Ondine Biomed Regulatory News (OBI)

Non-regulatory announcement

ONDINE BIOMEDICAL INC.

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

New study confirms nose is key source of infection

Findings include 86% of surgical site infections ("SSIs") caused by bacteria from the patients' own nose, skin, or gut and nearly 60% of infections are resistant to antibiotics

Ondine Biomedical Inc. (LON: OBI), the Canadian life sciences company pioneering light-activated antimicrobial treatments, announces new independent research published in the journal Science Translational Medicine showing that 86% of surgical site infections (SSIs)! after spinal surgery are caused by bacteria from the patient's own nose, skin, or gut. The study, "Contribution of the patient microbiome to surgical site infection and antibiotic prophylaxis failure in spine surgery", was undertaken by researchers from the University of Washington School of Medicine in Seattle and reinforces the findings of previous studies that have shown that nasal and skin decolonization result in significantly lower rates of SSIs. 

Over a 12-month period, the University of Washington researchers sampled bacteria living in the nose, skin and stool of over 200 patients prior to spine surgery. There was then a follow-up at 90 days to compare those samples with any post-surgical infections that occurred. The study showed that 86% of the bacteria causing infections after spine surgery were genetically matched to bacteria the patient carried before surgery. Researchers also discovered that bacteria colonizing the upper back around the neck and shoulders are more similar to those found in the nose, and those normally colonizing the lower back are more similar to those found in the gut and stool.

Another key finding of the study was that 59% of infections were resistant to the antibiotic used to prevent surgical site infections (SSIs), the antiseptic used to clean the skin before surgery, or both. Rising rates of resistant bacteria pose a fundamental threat to the safety of all types of surgery. There were an estimated 1.27 million deaths attributable to bacterial antimicrobial resistance (AMR) in 2019, and the two pathogens associated with the most AMR-related deaths - Escherichia coli and Staphylococcus aureus - are also the cause of most post-operative infections.[1]

SSIs are serious complications that can occur following surgery, and are the most common type of healthcare-associated infection (HAI). Spine SSIs can affect up to 18% of patients who then require long, complex and costly treatment.[2] Nasal decolonization is now deemed an essential practice prior to major surgeries, including spine and cardiac surgery, by the Society for Healthcare Epidemiology of America (SHEA).[3] SSIs involving drug-resistant pathogens are associated with significantly increased length of hospitalization and costs.[4]

Lead authors Dustin Long, Assistant Professor of Anesthesiology, School of Medicine, University of Washington and Chloe Bryson-Cahn, Associate Professor of Allergy and Infectious Diseases, School of Medicine, University of Washington, commented: "Surgical site infections occur following about one in 30 procedures, typically with no explanation. While rates of many other medical complications have shown steady improvement over time, data from the Agency for Healthcare Research and Quality and the Centers for Disease Control and Prevention show that the problem of surgical site infection is not getting better."

The University of Washington research demonstrates the benefits of focusing on novel solutions for nasal decolonization like Ondine Biomedical's light-activated antimicrobial, Steriwave®. Unlike traditional antibiotics, Steriwave is immediately effective with a single five-minute treatment and does not trigger antimicrobial resistance (AMR), making it an excellent alternative to the traditional antibiotics that many healthcare facilities use to prevent HAIs.

**ENDS**

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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%[5]-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,[6] and the Society for Healthcare Epidemiology of America (SHEA) guidelines, published in May 2023, recommend nasal decolonization for major surgical procedures.[7]