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

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• 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 JAMA¹, 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:

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.