Ondine Biomed Regulatory News (OBI)

29 September 2023

ONDINE BIOMEDICAL INC. 

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

Burnaby Hospital deploys Steriwave

Burnaby Hospital in British Columbia has deployed Steriwave nasal photodisinfection to help prevent surgical site infections and optimize patient outcomes

Burnaby Hospital, a large community hospital in British Columbia, has initiated use of Ondine Biomedical's (OBI:LON) Steriwave® nasal photodisinfection prior to orthopedic surgery to further reduce the incidence of post-surgical infections. Burnaby Hospital, which is affiliated with the University of British Columbia and an integral part of the Fraser Health Authority, has been focused on further reducing infections and optimizing patient outcomes following orthopedic surgery.

Post-surgical infections are a serious concern in the aftermath of any major surgical operation, including orthopedic surgeries. These infections are often correlated with adverse outcomes including prolonged hospital stays, escalated healthcare expenses, and elevated mortality rates.

During 2023 there has been a significant rise in Canadian hospitals deploying Steriwave nasal photodisinfection to reduce the incidence of post-surgical infections, improve patient care, and reduce costs. The Society for Healthcare Epidemiology of America (SHEA) updated guidelines, published in May 2023, recommend nasal decolonization for major surgical procedures which has encouraged more hospitals to adopt it as a standard practice.[1]

There is a growing concern over using the antibiotic mupirocin for nasal decolonization, which has been the standard of care but has resistance rates reported as high as 81%.[2] Steriwave nasal photodisinfection is non-antibiotic and kills all types of pathogens - viruses, bacteria, and fungi - in minutes without causing antimicrobial resistance (AMR).

Carolyn Cross CEO said:

"As a Canadian company pioneering this photodisinfection technology, it is fantastic to see more and more Canadian hospitals recognizing the importance of decolonizing pathogens in the nose to prevent post-surgical infections, and the need to do so without the use of antibiotics. We are very pleased to be working with the team at Burnaby Hospital who have initiated the use of our Steriwave nasal decolonization therapy to further enhance patient outcomes."

Pre-surgical use of Steriwave in hospital settings has resulted in significant improvements in post-surgical outcomes including lower rates of surgical site infections (SSIs), reduced patient length of stay, fewer readmissions, and lower rates of antibiotic prescribing.[3],[4],[5]

Ondine's nasal photodisinfection is already in use in or under evaluation at other major hospitals across Canada, including Vancouver General Hospital, The Ottawa Hospital, and the Montreal Heart Institute.

**ENDS**

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian headquartered company innovating in the field of photodisinfection therapies. Ondine has a pipeline of investigational products, based on its proprietary photodisinfection platform, in various stages of development. Products beyond nasal photodisinfection include therapies for a variety of medical indications such as chronic sinusitis, ventilator-associated pneumonia, burns, and other indications.

About Nasal Photodisinfection

Ondine's nasal photodisinfection is a patented technology using a proprietary photosensitizer (non- antibiotic, light-activated agent) to destroy pathogens. 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. A key benefit of this approach, unlike with antibiotics, is that pathogens do not develop resistance to the therapy.

Nasal decolonization with antibiotics is already standard practice in many hospitals prior to surgery, as pathogens in a patient's nasal cavities are a major cause of surgical site infections (SSIs). However, there is a growing need to reduce antibiotic use and find non-antibiotic methods of nasal decolonization as resistance rates have been reported as high as 81%.[6]

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®. It has been used in Canada for over ten years, with no serious adverse events reported. In the US, it is currently undergoing clinical trials for regulatory approval.

About Burnaby Hospital

Burnaby Hospital, with 286 beds and approximately 84,000 patient visits annually, is one of the largest hospitals in the region outside the City of Vancouver. It is operated by the Fraser Health Authority-which manages 11 hospitals in the region-and is affiliated with the University of British Columbia. Serving the communities of Burnaby and East Vancouver as a primary and secondary care centre, the hospital provides general surgery, orthopedic surgery, medicine, perinatal, neonatal ICU, critical care and emergency services.