REG - Ondine Biomedical - Steriwave ICU Study Completes Recruitment

Ondine BiomedicalAnnouncement

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RNS Number : 8279R  Ondine Biomedical Inc.  21 July 2025

21 July 2025

ONDINE BIOMEDICAL INC.

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

Steriwave ICU Study Completes Recruitment

Groundbreaking ICU Study completed Using Steriwave® Nasal Photodisinfection
Technology at Royal Columbian Hospital

 * Canada's Royal Columbian Hospital (British Columbia, Canada) completes a
291-patient pilot study in the intensive care unit (ICU) - world's first use
of nasal photodisinfection in the ICU.

 * ICU patients experience the highest rates of hospital-acquired infections
(HAIs), affecting an estimated 12-13% of admissions and contributing to high
mortality rates.

 * Over 62% of ICU-acquired infections are respiratory in origin and
predominantly caused by Gram-negative organisms which are not addressed by
topical antibiotics currently used in ICU.

 * Steriwave® uniquely eliminates Gram-negative, Gram-positive, viral, and
fungal nasal pathogens in minutes-without generating antimicrobial resistance.

 

Ondine Biomedical Inc. (AIM: OBI), a Canadian life sciences company pioneering
light-activated antimicrobial technologies, is pleased to announce completion
of the world's first ICU clinical study evaluating nasal photodisinfection in
critically-ill patients.

The study was conducted at Royal Columbian Hospital (RCH), a leading tertiary
care and trauma centre, marking a significant step forward in the fight
against hospital-acquired infections (HAIs). The study evaluated the use of
Steriwave® as a non-antibiotic nasal decolonization therapy in the ICU
setting.

Dr. Steven Reynolds, Head of ICU Research at RCH and Executive lead at RCH
Foundation's Advancing Innovation in Medicine (AIM), commented:

"We are pleased to complete this important pilot investigating Steriwave's
role in reducing ICU-acquired infections. Infection rates in ICU patients are
disproportionately high due to vulnerability of these patients. Reducing these
infections not only improves patient outcomes but also helps ease pressure on
nursing resources and ICU capacity. Nasal photodisinfection provides the
opportunity of reducing patient risk of infection while avoiding antimicrobial
resistance. This approach benefits my patients both today and in the long
term.  Patient acceptance of the Steriwave nasal treatment was high, and our
team appreciated how easily Steriwave was integrated into ICU workflows."

ICU patients are often critically ill and immunocompromised, making them more
susceptible to infections. Hospital-acquired infections in the ICU are
associated with high morbidity and mortality. According to a landmark study
published in JAMA(1), respiratory infections account for the majority of ICU
HAIs, with over 62% linked to Gram-negative organisms, including
drug-resistant pathogens such as Pseudomonas aeruginosa, Klebsiella pneumoniae
and Acinetobacter species. These infections are often difficult to treat,
especially in critically ill patients.  Mupirocin, a commonly used antibiotic
for nasal decolonization, is ineffective against Gram-negative organisms.

Steriwave® addresses this challenge by providing broad-spectrum antimicrobial
action without contributing to antimicrobial resistance. The light-activated
nasal photodisinfection treatment is non-invasive, fast-acting (under five
minutes), and effective against a wide range of pathogens including
Gram-negatives and microorganisms resistant to conventional antibiotics.

Carolyn Cross, CEO of Ondine Biomedical, stated:

"The outstanding expertise of the RCH clinical team and the unwavering
commitment of the ICU nursing staff at RCH were critical to this study. We are
deeply appreciative of the dedicated efforts of these RCH teams and of the RCH
Foundation's AIM support, which enabled us to accelerate nasal
photodisinfection into the intensive care unit."

"This first ICU nasal photodisinfection study is a major milestone and a
significant achievement for our organization. With ICU infection rates at an
unacceptably high 12-13%, producing high mortality, a better solution to
infection control is urgently needed for hundreds of thousands of ICU
patients. We believe that size of the ICU market is at least as large as the
pre-surgical decolonization market. Steriwave offers a resistance-free, rapid
approach to reducing infections and improving patient outcomes. Steriwave
currently stands as the only antimicrobial proven to eliminate a broad range
of multidrug-resistant pathogens from the nose within minutes, without
fostering antimicrobial resistance."

Rising antibiotic resistance increases the urgency and the opportunity for
non-antibiotic solutions in hospital infection prevention. Current guidelines
from the CDC and IDSA already recommend nasal decolonization for ICU patients,
particularly targeting Staphylococcus aureus. However, resistance to standard
decolonization agents such as mupirocin is rising sharply, with resistance
rates reaching as high as 80% in some settings. Steriwave's
non-resistance-forming photodisinfection platform directly addresses this
unmet need and offers an innovative solution for healthcare systems facing
mounting antimicrobial resistance and infection control pressures.

Jeff Norris, President and CEO of Royal Columbian Hospital Foundation
commented:

"Through our AIM Institute, Royal Columbian Hospital Foundation is proud to
support clinical research and commercial innovation that directly impact
patient care. By offering resources such as expert medical advice, AIM helps
validate promising ideas, accelerate the path to commercialization, and
ultimately bring better tools to the bedside faster."

About Steriwave®

Steriwave is Ondine's patented nasal photodisinfection technology that uses a
proprietary light-activated antimicrobial to eliminate pathogens in the nasal
passages. It has been proven effective against a wide spectrum of
bacteria-including multidrug-resistant organisms-as well as viruses and fungi.
The treatment is safe, painless, and preserves the natural microbiome while
offering immediate microbial reduction without the development of resistance.

 

Enquiries:

 Ondine Biomedical Inc.                                            www.ondinebio.com (http://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 (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., a Canadian life sciences company and CAN Health
Network member, is a 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 has a CE mark in Europe and has
regulatory approval in Canada, Australia, Mexico, and several other countries
under the name Steriwave(®). In the US, Ondine's nasal photodisinfection
therapy 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, chronic wounds, and other indications.

References:

(1.    )Vincent JL, et al. "Nosocomial Infections in Adult Intensive Care
Units in Europe." JAMA. 1995;274(8):639-644.

 

 

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