Policy & Regulation
Ondine Biomedical enrolls first patient in US Phase 3 trial
30 December 2024 -

Ondine Biomedical Inc (LON: OBI), a Canadian life sciences company, announced on Monday that it has enrolled its first patient in the US Phase 3 clinical trial for its Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections (LANTERN). The patient was treated at Centennial Medical Center in Nashville, Tennessee, on 27 December 2024.

The trial, involving approximately 5,000 patients across 14 hospitals, evaluates Ondine's non-antibiotic nasal photodisinfection technology, known as Steriwave outside the US. Conducted in collaboration with HCA Healthcare, the study aims to reduce surgical site infections by comparing standard infection prevention practices with Ondine's nasal photodisinfection. The final patient is expected to be enrolled by mid-2025, with preliminary results anticipated in Autumn 2025.

Ondine's nasal photodisinfection is a non-invasive, 5-minute procedure that eliminates infection-causing pathogens without antibiotics. It involves applying a photosensitive agent to the nostrils and illuminating it with red light to destroy bacteria, viruses and fungi. This technology aligns with WHO and SHEA guidelines for preventing surgical infections.

Ondine Biomedical's photodisinfection system holds a CE mark in Europe and is approved in Canada and other countries. In the US, it has received FDA Qualified Infectious Disease Product designation and Fast Track status. The company's product pipeline includes treatments for chronic sinusitis, ventilator-associated pneumonia, burns and other conditions.

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