2nd Dec 2022 09:23
(Alliance News) - Ondine Biomedical Inc said on Friday that the phase two trial of a nasal photodisinfection treatment showed positive results in reducing surgical site infection for pre-surgical patients.
The Vancouver-based life sciences company said the five minute treatment eliminated or significantly decreased the primary pathogen Staphylococcus aureus in 86% of trial carriers, while it also demonstrated a 0.6% surgical site infection rate among treated patients, lower than the US historical national average SSI rate of 3.0%.
The treatment consisted of swabbing each nostril with a proprietary light-activated solution followed by four minutes of non-thermal red laser light painlessly illuminating the area using single-use nasal light diffusers.
A second nasal culture was collected immediately following treatment to determine effectiveness. Patients were monitored within 24 hours, followed by at 14 days and 30 days to determine the incidence of adverse events and SSIs.
There were no treatment-related reportable adverse events, as the treatment was found to be safe and well tolerated.
SSIs are the leading cause of hospital admissions following surgery, with around 3% of patients who contracted an SSI later dying as a result. Up to 30% of the general population is nasally colonised with Staphylococcus aureus, causing up to 300,000 post-operative infections in US patients per year and costing the US healthcare system tens of billions of dollars per year.
"This study demonstrates that Ondine's photodisinfection technology robustly reduces nasal Staphylococcus aureus colonisation in pre-surgical patients. Proving that this technology works well in a safe and easy-to-apply format is a critical step in our US Food & Drug Administration regulatory pathway, and we hope will ultimately lead to wide utility across worldwide healthcare systems," said Non-Executive Director Simon Sinclair.
The Institutional Review Board-approved study of 319 treated patients was conducted at HCA Healthcare's Memorial Health University Medical Center in Savannah, the US state of Georgia.
Shares in Ondine Biomedical were up 1.5% to 24.14 pence in London on Friday morning.
By Greg Rosenvinge; [email protected]
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