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Highlights
- Phase III trial initiated: Ondine Biomedical begins large-scale clinical trial for non-antibiotic infection prevention technology, enrolling its first patient.
- 5,000 participants across 14 sites: The study will assess the effectiveness of the nasal photodisinfection therapy in preventing surgical site infections.
- Groundbreaking non-invasive solution: The Steriwave technology aims to reduce antimicrobial resistance with a five-minute, light-activated pathogen elimination process.
Ondine Biomedical (LSE:OBI) has launched its Phase III clinical trial, evaluating its innovative nasal photodisinfection technology, Steriwave, as a means to prevent surgical site infections. The AIM-listed company announced that the trial officially began with the enrollment of the first patient at Centennial Medical Center in Nashville, Tennessee, on 27 December.
The study, known as LANTERN (Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections), is a collaboration with HCA Healthcare, a leading US healthcare provider. It will involve approximately 5,000 patients across 14 hospitals, focusing on major surgeries, including cardiac, orthopedic, and neurosurgical procedures.
The trial adopts a randomised crossover design to compare standard infection prevention protocols with and without Steriwave technology. Ondine expects patient enrollment to conclude by mid-2025, with preliminary results anticipated in the autumn of the same year.
A Revolutionary Approach to Infection Control
Steriwave is a five-minute, non-invasive procedure designed to eliminate harmful pathogens from the nasal cavity without relying on antibiotics. The process involves the application of a photosensitive agent to the nostrils, followed by illumination with red light to activate an oxidative burst, effectively destroying bacteria, viruses, and fungi.
This method not only reduces the risk of antimicrobial resistance but also aligns with global recommendations from the World Health Organization and the Society for Healthcare Epidemiology of America.
The technology is particularly significant in light of growing concerns over antibiotic resistance and the limitations of existing infection prevention strategies. Unlike topical antibiotics, Steriwave does not depend on patient compliance, providing a faster and potentially more effective solution.
CEO’s Perspective
Carolyn Cross, Ondine Biomedical's chief executive officer, described the trial as a crucial milestone in bringing photodisinfection technology to the forefront of infection prevention.
“Our US phase three 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 fueling drug resistance or relying on patient compliance as is the case with topical antibiotics,” she stated.
Market Response
Following the announcement, shares in Ondine Biomedical rose 5.59% to 8.98p as of 0824 GMT, reflecting investor optimism about the potential impact of the Steriwave technology on infection prevention in healthcare settings.
The LANTERN trial underscores Ondine Biomedical’s commitment to advancing innovative, non-antibiotic solutions for combating infections. If successful, Steriwave could mark a significant step forward in reducing surgical site infections and mitigating the global challenge of antimicrobial resistance.