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Update on US Phase 3 Pivotal Study
Ondine Biomedical Inc. has announced a significant update on its LANTERN Phase 3 pivotal study for its nasal photodisinfection technology, Steriwave, with endpoint adjudication completed and queries resolved, paving the way for database lock within the coming week. The study, which enrolled 5,188 patients across 14 HCA Healthcare hospitals in the United States and four Canadian sites, is designed to assess the technology's safety and efficacy in reducing surgical site infections. Top-line results are anticipated within one to two weeks following the completion of statistical analysis. Disclaimer*
About this update from Ondine Biomedical, Inc.
22 June 2026 ONDINE BIOMEDICAL INC. ("Ondine Biomedical", "Ondine", or "the Company") Update on US Phase 3 Pivotal Study Ondine Biomedical Inc. (AIM: OBI), a leader in light-activated antimicrobial therapies to prevent and treat hospital infections, today provides an update on its LANTERN Phase 3 pivotal study evaluating the Company's non-antibiotic nasal photodisinfection technology (branded as Steriwave ® outside the US). Endpoint adjudication has been completed, all queries resolved, and site principal investigators are signing all case books which is a required administrative step towards database lock. This is expected to complete within the coming week, and once complete, the locked dataset will be transferred to statistical analysis in accordance with the Statistical Analysis Plan ("SAP"). The Company expects to report top-line results within one to two weeks thereafter. The LANTERN (Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections) study is designed to evaluate the safety and efficacy of Ondine's nasal photodisinfection technology in reducing the rate of surgical site infections ("SSIs"). C onducted in collaboration with HCA Healthcare and select Canadian hospitals, the study enrolled 5,188 patients across 14 HCA Healthcare hospitals in the United States and four sites in Canada. -- ENDS -- Enquiries: Ondine Biomedical Inc. www.ondinebio.com Carolyn Cross, CEO +1 604 669 0555 or via 5654 & Company Strand Hanson Limited (Nominated & Financial Adviser) James Harris, Richard Johnson +44 (0)20 7409 3494 Peel Hunt LLP (Broker & Joint Financial Adviser) James Steel, Dr. Chris Golden +44 (0)20 7418 8900 5654 & Company (Financial PR and IR Adviser) [email protected] Matthew Neal, Chris Gardner, Melissa Gardiner +44 0791 7800 011 +44 0775 7697 357 About Ondine Biomedical Inc. Ondine Biomedical Inc. is a Canadian life sciences company focused on the development of light-activated antimicrobial therapies ('photodisinfection') for the prevention and treatment of infections, including those associated with multidrug-resistant organisms. Ondine's lead product, Steriwave ® , is authorized for nasal decolonisation in Canada and certain international markets. In the United States, the technology has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration and recently completed enrolment in its Phase 3 clinical trial . The Company has a pipeline of additional photodisinfection products in various stages of development for application in areas including chronic sinusitis, ventilator-associated pneumonia, burns and other indications. U.S. Regulatory Status and Clinical Data Disclaimer Ondine's light-activated antimicrobial technology, commercially available as Steriwave ® in certain jurisdictions, is not approved, cleared, or commercially available for sale or clinical use in the United States and is limited by U.S. law to investigational use only. References to clinical outcomes in this release should be interpreted in the context of the specific studies or real-world evaluations described and do not imply regulatory approval for any particular indication.
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