LANTERN Safety Results Presented at IDWeek

Ondine Biomedical Inc.

28 October 2026

 

28 October 2026

ONDINE BIOMEDICAL INC.

("Ondine Biomedical", "Ondine", or the "Company")

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

Joint findings from Ondine Biomedical and HCA Healthcare Research Institute presented at IDWeek 2026 show treatment-related adverse events occurred in only 0.31% of patients with over 97% reporting high tolerability.

Ondine Biomedical Inc. (AIM: OBI), a leader in light-activated antimicrobial therapies announces additional safety and patient-reported tolerability results from the Phase 3 LANTERN clinical trial. The data were presented together with Ondine's research partner, HCA Healthcare Research Institute ("HRI"), at IDWeek 2026 in Washington, D.C. (Poster P-1520, available here) and build on the positive topline results announced in September 2026, which reported no treatment-related serious adverse events ("SAEs").

LANTERN (Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections) is a pivotal 5,188-patient Phase 3, cluster-randomised crossover trial conducted across 18 hospitals in the United States and Canada, evaluating Ondine's clinician-administered, non-antibiotic nasal photodisinfection in addition to standard of care versus standard of care alone. The safety analysis included the 2,543 participants who received nasal photodisinfection between 27 December 2024 and 27 April 2026, with patient-reported tolerability and willingness to receive the treatment again also assessed.

Key Findings:

·      No treatment-related SAEs; 0.31% treatment-related adverse event ("AE") rate: Among 2,543 treated participants, only eight experienced a treatment-related AE. All were mild-such as temporary nasal soreness, mild burning or transient bleeding.

·      97.4% high tolerability: Of 2,310 respondents, 2,249 rated the treatment "very bearable" or "bearable".

·      95.4% willing to receive treatment again: Of 2,309 respondents, 2,203 said they were "very likely" or "likely" to accept nasal photodisinfection again if prescribed by their doctor.

Dr Ken Sands, Chief Epidemiologist of HCA Healthcare and and representative from the HCA Healthcare Research Institute study team, stated:

"Preventing surgical site infections is critical to improving patient outcomes and overall healthcare delivery. These safety results from the LANTERN trial demonstrate that preoperative nasal photodisinfection was exceptionally well tolerated by patients in a real-world clinical setting."

Carolyn Cross, CEO of Ondine Biomedical, added:

"The very low number and mild nature of treatment-related adverse events, together with high patient acceptance, reinforce the practical suitability of nasal photodisinfection for preoperative use. For an intervention designed to fit into surgical workflows, having patients tolerate the treatment well and be willing to receive it again is an important part of the overall clinical profile."

The safety and tolerability findings complement the positive topline efficacy results from the full 5,188-patient LANTERN Phase 3 trial announced in September 2026. LANTERN met its prespecified Bayesian primary efficacy endpoint, demonstrating a 40.5% lower risk of 30-day surgical site infection with nasal photodisinfection plus standard of care compared with standard of care alone. Together, the efficacy, safety and patient-acceptance data further define the clinical profile of nasal photodisinfection as Ondine advances its planned U.S. regulatory submission.

Enquiries:

Ondine Biomedical Inc.	www.ondinebio.com
Carolyn Cross, CEO	[phone] or via 5654 & Company
Strand Hanson Limited (Nominated & Financial Adviser)
James Harris, Richard Johnson, Imogen Ellis	[phone]
Peel Hunt LLP (Broker & Joint Financial Adviser)
James Steel, Dr. Chris Golden	[phone]
5654 & Company (Financial PR and IR Adviser)	[e-mail]
Matthew Neal, Chris Gardner, Melissa Gardiner, Lucy Featherstone	[phone] [phone] [phone]

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 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 the LANTERN Phase 3 trial

LANTERN (Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections) is a multicentre, cluster-randomised, crossover, controlled Phase 3 superiority study evaluating nasal photodisinfection in addition to standard of care, versus standard of care alone for the prevention of surgical-site infections. The trial enrolled 5,188 patients undergoing major surgical procedures at 18 hospitals. The primary efficacy endpoint was the relative incidence of surgical site infection within 30 days of surgery, assessed and analysed according to prespecified criteria. Further detailed analyses of the primary endpoint as well as key secondary and exploratory endpoints are ongoing and will be reported in due course.

About Ondine's nasal photodisinfection technology

Ondine's nasal photodisinfection technology is a light-activated antimicrobial therapy designed to rapidly eliminate potentially pathogenic microorganisms in the nose, a major reservoir from which pathogens can spread to surgical sites and other parts of the body. Applied by a healthcare professional before surgery, the treatment uses a proprietary photosensitising agent activated by a specific wavelength of red light to produce a rapid antimicrobial effect through oxidative mechanisms. Because the mechanisms are non-antibiotic and act through multiple oxidative pathways, nasal photodisinfection is designed to have a low potential for 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 infections, including those associated with multidrug-resistant organisms. Ondine's lead photodisinfection product is authorised for nasal decolonisation in Canada, the UK and certain other international markets, where it is marketed as Steriwave^®. The Company also has a pipeline of additional photodisinfection products in various stages of development for applications including chronic sinusitis, ventilator-associated pneumonia, burns and other indications.

Regulatory Status and Clinical Data Disclaimer

Regulatory approvals, clearances and authorisations vary by jurisdiction, and indications, claims and availability may differ between markets. Ondine's photodisinfection products, including its nasal photodisinfection technology, are not approved or cleared by the U.S. Food and Drug Administration ("FDA") and are not commercially available in the United States, where they are limited by federal law to investigational use only. Their safety and effectiveness have not been established by the FDA, and any future U.S. marketing would be subject to FDA review and approval. No statement in this announcement should be interpreted as representing approval, clearance, authorisation or commercial availability in any jurisdiction, or for any use, where such status has not been granted.

References to clinical outcomes in this announcement should be interpreted in the context of the specific studies, real-world evaluations, endpoints and patient populations described, and do not imply regulatory approval for any particular indication or jurisdiction.

 

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