Positive Topline Results in US Phase 3 Study
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This Announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation No. 596/2014 as it forms part of UK law by virtue of the European Union (Withdrawal) Act 2018 as amended. Upon the publication of this Announcement, this inside information is now considered to be in the public domain.
1 September 2026
ONDINE BIOMEDICAL INC.
("Ondine Biomedical", "Ondine", or the "Company")
Ondine Biomedical Announces Positive Topline Results from Phase 3 Pivotal LANTERN Study
· The trial met its primary efficacy endpoint.
· Nasal photodisinfection in addition to standard of care was associated with an estimated 40% relative reduction in 30-day surgical site infections compared with standard of care alone in the primary analysis.
· No treatment-related serious safety concerns were identified in the topline review.
· 5,188 patients were enrolled across 18 hospitals in the United States and Canada.
· Ondine plans to share detailed results with FDA and engage with the Agency through the pre-New Drug Application process before submitting a formal marketing application.
Ondine Biomedical Inc. (AIM: OBI), a leader in light-activated antimicrobial therapies to prevent hospital infections, today announced positive topline results from its LANTERN pivotal Phase 3 clinical trial evaluating its nasal photodisinfection technology for the prevention of surgical site infections ("SSIs").
The LANTERN trial was designed to demonstrate whether nasal photodisinfection in addition to standard of care reduced surgical site infections compared to standard of care alone. The primary analysis estimated a 40% relative reduction in 30-day SSIs and met the trial's prespecified Bayesian criterion for treatment benefit. The safety profile observed in LANTERN was consistent with more than a decade of prior clinical experience with nasal photodisinfection, including more than 250,000 patient treatments performed outside the United States. No treatment-related serious safety concerns were identified in the topline review; these findings remain subject to completion of detailed efficacy, safety, subgroup and other analyses.
LANTERN enrolled a broad population of 5,188 patients undergoing major surgical procedures across 14 hospitals in the United States and 4 in Canada. Hospitals continued their usual standard of care infection-prevention practices, including permitted use of preoperative nasal mupirocin, presurgical antibiotics and other routine measures.
Ondine plans to request a pre-New Drug Application ("pre-NDA") meeting with the U.S. Food and Drug Administration ("FDA") to discuss the detailed LANTERN results and the Company's planned future regulatory submissions. Detailed study findings will also be presented at a major scientific meeting and submitted for publication in one or more peer-reviewed medical journals.
Carolyn Cross, Chief Executive Officer of Ondine Biomedical, said:
"The LANTERN results represent an important milestone for Ondine and for our development programme in surgical site infection prevention. Surgical site infections remain a major cause of avoidable complications following surgery, while increasing antibiotic resistance makes prevention using non-antibiotic approaches increasingly important.
"We are deeply grateful to the patients, investigators, clinical research teams and healthcare professionals at HCA Healthcare Research Institute and at four Canadian hospitals, whose joint participation made this large study possible. Our prior work in Canada and other countries over more than a decade has supported the potential benefits of nasal photodisinfection for patients and healthcare providers, and we look forward to engaging with the FDA through the regulatory process to bring this technology into the United States."
Enquiries:
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Ondine Biomedical Inc. |
www.ondinebio.com |
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Carolyn Cross, CEO |
+1 604 669 0555 |
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Strand Hanson Limited (Nominated & Financial Adviser) |
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James Harris, Richard Johnson, Imogen Ellis |
+44 (0)20 7409 3494 |
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Peel Hunt LLP (Broker & Joint Financial Adviser) |
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James Steel, Dr. Chris Golden |
+44 (0)20 7418 8900 |
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5654 & Company (Financial PR and IR Adviser) |
ondinebiomedical@5654.co.uk |
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Matthew Neal, Chris Gardner, Melissa Gardiner |
+44 0791 7800 011 +44 0775 7697 357 |
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 surgical site infections
More than 300 million surgical procedures are performed globally each year, including more than 35 million major surgical procedures annually in the United States. Surgical site infections remain one of the most serious complications of surgery, causing substantial patient morbidity, hospital readmissions, prolonged hospital stays and deaths. U.S. data have estimated that patients who develop an SSI face a two- to 11-fold increased risk of death compared with surgical patients without an infection. The economic burden is also substantial. Published U.S. estimates put the annual healthcare cost of SSIs at approximately $3.5 billion to $10 billion. The CDC also reports that an SSI can extend a patient's hospital stay by approximately 9.7 days and increase hospitalisation costs by more than $20,000 per admission.
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 product, branded as Steriwave® outside the United States, is authorised for nasal decolonisation in Canada, the UK, and certain other international markets. 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.
Regulatory approvals, clearances and authorisations vary by jurisdiction, and indications, claims and availability may differ between markets.
U.S. Regulatory Status
Ondine's nasal photodisinfection technology is not approved by FDA and is not commercially available for sale in the United States. In the United States, it is limited by federal law to investigational use only.
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