Announcement • Jul 13
Ondine Biomedical Provides Update On Lantern Phase 3 Pivotal Study Evaluating Non-Antibiotic Nasal Photodisinfection Technology Ondine Biomedical Inc. provided an update on its LANTERN Phase 3 pivotal study evaluating the Company's non-antibiotic nasal photodisinfection technology (branded as Steriwave® outside the US) to reduce the incidence of surgical site infections. The Company has updated the expected timeline for release of topline results from the LANTERN Phase 3 study. Results are now expected within approximately six weeks, reflecting recent guidancefrom the Company's independent data management and statistical advisersregarding the time required to complete final data management, reconciliation and database lock activities. The revised timeline reflects thescale of the study and the normal process of finalising a high-quality analysis dataset and associated documentation in preparation for regulatory submission. The primary endpoint and success criteria remain unchanged. 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). Conducted 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. Announcement • Jul 01
Ondine Biomedical Publishes Leeds Study Showing Steriwave Reduces Surgical Site Infections By 78% Versus Mupirocin In High Risk Endoscopic Endonasal Skull-Base Surgery Ondine Biomedical Inc. announced that full results from Leeds Teaching Hospitals' evaluation of Steriwave nasal photodisinfection versus mupirocin in endoscopic anterior skull-base surgery have been published in The Journal of Laryngology & Otology. The Leeds researchers state that given its broad-spectrum rapid action, excellent compliance and lack of resistance potential, Steriwave represents a compelling alternative to mupirocin-based decolonisation and should be considered for routine adoption. The Leeds researchers, Dr Paul Nix (Dept. of Otolaryngology) and Drs. Atul Tyagi, Nick Phillips and Asim Sheikh (Dept. of Neurosurgery) conclude that Steriwave significantly reduces SSI, antibiotic usage and ENT outpatient burden following endoscopic anterior skull base surgery. With a relative risk reduction of 78%, the number needed to treat would be 9 patients (95% CI: 5 to 27). The study finds an approximate cost of £774 per SSI prevented which compares (at only 12.3%) favourable to the published estimates of £6,300 average cost to treat a (non-meningitis) neurosurgery SSI and less than 2% of a meningitis related SSI. The publication entitled, 'Steriwave a Non-Antibiotic Nasal Photodisinfection Strategy Reduces Infection Burden in Endoscopic Skull Base Surgery', reports findings from a single-centre, before-and-after service evaluation conducted at Leeds General Infirmary, of the Leeds Teaching Hospitals NHS Trust. The evaluation compared outcomes between 105 patients (52.5%) managed with mupirocin (the standard 5-day pre-operative home-based topical antibiotic nasal decolonisation regimen) against 95 patients (47.5%) who received a single clinician-delivered Steriwave 5-minute nasal photodisinfection treatment immediately before EESB surgery. Full study results demonstrated that Steriwave nasal photodisinfection was associated with a statistically significant reduction in 30-day surgical site infections (SSIs) over mupirocin, with a relative risk reduction of 78% and an absolute risk reduction of 11.4% (95% CI 3.7%-19.1%, p=0.0059). The SSI rate was 3.2% in the Steriwave nasal photodisinfection arm compared with 14.6% in the standard-of-care arm using mupirocin topical nasal antibiotic. Compliance with Steriwave was 100%, compared with literature-reported compliance rates of about 39% for home-based mupirocin use. There were no adverse events related to Steriwave. Most importantly, no cases of meningitis were recorded in the Steriwave arm (0%), compared with 5 cases (4.8%) in the standard of care arm. Endoscopic anterior skull base surgery is classed as clean contaminated, with meningitis risk heightened by dural opening and CSF leak. Postoperative meningitis is a severe, potentially life-threatening infection and inflammation of the meninges. Meningitis poses a significant risk to the patient and results in prolonged hospital stays. With severe meningitis cases potentially exceeding $60,000 (~£47,000), the study generated a positive net Return on Investment (ROI), from the avoidance of these serious post-surgical infections alone. The study authors noted that Steriwave's rapid action, clinician-delivered administration, high compliance profile and non-antibiotic mechanism represents a compelling alternative to mupirocin-based decolonisation. The interim study findings from the Leeds researchers were previously presented on 18 June 2026 at ENDOAthens, the 10th World Congress for Endoscopic Surgery of Sinuses, Skull Base, Brain, Spine & Orbit. Steriwave is a five-minute, clinician-administered treatment designed to rapidly eliminate a broad spectrum of pathogens in the nasal vestibule using a light-activated antimicrobial process, without contributing to antimicrobial resistance. Because the treatment is delivered at the point of care immediately before surgery, it also helps address a practical challenge associated with multi-day, home-based decolonisation regimens: ensuring that the intended protocol has been completed before the patient enters the operating theatre. Announcement • Jun 22
Ondine Biomedical Provides Update on Us Phase 3 Pivotal Study for Nasal Photodisinfection Technology Ondine Biomedical Inc. provided 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"). Conducted 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. 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. 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. 
