New light-activated antimicrobial expands usage across Canada

• New technology does not generate antimicrobial resistance.
• Kills all types of bugs – viruses, bacteria and fungi – even in biofilm.

Ondine Biomedical Inc., the Canadian life sciences company pioneering light-activated antimicrobial treatments to prevent and treat healthcare-associated infections (HAIs), has deployed in five new Canadian healthcare facilities since the beginning of the year, including another site at The Ottawa Hospital, Sturgeon Community Hospital, and Nanaimo Regional General Hospital. This brings the total number of Canadian hospitals using Ondine’s Steriwave® technology to decolonise the nose prior to surgery to 18.

The Ottawa Hospital (TOH) has confirmed it is significantly expanding its use of Steriwave, building upon the success of its pilot and a comprehensive cost-benefit assessment within spine surgeries. This expansion means that Steriwave will now be used across an additional site, and also extends its application from spinal surgeries to also include TOH’s orthopedic and vascular surgery patients. Annually, Steriwave will now be used prior to approximately 2,600 surgical procedures at TOH, a threefold increase from the Steriwave pilot.

Ondine has pioneered light-activated antimicrobial technology to replace traditional antibiotics that generate resistance. The Company at present is focussed on decolonising the nose – a major reservoir of pathogens and leading cause of HAIs – prior to surgery. According to the US’s NIH, HAIs affect more than two million patients a year in the US, with more than 90,000 dying every year.[i] HAIs are known to cost more than $28.4 billion a year,[ii] costing the major US hospital groups hundreds of millions of dollars each year.

Ondine’s Steriwave destroys pathogens by stimulating an ‘oxidative burst’ that eliminates pathogens so rapidly that they do not have the opportunity to develop resistance. The patented light-activated antimicrobial (photosensitizer) is applied to each nostril using a nasal swab, then the area is illuminated with a specific wavelength of red light. 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. This painless, easy-to-use process is repeated once more and takes a total of about five minutes.

In the US, Ondine is working together with partner HCA Healthcare, the US’s largest hospital group, on the final US Phase 3 design with the ultimate goal of obtaining FDA approval. HCA approached Ondine with the goal of accelerating Ondine’s light-activated antimicrobial technology into the US as antimicrobial resistance is creating an upsurge in untreatable infections. Steriwave has a CE mark in the UK and EU and approval in Canada. Discussions are ongoing with medical device distributors to further expand the commercial reach of Steriwave.

The increased interest in Steriwave from hospitals across Canada is driven by the growing need to reduce avoidable hospital costs in an era of rising antibiotic resistance. Recently published findings reported a net saving approaching C$2,600 per spine surgery patient treated with Steriwave nasal photodisinfection and chlorhexidine skin decolonization.[iii] Despite case complexity increasing over the study period, the post-surgical infection rate dropped by 67%, resulting in estimated annual cumulative institutional savings of $2.49 million attributable to the use of the bundled protocol with Steriwave.

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. A 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 traditional antibiotics, which have resistance rates reported as high as 81%[iv]—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,[v] and the Society for Healthcare Epidemiology of America (SHEA) guidelines, published in May 2023, recommend nasal decolonization for major surgical procedures.[vi]

[i] Stone PW. Economic burden of healthcare-associated infections: an American perspective. Expert Rev Pharmacoecon Outcomes Res. 2009 Oct;9(5):417-22. doi: 10.1586/erp.09.53. PMID: 19817525; PMCID: PMC2827870.

[ii] Scott, R. Douglas. The Direct medical costs of healthcare-associated infections in U.S. hospitals and the benefits of prevention. National Center for Preparedness, Detection, and Control of Infectious Diseases (U.S.). Division of Healthcare Quality Promotion. March 2009. https://stacks.cdc.gov/view/cdc/11550

[iii] $2,484,856-$2,495,016 average annual net savings divided by 964 mean number of patients per year= $2,582.92 net saving per patient. Moskven E et al. Effectiveness of prophylactic intranasal photodynamic disinfection therapy and chlorhexidine gluconate body wipes for surgical site infection prophylaxis in adult spine surgery. Can J Surg. 2023 Nov;66(6), E550–E560. https://doi.org/10.1503/cjs.016922

[iv] 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

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

[vi] 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