Ondine Biomedical Inc Announces Steriwave use Expanded Following Successful Pilot

· Alberta Health Services has expanded its use of Steriwave nasal photodisinfection to reduce the incidence of surgical site infections (SSIs) in orthopedic surgery following a successful pilot at the Mazankowski Alberta Heart Institute.

· SSIs, the most common of healthcare-associated infections (HAIs), are a significant burden to healthcare systems as well as to patients, with the estimated cost of a prosthetic hip or knee infection ranging from C$31,000 to more than C$100,000.^[1]

VANCOUVER, BC / ACCESSWIRE / October 31, 2023 / Ondine Biomedical Inc (AIM:OBI), the Canadian life sciences company developing non-antibiotic photodisinfection therapies to prevent and treat healthcare-associated and drug-resistant infections announces that Alberta Health Services has confirmed that it is expanding its use of Ondine's Steriwave® nasal photodisinfection following early data from its pilot introduction at the Mazankowski Alberta Heart Institute, which saw significant reductions in surgical site infections following cardiac surgery. The Royal Alexandra Hospital in Edmonton, Canada, will use Steriwave nasal photodisinfection prior to its c. 3,000 orthopedic surgeries over the next year.

Ondine has pioneered nasal photodisinfection as a rapid, non-antibiotic method for decolonizing the nose of the pathogens carried by patients that can lead to HAIs. Steriwave uses a proprietary red light-activated agent to eliminate infection-causing bacteria, viruses, and fungi in the nose, a major reservoir of germs^[2], without causing resistance. At the Mazankowski Alberta Heart Institute, Steriwave replaced the previous standard of care, the antibiotic mupirocin. Mupirocin is commonly used for nasal decolonization to prevent SSIs, but has poor rates of patient compliance and reported resistance rates as high as 81%.^[3]

Ondine Biomedical's CEO Carolyn Cross said:

"We are very pleased to be collaborating with Alberta Health Services to reduce the incidence of SSIs in Alberta without generating antibiotic resistance. The successful initial implementation of Steriwave into the pre-surgical treatment protocols at the Mazankowski Alberta Heart Institute has driven rapid adoption of Steriwave for orthopedic surgeries at the Royal Alexandra Hospital.

"The rising rate of antimicrobial resistance (AMR) makes it more important than ever to have cost-effective, non-antibiotic methods for preventing HAIs. Alongside growing global concerns about the consequences of AMR, we are seeing more hospitals looking to move away from topical antibiotic nasal decolonization. In addition to growing resistance, topical antibiotics require patient compliance with twice daily treatments for five days to achieve efficacy on a limited number of bacterial species as compared to five minutes for photodisinfection to eradicate a broad spectrum of bacteria, viruses and fungi just prior to surgery. Photodisinfection's rapid eradication of potentially harmful pathogens gives healthcare professionals better control over patient outcomes."

Rising rates of AMR are making infections more difficult to prevent and treat, as some commonly used antibiotics are now ineffective.^[4] Many hospitals are adapting their infection prevention protocols to combat drug-resistant pathogens. As many as one in 19 deaths in Canada is now attributable to antibiotic-resistant infections,^[5] and the cost of AMR to the Canadian healthcare sector is also projected to increase to $7.6 billion per year by 2050.^[6] SSIs, the most common of HAIs, are a big burden to healthcare systems as well as to patients, with the estimated cost of a prosthetic hip or knee infection ranging from C$31,000 to more than C$100,000.^[7]

Steriwave is already in use in major hospitals across Canada, including Vancouver General and UBC Hospitals in BC, The Ottawa Hospital (Ontario), Montreal Heart Institute, Sherbrooke Fleurimont (Quebec), and the Queen Elizabeth II Health Sciences Centre (Nova Scotia). In hospital settings, pre-surgical use of Steriwave has resulted in significant improvement in post-surgical outcomes including lower rates of infection, reduced patient length of stay, fewer readmissions, lower rates of antibiotic prescribing and significant cost savings.^[8],[9],[10]

**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). Nasal decolonization is recommended in the 2016 WHO Global guidelines for the prevention of surgical site infections,^[11] and the Society for Healthcare Epidemiology of America (SHEA) guidelines, published in May 2023, recommend nasal decolonization for major surgical procedures.^[12] 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%.^[13]

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 Alberta Health Services

Alberta Health Services (AHS) is proud to be part of Canada's first and largest provincewide, integrated health system, responsible for delivering health services to more than 4.4 million people living in Alberta, as well as to some residents of Saskatchewan, B.C. and the Northwest Territories.

AHS has 106 acute care hospitals, five stand-alone psychiatric facilities, 8,523 acute care beds, 28,360 continuing care beds/spaces and 3,077 addiction and mental health beds/spaces, plus equity partnership in 40 primary care networks. Programs and services are offered at more than 900 facilities throughout the province, including hospitals, clinics, continuing care facilities, cancer centres, mental health facilities and community health sites.

^[1] Rennert-May ED, Conly J, Smith S, et al. The cost of managing complex surgical site infections following primary hip and knee arthroplasty: A population-based cohort study in Alberta, Canada. Infection Control & Hospital Epidemiology. 2018;39(10):1183-1188. doi:10.1017/ice.2018.199

^[2] Liu Z, Norman G, Iheozor-Ejiofor Z, Wong JK, Crosbie EJ, Wilson P. Nasal decontamination for the prevention of surgical site infection in Staphylococcus aureus carriers. Cochrane Database Syst Rev. 2017 May 18;5(5):CD012462. doi: 10.1002/14651858.CD012462.pub2. PMID: 28516472; PMCID: PMC6481881.

^[3]Poovelikunnel T, Gethin G, Humphreys H. Mupirocin resistance: clinical implications and potential alternatives for the eradication of MRSA. J Antimicrob Chemother. 2015;70(10):2681-2692. doi:10.1093/jac/dkv169

^[4] Poovelikunnel T, Gethin G, Humphreys H. Mupirocin resistance: clinical implications and potential alternatives for the eradication of MRSA. J Antimicrob Chemother. 2015 Oct;70(10):2681-92. doi: 10.1093/jac/dkv169. Epub 2015 Jul 3.

^[5] Healthcare-associated infections and antimicrobial resistance in Canadian acute care hospitals, CCDR 49(5) - Canada.ca

^[6] Healthcare-associated infections and antimicrobial resistance in Canadian acute care hospitals, CCDR 49(5) - Canada.ca

^[7] Rennert-May ED, Conly J, Smith S, et al. The cost of managing complex surgical site infections following primary hip and knee arthroplasty: A population-based cohort study in Alberta, Canada. Infection Control & Hospital Epidemiology. 2018;39(10):1183-1188. doi:10.1017/ice.2018.199

^[8] Banaszek D, Inglis T, Tamir Ailon T, Charest-Morin R, Dea N, Fisher C, Kwon B, Paquette S, Street J. The efficacy and cost-effectiveness of photodynamic therapy in prevention of surgical site infection. The Spine Journal, Volume 19, Issue 9, Supplement, 2019, Page S138.

^[9] https://www.londonstockexchange.com/news-article/OBI/ottawa-hospital-presents-steriwave-study- results/15860312

^[10] Bryce E, Wong T, Forrester L, et al. Nasal photodisinfection and chlorhexidine wipes decrease surgical site infections: a historical control study and propensity analysis [published correction appears in J Hosp Infect. 2015 Sep;91(1):93]. J Hosp Infect. 2014;88(2):89-95. doi:10.1016/j.jhin.2014.06.017

^[11] https://cdn.who.int/media/docs/default-source/integrated-health-services-(ihs)/ssi/fact-sheet-staphylococcus-web.pdf?sfvrsn=7e7266ed_2

^[12] Calderwood MS, Anderson DJ, Bratzler DW, et al. Strategies to prevent surgical site infections in acute-care hospitals: 2022 Update. Infect Control Hosp Epidemiol. 2023;44(5):695-720. doi:10.1017/ice.2023.67

^[13]Poovelikunnel T, Gethin G, Humphreys H. Mupirocin resistance: clinical implications and potential alternatives for the eradication of MRSA. J Antimicrob Chemother. 2015;70(10):2681-2692. doi:10.1093/jac/dkv169

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SOURCE: Ondine Biomedical Inc