Routine pre-surgical use of nasal photodisinfection could prevent tens of thousands of surgical site infections a year in the US alone[i]

Ondine Biomedical Inc. (LON: OBI) presented detailed results from its US Phase 2 BENEFIT-aPDT clinical trial to the 33^rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Copenhagen, Denmark. The results indicate that patients who underwent Ondine’s nasal photodisinfection prior to surgery experienced 66% fewer surgical site infections (SSIs) than the US national average. The Centers for Disease Control and Prevention (CDC) estimates that over 110,000 SSIs occur in the US each year, costing the healthcare system approximately $3.3 billion.[i] 

Moreover, the study results showed that Ondine’s nasal photodisinfection eliminated or significantly reduced Staphylococcus aureus, including MRSA, in 88% of carriers immediately after treatment. Of the 313 patients who underwent the treatment prior to surgery, 21% were found to have S. aureus colonization in their nose. The nose is a well-known reservoir of infection-causing pathogens.[ii]

1. S. aureus, including MRSA, is a major contributor to SSIs, and nasal decolonization has proven to be highly effective in preventing SSIs by eradicating S. aureus. SSIs are responsible for most hospital readmissions following surgery and are a significant cause of post-surgical morbidity and mortality, increasing the risk of mortality by 2- to 11-fold.[iii] A patient who develops an SSI will spend an average of five additional days in hospital,[iv] significantly increasing their recovery time and costs.

Roger Andersen, MD, MPH, Ondine Biomedical’s VP, Regulatory and Medical Affairs said:

“Our US Phase 2 trial met its primary endpoint last year, and these results confirm that a single, 5-minute treatment of nasal photodisinfection pre-surgically significantly reduces Staphylococcus aureus, a primary pathogen causing surgical site infections. These exciting results demonstrate the capabilities of this advanced infection prevention. Universal treatment with nasal photodisinfection before surgery could have a transformative effect on preventing SSIs and potentially lead to substantial cost savings for the US healthcare system.”

All patients in the study were treated with a single, 5-minute treatment of Ondine’s nasal photodisinfection, which eliminates infection-causing bacteria, viruses and fungi in the nose. Ondine’s nasal photodisinfection is a patented technology which uses a proprietary, non-antibiotic photosensitizer to destroy pathogens. When illuminated with a specific wavelength of light, the photosensitizer is activated, causing an oxidative burst that is lethal to all types of pathogens.

The findings of the Phase 2 study were consistent with previously reported research from Vancouver General Hospital (VGH) has shown that pre-surgical nasal photodisinfection resulted in a 78% reduction in SSIs among spine surgery patients.[v]

Ondine’s nasal photodisinfection system has a CE mark and is approved in Canada and several other countries under the name Steriwave™. It has been used in numerous Canadian hospitals for over ten years, with no serious adverse events reportedOndine is currently preparing for a US Phase 3 trial of its nasal photodisinfection, with further details to be announced later this year.

[i] https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf

[ii] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2908500/

[iii] Ban KA, Minei JP, Laronga C, et al. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2017;224(1):59-74. doi:10.1016/j.jamcollsurg.2016.10.029.

[iv] Shepard J, Ward W, Milstone A, et al. Financial Impact of Surgical Site Infections on Hospitals: The Hospital Management Perspective. JAMA Surg. 2013;148(10):907–914. doi:10.1001/jamasurg.2013.2246

[v] Daniel Banaszek, Tom Inglis, Tamir Ailon, Raphaële Charest-Morin, Nicolas Dea, Charles G. Fisher, Brian K. Kwon, Scott J. Paquette, John Street. 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, https://doi.org/10.1016/j.spinee.2019.05.299.