REG - Ondine Biomedical - Ondine Provides Update on US Phase 3 Pivotal Study

Ondine BiomedicalAnnouncement

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RNS Number : 0241W  Ondine Biomedical Inc.  10 March 2026

10 March 2026

 

ONDINE BIOMEDICAL INC.

 

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

 

Ondine Provides Update on US Phase 3 Pivotal Study

 

Trial remains on track to report top-line results in Spring 2026

 

Ondine Biomedical Inc. (AIM: OBI), a global leader in light-activated
antimicrobial therapies, announces an operational update on its LANTERN Phase
3 pivotal study. The study, evaluating the Company's non-antibiotic nasal
photodisinfection technology (branded as Steriwave(®) outside the US) remains
on schedule to report top-line results in Spring 2026 in line with prior
guidance.

 

With 93% of patients enrolled across 14 HCA Healthcare hospitals and four
major Canadian centres, the LANTERN study is entering its final stages of
recruitment, data collection and verification, and continues to meet projected
data quality and monitoring benchmarks:

 

·  Data integrity: Over 92% of clinical report forms are complete with 92%
of all database queries successfully resolved.

·   Monitoring progress: 80% of monitoring visits are now complete.

·   Endpoint adjudication: Nearly 80% of all primary endpoint adjudications
are complete.

·   Participant retention: Follow-up completion currently exceeds 98%.

 

Topline analysis will commence immediately following completion of endpoint
adjudication and database lock. Reporting will include the estimated treatment
effect of surgical site infection rate reduction (derived from a generalized
linear mixed-effects model comparing treatment to control arm), as well as
primary safety data.

 

Carolyn Cross, CEO of Ondine Biomedical, commented:

"Healthcare-associated infections remain a persistent $35 billion burden on
the U.S. healthcare system and, as antibiotic resistance continues to rise,
the need for effective non-antibiotic prevention strategies has never been
greater. The LANTERN study represents a landmark investigation into universal
nasal decolonisation prior to surgery and its potential to meaningfully reduce
surgical site infections.

 

"This large-scale study with over 5,000 participants represents a remarkable
team effort. We are deeply grateful to our clinical and academic partners for
their immense amount of work and diligence they have undertaken throughout
this study. We look forward to sharing top-line results and moving forward
with the submission."

 

About the LANTERN Study

LANTERN (Light-Activated Antimicrobial Therapy to Prevent Surgical Site
Infections) is a Phase 3 pivotal study designed to evaluate the safety and
efficacy of Ondine's nasal photodisinfection technology in reducing the rate
of SSIs. The study is a key component of Ondine's regulatory pathway for the
U.S. market.

 

About Nasal Photodisinfection and its Mode of Action

 

Nasal photodisinfection is a non-invasive and painless treatment that uses a
proprietary light-activated photosensitive agent to destroy harmful bacteria,
viruses, and fungi, including antibiotic-resistant strains, in the nasal
passages. The procedure takes five minutes and, unlike antibiotics, acts
immediately and without fostering antimicrobial resistance.

 

The two-step process involves applying the proprietary formulation in the
nostrils where it electrostatically binds to microbes rather than human cells.
The area is then illuminated with safe red light to activate the formulation,
triggering an oxidative burst that physically destroys all manner of pathogens
within minutes. This rapid and overwhelming oxidative stress makes it
extremely difficult for pathogens to develop resistance.

 

 

Enquiries:

 

 Ondine Biomedical Inc.                                www.ondinebio.com (http://www.ondinebio.com/)
 Carolyn Cross, CEO                                    +1 604 669 0555

 Strand Hanson Limited (Nominated & Joint Financial Adviser)
 James Harris, Richard Johnson                         +44 (0)20 7409 3494

 Peel Hunt LLP (Broker & Joint Financial Adviser)
 James Steel, Dr. Chris Golden                         +44 (0)20 7418 8900

 5654 & Company (Financial PR and IR Adviser)          ondinebiomedical@5654.co.uk
 Matthew Neal, Chris Gardner, Melissa Gardiner         +44 0791 7800 011

                                                       +44 0775 7697 357

 

 

 

About Ondine Biomedical Inc.

 

Ondine Biomedical Inc. is a Canadian life sciences company and leader in
light-activated antimicrobial therapies ('photodisinfection') for the
prevention and treatment of infections, including those caused by
multidrug-resistant organisms. Ondine has a pipeline of investigational
products, based on its proprietary photodisinfection technology, in various
stages of development.

 

Ondine's nasal photodisinfection system is CE-marked in Europe and is approved
for nasal decolonisation in Canada, Australia, Mexico, and several other
countries under the name Steriwave®. In the US, it has been granted Qualified
Infectious Disease Product designation and Fast Track status by the FDA and is
currently undergoing clinical trials for regulatory approval. Products beyond
nasal photodisinfection include therapies for a variety of medical indications
such as chronic sinusitis, ventilator-associated pneumonia, burns, and other
indications.

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