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Ondine BiomedicalAnnouncement

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RNS Number : 1590A  Ondine Biomedical Inc.  13 April 2026

13 April 2026

 

ONDINE BIOMEDICAL INC.

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

 

Business Update

Preparing for next phase of growth

·     Clinical Milestones: Completed patient enrolment in the pivotal
LANTERN Phase 3 U.S. trial, with results expected in Spring 2026.

·     Real-World Evidence Expansion: SSI reduction programmes at top
hospitals and real-world evidence growing globally support broader commercial
opportunities.

·     Revenue Growth and Operational Scale-up: 29% unaudited revenue
growth in 2025; in-house manufacturing and facility upgrades underway for
larger scale future growth and stronger supply chain control.

Ondine Biomedical Inc. (AIM: OBI), a global leader in light-activated
antimicrobial therapies to prevent and treat hospital infections, today
provides a business update on its nasal photodisinfection technology, branded
as Steriwave(®) outside the U.S.

 

Carolyn Cross, CEO of Ondine Biomedical, commented:

“Ondine Biomedical has recently achieved major milestones in both national
and international clinical programmes. The recent completion of enrolment in
the LANTERN Phase 3 study, involving 18 hospitals and over 5,000 patients,
highlights our capability to operationalise and control complex multinational
trials. We've also expanded our evidence base through innovative ICU and SSI
pilot projects in Switzerland, Germany and Mexico, showcasing the clinical
value of our technology.

 

"In parallel, we have made substantial investments in facility upgrades,
in-house production automation equipment, and enhanced system processes,
ensuring both operational efficacy and resilience. Vertical integration of our
manufacturing operations reduces reliance on external subcontractors, and
simultaneously allows gross margin enhancement, both critical as we expand our
leadership in the prevention and treatment of hospital acquired infections.”

 

Clinical Progress

Patient enrolment for the LANTERN Phase 3 study, encompassing 14 hospitals in
the United States and 4 in Canada, has been successfully completed.  With
over 5,000 patients enrolled across two countries, this large-scale,
private/public multicentre trial represents a significant milestone for
Ondine. The Company is now focused on the next phases of its New Drug
Application ("NDA") to FDA, with top-line results due in Spring 2026.

 

Growing Body of Real-World Evidence

Pilot studies are an important pathway for both clinical validation and early
commercial adoption. Last year, the Company expanded into the intensive care
setting with a first-of-its-kind deployment of nasal photodisinfection
involving patients in a critical care setting at Royal Columbia Hospital (RCH)
in British Columbia, Canada.

 

The RCH ICU pilot study, which was intended to inform a larger clinical trial,
demonstrated product safety, ease of workflow, good patient compliance, and an
80% reduction (p<0.05) in opportunistic pathogen carriage of ICU patients.
The full manuscript documenting the RCH findings, "Suppression of Microbial
Burden to Reduce Pneumonia in Critical Illness: the SMURF Feasibility Pilot
Study", has been accepted for publication in the Journal of Critical Care and
will soon be available online.

 

Additional studies, pilots and evaluations are underway across leading
institutions internationally, including Royal Papworth Hospital NHS Foundation
Trust, University Hospital Zurich, LMU University Hospital in Munich, and
additional centres in Spain, Mexico, and Australia. Together, these activities
are generating a growing body of clinical and real-world evidence to support
broader adoption of Steriwave across multiple clinical settings. Further
manuscripts and conference presentations are expected throughout the year.

 

Commercial Progress

Revenue in 2025 increased by 29% (unaudited), driven by new hospital
deployments and increased utilisation within existing accounts.

 

Building on this expanding body of clinical and real-world evidence, Ondine is
progressing commercial adoption through targeted deployments under its 'land
and expand' strategy. In Canada, five new hospitals have recently approved
implementation with onboarding in Q2 2026, while four major tertiary hospitals
were introduced to Steriwave during the LANTERN Study, reflecting continued
domestic expansion with a small, dedicated sales team. Programmes in
international markets are increasing awareness and supporting evidence
generation with key pilots and early-stage adoption through its distributors.

 

In the UK, Ondine has several hospital and pilot sites deploying nasal
photodisinfection. Steriwave also is now classified as an 'Innovation Product'
by NHS Supply Chain, increasing visibility among NHS Trusts and procurement
teams. Steriwave has been awarded this classification for its alignment with
key long-term NHS goals of reducing serious infections, waitlists, healthcare
costs and antimicrobial resistance. Ondine's collaboration with Mid Yorkshire
Teaching NHS Trust earned the Company and Steriwave finalist and winning
recognition across a number of national awards, including the Excellence in
Healthcare Partnership Awards, 2026 BioNow Product of the Year, and several
HSJ and HSJ Partnership awards.

 

Operational Readiness and Scale-up

Ondine is investing in its operational infrastructure, expanding production
capacity and upgrading facilities to improve production flow, inventory
management, cost of goods, and FDA audit readiness. A key initiative is the
installation of automation equipment for the in-house production of
photosensitizer formulation applicators, providing greater control over
quality, cost efficiencies, and strengthening supply chain resilience. These
investments are expected to support ongoing sales growth and prepare the
Company for further increased demand.

 

Ondine Biomedical expects to report its 2025 Full Year Results on 21 May 2026.

 

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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