Ondine Completes £10M Financing to Advance US Regulatory Pathway and International Commercialisation of Steriwave

VANCOUVER, CANADA, November 2, 2026 /EINPresswire.com/ -- Ondine Biomedical Completes £10M Financing to Advance US Regulatory Pathway and International Commercialisation of Steriwave its Nasal Photodisinfection Technology to Reduce Infections in Surgical and ICU Patients

- Priced at a Premium: £10.0M raise completed at a premium to the pre-announcement closing share price, with strong support from new and existing institutional backers.
- Runway into 2028: Net proceeds support ongoing operations past targeted US regulatory engagement and the planned NDA submission.
- Unanimous Board Participation with CEO Carolyn Cross subscribing for c. 10% (c. £1.06M / C$2.0M)
- Pivotal Phase 3 Trial Milestone: Phase 3 LANTERN trial (5,188 patients across 18 centers) met its primary efficacy endpoint, demonstrating an estimated 40.5% lower risk of surgical site infections (SSIs) with a 98.2% posterior probability of treatment benefit in the primary Bayesian analysis.
- Near-Term Regulatory Objectives: Targeted US FDA pre-submission meeting in Q1 2027, working toward a planned New Drug Application (NDA) submission targeted for mid-2027.
- Expanding International Footprint: Commercial deployments and clinical evaluations progressing across authorised jurisdictions including Canada, the UK (NHS), Europe, Mexico, and Australia.

Ondine Biomedical Inc. (AIM: OBI), a Canadian life science company developing light-activated antimicrobial therapies, has completed a £10 million fundraising on London’s AIM market to advance its planned US regulatory submission and accelerate the commercial expansion of its proprietary Steriwave^® nasal photodisinfection technology to reduce surgical site infections and infections in the ICU in approved international markets.

Financing Extends Operational Runway
The fundraising was completed at a premium to the company’s middle-market closing price, with the support of all the directors, with Chief Executive Officer Carolyn Cross subscribing for approximately 10% (c. £1.06 million / C$2.0 million) of the issue.
The proceeds extend Ondine’s operational runway through early 2028, funding the company through key US FDA regulatory milestones and ongoing commercialisation in markets where it has regulatory approval, including the EU, UK, Mexico, and Australia.

Pivotal Phase 3 LANTERN Trial Results
The financing follows reported topline results from the Phase 3 LANTERN trial, which involved 5,188 surgical patients and was conducted in collaboration with HCA's Health Research Institute (HRI) across 14 HCA clinical centres in the United States, the largest US hospital group, and four tertiary hospitals in Canada.

The trial met its prespecified primary efficacy endpoint:
- 40.5% lower risk of surgical site infections (SSIs) within 30 days based on the primary Bayesian analysis model.
- 98.2% posterior probability of treatment benefit compared to standard of care.
- Exploratory frequentist analyses also demonstrated consistency with the primary Bayesian outcome (p <0.05)

Based on these Phase 3 results, Ondine is finalizing its full study dataset to support a formal pre-submission meeting with the US FDA in Q1 2027, ahead of a planned NDA submission targeted for mid-2027.

Steriwave is a simple, five-minute, nurse-administered treatment that integrates easily into the hospital workflow before surgery. Non-thermal red light cones are inserted into the nose, activating a localised photosensitising formulation in the nose – a reservoir of bugs. This generates transient reactive oxygen species (ROS) that rapidly disrupt bacterial, fungal, and viral cellular membranes and macromolecules. Unlike traditional antibiotics, this oxidative cascade acts across multiple cellular targets simultaneously; repeated pre-clinical investigations have shown no evidence of induced microbial resistance.

Outside the United States, commercial adoption and clinical evaluations continue to accelerate in markets where Steriwave is approved:
- Canada & United Kingdom: Expanding hospital deployments across NHS Hospital Trusts and Canadian provincial healthcare networks under existing national regulatory clearances.
- Latin America: Clinical evaluations underway across three private hospitals within two major healthcare networks.
- Continental Europe & Switzerland: Hospital research and clinical evaluation pilots ongoing at major academic centers, including LMU University Hospital Munich (Germany) and University Hospital Zürich (Switzerland).

There is a growing body of independent, investigator-led clinical research projects in authorized markets (Canada and the UK) that continue to evaluate photodisinfection across high-risk surgical and critical care cohorts:
- Complex Skull-Base Surgeries: A published single-center study from Leeds Teaching Hospitals NHS Trust (The Journal of Laryngology & Otology) observed a 78% relative reduction in SSIs compared to a historical control cohort treated with topical mupirocin, with zero cases of post-operative meningitis in the Steriwave group (0/95) versus five cases in the control group (5/105).
- Critical Care Settings (ICU): The published SMURF pilot feasibility study published by Royal Columbian Hospital in the journal Critical Care Explorations reported a statistically significant reduction in nasal microbial burden and an exploratory 39.5% lower rate of pneumonia; the pilot was not powered for statistical significance regarding pneumonia, supporting the rationale for further clinical investigation in critically ill patients.
- Cardiac Surgery (CABG): An observational evaluation of 2,172 patients at the University of Ottawa Heart Institute reported a 51.5% lower rate of conduit harvest site infections in CABG surgery patients presented at the 2026 Canadian Cardiovascular Congress following the introduction of nasal photodisinfection into pre-operative protocols.

These data add to a growing clinical evidence base presented at major international forums, including IPC 2026, the World Congress of Infectious Diseases, ENDOAthens, the RCN International Nursing Research Conference 2026, and other cardiovascular, respiratory, nursing, infection prevention, and critical care meetings.

Mechanism of Action: Overcoming Antimicrobial Resistance
Hospital-acquired infections and antimicrobial resistance (AMR) place a substantial burden on global health systems. Conventional topical antimicrobials, such as mupirocin, face clinical challenges from emerging pathogen resistance and low compliance with patient-led, multi-day dosing regimens.

ENDS

NOTES TO EDITORS

For media information

Contact Simon Vane Percy (e) simon@vanepercy.com (m) +44(0)7710 005 910

About Steriwave^® and its Mode of Action

Steriwave nasal photodisinfection is a light-activated antimicrobial therapy designed to rapidly eliminate potentially pathogenic microorganisms in the nose, a major reservoir from which pathogens spread to surgical sites and lower respiratory tracts. Applied by a healthcare professional, the treatment uses a proprietary photosensitising agent activated by red light to produce a rapid antimicrobial effect through oxidative mechanisms. Because the mechanisms act through non-antibiotic oxidative pathways, Steriwave has a low potential for the 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 hospital-acquired infections. Ondine's lead product, Steriwave^®, is authorised for nasal decolonisation in Canada and key international markets. In the United States, the technology has been granted Qualified Infectious Disease Product (QIDP) designation and Fast Track status by the FDA.

Regulatory Status & Forward-Looking Clarification

Notice Regarding Investigational Status in the United States:

Steriwave^® is CE-marked in Europe and is authorized for nasal decolonization in Canada, the United Kingdom, Australia, and Mexico. In the United States, Steriwave has been granted Qualified Infectious Disease Product (QIDP) designation and Fast Track status by the U.S. Food and Drug Administration (FDA). Steriwave is currently an investigational product in the United States and is limited by U.S. law to investigational use only. It has not been approved by the FDA as safe or effective for any indication, and it is not commercially available for sale or clinical use in the United States. Statements regarding clinical study results are factual summaries of completed research and do not constitute representations of FDA approval or guaranteed regulatory outcomes.

S J VANE PERCY
VANE PERCY & ROBERTS
+44 7710 005910