Update on US Phase 3 Pivotal Study

Ondine Biomedical Inc.

13 July 2026

 

13 July 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) 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 guidance from the Company's independent data management and statistical advisers regarding the time required to complete final data management, reconciliation and database lock activities. The revised timeline reflects the scale 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.

Carolyn Cross, CEO of Ondine Biomedical, commented:

"The LANTERN study includes more than 350,000 data points sourced from 18 hospitals. Final database activities are progressing well, and we remain focused on reporting topline results as soon as possible. We are encouraged by the progress being made and believe results may be available ahead of the revised schedule. Meanwhile, Ondine continues to expand use of Steriwave in more hospitals and surgical specialities in markets where Steriwave is already approved."

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.

-- ENDS --

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	[phone] [phone]

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.

 

END