Ondine Provides Update on US Phase 3 Pivotal Study

Ondine Provides Update on US Phase 3 Pivotal Study  

Trial remains on track to report top-line results in Spring 2026

Ondine Biomedical Inc. (AIM: OBI), a global leader in light-activated antimicrobial therapies, announces an operational update on its LANTERN Phase 3 pivotal study. The study, evaluating the Company’s non-antibiotic nasal photodisinfection technology (branded as Steriwave^? outside the US) remains on schedule to report top-line results in Spring 2026 in line with prior guidance.

With 93% of patients enrolled across 14 HCA Healthcare hospitals and four major Canadian centres, the LANTERN study is entering its final stages of recruitment, data collection and verification, and continues to meet projected data quality and monitoring benchmarks:

• Data integrity: Over 92% of clinical report forms are complete with 92% of all database queries successfully resolved.
• Monitoring progress: 80% of monitoring visits are now complete.
• Endpoint adjudication: Nearly 80% of all primary endpoint adjudications are complete.
• Participant retention: Follow-up completion currently exceeds 98%.

Topline analysis will commence immediately following completion of endpoint adjudication and database lock. Reporting will include the estimated treatment effect of surgical site infection rate reduction (derived from a generalized linear mixed-effects model comparing treatment to control arm), as well as primary safety data.

Carolyn Cross, CEO of Ondine Biomedical, commented:

“Healthcare-associated infections remain a persistent $35 billion burden on the U.S. healthcare system and, as antibiotic resistance continues to rise, the need for effective non-antibiotic prevention strategies has never been greater. The LANTERN study represents a landmark investigation into universal nasal decolonisation prior to surgery and its potential to meaningfully reduce surgical site infections.

“This large-scale study with over 5,000 participants represents a remarkable team effort. We are deeply grateful to our clinical and academic partners for their immense amount of work and diligence they have undertaken throughout this study. We look forward to sharing top-line results and moving forward with the submission.”

About the LANTERN Study

LANTERN (Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections) is a Phase 3 pivotal study designed to evaluate the safety and efficacy of Ondine’s nasal photodisinfection technology in reducing the rate of SSIs. The study is a key component of Ondine’s regulatory pathway for the U.S. market.

About Nasal Photodisinfection and its Mode of Action

Nasal photodisinfection is a non-invasive and painless treatment that uses a proprietary light-activated photosensitive agent to destroy harmful bacteria, viruses, and fungi, including antibiotic-resistant strains, in the nasal passages. The procedure takes five minutes and, unlike antibiotics, acts immediately and without fostering antimicrobial resistance.

The two-step process involves applying the proprietary formulation in the nostrils where it electrostatically binds to microbes rather than human cells. The area is then illuminated with safe red light to activate the formulation, triggering an oxidative burst that physically destroys all manner of pathogens within minutes. This rapid and overwhelming oxidative stress makes it extremely difficult for pathogens to develop resistance.