evidence of an effect is not evidence that there is none.

Peer review: The process in which a journal sends a submitted manuscript to experts in the same field, who judge its validity, significance, and originality and suggest improvements before the editors decide whether to publish it. It is meant to filter out weak work and raise the quality of what is published, but it has been criticized as slow, open to bias from editors and reviewers, and a poor screen against plagiarism.

Peripheral artery disease (PAD): Narrowing of arteries outside the heart, most often those supplying the legs, caused by atherosclerosis, the buildup of plaque made of fat and cholesterol. Reduced blood flow can cause leg pain when walking and slow-healing sores and, if severe, tissue death that can lead to amputation, though many people have no symptoms. Smoking is the main risk factor, and PAD raises the risk of heart attack and stroke.

Placebo: A pill or liquid that looks like the treatment being tested but has no treatment value from active ingredients. A clinical trial can assign some participants to a placebo, or to another control, so that the effects of the real treatment can be measured against it.

Plasmapheresis / therapeutic plasma exchange: A form of apheresis in which plasma is separated from the blood cells, by centrifuge or membrane, and removed, taking with it most plasma components, including antibodies and clotting factors; albumin or saline replaces it. A 2023 review reports evidence from many randomized trials supporting it as a first-line treatment for myasthenia gravis crisis and acute Guillain-Barré syndrome.

Post-treatment Lyme disease syndrome (PTLDS): CDC's term for prolonged fatigue, body aches, or difficulty thinking that some people have after antibiotic treatment for Lyme disease; its cause is unknown. CDC discourages the term "chronic Lyme disease" because it implies an ongoing infection, says more antibiotics are unlikely to help, and notes that long-term antibiotic use has been linked to serious, even deadly, complications. Most people improve over time, though it can take months.

Premarket approval (PMA): The FDA's most stringent review for medical devices, required for most high-risk (Class III) devices, such as those that support or sustain human life. The maker must submit sufficient valid scientific evidence, including data from clinical investigations, that the device is safe and effective for its intended use, and must receive FDA approval before selling it. This is the device route that ends in approval; a 510(k) ends in clearance instead.

Preprint: A complete, public draft of a scientific paper, usually written in the style of a journal article but not yet peer reviewed. Scientists post preprints to share results faster, establish priority, get feedback, and offset publication bias. A preprint is not the final version of the work, so its content can still change.

Publication bias: Bias that arises when whether research is published depends on the nature and direction of its results. Cochrane reports convincing evidence that results that are not statistically significant and are unfavorable to the treatment being tested are less likely to be published than significant ones, so systematic reviews find them less easily. Cochrane calls the wider problem non-reporting bias.

Randomized controlled trial (RCT): A study in which participants are assigned by chance either to the treatment being tested or to a comparator, such as another treatment. Done properly, random assignment stops known and unknown factors that predict the outcome, such as how sick someone is, from deciding who gets which treatment, so on average each group starts with the same prognosis.

Reactive oxygen species (ROS): Reactive, oxygen-containing molecules such as superoxide, hydrogen peroxide, and the hydroxyl radical. The body makes them during normal oxygen use and exercise and keeps them in check with antioxidants; they can be toxic but also act as signals that help regulate genes. Ozone-therapy researchers describe ozone reacting with fatty acids in blood to form ROS, including hydrogen peroxide, which they call one of ozone's two main messengers.

Recall classes (Class I, II, III): A recall is an action a company takes, on its own initiative, at FDA's request, or by FDA order, to remove a product from the market. FDA ranks recalls by hazard: Class I means a reasonable probability of serious harm or death; Class II means possible temporary or medically reversible harm, or a remote chance of serious harm; Class III means harm is unlikely. Recall classes are separate from the Class I, II, and III risk classes of medical devices.

Rectal or vaginal ozone insufflation: Introducing an oxygen/ozone gas mixture into a body cavity. Ozone-therapy researchers Bocci, Zanardi, and Travagli (2011) describe rectal insufflation of 200 to 300 mL of gas at up to 35 µg/mL and call its effective dose unpredictable because of gas loss and bowel contents; for infections, 50 to 200 mL at 10 to 15 µg/mL can be insufflated into the vagina, urethra, or bladder.

Red blood cell: The blood cell that carries oxygen from the lungs to every cell in the body, using the iron-rich protein hemoglobin it contains. Red blood cells are made in the bone marrow, and a red blood cell (RBC) count, almost always done as part of a complete blood count, measures how many are in the blood.

Retraction: The withdrawal of a published article, announced in a notice by its authors, their institution, or the journal editor, for reasons such as pervasive error or data that cannot be substantiated or reproduced. PubMed marks retracted articles and does not distinguish honest error from misconduct. Before deciding, an editor may publish an expression of concern while the article's integrity is investigated.

Sham procedure: An imitation of a procedure that mimics the real one but leaves out the element believed to produce its effect, used as the comparison in a trial so participants cannot tell which they received. In a 2014 systematic review of 53 surgical trials with a placebo arm, patients in that arm improved in 39 trials, and in about half the trials the real surgery did no better than the imitation.

Sjögren's disease: A chronic autoimmune disease in which the immune system attacks the glands that make moisture, causing mainly dry eyes and dry mouth; it can also cause joint and muscle pain, dry skin, rashes, numbness, and lasting fatigue. Most people with it are women; it is most common in people in their 40s and 50s and in people with other autoimmune diseases such as rheumatoid arthritis or lupus. There is no single test for it, and treatment focuses on relieving symptoms.

State medical board: The state agency that licenses physicians to practice in that state and disciplines them, with sanctions that can include suspending or revoking a license. In the US, medical licensing is delegated to the states; boards describe their main goal as protecting the public, and discipline, including investigating complaints, is their most resource-intensive work.

Surrogate endpoint: A trial measurement used in place of a direct measure of how patients feel, function, or survive, because it is expected to predict that benefit, as lower blood pressure stands in for fewer strokes. FDA treats a surrogate as validated only after extensive evidence, usually including clinical trials, shows it reliably predicts the benefit; candidate surrogates are still under evaluation.

Systematic review: A review that tries to collect all the research meeting criteria set in advance in order to answer a specific question, using methods that are stated explicitly and chosen to reduce bias. The question and the rules for which studies count are fixed first, every effort is made to find all relevant studies, and bias in the included studies is taken into account before conclusions are drawn.

Thiols: Molecules that contain a sulfhydryl (SH) group, which lets them act as antioxidants by stabilizing free radicals. The amino acids cysteine and methionine are dietary thiols that the body uses to make glutathione, a major internal antioxidant, and a low ratio of reduced to oxidized glutathione is read as a sign of oxidative stress.

Ultrafiltration: Removal of water from blood, along with some dissolved substances, by pushing it across a semipermeable membrane, the way a dialysis filter takes off excess fluid. FDA's rule for high-permeability hemodialyzers rates them by an ultrafiltration coefficient, the milliliters of fluid passed per hour for each millimeter of mercury of pressure, and requires an ultrafiltration controller or other control to prevent fluid imbalance.

Venous access: Placing a needle or catheter into a vein so that blood can be drawn out or returned. In a 2023 paper on ozone dialysis, a form of EBOO, a California clinic describes giving each patient one 20-gauge intravenous catheter in each arm, one for blood to flow out and one for its return.

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# Research bibliography

Source: https://ebo2.com/research/

Cacciatore S, Abbatecola G, Calvani R, Veronese N (2026). Effectiveness and Safety of Ozone Therapy in Humans: An Umbrella Review of Systematic Reviews with Meta-Analyses of Randomized Clinical Trials. Medical Sciences (Basel). https://pubmed.ncbi.nlm.nih.gov/42346828/
Study type: meta-analysis
Finding: Seven meta-analyses (from 1243 records) were included, covering periodontitis, COVID-19, diabetic foot ulcers, and third-molar surgery. Ozone therapy showed no consistent benefit over non-active controls. Safety was inconsistently reported; the one pooled safety analysis found no significant difference in adverse events (RR 2.27; 95% CI 0.48-10.79). Evidence certainty was low or very low.
Limitations: An umbrella review of published meta-analyses without individual patient data; only four indications had eligible reviews, and adverse events were pooled in one of them (three trials). The authors cite possible omission of recent trials, varied ozone routes and doses, and the limited quality of the included reviews: two of seven were rated high confidence on AMSTAR-2.

Casale R, Petrikonis K, Ahmadian A, Bazzichi L, et al. (2026). Oxygen-ozone autohaemotherapy in fibromyalgia: safety profile and adverse events. A scoping review. Clinical and Experimental Rheumatology. https://pubmed.ncbi.nlm.nih.gov/42328943/
Study type: review
Finding: The search found mainly case reports of adverse events: haemolysis and renal failure with ozone above 60 μg/mL, hyperkalaemia, myocardial infarction and ischaemic events, cerebral gas embolism with patent foramen ovale, autonomic reactions to rapid reinfusion, anaphylaxis linked to equipment, and infections from protocol breaches. The authors state incidence cannot be reliably quantified.
Limitations: Scoping review, read from the abstract only. It draws mostly on case reports from mixed clinical populations, covers the last decade and systemic routes only, and the authors state that incidence cannot be reliably quantified given the absence of prospective registries and reliable denominator data.

Clark WR, Lorenzin A, Ronco C (2026). Dialysis membranes and hemodialyzers. Contributions to Nephrology. https://pubmed.ncbi.nlm.nih.gov/42721103/
Study type: review
Finding: A nephrology review of how hollow-fiber hemodialysis membranes are classified by pore size and permeability, and how pore size determines which molecules a filter can remove by convection.
Limitations: Describes dialysis and hemodiafiltration membranes generally, not any EBO2 device specifically, and includes no ozone-related content.

Cortez F, Roncolato E, Machado M, Cubas V (2026). Septic Arthritis of the Shoulder Following Ozone Therapy: A Case Report. Cureus. https://pubmed.ncbi.nlm.nih.gov/41728388/
Study type: case-report; n=1
Finding: After a single ozone therapy session with a physical therapist for two years of right shoulder pain, the patient worsened; 15 days later he had inflammatory signs, a 60 cm³ subcutaneous collection, and bone rarefaction of the clavicle and acromion. Debridement drained pus, and culture grew Staphylococcus aureus. After four weeks of oral antibiotics he had no pain at six weeks or six months.
Limitations: Single case report; the authors state that it does not establish a causal relationship and that patient comorbidities, including HIV, and procedural factors cannot be excluded. The ozone route, injection site, and dose are not reported.

Elmas Dal S (2026). Simultaneous pneumocephalus and meningitis as a complication of ozone therapy. Northern Clinics of Istanbul. https://pubmed.ncbi.nlm.nih.gov/42516792/
Study type: case-report; n=1
Finding: A day after paravertebral ozone injections along the back and lumbar area and into the front of the neck at a private clinic, the patient had headache, fever, vomiting, confusion, and neck stiffness. CT showed air in the left lateral ventricle; cerebrospinal fluid held 4000 leukocytes/mm3, with negative cultures. On empirical antibiotics and dexamethasone the air was gone by day 14; he recovered.
Limitations: Single case report. Cerebrospinal fluid was sampled after antibiotics had begun, and no organism was identified. The author considers a contaminated needle that entered the subarachnoid space the likely cause; no ozone dose, volume, or needle depth is reported, and follow-up ended one week after discharge.

Kuculmez O (2026). Efficacy of major ozone autohemotherapy in patients with post-COVID syndrome. Frontiers in Medicine. https://pubmed.ncbi.nlm.nih.gov/41767530/
Study type: case-series; n=40
Finding: A retrospective review of 40 patients given 10 sessions of major ozone autohemotherapy for post-COVID syndrome found statistically significant improvement in anxiety, depression, fatigue, and quality-of-life scores after treatment.
Limitations: Retrospective single-center chart review with no control group and no blinding; a before-after comparison cannot rule out natural recovery or other concurrent care.

Singh S, Nevarez J (2026). Hyperbaric Oxygen Treatment for Arterial Gas Embolism With Transient Cortical Blindness Following Intravenous Ozone Therapy: A Case Report. Undersea & Hyperbaric Medicine. https://pubmed.ncbi.nlm.nih.gov/42365944/
Study type: case-report; n=1
Finding: After a session of intravenous ozone therapy, a 64-year-old woman had sudden left lower extremity weakness and bilateral vision loss. Initial imaging showed no acute abnormality, but her presentation was consistent with cerebral arterial gas embolism. After hyperbaric oxygen at 2.8 ATA and further sessions at 2.0 ATA, her visual and motor deficits resolved fully.
Limitations: Single case report, read from the abstract only. The gas embolism was a clinical diagnosis, since initial imaging showed no acute abnormality; the abstract gives no ozone dose or volume, no method of intravenous administration, and no number of hyperbaric sessions.

Velluto C, Mazzella GG, Inverso M, Borruto MI, et al. (2026). Spondylodiscitis Following Oxygen-Ozone Therapy: A Case Report of Lactobacillus iners Infection and a Systematic Literature Review. Diseases (Basel). https://pubmed.ncbi.nlm.nih.gov/41892016/
Study type: case-report; n=1
Finding: After five sessions of intradiscal oxygen-ozone in March 2022 for an L4-L5 herniation, pain worsened from July; CRP was 91 mg/L and MRI showed L4-L5 spondylodiscitis. Biopsy identified Lactobacillus iners, and she recovered fully after decompression and intravenous antibiotics. The review found eight earlier cases with varied pathogens; all but one, a death from septic shock, ended favorably.
Limitations: Single case; the authors state that a direct causal link cannot be proven. The review rests on a few case reports, its abstract gives both six included and eight identified cases, and the authors cite incomplete microbiological data and publication bias. The paper's conflict-of-interest section holds a consent sentence rather than a declaration.

Bennett SJ, Kuo J, Wang S, et al. (2025). Observed Reduction in Urinary Toxin Excretion With Extracorporeal Blood Oxygenation and Ozonation (EBOO) Treatment in an 88-Year-Old With Chronic Anemia: A Case Report. Cureus. https://pubmed.ncbi.nlm.nih.gov/41583215/
Study type: case-report; n=1
Finding: Across two series of EBOO treatments, urinary toxin/creatinine ratios declined on average by 64.8% for mycotoxins, 25.7% for heavy metals, and 55.1% for other environmental toxins; nickel was the only toxin with an overall increase from baseline to the end of series II, and hemoglobin stayed largely unchanged.
Limitations: Single-patient case report with no control for ongoing environmental exposure between tests; it cannot establish causation or generalize beyond one patient. All four authors list New York practices (Hudson Health, Hudson Medical Group, Extension Health), and an Extension Health in New York is listed in this site's clinic directory as offering EBO2. The paper declares no conflicts of interest.

Franzini M, Chirumbolo S, Valdenassi L (2025). Haemolysis Generated with the Use of Glass Bottles Instead of PVC, DEHP-Free Blood Collection Bags in the Oxygen-Ozone Therapy. Maedica. https://pubmed.ncbi.nlm.nih.gov/40880716/
Study type: other
Finding: The authors modelled haemolysis, methaemoglobin formation, and inflammation with differential equations, drawing on 25 laboratory experiments (12 DEHP-free PVC bags, 13 glass bottles) and the literature. They report faster red-cell rupture in glass (p = 0.03433) and a higher safety index with plastic bags, and conclude that glass bottles should be phased out of major autohaemotherapy.
Limitations: A self-described commentary based on modelling; no adverse events in patients are reported. The equations and tables appear only as images, the 25 experiments are not described in detail, and the text and a figure caption disagree on how the safety index changes with ozone dose. Two of the three authors are from SIOOT, and the products compared are named brands.

Franzini M, Chirumbolo S, Vaiano F, Valdenassi L, et al. (2025). How Safe Are Oxygen-Ozone Therapy Procedures for Spine Disc Herniation? The SIOOT Protocols for Treating Spine Disorders. Journal of Imaging. https://pubmed.ncbi.nlm.nih.gov/41440568/
Study type: other
Finding: CT of one man showed gas in a lumbar disc minutes after a paravertebral intramuscular oxygen-ozone injection, which the authors attribute to diffusion. A meta-analysis of seven studies gave pain effect sizes of g = -1.55 (intramuscular) and 2.87 (intradiscal), and the authors put severe adverse events at 6.57 times as likely with intradiscal procedures (number needed to harm about 1180).
Limitations: Nine of the 13 authors are from SIOOT, whose intramuscular protocol the paper recommends. The imaging is one patient, and the intradiscal estimate comes from uncontrolled cohorts. The abstract's 120 patients conflicts with Table 1, the text gives intradiscal complication rates of 9.52% and about 0.1%, and the intramuscular rate behind the NNH was back-calculated from the 6.57 ratio.

Franzini M, Vaiano F, Tirelli U, et al. (2025). SIOOT recommendations for the optimal application of the oxygen-ozone therapy in clinical medicine. International Immunopharmacology. https://pubmed.ncbi.nlm.nih.gov/39657536/
Study type: other
Finding: A professional-society position paper arguing that oxygen-ozone therapy needs standardized protocols and physician training, stating that inconsistent practice currently limits safety, efficacy, and reproducibility across the field.
Limitations: A recommendations and position statement from an ozone-therapy society (SIOOT), not a controlled study; reports no new patient outcomes or trial data of its own.

Gante C, Dias L (2025). Ozone-Induced Encephalopathy Following Subcutaneous Ozone Injection: A Case Report. Cureus. https://pubmed.ncbi.nlm.nih.gov/41492606/
Study type: case-report; n=1
Finding: About 10 minutes after a subcutaneous ozone injection at acupuncture points in the face, the patient developed confusion, ataxia, and involuntary limb movements and was intubated. CT was normal; MRI showed transient cortical diffusion abnormalities. Symptoms resolved without specific therapy after 48 hours of ventilation, and a repeat MRI 4 days later was normal.
Limitations: Single case report. The authors state that definitive causality cannot be established; the diagnosis of ozone-induced encephalopathy rests on timing and the exclusion of other causes. No ozone dose or volume is reported, and the patient did not attend the six-month follow-up.

Rundgren H, Sjöholm J, Juric S, et al. (2025). Immunomodulation by extracorporeal ozone-based bactericide system in porcine Pseudomonas aeruginosa septic shock. Scientific Reports. https://pubmed.ncbi.nlm.nih.gov/40562794/
Study type: animal; n=13
Finding: In pigs with P. aeruginosa septic shock (7 ozone, 6 none), one pass through the system cut viable bacteria by 53%, but bacteria in peripheral blood and survival (median 134 vs 159 min) did not differ. IL-1β, IL-4, IL-6, IL-8 and IFN-γ fell with ozonation, complement did not; hemoglobin, hematocrit, noradrenaline doses, breathing rate and peak airway pressure were lower with ozone.
Limitations: Not the EBOO procedure: a prototype that cools blood and mixes it with oxygen-ozone gas, at about 50 mL/min (about 2 L over 4 hours), in pigs. Small 4-hour feasibility study; groups were allocated, not stated as randomized, and with no ozone-free control circuit ozone is not separated from cooling or circuit effects. Funded by Sangair; two authors own or work for Sangair.

Shamohammadi M, Mazraeh M, Tayebi A, Olamaeian F, et al. (2025). Ozone therapy-associated pneumoperitoneum in a patient with low back pain: A case report. International Journal of Surgery Case Reports. https://pubmed.ncbi.nlm.nih.gov/40233642/
Study type: case-report; n=1
Finding: Ten minutes after her second ozone therapy session for lumbar disc herniation the patient developed abdominal pain and distension. X-rays and CT showed free air in the peritoneum and retroperitoneum without free fluid, and blood tests showed no notable abnormalities. She was treated without surgery in intensive care, discharged after five days, and was asymptomatic at one month.
Limitations: Single case report. The authors state that the mechanism is undefined and suggest high-pressure ozone administration or improper instrument insertion. The route, site, ozone concentration, and volume of the session are not reported, and follow-up was one month.

Sitoe EDPE, Pacheco FC, Chilala FD (2025). Advances in ozone technology for preservation of grains and end products: application techniques, control of microbial contaminants, mitigation of mycotoxins, impact on quality, and regulatory approvals. Comprehensive Reviews in Food Science and Food Safety. https://pubmed.ncbi.nlm.nih.gov/40260769/
Study type: review
Finding: A food-science review of how gaseous ozone controls microbes and mycotoxins in stored grain, describing ozone's biocidal mechanism and regulatory approvals for food preservation.
Limitations: Entirely about industrial food and grain preservation, not human medicine or blood therapy; provides no evidence about mycotoxin removal from blood by EBO2 or any ozone therapy.

Wong CYY, Saxena K, Meneer J, George K, et al. (2025). Neurological Crisis Following Intravenous Ozone Therapy; a Case Report. Archives of Academic Emergency Medicine. https://pubmed.ncbi.nlm.nih.gov/40027218/
Study type: case-report; n=1
Finding: Minutes after an intravenous ozone session (autotransfusion of 150 mL of ozone-infused blood with heparin) the patient had chest pain, syncope, and a seizure. MRI showed multiple ischemic infarcts consistent with an embolic event, and echocardiography a small patent foramen ovale. She needed intubation and intensive care; at nine months she still had cognitive difficulties.
Limitations: Single case report: it shows the event followed this procedure, not how often it occurs. Cerebral air embolism was the suspected, not a confirmed, diagnosis, and no ozone concentration is reported. The authors cite delays in diagnosis, limited generalizability to other healthcare settings, and no follow-up beyond 9 months.

de Araújo LT, da Silva PC, Masini M (2024). Medical Ozone as a Therapeutic Option in Musculoskeletal Pain Control: A Critical Review of Clinical Trials Considering Safety and Quality Indicators for Procedures and Devices. Yale Journal of Biology and Medicine. https://pubmed.ncbi.nlm.nih.gov/39351322/
Study type: review
Finding: From 249 records, 27 studies were included, most on low back pain. By the authors' grading, 77.8% of studies had no adverse events, 14.8% mild, 3.7% moderate, and 3.7% serious events, none involving death or disability. Ten studies did not name the ozone generator used. The authors conclude that medical ozone is safe and effective for musculoskeletal pain and call for longer, rigorous trials.
Limitations: A critical review that grades quality indicators but uses no formal risk-of-bias tool. Case reports, case series, and studies with fewer than five participants were excluded, and only Portuguese, Spanish, and English papers were searched. The abstract gives the no-adverse-event share as "77 (8%)" and the text 77.8%. One author works for an ozone-generator maker that paid for the illustrations.

Gianos E, Duell PB, Toth PP, et al. (2024). Lipoprotein apheresis: utility, outcomes, and implementation in clinical practice: a scientific statement from the American Heart Association. Arteriosclerosis, Thrombosis, and Vascular Biology. https://pubmed.ncbi.nlm.nih.gov/39370995/
Study type: review
Finding: An American Heart Association scientific statement on lipoprotein apheresis, an extracorporeal procedure with FDA-approved indications that the authors call a valuable but underused option for lowering LDL cholesterol and lipoprotein(a), reviewing its history, mechanisms, outcomes, and indications.
Limitations: Reviews an established, evidence-graded procedure for cholesterol removal; does not evaluate EBO2 or claim that EBO2's filter achieves comparable, measured lipid removal.

He Y, Liu X, Zha S, et al. (2024). A pilot randomized controlled trial of major ozone autohemotherapy for patients with post-acute sequelae of COVID-19. International Immunopharmacology. https://pubmed.ncbi.nlm.nih.gov/39018686/
Study type: rct; n=73
Finding: In a pilot RCT, 35 patients given major ozone autohemotherapy plus conventional therapy had a higher symptom-score response rate (71%) than 38 given conventional therapy alone (45%), with better walk distance and lung function measures.
Limitations: The authors describe it as a pilot needing validation; tests major autohemotherapy, not EBO2, and the abstract does not describe blinding of outcome assessment.

Khosravi S, Mirzaasgari Z (2024). Cerebral gas embolism and multifocal ischemic stroke during oxygen-ozone therapy: a case report. BMJ Neurology Open. https://pubmed.ncbi.nlm.nih.gov/39720509/
Study type: case-report; n=1
Finding: During a lumbar intradiscal oxygen-ozone injection the patient developed speech disturbance and limb weakness; CT showed multiple cerebral gas bubbles and MRI showed acute infarcts in both hemispheres. Contrast echocardiography suggested a small patent foramen ovale. At 12 months she had no symptoms (Modified Rankin Scale 0).
Limitations: Single case report: it shows the event can occur during this procedure, not how often it occurs or who is at risk. No ozone concentration or injected gas volume is reported, and the authors note that how the gas reaches the arterial circulation is not fully understood.

Migliorini F, Giorgino R, Mazzoleni MG, et al. (2024). Intra-articular injections of ozone versus hyaluronic acid for knee osteoarthritis: a level I meta-analysis. European Journal of Orthopaedic Surgery & Traumatology. https://pubmed.ncbi.nlm.nih.gov/39579218/
Study type: meta-analysis; n=424
Finding: A level-I meta-analysis pooling 424 patients from randomized trials found intra-articular ozone injections produced pain scores (visual analogue scale) statistically similar to hyaluronic acid injections at 4-6 months follow-up.
Limitations: Restricted to studies with 4-6 month follow-up, so longer-term comparative efficacy is unknown; only ozone-versus-hyaluronic-acid comparisons were analyzed, with no placebo arm.

Pan Y, Fang Y, Chen Y, et al. (2023). Associations between particulate matter air pollutants and hospitalization risk for systemic lupus erythematosus: a time-series study from Xi'an, China. Environmental Geochemistry and Health. https://pubmed.ncbi.nlm.nih.gov/36287357/
Study type: other
Finding: A time-series study in Xi'an, China linked fine and coarse particulate matter with increased hospital admissions for systemic lupus erythematosus, while finding no significant association between ambient ozone (O3) and SLE admissions.
Limitations: An ecological, population-level air-pollution study of ambient exposure, not any ozone therapy; cannot show what a controlled medical ozone exposure does in an individual patient.

Rowen RJ, Grabovac S, Su TB (2023). Ozone dialysis delivers three or more times the ozone than other forms of ozone blood treatment. Medical Gas Research. https://pubmed.ncbi.nlm.nih.gov/36204785/
Study type: case-series; n=12
Finding: In 85 measurements on 12 patients receiving ozone dialysis, the authors report an average uptake of 37% of the generator output (range 25-50%) and conclude uptake is at least 3 times higher than other blood-ozone methods, using theoretical delivery figures for those methods.
Limitations: Measurements from one clinic, reported by the technique's own practitioners, with no comparison group and no clinical outcomes; the figures for other methods are theoretical maximums, not measurements. PubMed lists no design type; we call it a case series.

Serra MEG, Baeza-Noci J, Abdala CVM, et al. (2023). Clinical effectiveness of medical ozone therapy in COVID-19: the evidence and gaps map. Medical Gas Research. https://pubmed.ncbi.nlm.nih.gov/37077114/
Study type: review; n=271
Finding: An evidence-and-gaps map of 13 clinical studies (271 patients total) on medical ozone therapy for COVID-19, mostly major or minor autohemotherapy or rectal insufflation in acute, often hospitalized infection.
Limitations: Authored by ozone-therapy society members; maps existing acute-COVID studies rather than long COVID, and includes no EBO2-specific study.

König B, Lahodny J (2022). Ozone high dose therapy (OHT) improves mitochondrial bioenergetics in peripheral blood mononuclear cells. Translational Medicine Communications. https://pubmed.ncbi.nlm.nih.gov/35880042/
Study type: case-series; n=6
Finding: In 6 patients given two 10-pass ozone high-dose therapy (OHT) sessions within a week, a laboratory bioenergetic health index in blood cells improved, driven mainly by increased mitochondrial reserve capacity.
Limitations: Six patients, no control group; a laboratory biomarker rather than a symptom or clinical outcome, co-authored by the technique's own developer. The abstract does not state a specific cumulative ozone dose in micrograms.

Shen W, Liu N, Ji Z, et al. (2022). Combining Ozonated Autohemotherapy with Pharmacological Therapy for Comorbid Insomnia and Myofascial Pain Syndrome: A Prospective Randomized Controlled Study. Pain Research & Management. https://pubmed.ncbi.nlm.nih.gov/37214227/
Study type: rct; n=118
Finding: No adverse complications were observed in either group of this randomized trial, in which 118 patients were randomized and 103 completed follow-up. Compared with the control group, the group given ozonated autohemotherapy with the same drugs had significantly improved sleep quality, pain, and negative mood at different time points.
Limitations: Single-center trial. Controls had blood drawn without ozone and a sham infusion, and only the operator giving the infusions knew each patient's group, but the authors state that double blinding was not used. Of 118 randomized, 103 (50 control, 53 ozone) completed follow-up and are the ones reported. Harms were checked against a list of possible complications, and follow-up ended at 6 months.

Skorup P, Fransson A, Gustavsson J, et al. (2022). Evaluation of an extracorporeal ozone-based bactericide system for the treatment of Escherichia coli sepsis. Intensive Care Medicine Experimental. https://pubmed.ncbi.nlm.nih.gov/35467176/
Study type: animal; n=10
Finding: One pass of E. coli-infected human whole blood through the extracorporeal ozonation prototype lowered viable E. coli by 27% (6 runs). In randomized septic swine (5 ozone, 5 none), 30 minutes of treatment did not change circulatory, respiratory or metabolic measures, bacteria in blood or organs, hemoglobin, leucocytes or methemoglobin; one ozone-group pig died before treatment began.
Limitations: Not the EBOO procedure: a prototype that cools blood and mixes it with oxygen-ozone gas, run for 30 minutes in a 3.5-hour pig sepsis model. Small feasibility study; the in vitro runs had no ozone-free control, and the authors call the model likely too short to detect improvement. Funded by an unrestricted Sangair AB grant; two authors own or work for Sangair.

Valdenassi L, Rossi E, Corsetti MT, et al. (2022). Sjögren syndrome successfully treated with oxygen-ozone auto-hemotherapy (O2-O3-AHT). A case report. European Review for Medical and Pharmacological Sciences. https://pubmed.ncbi.nlm.nih.gov/36066166/
Study type: case-report; n=1
Finding: A 69-year-old woman with primary Sjögren syndrome was given two series of three weekly oxygen-ozone autohemotherapy sessions; the authors report that she improved after two sessions and that her ocular dryness, fatigue, and pain rapidly disappeared.
Limitations: One patient, no control group, and no blinding; cannot separate any ozone effect from the natural course of the disease or other concurrent care. The first and last authors list the Italian Society of Oxygen-Ozone Therapy (SIOOT), four authors a university master's course in oxygen-ozone therapy, and the paper thanks SIOOT staff for technical support.

Wen Q, Liu D, Wang X, et al. (2022). A systematic review of ozone therapy for treating chronically refractory wounds and ulcers. International Wound Journal. https://pubmed.ncbi.nlm.nih.gov/34612569/
Study type: meta-analysis
Finding: Pooling 12 randomized trials of topical or systemic ozone therapy for chronic wounds, this review found ozone accelerated wound-area improvement and reduced amputation rate for diabetic foot ulcers versus standard care, though complete wound healing rates and hospital stay did not differ, with no reported adverse events attributed to ozone across included studies.
Limitations: Included trials varied widely in ozone delivery method and wound type; the authors state evidence for wound types other than diabetic foot ulcers remains uncertain due to insufficient studies.

Haggiag S, Prosperini L, Stasolla A, Gerace C, et al. (2021). Ozone-induced encephalopathy: A novel iatrogenic entity. European Journal of Neurology. https://pubmed.ncbi.nlm.nih.gov/33657263/
Study type: case-series; n=3
Finding: Three patients had neurological symptoms immediately or 5 minutes after cervical or lumbar ozone therapy, among them loss of consciousness, cortical blindness, visual impairment, and vertigo. Brain MRI was normal except a subtle cerebellar change on one follow-up scan; two had a patent foramen ovale. All recovered fully within 48 hours. The authors found eight more cases in the literature.
Limitations: Three cases, read from the abstract only. The authors describe the findings as suggestive of ozone-induced encephalopathy, a term they introduce, and state that it likely has a complex pathogenesis; the abstract gives no ozone doses or volumes and no follow-up beyond recovery within 48 hours.

Mehdi MM, Solanki P, Singh P (2021). Oxidative stress, antioxidants, hormesis and calorie restriction: the current perspective in the biology of aging. Archives of Gerontology and Geriatrics. https://pubmed.ncbi.nlm.nih.gov/33845417/
Study type: review
Finding: A narrative review of how oxidative stress, antioxidant defenses, and hormesis (a low-dose stress producing a protective response) are theorized to shape biological aging.
Limitations: A general biology-of-aging review with no mention of ozone or EBO2; describes hormesis as a broad concept, not evidence that any ozone procedure slows aging.

Salaria AK, Dhatt SS, Kumar V, Neradi D, et al. (2021). Mycobacterium tuberculosis Infection of the Spine Secondary to Oxygen - Ozone Therapy for Prolapse Intervertebral Disc: A Scoping Review. Journal of Orthopaedic Case Reports. https://pubmed.ncbi.nlm.nih.gov/35437492/
Study type: case-report; n=1
Finding: After intradiscal instillation of 30% ozone (20 ml) with a steroid at L3/L4 and L4/L5, pain returned within 10 days. After 3 months of progressive symptoms she had fever, weight loss, and pre- and paravertebral and epidural collections reaching both psoas muscles, with aspiration cytology positive for acid-fast bacilli. On anti-tuberculosis treatment, MRI at 6 months showed partial healing.
Limitations: Single case report; the infection is linked to the injection by its history and timing. Tuberculosis was diagnosed from a positive acid-fast stain, and no culture result is reported. Although titled a scoping review, the paper describes no search method, and the patient was still under follow-up on treatment at the time of writing.

Tahmasebi S, Qasim MT, Krivenkova MV, et al. (2021). The effects of oxygen-ozone therapy on regulatory T-cell responses in multiple sclerosis patients. Cell Biology International. https://pubmed.ncbi.nlm.nih.gov/33724614/
Study type: case-series; n=20
Finding: In 20 relapsing-remitting MS patients treated with ozone autohemotherapy twice weekly for 6 months, regulatory T-cell frequency and related anti-inflammatory markers (FoxP3, IL-10, TGF-beta) rose after treatment compared with before.
Limitations: Single-arm before-after design with no untreated control group and no blinding; measures a laboratory immune marker, not a clinical disability or symptom outcome.

Tirelli U, Franzini M, Valdenassi L, et al. (2021). Fatigue in post-acute sequelae of SARS-CoV2 (PASC) treated with oxygen-ozone autohemotherapy, preliminary results on 100 patients. European Review for Medical and Pharmacological Sciences. https://pubmed.ncbi.nlm.nih.gov/34604980/
Study type: case-series; n=100
Finding: In 100 patients with post-COVID fatigue, a preliminary, uncontrolled series of oxygen-ozone autohemotherapy reported reduced fatigue scores after treatment.
Limitations: No comparison group, so how much of the change would have occurred anyway cannot be determined; preliminary results from ozone-therapy society-affiliated authors.

Bingham A, Platt M (2020). A Non-ST Elevation Myocardial Infarction Associated with Alternative Medicine Ozone Infusion. Journal of Emergency Medicine. https://pubmed.ncbi.nlm.nih.gov/31708316/
Study type: case-report; n=1
Finding: After an ozone infusion (her blood drawn, ozone gas injected into it, and the blood transfused back intravenously), a 50-year-old woman had syncope. Her first electrocardiogram showed no infarction or ischemia, but troponin I was elevated and rising; she was admitted with a non-ST elevation myocardial infarction, which the authors associate with oxidative myocardial stress from ozone.
Limitations: Single case report, read from the abstract only. The abstract gives no ozone concentration, gas or blood volume, or findings of the cardiac evaluation, and it shows the event followed this procedure, not how often it occurs.

Izadi M, Tahmasebi S, Pustokhina I, et al. (2020). Changes in Th17 cells frequency and function after ozone therapy used to treat multiple sclerosis patients. Multiple Sclerosis and Related Disorders. https://pubmed.ncbi.nlm.nih.gov/32862036/
Study type: case-series; n=20
Finding: In 20 MS patients, the authors' own "non-controlled study" found ozone autohemotherapy lowered the frequency of pro-inflammatory Th17 cells and related markers after treatment compared with before.
Limitations: The authors describe it as non-controlled; a before-after comparison in one treated group measuring a laboratory immune marker rather than disability or symptom outcomes.

Re L, Noci JB, Gadelha Serra ME, Mollica P, et al. (2020). Safety, pitfalls, and misunderstandings about the use of ozone therapy as a regenerative medicine tool. A narrative review. Journal of Biological Regulators and Homeostatic Agents. https://pubmed.ncbi.nlm.nih.gov/33176412/
Study type: review
Finding: Discussing published case reports of adverse reactions attributed to ozone therapy, by technique of administration, the authors state that most safety issues are secondary to infections or traumatic reactions due to malpractice, and that the ozone molecule itself is commonly not responsible for severe reactions under the therapeutic modalities.
Limitations: Narrative review, read from the abstract only. The abstract states no search method, number of reports reviewed, or event counts, and gives no counted figures for its statement that the millions of patients treated worldwide over 40 years demonstrate the therapy's safety.

Scassellati C, Galoforo AC, Bonvicini C, et al. (2020). Ozone: a natural bioactive molecule with antioxidant property as potential new strategy in aging and in neurodegenerative disorders. Ageing Research Reviews. https://pubmed.ncbi.nlm.nih.gov/32810649/
Study type: review
Finding: A review arguing that ozone, through the Nrf2 antioxidant system, could be a new strategy in aging and to delay neurodegeneration. Through what it calls a meta-analytic approach, it reports significant modulation by ozone of endogenous antioxidant-Nrf2 (OR 1.71) and vitagene-Nrf2 (OR 1.80) systems.
Limitations: A hypothesis-generating review, not a clinical trial. Its pooled odds ratios combine before-and-after marker levels, from human studies for the antioxidant markers and from human, animal, and cell samples for the vitagene markers, with high heterogeneity (I² 97% and 66%); no human outcome links ozone to slower aging. One of its two co-first authors lists the ozone-therapy society SIOOT.

Shahi PB, Panigrahi V, Adsul N, Kumar M, et al. (2020). Mycobacterium abscessus mimicking tubercular spondylodiscitis following ozone therapy: A case report and review of literature. Surgical Neurology International. https://pubmed.ncbi.nlm.nih.gov/32363058/
Study type: case-report; n=1
Finding: Three months after a fluoroscopically guided percutaneous ozone treatment at L4-L5, the patient had severe back pain, radiculopathy in both legs, a partial right foot drop, and raised CRP and ESR; MRI showed L4-L5 spondylodiscitis. Mycobacterium abscessus grew from epidural pus taken at fusion surgery. After a later wound debridement she was treated with amikacin and clarithromycin.
Limitations: Single case report; the infection is linked to the ozone treatment by its timing. The ozone dose, volume, and technique are not reported. The abstract and the case text describe the antibiotic course differently, and the case text gives no length of follow-up and no outcome beyond resolution of the primary infection.

Chirchiglia D, Chirchiglia P, Stroscio C, Volpentesta G, et al. (2019). Suspected Pulmonary Embolism after Oxygen-Ozone Therapy for Low Back Pain. Journal of Neurological Surgery Part A: Central European Neurosurgery. https://pubmed.ncbi.nlm.nih.gov/31430795/
Study type: case-report; n=1
Finding: An elderly woman treated with oxygen-ozone therapy for lumbar pain from a disk protrusion had a suspected pulmonary embolism followed by sudden death. The authors believe a massive pulmonary embolism occurred, probably caused by an intradiskal injection that accidentally punctured a venous vessel and created emboli.
Limitations: Single case report, read from the abstract only. The embolism is described as suspected and its cause as the authors' belief; the abstract gives no age beyond "elderly", no ozone dose or volume, and no timing, and does not say how the diagnosis was investigated.

Freund PR, Alshafai L, Margolin EA (2019). Multifocal Stroke From Ozone Gas Emboli. Journal of Neuro-Ophthalmology. https://pubmed.ncbi.nlm.nih.gov/30741783/
Study type: case-report; n=1
Finding: After his last cervical paravertebral ozone injection, a 34-year-old man treated regularly with such injections for chronic neck pain had a syncopal episode and woke with ataxia, aphasia, hemiparesis, and a left sixth nerve palsy. CT angiography showed gas inside the right vertebral artery, and brain MRI showed multiple posterior circulation infarcts.
Limitations: Single case report, read from a four-sentence abstract only. The abstract gives no ozone dose or volume, number of injections, treatment of the stroke, or outcome, and it shows the event occurred, not how often it occurs.

He R, Huang Q, Yan X, Liu Y, et al. (2019). A Case of Paradoxical Embolism Causing Anterior Spinal Cord Syndrome and Acute Myocardial Infarction Following the Intradiscal Oxygen-Ozone Therapy. Frontiers in Neurology. https://pubmed.ncbi.nlm.nih.gov/30853936/
Study type: case-report; n=1
Finding: During a CT-guided intradiscal oxygen-ozone injection, after 8 ml of gas, the patient developed flaccid paralysis of both legs, then chest pain with ST elevation; coronary angiography found no vascular abnormality. MRI showed a thoracic cord lesion from T2 to T10, and contrast echocardiography a large patent foramen ovale. At nine months she could stand with a cane.
Limitations: Single case report. The authors judge air embolism through a patent foramen ovale the most likely cause after excluding other causes; the gas itself was not imaged. No ozone concentration is reported, and the abstract and case text give different times for the onset of chest pain.

Rowen RJ (2019). Ozone and oxidation therapies as a solution to the emerging crisis in infectious disease management: a review of current knowledge and experience. Medical Gas Research. https://pubmed.ncbi.nlm.nih.gov/31898609/
Study type: review
Finding: A narrative review arguing ozone therapy could serve as an adjunctive or stand-alone treatment for drug-resistant infections and outbreaks such as Ebola, describing it as having a strong safety record.
Limitations: A single author's advocacy-oriented narrative review with no systematic search or new controlled data, and no study of ozone against Borrelia or Lyme disease specifically.

Beyaz SG, Altaş C, Sayhan H (2018). Cardiopulmonary Arrest and Pneumoencephaly Developing after Epidural Oxygen-ozone Mixture Therapy. Anesthesia, Essays and Researches. https://pubmed.ncbi.nlm.nih.gov/29628600/
Study type: case-report; n=1
Finding: On the second day of planned epidural oxygen-ozone injections through a Racz catheter, 20 mL (20 μg/mL) was injected instead of the planned 8 mL. Two minutes later the patient lost consciousness and had a cardiopulmonary arrest; sinus rhythm returned after 10 minutes of resuscitation. CT showed widespread intracranial air, which had resolved by day 7. She was extubated on day 4 and discharged.
Limitations: Single case report. The authors infer from the timing and the imaging that the mixture reached the cranium through the intrathecal route, possibly after the catheter injured the dura. The event followed an accidental injection of 20 mL instead of the planned 8 mL, and no follow-up after discharge is reported.

Niu T, Lv C, Yi G, et al. (2018). Therapeutic Effect of Medical Ozone on Lumbar Disc Herniation. Medical Science Monitor. https://pubmed.ncbi.nlm.nih.gov/29611536/
Study type: rct; n=80
Finding: In 80 patients randomized to control or low, medium (40 ug/mL), or high (60 ug/mL) concentrations of medical ozone, the medium concentration produced the greatest disc retraction and reduced inflammatory markers, while the highest concentration increased inflammatory marker expression instead of reducing it.
Limitations: Single-center trial; the abstract does not describe blinding; biochemical and imaging surrogate endpoints are emphasized alongside clinical pain scores.

Tang WJ, Jiang L, Wang Y, et al. (2017). Ozone therapy induced sinus arrest in a hypertensive patient with chronic kidney disease: A case report. Medicine (Baltimore). https://pubmed.ncbi.nlm.nih.gov/29390373/
Study type: case-report; n=1
Finding: A patient using ozone autohemotherapy for hypertension and diabetes developed sudden dizziness from hyperkalemia that progressed to sinus arrest; the arrhythmia resolved after stopping ozone therapy and treating the hyperkalemia.
Limitations: Single case report; the association between ozone autohemotherapy and hyperkalemia-induced sinus arrest is based on temporal sequence, not confirmed mechanistic causation.

Andrés-Cano P, Vela T, Cano C, García G, et al. (2016). Cervical Spondylodiscitis After Oxygen-Ozone Therapy for Treatment of a Cervical Disc Herniation: a Case Report and Review of the Literature. HSS Journal. https://pubmed.ncbi.nlm.nih.gov/27703423/
Study type: case-report; n=1
Finding: Ten days after C6-C7 intradiscal oxygen-ozone chemonucleolysis, the patient had severe sepsis from C6-C7 spondylodiscitis, with an epidural abscess from C4 to T1 compressing the cord. Beta-hemolytic streptococcus grew, and the authors suspect a puncture through the esophagus. After drainage, laminectomies, and two fusions for kyphosis and non-union, she was satisfied at 1 year.
Limitations: Single case report from 2005. The route of contamination, a transesophageal puncture, is the authors' inference from the organism found, and the procedure details come from the patient's account; the ozone concentration and volume used at the outside hospital are not reported. The literature review is narrative, without a stated search method.

Tsuzuki N, Endo Y, Kikkawa L, et al. (2016). Effects of ozonated autohemotherapy on the antioxidant capacity of Thoroughbred horses. Journal of Veterinary Medical Science. https://pubmed.ncbi.nlm.nih.gov/26166812/
Study type: animal; n=10
Finding: In 10 non-race Thoroughbred geldings, each used as its own control, ozonated autohemotherapy was followed by a higher biological antioxidant potential at 3 and 7 days and a lower oxidative stress index; the reactive-oxygen-metabolite marker did not differ, and the antioxidant change was no longer measurable at 14 days.
Limitations: Animal study in ten horses, not humans; each horse served as its own control; measures blood antioxidant markers rather than any disease outcome, and does not test EBO2's continuous-filtration circuit.

Vaiano AS, Valente C, De Benedetti G, Caramello G (2016). Transient cortical blindness after intradiscal oxygen-ozone therapy. Indian Journal of Ophthalmology. https://pubmed.ncbi.nlm.nih.gov/28112142/
Study type: case-report; n=1
Finding: About one minute after an L5-S1 oxygen-ozone injection (4 ml intradiscal and 11 ml periganglionic; ozone 27 μg/mL) the patient lost vision in both eyes, followed by headache and vomiting. MRI showed ischemic lesions in both posterior cerebral artery territories, and transesophageal echocardiography a large patent foramen ovale. Vision recovered fully by day 9 and was normal at 2 months.
Limitations: Single case report: it shows the event can follow this procedure, not how often it occurs. The authors consider air embolism through a patent foramen ovale the most likely cause but state that the pathophysiology remains elusive; the diagnosis rests on clinical findings and timing, and they also list an incidental stroke unrelated to the procedure as possible.

Vanni D, Galzio R, Kazakova A, Pantalone A, et al. (2016). Intraforaminal ozone therapy and particular side effects: preliminary results and early warning. Acta Neurochirurgica. https://pubmed.ncbi.nlm.nih.gov/26293228/
Study type: case-series; n=186
Finding: During lumbar microsurgery in 186 patients, surgeons found hard adhesions between soft tissues and bone, with the nerve root contracted and firmly adherent to the dural sac or disc fragments, only in the group previously given intraforaminal ozone (23 patients, treated elsewhere 12 to 24 months earlier). Patients with no injections or with intraforaminal steroids showed no such abnormalities.
Limitations: Surgical series reported as preliminary results, read from the abstract only. The abstract does not give the size of the no-injection group, how many of the 23 ozone-treated patients had adhesions, whether the surgeons knew each patient's treatment history, or the ozone concentration and volume used.

Liu J, Zhang P, Tian J, et al. (2015). Ozone therapy for treating foot ulcers in people with diabetes. Cochrane Database of Systematic Reviews. https://pubmed.ncbi.nlm.nih.gov/26505864/
Study type: meta-analysis; n=212
Finding: This Cochrane review pooled 3 small randomized trials (212 participants): one found greater ulcer-area reduction and shorter hospitalization with ozone versus antibiotics, but pooled analysis of the other two found no significant difference from usual care in ulcer healing, adverse events, or amputation rate.
Limitations: Only three included trials, all judged at high or unclear risk of bias; the review authors conclude they are unable to draw any firm conclusions about effectiveness.

Üreyen CM, Baş CY, Arslan Ş (2015). Myocardial Infarction after Ozone Therapy: Is Ozone Therapy Dr. Jekyll or Mr. Hyde?. Cardiology. https://pubmed.ncbi.nlm.nih.gov/26139204/
Study type: case-report; n=1
Finding: A 46-year-old man without traditional atherosclerotic risk factors presented with acute inferior myocardial infarction after ozonated autohemotherapy at a private clinic that morning. Angiography showed vasospasm of the left main and proximal left anterior descending arteries, which resolved after nitrate, and a thrombotic total occlusion of the right coronary artery, which was stented.
Limitations: Single case report, read from the abstract only. The authors present ozone as a possible cause, supported by timing and the literature they refer to; the abstract gives no ozone dose, blood volume, or follow-up, and it shows the event occurred, not how often it occurs.

Paoli A, Bianco A, Battaglia G, et al. (2013). Sports massage with ozonised oil or non-ozonised oil: comparative effects on recovery parameters after maximal effort in cyclists. Physical Therapy in Sport. https://pubmed.ncbi.nlm.nih.gov/23623301/
Study type: controlled-trial; n=15
Finding: In a within-subject comparison of 15 cyclists, sports massage with ozonised oil produced higher peak power and lower perceived fatigue after fatiguing exercise than massage without ozone or passive rest.
Limitations: Topical ozonised massage oil, not autohemotherapy or EBO2; a small single-center sample measuring short-term performance rather than any clinical outcome.

Borrelli E, Diadori A, Zalaffi A, et al. (2012). Effects of major ozonated autohemotherapy in the treatment of dry age related macular degeneration: a randomized controlled clinical study. International Journal of Ophthalmology. https://pubmed.ncbi.nlm.nih.gov/23275905/
Study type: rct; n=140
Finding: An open randomized trial of 140 patients compared 27 major ozonated autohemotherapy sessions over 12 months with multivitamins. The primary outcome, mean logMAR acuity change, did not differ significantly between groups (Table 3a). The abstract reports no acuity loss in treated eyes against 16% and 40% of controls losing 2 or more lines at 6 and 12 months, and higher plasma antioxidant potential.
Limitations: An open trial: by the authors' own description, neither the patients nor the investigator were blinded. The paper's Table 3a marks every comparison of the primary logMAR outcome as not significant, which the abstract does not mention; the line-loss percentages in the abstract are a secondary outcome. The senior author, Velio Bocci, was a leading proponent of ozone therapy.

Magalhaes FN, Dotta L, Sasse A, et al. (2012). Ozone therapy as a treatment for low back pain secondary to herniated disc: a systematic review and meta-analysis of randomized controlled trials. Pain Physician. https://pubmed.ncbi.nlm.nih.gov/22430658/
Study type: meta-analysis
Finding: A systematic review of 8 observational studies and meta-analysis of 4 randomized trials found percutaneous ozone injection (intradiscal or paravertebral) associated with positive pain outcomes and low morbidity, graded as evidence level II-1 to II-3 depending on route of injection.
Limitations: The authors themselves note a lack of precise diagnostic criteria and frequent use of mixed therapeutic agents across studies, that included trials were mainly active-control, and that no placebo-controlled trial was found.

Uzun G, Mutluoğlu M, Karagöz H, Memiş A, et al. (2012). Pitfalls of Intralesional Ozone Injection in Diabetic Foot Ulcers: A Case Study. Journal of the American College of Clinical Wound Specialists. https://pubmed.ncbi.nlm.nih.gov/26199878/
Study type: case-report; n=1
Finding: After a week of topical ozone and major autohemotherapy failed, a physician at an ozone therapy center injected ozone into a 1 x 2 cm toe ulcer. After the second daily injection redness spread to the sole, and within two days the forefoot was necrotic. Healing took debridement, intravenous antibiotics, hyperbaric oxygen, a failed skin graft with fourth-toe amputation, and a great-toe fillet flap.
Limitations: Single case report. The ozone concentration and volume of the injections are not reported. The ulcer already had surrounding erythema and swelling before the ozone treatments, and glycemic control was poor on admission (HbA1c 11%). The last reported follow-up was at two months.

Elvis AM, Ekta JS (2011). Ozone therapy: a clinical review. Journal of Natural Science, Biology, and Medicine. https://pubmed.ncbi.nlm.nih.gov/22470237/
Study type: review
Finding: A general clinical review describing ozone's history, proposed mechanisms (antimicrobial action, immune stimulation), application methods, and the diseases it says ozone treats, from infected wounds and circulatory disorders to cancer, SARS, and AIDS.
Limitations: A broad narrative review without a systematic search or a stated evidence grade for the conditions it lists; does not address EBO2 specifically.

Onishchenko AL, Kolbasko AV, Chernysheva AD, et al. (2011). Plasmapheresis combined with cell mass ozonation in endogenous uveitis treatment. Vestnik Oftalmologii. https://pubmed.ncbi.nlm.nih.gov/22442992/
Study type: other; n=179
Finding: Analyzing treatment results in 3 patient groups (179 patients, 209 eyes) with endogenous uveitis, the authors report an advantage for their modification of plasmapheresis combined with ozonation of the cell mass, and describe effects such as correction of T-cell immunodeficiency and a decrease of circulating immune complexes. The abstract gives no figures.
Limitations: Abstract only (PubMed lists an English abstract for a non-English article). The abstract does not say how patients were assigned to the 3 groups, what the comparison groups received, the ozone dose, the follow-up, or any numeric result. Not the EBOO procedure: ozone is applied to the cell mass during plasmapheresis.

Steppan J, Meaders T, Muto M, Murphy KJ (2010). A metaanalysis of the effectiveness and safety of ozone treatments for herniated lumbar discs. Journal of Vascular and Interventional Radiology. https://pubmed.ncbi.nlm.nih.gov/20188591/
Study type: meta-analysis
Finding: The likelihood of complications was 0.064% in random-effects meta-analyses of 12 studies of oxygen/ozone covering almost 8,000 patients. The mean improvement was 3.9 on the visual analog scale and 25.7 on the Oswestry Disability Index, and the likelihood of improvement on the modified MacNab scale was 79.7%. The authors conclude that pain and function outcomes are similar to surgical discectomy.
Limitations: Read from the abstract only. The pooled figures describe ozone-treated patients, and the abstract reports no pooled comparison with a control group. The 12 studies were weighted by a study quality score; the abstract does not say how many were randomized or how complications were defined and recorded.

Travagli V, Zanardi I, Gabbrielli A, et al. (2010). Are dialysis devices usable as ozone gas exchangers?. Artificial Organs. https://pubmed.ncbi.nlm.nih.gov/19817737/
Study type: in-vitro
Finding: Comparing ozone transfer in four hydrophilic dialysis filters and one hydrophobic gas-exchange device, the authors report filter yields from 0 to 70%, often varying with treatment time, and filter fibers somewhat altered by ozone under scanning microscopy. They state the filters may release toxic compounds, while the gas-exchange device was efficient and ozone-resistant.
Limitations: Bench comparison of devices, not the EBOO procedure as given to patients, and no clinical outcomes. The abstract names neither the filters nor the fluid tested, and the release of toxic compounds is stated as a possibility, not a measurement. Abstract only.

Bocci V, Borrelli E, Travagli V, et al. (2009). The ozone paradox: ozone is a strong oxidant as well as a medical drug. Medicinal Research Reviews. https://pubmed.ncbi.nlm.nih.gov/19260079/
Study type: review
Finding: Explains that prolonged ozone inhalation is toxic to the lungs and body, whereas a single, precisely calibrated ozone dose dissolved in blood ex vivo triggers antioxidant and biochemical responses in blood cells and endothelium that the authors describe as therapeutically useful without toxicity in selected diseases.
Limitations: Narrative review by long-time ozone-therapy proponents that synthesizes prior mechanistic work rather than presenting new controlled data.

Bocci V, Zanardi I, Travagli V, et al. (2007). Oxygenation-ozonation of blood during extracorporeal circulation: in vitro efficiency of a new gas exchange device. Artificial Organs. https://pubmed.ncbi.nlm.nih.gov/17725702/
Study type: in-vitro
Finding: Bench testing of a new hollow-fiber gas exchange device (L001) for EBOO, using a buffered saline solution containing KI rather than blood, showed efficient gas transfer with minimal foreign surface contact and negligible priming volume across the tested parameters.
Limitations: In vitro test on a saline solution, not blood or patients, with no clinical outcomes; PubMed lists no study-design publication type, so "in vitro" is inferred from the described bench methodology; authored by the EBOO technique's developers.

Gazzeri R, Galarza M, Neroni M, Esposito S, et al. (2007). Fulminating septicemia secondary to oxygen-ozone therapy for lumbar disc herniation: case report. Spine. https://pubmed.ncbi.nlm.nih.gov/17268255/
Study type: case-report; n=1
Finding: Three days after admission to hospital, a 57-year-old man previously treated with oxygen-ozone therapy for lumbar disc herniation developed fulminant septicemia. CT and blood culture showed pyogenic involvement of the lumbar muscles with septic pulmonary embolism from Escherichia coli infection. The authors describe the complication as fatal.
Limitations: Single case report, read from the abstract only. The abstract does not state the route, number, or timing of the oxygen-ozone treatments, the ozone dose, or how and when the patient died, and it shows the event occurred, not how often it occurs.

Di Paolo N, Gaggiotti E, Galli F (2005). Extracorporeal blood oxygenation and ozonation: clinical and biological implications of ozone therapy. Redox Report. https://pubmed.ncbi.nlm.nih.gov/16156950/
Study type: review
Finding: Describes EBOO as run on a high-efficiency apparatus that treats up to 4,800 ml of heparinized blood in 1 h with an oxygen-ozone mixture (0.5-1 microg/ml oxygen), against 250 ml by autohemotherapy, in a standard cycle of 14 one-hour sessions over 7 weeks. The authors report more than 1,200 treatments in 82 patients and state their experience confirms therapeutic potential.
Limitations: Narrative review from the Siena nephrology and dialysis department, the group behind the EBOO papers in this library. The abstract reports no controlled outcome data, and the clinical statements are the authors' own. Read from the abstract only.

Di Paolo N, Bocci V, Salvo DP, et al. (2005). Extracorporeal blood oxygenation and ozonation (EBOO): a controlled trial in patients with peripheral artery disease. International Journal of Artificial Organs. https://pubmed.ncbi.nlm.nih.gov/16288443/
Study type: rct; n=28
Finding: In 28 patients with peripheral artery disease randomized to EBOO or intravenous prostacyclin, the abstract reports highly significant regression of skin lesions with EBOO, and says pain, pruritus, heavy legs and well-being differed significantly between the two groups; it found no significant change in vascularisation of the lower limbs before and after treatment in either group.
Limitations: Small sample of 28 patients from a single Italian center; the available abstract does not describe blinding of outcome assessment or the randomization method.

Faustini A, Capobianchi MR, Martinelli M, Abbate I, et al. (2005). A cluster of hepatitis C virus infections associated with ozone-enriched transfusion of autologous blood in Rome, Italy. Infection Control and Hospital Epidemiology. https://pubmed.ncbi.nlm.nih.gov/16209382/
Study type: cohort; n=31
Finding: Of 31 participating patients, six were positive for HCV antibodies and HCV RNA, a prevalence of 19.4% against an estimated 0.9% in the population, and three (9.7%) had symptoms of HCV infection. One of the six had been known to be infected since 1986 and could have been the source. All infected patients had received ozone-enriched transfusions of autologous blood.
Limitations: Retrospective investigation of one outbreak at one outpatient department, read from the abstract only. Of the 42 exposed patients, 31 took part, and the authors state that the specific mode of transmission between patients was not detected.

Bocci V (2004). Ozone as Janus: this controversial gas can be either toxic or medically useful. Mediators of Inflammation. https://pubmed.ncbi.nlm.nih.gov/15203558/
Study type: review
Finding: Argues that ozone, though intrinsically toxic as an inhaled gas, produces a cascade of ozone-derived compounds when dissolved in blood at judicious, physician-controlled doses, yielding multifactorial beneficial effects in infections, vasculopathies, and orthopedic and dental conditions.
Limitations: Single-author narrative review without a systematic search methodology or quantitative synthesis of the underlying evidence.

Corea F, Amici S, Murgia N, Tambasco N (2004). A case of vertebrobasilar stroke during oxygen-ozone therapy. Journal of Stroke and Cerebrovascular Diseases. https://pubmed.ncbi.nlm.nih.gov/17903984/
Study type: case-report; n=1
Finding: The authors report what they describe as the first case of stroke during medical oxygen-ozone therapy, which the abstract discusses as combined intradiscal and periganglionic injection for lumbar disk herniation. The patient had Anton's syndrome as a result of hypoperfusion at the top of the basilar artery.
Limitations: Single case report, read from a four-sentence abstract only. The abstract does not state the patient's age or sex, the injection route or ozone dose, the timing of the stroke, or the outcome.

Lo Giudice G, Valdi F, Gismondi M, Prosdocimo G, et al. (2004). Acute bilateral vitreo-retinal hemorrhages following oxygen-ozone therapy for lumbar disk herniation. American Journal of Ophthalmology. https://pubmed.ncbi.nlm.nih.gov/15234314/
Study type: case-report; n=1
Finding: After intradiscal and periganglionic injection of an oxygen-ozone mixture for lumbar disk herniation, a 45-year-old woman had acute visual loss in both eyes: a premacular hemorrhage involving the left macula and multiple flat retinal hemorrhages in the right eye. MRI showed no intracranial hemorrhage; the left premacular hemorrhage was drained with Nd:YAG laser a few weeks later.
Limitations: Single case report, read from the abstract only. The abstract gives no ozone concentration or volume, no visual acuity before or after treatment, and no length of follow-up, and it shows the event occurred, not how often it occurs.

Tylicki L, Biedunkiewicz B, Rachon D, et al. (2004). No effects of ozonated autohemotherapy on inflammation response in hemodialyzed patients. Mediators of Inflammation. https://pubmed.ncbi.nlm.nih.gov/15770057/
Study type: controlled-trial; n=12
Finding: In a controlled, single-blind, cross-over study of 12 hemodialysis patients, nine sessions of ozonated autohemotherapy produced no significant change in plasma C-reactive protein or interleukin-6 compared with nine sham (oxygen-only) autohemotherapy sessions.
Limitations: Small sample of 12 patients in a single crossover study; a null result for these two inflammatory markers does not rule out other biological effects of ozone.

Di Paolo N, Bocci V, Cappelletti F, et al. (2002). Necrotizing fasciitis successfully treated with extracorporeal blood oxygenation and ozonization (EBOO). International Journal of Artificial Organs. https://pubmed.ncbi.nlm.nih.gov/12518965/
Study type: case-report; n=1
Finding: A dialysis patient with necrotizing fasciitis who had not improved with traditional therapies improved radically after treatment with EBOO, which the authors describe as already used routinely at their hospital.
Limitations: Single case report from the technique's own developers, read from a four-sentence abstract only. That abstract gives no outcome measure, follow-up, or procedure details such as the number of sessions or the ozone dose, and the case has no control patient.

Bocci V, Di Paolo N, Borrelli E, et al. (2001). Ozonation of blood during extracorporeal circulation. II. Comparative analysis of several oxygenator-ozonators and selection of one type. International Journal of Artificial Organs. https://pubmed.ncbi.nlm.nih.gov/11831595/
Study type: in-vitro
Finding: Comparing devices for exposing human blood to oxygen-ozone ex vivo, the authors found dialysis membranes unsuitable (all but one gas-transfer inefficient, allowing ultrafiltration, ozone-vulnerable) and improperly coated polypropylene fibers prone to platelet aggregation and clotting, prohibitive with ozone. Newer biocompatible oxygenators could treat up to 5 L of blood in about an hour.
Limitations: Bench comparison of devices with human blood ex vivo, not the EBOO procedure as given to patients, and no clinical outcomes. The abstract names neither the devices compared nor the one selected, and gives no numeric results. Abstract only.

Di Paolo N, Bocci V, Garosi G, et al. (2000). Extracorporeal blood oxygenation and ozonation (EBOO) in man. preliminary report. International Journal of Artificial Organs. https://pubmed.ncbi.nlm.nih.gov/10741810/
Study type: case-series
Finding: In the first human use of the EBOO apparatus, an author who volunteered to test the system noted disappearance of two lipomas after six treatments; the device was then used in a patient with Madelung disease and several patients with atherosclerotic vasculopathy. The authors state the preliminary results show therapeutic effects and no side effects.
Limitations: Uncontrolled preliminary case series performed by the device's own inventors, including self-experimentation; no blinding, randomization, or precisely reported total sample size.

Marchetti D, La Monaca G (2000). An unexpected death during oxygen-ozone therapy. American Journal of Forensic Medicine and Pathology. https://pubmed.ncbi.nlm.nih.gov/10871129/
Study type: case-report; n=1
Finding: The authors describe an unexpected death caused by gas embolism that occurred during oxygen-ozone therapy administered by autohemotransfusion for psoriasis, and state that this complication suggests the need to investigate the benefits and adverse effects of medical ozone application.
Limitations: Single case report, read from a two-sentence abstract only: the abstract gives no patient details, ozone dose, blood volume, or account of how the gas embolism was identified. It shows the event occurred, not how often it occurs.

Bocci V, Di Paolo N, Garosi G, et al. (1999). Ozonation of blood during extracorporeal circulation. I. Rationale, methodology and preliminary studies. International Journal of Artificial Organs. https://pubmed.ncbi.nlm.nih.gov/10532435/
Study type: animal
Finding: Dialysis-type membranes proved unsuitable for exposing blood to oxygen-ozone, so the authors used hydrophobic ozone-resistant hollow fibers. In saline, swine-blood and sheep tests they report that 10 µg/mL ozone produced biochemical effects, heparin was not an ideal anticoagulant, and sheep had no adverse effects after 50 min at 20 to 40 µg/mL, though the exchanger clogged with cells.
Limitations: Bench and sheep development work on an extracorporeal gas-exchanger circuit, not the EBOO procedure as given to patients, and no clinical outcomes. The abstract does not say how many sheep were studied, describes no control group, and gives no numeric biochemical results. Abstract only.

Lippmann M (1989). Health effects of ozone. A critical review. JAPCA (Journal of the Air Pollution Control Association). https://pubmed.ncbi.nlm.nih.gov/2659744/
Study type: review
Finding: A critical review of inhaled ambient ozone air pollution finding that peak levels common in US air cause measurable transient lung-function changes, respiratory symptoms, and airway inflammation, with animal data suggesting cumulative structural lung damage from repeated exposure.
Limitations: Covers inhaled ambient ozone air pollution, not any medical ozone therapy; describes breathing exposure, not the injected or blood-contact routes clinics use.

Calabrese EJ, Kojola WH, Carnow BW (1977). Ozone: a possible cause of hemolytic anemia in glucose-6-phosphate dehydrogenase deficient individuals. Journal of Toxicology and Environmental Health. https://pubmed.ncbi.nlm.nih.gov/846014/
Study type: other
Finding: A theoretical model predicting that people with glucose-6-phosphate dehydrogenase (G6PD) deficiency may experience acute hemolysis on exposure to ozone at levels reached in polluted urban air.
Limitations: A theoretical, computational model of inhaled ambient ozone, not an experiment on blood or on any ozone therapy procedure; does not test the brief controlled blood contact EBO2 or MAH use.