HCA and Ondine present safety results of phase III trial of nasal photodisinfection to reduce surgical site infections

Interim Phase 3 LANTERN Trial Data: 0.31% Treatment-Related Adverse Event Rate and High Patient Tolerability Reported at IDWeek 2026

VANCOUVER, CANADA, November 2, 2026 /EINPresswire.com/ -- Joint findings from HCA Healthcare Research Institute and Ondine Biomedical Inc. presented at IDWeek 2026 show treatment-related adverse events occurred in only 0.31% of patients with over 97% reporting high tolerability.

HCA Healthcare Research Institute (HRI), the research arm of HCA Healthcare, and Ondine Biomedical Inc., a Canadian life sciences company developing light-activated antimicrobial therapies, announced positive interim safety and patient-reported tolerability results from the Phase 3 LANTERN clinical trial. The data, presented at IDWeek 2026 in Washington DC, highlights the low adverse event rate and high acceptance of preoperative nasal photodisinfection in patients undergoing major surgery. Link to poster here: [Link]

IDWeek is the leading joint annual meeting of five major U.S. infectious-disease organizations, bringing together clinicians, researchers, epidemiologists, infection-prevention specialists, pharmacists and public-health leaders. Its focus on infectious diseases, healthcare epidemiology, antimicrobial stewardship and patient safety makes it an important annual forum for sharing research that can influence clinical practice and infection-prevention strategies.

Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections (LANTERN) is a pivotal Phase 3 study evaluating the safety and efficacy of Ondine’s non-antibiotic nasal photodisinfection technology. The 5,188-patient, cluster-randomized crossover trial was conducted across 18 hospitals—14 in the United States and four in Canada—between December 27, 2024, and April 27, 2026. The interim observations were:

Adverse events: Of 2,543 treated participants (2,291 in the United States and 252 in Canada), eight (8/2,543 = 0.31%) had an adverse event (AE) assessed as related to treatment. All eight were classified as mild. No serious adverse events (SAEs) were assessed as related to treatment.
Tolerability: Of 2,310 participants who completed the tolerability survey, 2,249 (97.4%) rated the two-minute procedure as "very bearable" or "bearable".
Willingness to repeat: Of 2,309 participants who answered the question, 2,203 (95.4%) said they were "very likely" or "likely" to undergo the procedure again if prescribed.

These interim findings remain subject to primary endpoint verification, completion of the prespecified analyses and database lock. Final safety, efficacy and clinical outcome results will be reported after completion of these processes.

"Preventing surgical site infections is critical to improving patient outcomes and overall healthcare delivery," said Dr. Ken Sands, Chief Epidemiologist of HCA Healthcare and representative from the HCA Healthcare Research Institute study team. "These interim safety results from the LANTERN trial indicate that preoperative nasal photodisinfection was well tolerated among participants in this interim evaluation in a real-world clinical setting."

“For a preoperative intervention, compliance is critical, therefore patient acceptability and a favorable safety profile are important considerations,” said Carolyn Cross, CEO of Ondine Biomedical Inc. “In this interim analysis, treatment-related adverse events were uncommon and mild, and most surveyed participants reported that the procedure was bearable and that they would be likely to undergo it again if prescribed. These findings support continued evaluation of nasal photodisinfection in the Phase 3 LANTERN trial as we complete primary analyses.”

About HCA Healthcare Research Institute (HRI)

HCA Healthcare Research Institute is the multispecialty clinical research arm of HCA Healthcare, conducting clinical trials across HCA Healthcare's network of hospitals and care sites to unlock insights from real-world data and conduct clinical studies leading to breakthroughs in science, medicine and care for all people. HCA Healthcare offers access to clinical trials across a wide range of conditions and specialties, helping patients and families explore new treatment options.

About IDWeek

IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS) and the Society of Infectious Diseases Pharmacists (SIDP). Its program covers infectious diseases and healthcare epidemiology and prevention, and its audience includes clinicians, researchers, hospital epidemiologists, infection prevention and patient-safety practitioners, pharmacists and public health officials. Co-sponsor SHEA is the US professional society for healthcare epidemiology, which includes infection prevention and antimicrobial stewardship.

About LANTERN

Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections (LANTERN) is a pivotal Phase 3 study evaluating the safety and efficacy of Ondine’s non-antibiotic nasal photodisinfection technology. Commercially known outside the USA as Steriwave^® Nasal Photodisinfection, the therapy is administered by a nurse before surgery in preop prep to reduce surgical site infections (SSIs). The 5,188-patient, 18-site, cluster-randomized crossover trial compared preoperative nasal photodisinfection with the current standard of care and was conducted from 27 December 2024 to 27 April 2026 with HCA Healthcare Research Institute at 14 HCA hospitals in the United States and four tertiary hospitals in Canada: Foothills, Rockyview, Royal Columbian and University of Alberta Hospitals.

About Steriwave^® and its Mode of Action

Steriwave nasal photodisinfection is a light-activated antimicrobial therapy designed to rapidly eliminate potentially pathogenic microorganisms in the nose, a major reservoir from which pathogens spread to surgical sites and lower respiratory tracts. Applied by a healthcare professional, the treatment uses a proprietary photosensitising agent activated by red light to produce a rapid antimicrobial effect through oxidative mechanisms. Because the mechanisms act through non-antibiotic oxidative pathways, Steriwave has a low potential for the development of microbial resistance.

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 hospital-acquired infections. Ondine's lead product, Steriwave^®, is authorised for nasal decolonisation in Canada and key international markets. In the United States, the technology has been granted Qualified Infectious Disease Product (QIDP) designation and Fast Track status by the FDA.

Regulatory Status & Forward-Looking Clarification

Notice Regarding Investigational Status in the United States:

Steriwave^® is CE-marked in Europe and is authorized for nasal decolonization in Canada, the United Kingdom, Australia, and Mexico. In the United States, Steriwave has been granted Qualified Infectious Disease Product (QIDP) designation and Fast Track status by the U.S. Food and Drug Administration (FDA). Steriwave is currently an investigational product in the United States and is limited by U.S. law to investigational use only. It has not been approved by the FDA as safe or effective for any indication, and it is not commercially available for sale or clinical use in the United States. Statements regarding clinical study results are factual summaries of completed research and do not constitute representations of FDA approval or guaranteed regulatory outcomes.

S J VANE PERCY
VANE PERCY & ROBERTS