Ondine Biomedical (AIM:OBI) highlighted that it recently closed patient enrolment in the LANTERN Phase 3 study — 14 hospitals in the US and four in Canada — with more than 5,000 patients taking part across 18 sites.
Top‑line results are expected in Spring 2026 as Ondine focuses on the next phases of its New Drug Application to the FDA, it said in a business update to investors.
A Royal Columbian Hospital ICU pilot showed an 80% reduction (p<0.05) in opportunistic pathogen carriage and the manuscript, "Suppression of Microbial Burden to Reduce Pneumonia in Critical Illness: the SMURF Feasibility Pilot Study", has been accepted for publication in the Journal of Critical Care. Further pilots and studies are underway at Royal Papworth, University Hospital Zurich, LMU Munich and centres in Spain, Mexico and Australia, with additional papers and conference presentations expected this year.
Commercial traction accompanied clinical progress: unaudited revenue grew 29% in 2025, driven by new hospital deployments and higher utilisation at existing accounts, the company said.
Ondine is pursuing a "land and expand" rollout; five Canadian hospitals have approved implementation with onboarding planned for Q2 2026 and four major tertiary hospitals were introduced to Steriwave during the LANTERN study. International awareness and early adoption continue through distributor programmes.
Operationally, Ondine highlighted it is investing in facility upgrades, automation and in‑house production capacity to improve production flow, inventory management, cost of goods and FDA audit readiness.
"We've also expanded our evidence base through innovative ICU and SSI pilot projects in Switzerland, Germany and Mexico, showcasing the clinical value of our technology," Carolyn Cross, CEO, said.
Regulatory progress outside the US underpins commercialization plans: Steriwave is CE‑marked and approved for nasal decolonisation in Canada, Australia, Mexico and other countries, and in the US has been granted Qualified Infectious Disease Product designation and Fast Track status by the FDA, the company said.
Ondine Biomedical expects to publish its 2025 Full Year Results on 21 May 2026.
