REG - Ondine Biomedical - Topline Results Significant in Steriwave ICU Study

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RNS Number : 9117E  Ondine Biomedical Inc.  27 October 2025

27 October 2025

ONDINE BIOMEDICAL INC.

("Ondine Biomedical", "Ondine" or the "Company")

 

Topline Results Significant in Steriwave ICU Study

Steriwave Shows Significant Sustained ICU Pathogen Reduction in Royal
Columbian Hospital Study Reinforcing Universal Nasal Decolonisation for
Infection Control

·    Steriwave nasal decolonisation study proves pathogen reduction in ICU
setting

·    ICU market represents a multi billion-dollar opportunity for Ondine

·    Nasal decolonisation is already Standard of Care in the USA using
topical antibiotics

·    ICU-acquired infections affect 12-13% of critical care patients,
dramatically increasing mortality risk and adding significant costs from added
length of stay

 

Ondine Biomedical Inc. (AIM: OBI) is pleased to announce that preliminary
results from the Steriwave ICU Pilot Study at Royal Columbian Hospital (RCH)
demonstrate that Steriwave(®) nasal photodisinfection, a non-antibiotic,
topical and fast acting broad spectrum antimicrobial, significantly reduces
harmful pathogens in critically ill Intensive Care Unit (ICU) patients. There
was a significant reduction in nasal bacterial load over the course of the
study (p < 0.05) in the Steriwave group, but not in the control group. By
day 8, the share of swabs positive for non-respiratory flora (opportunistic)
pathogens was 22.4% (control) vs 4.5% (treatment), an 80% relative risk
reduction in colonisation. This 4-fold colonisation reduction compared to
controls is an impressively strong result in the ICU setting.

Dr. Elizabeth Rohrs, RCH principal investigator and RCH Foundation Research
Director, said:

"Preliminary results from the Steriwave ICU pilot study reinforce the
potential of Steriwave as a practical, non-antibiotic infection-prevention
tool in the ICU where reducing multidrug-resistant pathogens can save lives,
shorten ICU stays, and significantly reduce healthcare costs. Reducing airway
pathogens in vulnerable ICU patients can help lower high ICU infection and
mortality rates. Gram-negative Pseudomonas aeruginosa is particularly
concerning because of its multidrug resistance and its role in many
hospital-acquired infections."

Study Design

The crossover ICU study, the first photodisinfection study of its kind, was
carried out with 249 critically ill patients who were resident for at least 48
hours. In the treatment arm, researchers applied Steriwave treatments to all
ICU study participants every second day and took microbial assessments every
fourth day to monitor treatment efficacy and pathogen dynamics. This pragmatic
design ensured that all patients were decolonized in the treatment phase,
reducing bioburden at the hospital unit level and thereby minimizing the
potential for cross-contamination between patients.

Study Findings

Key findings showed that by Day 8 there was an absolute risk reduction in the
carriage of pathogenic bacteria of 17.9% (from 22.4% to 4.5%), a 4-fold
reduction compared to controls. These large absolute reductions over the
controls, expanding over the course of the study, are consistent with strong
on-target effect indicating efficacy of the treatment.  Detailed assessments
of carriage microflora showed a significant reduction in nasal bioburden (all
species) in treated patients compared to controls, with 69% of swabs
(treatment) showing no growth at day 8 compared to 26% (control) (p<0.05).

Overall results demonstrate strong on-target effect, with statistically
significant outcomes on microbial load over time, faster bioburden reduction,
and higher within‑patient clearance in the treatment arm versus control.
Access to patients proved slightly more limited than patients in the
presurgical environment, with 70% of all planned decolonisation events
completed mostly due to deferrals for patient instability or airway devices.
Meticulous microbial surveillance was conducted in these patients, with over
97% compliance rate (of 797 planned swabs, only 18 were missed).  Both
treatment and control groups were broadly comparable at baseline, with no
significant differences between treatment and control arms in age, ICU length
of stay, mortality, Sequential Organ Failure Assessment score, gender,
baseline community-acquired pneumonia / hospital-acquired pneumonia scores,
and baseline blood-culture positivity. Overall, the study showed notable
benefits for the treatment group: lower microbial loads, quicker reductions in
bioburden, and higher rates of patient-level clearance compared with controls.
No product related significant adverse events were noted, and the treatment
was well tolerated.

The trial's success in demonstrating clinical non-antibiotic antimicrobial
efficacy is particularly timely and relevant for healthcare systems across the
globe. Antibiotic resistance is soaring, a crisis highlighted by the recent
WHO Global Antibiotic Resistance Surveillance Report 2025
(https://iris.who.int/items/f3fbf314-1b0a-4d34-9d22-c0175309dc75) . This
report found that a concerning one in six lab-confirmed bacterial infections
worldwide was resistant to antibiotic treatment.  Study results are
particularly important given that mupirocin-an antibiotic derived from
Pseudomonas bacteria-is often used for nasal decolonisation, causing rising
levels of resistance (up to 63% of MRSA in some settings).  By contrast,
Steriwave photodisinfection kills microbes via a free-radical process, with no
known resistance development.  This offers a stewardship-friendly path to
suppress S. aureus/MRSA carriage without adding antibiotic pressure.

Dr. Steven Reynolds, Executive Lead of the Advancing Innovations in Medicine
(AIM) Institute, Associate Professor as Simon Fraser University and specialist
in Infectious Diseases and Critical Care, stated:

"This single-center study was powered to detect microbial rather than clinical
outcomes, an important finding because reducing a patient's bioburden remains
a critical step in preventing ICU infections. The absence of known resistance
to Steriwave, and its lack of contribution to further antimicrobial
resistance, make it an appealing alternative to mupirocin. It's encouraging to
see a potential new option for infection prevention that aligns with the
principles of antimicrobial stewardship."

Carolyn Cross, CEO of Ondine Biomedical Inc commented:

"We would like to extend our sincere appreciation to RCH Foundation's
Advancing Innovation in Medicine (AIM) Fund and to its commitment to advancing
clinical innovation in Canada. Its vital support has been instrumental in
enabling us to undertake this significant study within the Intensive Care Unit
(ICU).

We would also like to express our profound gratitude to Dr. Steven Reynolds,
Dr. Elizabeth Rohrs, Jessica Wittman, and the exceptional RCH research team
for their efforts and professionalism, as well as to the RCH ICU nurses for
their invaluable support throughout Steriwave's first ICU study.  Their
collective work sets a new standard for translational infection-control,
conclusively demonstrating the utility of a rapid, point-of-care
decolonisation method which eliminates all pathogens, not just Gram-positive
species like MRSA.  Reducing bioburden has been proven to reduce the rate of
ICU infections, which in turn reduces mortality rates, antibiotic use and
length of stay, thereby freeing up more capacity in overcrowded ICUs.  We
cannot thank Drs. Reynolds, Rohrs and colleagues enough for the perseverance
and innovative spirit that powered Steriwave's first ICU study from concept to
clinic."

 

Infection Control in Critical Care

Intensive Care Unit-acquired infections represent a critical challenge for
healthcare systems, significantly raising both patient mortality risk and the
cost of care. Infection control in critical care requires a comprehensive
strategy, as patients are frequently immunocompromised and highly vulnerable
to numerous ICU pathogens. These patients face increased risk of infection
from various environmental and procedural factors present in ICU. Studies
demonstrate that when a patient acquires an infection in the ICU, their risk
of death rises markedly, and an infection can add an additional 7-14 extra
days to an ICU patient's length of stay.

Respiratory infections, in particular, remain a major cause of morbidity and
mortality in critical care settings. Many of these infections are caused by
complex, multidrug-resistant bacteria such as MRSA and resistant Gram-negative
bacilli including Pseudomonas aeruginosa, Klebsiella pneumoniae, and
Acinetobacter baumannii, which are not effectively addressed by topical
antibiotics. ICU infection-prevention should prioritize Gram-negative
bacteria, which represent more than 50-70% of bacterial isolates and are
responsible for the majority of ICU pneumonia cases and significantly
contribute to ICU mortality rates. The increasing prevalence of such bacteria
and rapid rise of antimicrobial resistance underscores the need for
innovative, broad-spectrum solutions such as Steriwave.

 

About Steriwave(®) and its Mode of Action

Steriwave nasal photodisinfection is a non-invasive and painless treatment
that uses a proprietary light-activated photosensitive agent to destroy
harmful bacteria, viruses, and fungi-including antibiotic-resistant strains-in
the nasal passages. The procedure takes five minutes and, unlike antibiotics,
is effective immediately and allows the normal nasal microbiome to recover
quickly, without fostering antimicrobial resistance.

The two-step process involves applying the Steriwave formulation in the
nostrils where it electrostatically binds to microbes rather than human cells.
The area is then illuminated with safe red light to activate the formulation,
triggering an oxidative burst that physically destroys all manner of pathogens
within minutes. This rapid and overwhelming oxidative stress makes it
extremely difficult for pathogens to develop resistance even across repeated
applications.  Steriwave is already being successfully used in hospitals
across Canada and in the UK to decolonise the nose - a major pathogen
reservoir - prior to surgery to reduce surgical site infections.

 

About the Royal Columbian Hospital, Royal Columbian Hospital Foundation (RCHF)
and Advancing Innovation in Medicine (AIM)

Royal Columbian Hospital (RCH) is a large tertiary care hospital in Fraser
Health, one of Canada's largest health authorities. It has a legacy of care
since 1862 and serves more than 2.2 million people with unparalleled expertise
in cardiac, trauma, neurosciences, and high-risk maternity as a provincial
referral centre, making it a vital lifeline for critical medical needs in
British Columbia, Canada.

The hospital's foundation, a non-profit organization that supports RCH through
public donations, is the largest external funder of research and innovation at
RCH. Advancing Innovation in Medicine (AIM) is the research and innovation
division of the Royal Columbian Hospital Foundation. AIM is dedicated to
pioneering innovative clinical solutions that enhance patient outcomes,
improve healthcare productivity, and create global impact through strategic
partnerships. Find out more:  www.rchfoundation.com/aiminstitute
(http://www.rchfoundation.com/aiminstitute)

 

Enquiries:

 

 Ondine Biomedical Inc.                                           www.ondinebio.com
 Carolyn Cross, CEO                                               +1 604 669 0555

or via Vane Percy & Roberts
 Strand Hanson Limited (Nominated & Joint Financial Adviser)
 James Harris, Richard Johnson                                    +44 (0)20 7409 3494

 Peel Hunt LLP (Broker & Joint Financial Adviser)
 James Steel, Dr. Chris Golden                                    +44 (0)20 7418 8900

 Vane Percy & Roberts (Media Contact)
 Simon Vane Percy                                                 +44 (0)77 1000 5910

 

 

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian life sciences company and leader in
light-activated antimicrobial therapies ('photodisinfection') for the
prevention and treatment of infections, including those caused by
multidrug-resistant organisms. Ondine has a pipeline of investigational
products, based on its proprietary photodisinfection technology, in various
stages of development.

Ondine's nasal photodisinfection system is CE-marked in Europe and is approved
for nasal decolonisation in Canada, UK, Australia, Mexico, and several other
countries under the name Steriwave(®). In the US, it has been granted
Qualified Infectious Disease Product designation and Fast Track status by the
FDA and is currently undergoing clinical trials for regulatory approval.
Products beyond nasal photodisinfection include therapies for a variety of
medical indications such as chronic sinusitis, ventilator-associated
pneumonia, burns and other indications.

 

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