Non-regulatory announcement

ONDINE BIOMEDICAL INC.

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

Steriwave authorized for use by HCA UK   

Light-activated antimicrobial that does not generate antimicrobial resistance (AMR) approved for use in healthcare facilities operated by leading private healthcare provider HCA Healthcare UK

Leading private healthcare provider, HCA Healthcare UK, has approved the Steriwave® light-activated antimicrobial developed by Ondine Biomedical Inc. (LON:OBI) for use in its healthcare facilities to prevent healthcare-associated infections (HAIs) and reduce the use of antibiotics. HCA Healthcare is the largest private healthcare provider in the world, and one of the leading private healthcare providers in the UK, where it operates over 30 healthcare facilities.

Antimicrobial resistance (AMR) is a growing concern for healthcare providers around the world, particularly in the prevention and treatment of HAIs. Steriwave is a light-activated antimicrobial with a distinct mechanism of action from traditional antibiotics, allowing it to be used without fear of generating AMR. Its broad-spectrum efficacy destroys bacteria, viruses, and fungi in a single, 5-minute treatment.

Steriwave has already been successfully used in a small patient population in HCA Healthcare UK hospitals, but this approval will allow additional hospitals and healthcare facilities to adopt the technology more widely at the discretion of the clinician.

Professor Claire Hopkins, Professor of Rhinology at King's College London and Consultant ENT Surgeon at Guy's & St Thomas' NHS Foundation Trust and London Bridge Hospital, has used Steriwave routinely to nasally decolonise her endoscopic sinus surgery patients at HCA Healthcare UK's London Bridge Hospital since 2021. A retrospective study showed that using Steriwave in endoscopic sinus surgery patients led to antibiotic use across all her patients dropping from 22% to less than 5% - a 77% reduction.

Professor Hopkins commented: "I was amazed that studies show that by treating the nose you can reduce spinal surgical site infections - so it seemed an ideal way to reduce the risk of post-operative infection after nasal surgery. I have seen a significant reduction in post-operative infections requiring antibiotics, which is good for the patients, reducing the risk of antibiotic-related side effects, and important to help prevent ever-increasing antibiotic resistance. It needs formal controlled studies to further evaluate the effectiveness, but I am impressed with the difference that I have seen in my practice."

Interview with Professor Hopkins: Steriwave prevents sinonasal SSIs

Carolyn Cross, Ondine Biomedical CEO, commented: "We are delighted that Steriwave has now been authorized for use across HCA Healthcare UK's healthcare facilities. We are already working closely with HCA Healthcare in the US on our US Phase 3 trial and the FDA regulatory submission for Steriwave, so it is fantastic to be getting such good support from them in the UK as well. The study undertaken at London Bridge Hospital has demonstrated Steriwave's potential for addressing the threat of AMR by preventing infections and reducing antibiotic use."

HCA Healthcare is partnering with Ondine in the United States to conduct a US Phase 3 clinical trial with the ultimate goal of obtaining FDA approval to bring Ondine's nasal photodisinfection into the US market. HCA Healthcare operates 184 hospitals and over 2,000 sites of care across the United States, making it the largest healthcare system in the US.

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About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian life sciences company and leader innovating light-activated antimicrobial therapies (also known as 'photodisinfection'). 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 the UK and is approved in Canada 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 many other indications.

About Steriwave®

Ondine's Steriwave® nasal photodisinfection system is a patented technology using a proprietary light-activated antimicrobial (photosensitizer) to destroy bacteria, viruses, and fungi colonizing the nose. The photodisinfection treatment is carried out by a trained healthcare professional and is an easy to use, painless, two-step process. The photosensitizer is applied to each nostril using a nasal swab, followed by illumination of the area with a specific wavelength of red laser light for less than five minutes. The light activates the photosensitizer, causing an oxidative burst that is lethal to all types of pathogens without causing long-term adverse effects on the nasal microbiome. A key benefit of this approach-unlike with antibiotics, which have resistance rates reported as high as 81%^[i]-is that pathogens do not develop resistance to the therapy. Nasal decolonization is recommended in the 2016 WHO Global guidelines for the prevention of surgical site infections,^[ii] and the Society for Healthcare Epidemiology of America (SHEA) guidelines, published in May 2023, recommend nasal decolonisation for major surgical procedures.^[iii]