Ondine Biomedical Hits 93% Enrolment Milestone in Landmark Phase 3 U.S. Clinical Study for Steriwave®

VANCOUVER, BC – 19^th March, 2026 – Ondine Biomedical Inc. (LON: OBI) reports that its North American Phase 3 LANTERN pivotal study has reached over 93% enrolment. This major milestone brings the company closer to its planned FDA submission for its non-antibiotic nasal photodisinfection technology, Steriwave*, which is being evaluated for the reduction of surgical site infections (SSIs).

A New Standard in Surgical Safety

Currently, there is no FDA-approved drug or device specifically indicated for the prevention of SSIs in the United States. The LANTERN study (Light-Activated Antimicrobial Nasal Therapy to Prevent Surgical Site Infections) is investigating Steriwave as a potential alternative to the current standard of care, the antibiotic mupirocin.

Unlike traditional antibiotic regimens that require five days of self-administration at home - often resulting in compliance rates as low as 30–40% - and growing rates of resistance, Steriwave is a five-minute, nurse assistant-administered treatment. This ensures 100% adherence immediately prior to surgery without contributing to the growing global crisis of antimicrobial resistance.

Addressing a $35 Billion Crisis

Healthcare-associated infections cost the U.S. healthcare system approximately $35 billion annually. With antibiotic resistance (AMR) rising - reaching up to 70% for some treatments in certain regions - the medical community is in urgent need of non-antibiotic alternatives which don’t generate resistance.

Carolyn Cross, CEO of Ondine Biomedical, stated:

“The LANTERN study represents a landmark investigation into the potential for universal nasal decolonization to meaningfully reduce surgical site infections. As we approach full enrolment, we look forward to sharing our top-line results and moving forward with our FDA submission to address this multi-billion-dollar burden on the U.S. healthcare system.”

Study Highlights & Progress

The LANTERN study is one of the most significant investigations into universal nasal decolonization to date:

Scale: Over 5,000 surgical patients across 14 HCA Healthcare hospitals in the U.S. and four major Canadian centers.

Data Integrity: 92% of clinical report forms are complete, with participant retention exceeding 98%.

Timeline: Top-line results are expected in Spring 2026, following the completion of endpoint adjudication and database lock.

Outside United States, Ondine’s photodisinfection technology (marketed as Steriwave™) is cleared for use and currently utilized in hospitals across the UK, EU, and Canada. In these regions, it is used preoperatively for patients undergoing surgical procedures and for infection control in Intensive Care Units (ICUs).

About Steriwave®

Steriwave uses a patented photodisinfection process. A light-activated photosensitizer is applied to the nasal passages and activated by a specific wavelength of red light, triggering an oxidative burst that eliminates bacteria, viruses, and fungi in minutes. While investigational in the U.S., the technology is already successfully deployed in leading hospitals across the UK, EU, and Canada.

*The tradename Steriwave is used worldwide but will be subject to US-specific branding following FDA approval.

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian life sciences company and leader in light-activated antimicrobial therapies (‘photodisinfection’) for the prevention and treatment of infections, including those caused by multidrug-resistant organisms. Ondine has a pipeline of investigational products, based on its proprietary photodisinfection technology, in various stages of development.

Ondine’s nasal photodisinfection system is CE-marked in Europe and is approved for nasal decolonisation in Canada, Australia, Mexico and several other countries under the name Steriwave®. In the US, it has been granted Qualified Infectious Disease Product designation and Fast Track status by the FDA and is currently undergoing clinical trials for regulatory approval. Products beyond nasal photodisinfection include therapies for a variety of medical indications such as chronic sinusitis, ventilator-associated pneumonia, burns and other indications.