Ondine Biomedical (LON:OBI) treated the first patients in its nasal photodisinfection exploratory Phase 2 trial to evaluate how effectively the treatment eradicates pathogens – Staphylococcus aureus – in the nose, and occurrence of surgical site infections (SSIs) within 30 days of surgery.
The single-center, BENEFIT-ADPT open-label study is being carried out at HCA Healthcare’s Memorial Health University Medical Center in Savannah, GA. and will involve up to 500 surgical patients.
Ondine’s nasal photodisinfection has a CE mark for use in the EU and is approved in Canada and number of other countries under the name, Steriwave. In the U.S., it has received qualified infectious disease product status and been granted fast track by the FDA. The Phase 2 trial is part of the FDA regulatory application.
“This is a truly novel approach to nasal disinfection, and we believe that our technology has the potential to have a significant effect on combatting SSIs, complications, and extended hospital stays,” Carolyn Cross, CEO of Ondine, said in a statement.
Ondine’s nasal photodisinfection is a patented platform technology involving a two-step process: the application of a light-activated agent to each nostril using a nasal swab, followed by illumination of the area with a specific wavelength of laser light for less than five minutes. A key benefit of this approach is that pathogens do not develop resistance to the therapy.
Prior to surgery, all clinical trial patients will undergo a nasal culture to determine the prevalence of Staphylococcus aureus, the main cause of surgical site infections. Each patient will then receive Ondine’s nasal photodisinfection followed by a post-treatment culture, enabling evaluation of the efficacy of nasal photodisinfection across a wide range of patients and surgery types.
Experience in Canada has found that the procedure has resulted in no major adverse reactions being reported.
SSIs are the leading cause of readmissions to hospital following surgery and a significant cause of post-surgical morbidity and mortality, with approximately 3% of patients who contract an SSI dying as a consequence.
