Ondine Biomed Regulatory News (OBI)

23 October 2023

ONDINE BIOMEDICAL INC.

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

66.5% reduction in spine surgery infection rate

Pre-surgical Steriwave® nasal photodisinfection protocol contributed to 66.5% reduction in spine surgery infection rates and $2.5 million annual savings in Vancouver General Hospital

Canadian life sciences company, Ondine Biomedical Inc. (OBI: LON), reports new independent research findings from Vancouver General Hospital which were presented at the IP2023 conference in Liverpool, England.

· Canada's British Columbia-based hospitals, Vancouver General & University of British Columbia (UBC) Hospitals, pioneered the universal pre-surgical nasal photodisinfection and chlorhexidine gluconate (CHG) wipes protocol and were the first hospitals to adopt this approach as a standard of care, reducing post-surgical infection rates without generating resistance.

· 66.5% reduction in surgical site infection rate in spine patients (7.98% vs 2.67%, p

· $19.9 million net cost savings over the 8-year study period between 2011 and 2019 from reduced infection rates.

· Demonstration of long-term safety - no complications or adverse events specific to the administration of nasal photodisinfection.

With the inclusion of Steriwave nasal photodisinfection in its presurgical quality improvement protocols, researchers at Vancouver General Hospital (VGH) were able to demonstrate a 66.5% reduction in its surgical site infection (SSI) rate in spine surgery patients. The VGH spine group, led by Dr. John Street, presented its research findings showing a significant and sustained reduction of surgical site infections (SSIs) in spine surgery patients using this universal pre-surgical protocol.

In collaboration with UBC Hospital, the new decolonization protocol pioneered by the Vancouver Coastal Health Infection Control team included Steriwave nasal photodisinfection alongside skin cleansing with chlorhexidine gluconate (CHG) wipes to prevent SSIs in patients undergoing major surgeries. As one of Canada's largest tertiary hospitals, the VGH spine group also estimated that the prevented SSIs over the 8-year study period between 2011-2019 resulted in institutional cost savings of $19.9 million, a net annual cost saving of $2.49 million.

The poster, presented by Dr. Eryck Moskven, concludes that the universal presurgical protocol involving nasal photodisinfection and CHG skin decolonization "is a simple, safe, and clinically effective preventative strategy for reducing the incidence of SSI following emergent or elective spine surgery." Moreover, no performance impact from resistance generation was observed during the study period.

Surgical site infections are serious complications that can occur following surgery. Spine SSIs can affect up to 18% of patients who then require long, complex and costly treatment.[1]

The full poster is available for viewing here.

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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 Steriwave Nasal Photodisinfection

Nasal photodisinfection is a non-antibiotic method for nasal decolonization that uses a proprietary light-activated agent (photosensitizer) to destroy pathogens in minutes without causing resistance. 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 pathogens. In this single, 5-minute treatment, Steriwave eliminates infection-causing bacteria, viruses, and fungi in the nose - a major reservoir of pathogens.[2]

Pre-operative nasal decolonization has been found to significantly decrease SSIs caused by the infection-causing pathogen S. aureus.[3] The Society for Healthcare Epidemiology of America (SHEA) updated guidelines to elevate nasal decolonization from a recommended practice to essential for orthopaedic (including spine) and cardiothoracic surgical procedures.[4]

Rising rates of antimicrobial resistance are a serious concern: the reported resistance rates for the antibiotic commonly used for nasal decolonization, mupirocin, are as high as 81%.[5] SSIs involving resistant pathogens are associated with significant increases in the length of hospitalization and costs.[6] Unlike currently used topical antibiotics, Steriwave can eradicate pathogens including extensively drug-resistant (XDR) bacteria, viruses (including coronaviruses), and fungi such as Candida auris.[7]

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 the Photodisinfection Protocol used at Vancouver Coastal Health:

Photodisinfection-based nasal decolonization therapy was first introduced at Vancouver Coastal Health for universal pre-surgical decolonization to reduce surgical site infections. In 2011, Dr. Elizabeth Bryce, Regional Medical Director for Infection Control at Vancouver Coastal Health Acute, led a multidisciplinary team involving the Division of Medical Microbiology and Infection Prevention, the Department of Orthopaedics and the Peri-operative Care groups at Vancouver General Hospital and University of British Columbia Hospital. The original Vancouver Coastal Health decolonization team included:

· Surgery: Bas Masri; Gary Redekop

· Perioperative Services: Debbie Jeske; Claire Johnston; Kelly Barr; Shelly Errico; Anna- Marie MacDonald; Tammy Thandi; Lorraine Haas; Pauline Goundar; Lucia Allocca; Dawn Breedveld; Steve Kabanuk

· Infection Control: Elizabeth Bryce; Chandi Panditha; Leslie Forrester; Diane Louke; Tracey Woznow

· Medical Microbiology: Diane Roscoe; Titus Wong

· Patient Safety: Linda Dempster

· Quality Assurance, Training: Shelagh Weatherill

Having demonstrated significant patient safety outcomes and cost savings with the first ever deployment of universal nasal Photodisinfection, the VCH team received the 2013 Innovation Award of Excellence from the International Conference for Prevention and Infection Control (ICPIC), which is endorsed by the World Health Organization.