Ondine Biomed Regulatory News (OBI)

Non-regulatory announcement

ONDINE BIOMEDICAL INC.

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

32% Fewer SSIs After Steriwave Replaced Mupirocin

New data shows reduced cardiac infections and significant cost savings after the light-activated antimicrobial, Steriwave, replaced the antibiotic standard of care at the Mazankowski Alberta Heart Institute

Ondine Biomedical Inc. (LON: OBI), the Canadian life sciences company pioneering light-activated antimicrobial treatments, announces that an independent study undertaken at the world renowned Mazankowski Alberta Heart Institute demonstrated a 32% reduction in cardiac surgical site infections (SSIs) following the implementation of Steriwave as a replacement for the antibiotic Mupirocin. Researchers from the University of Alberta presented this data in a poster at the AMMI Canada-CACMID annual conference, a major conference on clinical microbiology and infectious diseases. 

In June 2023, Steriwave was implemented on a pilot basis as a replacement for the antibiotic Mupirocin, which has resistance rates as high as 81% and is used by many hospitals as the standard of care for the prevention of SSIs.[1] The average SSI rate prior to the implementation of Steriwave was 1.67 per 100 surgeries, and the final rate following the implementation of Steriwave was 0.7 per 100 surgeries. The researchers estimated that this reduction in SSIs represented a $56,000 cost saving during the quarter. The compliance rate for Steriwave was 94%, and treatment was well-tolerated with no adverse reactions reported.

Lead author Dr. Stephanie Smith, Director of Hospital Infection Prevention and Control at the University of Alberta Hospital and the Mazankowski Alberta Heart Institute, commented: "We are very pleased to be able to share these initial results from the Steriwave pilot. To see a reduction in SSIs in excess of the already low rate we had when using Mupirocin is fantastic, particularly as many hospitals are looking to reduce their use of Mupirocin because of challenges with compliance and concerns about antibiotic resistance."

SSIs are one of the most significant complications in cardiac surgery patients and are strongly associated with poorer prognosis. SSIs can complicate up to 27% of cardiac surgery procedures[2] and result in substantially higher costs because of the need for additional treatments and extended patient recovery time. Nasal decolonization has been found to significantly decrease SSIs caused by the infection-causing pathogen S. aureus following cardiac procedures.[3]

Steriwave is a broad-spectrum light-activated antimicrobial that uses a patented photosensitizer and associated red activating light to destroy pathogens in the nose. The nose is a major reservoir of bacteria, fungi and viruses which can spread and cause serious infections. Unlike traditional antibiotics, Steriwave is immediately effective with a single five-minute treatment and does not trigger antimicrobial resistance (AMR).

Mupirocin, as well as having high resistance rates, tends to have a low compliance rate less than 40%, as patients need to self-administer in the five days leading up to their surgery. Both these factors led to Alberta Health Services' previously announced decision to expand its use of Steriwave.

About the pilot:

The Mazankowski Alberta Heart Institute pilot commenced in June 2023. Between June 2023 and February 2024, Steriwave was used to nasally decolonize 828 patients prior to cardiac surgery. The Steriwave compliance rate was 94%, and it was well-tolerated with no adverse reactions reported. The results presented at the AMMI Canada-CACMID annual conference were based on data including the first three months of the pilot.

**ENDS**

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About The Mazankowski Alberta Heart Institute

The Mazankowski Alberta Heart Institute in Edmonton is a world leader in complex cardiac care and surgery. With a collaborative approach, our team of highly skilled cardiologists, cardiovascular surgeons, cardiac care professionals, researchers and educators are advancing the prevention, detection, treatment and study of cardiovascular disease.

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian life science company and a world leader in the development and clinical use of light-activated antimicrobial therapies (also known as 'photodisinfection'). Based on its proprietary light-activated technology, Ondine has a pipeline of investigational products in various stages of development.

Ondine's nasal decolonisation light-activated technology has a CE mark in Europe and the UK-CA mark, 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. Light-activated antimicrobial products in development include therapies for a variety of medical indications such as chronic sinusitis, ventilator-associated pneumonia, burns, and other indications.

About Steriwave®

Ondine's Steriwave is a patented technology using a proprietary light-activated antimicrobial (photosensitizer) to destroy bacteria, viruses, and fungi colonizing the nose - a major reservoir of pathogens. The 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 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%,1 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,[4] and the Society for Healthcare Epidemiology of America (SHEA) guidelines, published in May 2023, recommend nasal decolonisation for major surgical procedures.[5]

[1] 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

[2] Zukowska A, Zukowski M. Surgical Site Infection in Cardiac Surgery. J Clin Med. 2022 Nov 26;11(23):6991. doi: 10.3390/jcm11236991. PMID: 36498567; PMCID: PMC9738257.

[3] Lemaignen A, Armand-Lefevre L, Birgand G, Mabileau G, Lolom I, Ghodbane W, Dilly MP, Nataf P, Lucet JC. Thirteen-year experience with universal Staphylococcus aureus nasal decolonization prior to cardiac surgery: a quasi-experimental study. J Hosp Infect. 2018 Nov;100(3):322-328. doi: 10.1016/j.jhin.2018.04.023. Epub 2018 May 5.

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

[5] 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