Ondine Biomedical Inc (AIM:OBI) reported full results of the Phase-2 clinical trial of its nasal photodisinfection technology, which met its primary and secondary endpoint targets.
Firstly, the BENEFIT-PDT study in 322 pre-surgical patients demonstrated that treatment with Ondine's photodisinfection technology reduced Staphylococcus aureus colonisation in the nostrils in 86% of cases.
Nostrils are considered a primary reservoir of pathogens, with almost a third of the US population found to be carrying S aureus and multidrug-resistant S aureus (MRSA), the leading cause of surgical site infections (SSI).
A far lower SSI rate of 0.6% among treated patients was also demonstrated versus the US historical national average SSI rate of 3%, which met the secondary endpoint of the study.
Ondine noted that lowering SSI rates has been an elusive target for hospitals for many years as SSIs are the leading cause of readmissions to hospital following surgery with approximately 3% of patients who contract an SSI dying as a consequence of these infections.
There were no treatment-related reportable adverse events, meaning the treatment continued to be found to be safe and well tolerated.
The study was conducted at HCA Healthcare's Memorial Health University Medical Center in Savannah, Georgia, USA and was approved by the Institutional Review Board (IRB).
Dr Simon Sinclair, non-executive director of Ondine and former medical director at J&J Medical Devices EMEA, said: "This study demonstrates that Ondine's photodisinfection technology robustly reduces nasal S aureus colonisation in presurgical patients.
“Proving that this technology works well in a safe and easy-to-apply format is a critical step in our FDA regulatory pathway, and we hope will ultimately lead to wide utility across worldwide healthcare systems."
In this latest clinical trial, each patient received a baseline nasal culture to determine S aureus carrier status before receiving photodisinfection treatment, which 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 treatment effectiveness.
Patients were monitored within 24 hours, and then at 14 days and 30 days to determine the incidence of adverse events and SSIs.