Ondine recruits first patient for US Phase 3 trial
Ondine enrolls first patient in US Phase 3 trial of nasal photodisinfection technology for surgical site infection prevention.
- Phase 3 trial patient target approximately 5,000 patients
- Number of hospitals 14
- Nasal photodisinfection procedure duration 5 minutes
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Ondine Biomedical Inc. (LON: OBI), a Canadian life sciences company, has enrolled and treated the first patient in the Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections ('LANTERN') Phase 3 clinical trial. The trial, involving approximately 5,000 patients in 14 hospitals, is evaluating Ondine's non-antibiotic nasal photodisinfection technology, branded as Steriwave® outside the US. The first patient was enrolled at Centennial Medical Center in Nashville, Tennessee, on Friday December 27th, 2024.
The Phase 3 trial is being conducted in collaboration with HCA Healthcare, a leading healthcare provider in the United States. This group-randomized crossover study will enroll approximately 5,000 surgical patients undergoing cardiac, orthopaedic, vascular, neurosurgical or radical mastectomy procedures. The study will compare standard infection prevention practices with, and without, Ondine's nasal photodisinfection technology in order to reduce the incidence of surgical site infections. The final patient is expected to enroll in mid-2025, and preliminary trial results are projected for release in Autumn 2025.
Ondine Biomedical's CEO Carolyn Cross said:
"Our US Phase 3 trial initiation is an exciting milestone towards making photodisinfection technology available to healthcare professionals who want to rapidly eliminate a broad spectrum of infection-causing pathogens without fuelling drug resistance or relying on patient compliance as is the case with topical antibiotics."
Ondine's nasal photodisinfection is a 5-minute, non-invasive procedure that rapidly decolonizes the nose of infection-causing pathogens without the use of antibiotics. This innovative approach avoids contributing to antimicrobial resistance (AMR). The process involves applying a proprietary photosensitive agent to each nostril with a nasal swab, followed by illumination with a specific wavelength of red light. The light activates the agent, producing an oxidative burst that destroys bacteria, viruses and fungi in a single treatment.
Ondine Biomedical Inc.
| Carolyn Cross, CEO | +001 (604) 665 0555 |
| RBC Capital Markets (Joint Broker) Rupert Walford, Kathryn Deegan Singer Capital Markets (Nominated Adviser and Joint Broker) | +44 (0) 20 7653 4000 |
| Phil Davies, Sam Butcher | +44 (0)20 7496 3000 |
| Vane Percy & Roberts (Media Contact) | |
| Simon Vane Percy, Amanda Bernard | +44 (0)77 1000 5910 |
About Ondine Biomedical Inc.
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