Ondine Biomedical has secured fresh capital at a premium to its share price, a vote of confidence that arrives just as the Canadian life sciences firm prepares to take its nasal photodisinfection technology to US regulators. The £10 million raise, backed by all of the company’s directors, extends Ondine’s runway into early 2028 and keeps its Steriwave programme on track toward a planned New Drug Application.
VANCOUVER, CANADA, November 2, 2026 /EINPresswire.com/ — Ondine Biomedical has closed a £10 million financing on London’s AIM market, capital it will use to push its Steriwave nasal photodisinfection technology through the US regulatory process and to speed commercial expansion in international markets where the product is already approved for reducing infections in surgical and ICU patients.
- A premium price: The £10.0M raise was completed above the pre-announcement closing share price, drawing strong backing from new and existing institutional investors.
- Funding through 2028: Net proceeds will carry ongoing operations past the targeted US regulatory engagement and the planned NDA submission.
- Board unanimity: Every director took part, with CEO Carolyn Cross subscribing for roughly 10% (c. £1.06M / C$2.0M).
- Phase 3 milestone: The LANTERN trial (5,188 patients across 18 centers) hit its primary efficacy endpoint, showing 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 goals: A targeted US FDA pre-submission meeting is set for Q1 2027, working toward a planned New Drug Application (NDA) submission targeted for mid-2027.
- Widening international reach: Commercial deployments and clinical evaluations are advancing across authorised jurisdictions including Canada, the UK (NHS), Europe, Mexico, and Australia.
Ondine Biomedical Inc. (AIM: OBI) is a Canadian life science company developing light-activated antimicrobial therapies. Its proprietary Steriwave® nasal photodisinfection platform is designed to reduce surgical site infections and infections in the ICU in approved international markets.
Financing Extends Operational Runway
The fundraising was priced at a premium to the company’s middle-market closing price, and all directors participated. Chief Executive Officer Carolyn Cross subscribed for approximately 10% (c. £1.06 million / C$2.0 million) of the issue.
With the proceeds, Ondine says its operational runway now stretches through early 2028, carrying it through key US FDA regulatory milestones and continued commercialisation in markets where it holds regulatory approval, including the EU, UK, Mexico, and Australia.
Pivotal Phase 3 LANTERN Trial Results
The raise follows reported topline results from the Phase 3 LANTERN trial. That study enrolled 5,188 surgical patients and was run in collaboration with HCA's Health Research Institute (HRI) across 14 HCA clinical centres in the United States — the largest US hospital group — plus four tertiary hospitals in Canada.
The trial met its prespecified primary efficacy endpoint:
- A 40.5% lower risk of surgical site infections (SSIs) within 30 days, based on the primary Bayesian analysis model.
- A 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).
On the strength of these Phase 3 results, Ondine is finalising 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 treatment administered by a nurse and easily folded into the hospital workflow before surgery. Non-thermal red light cones are inserted into the nose, activating a localised photosensitising formulation in the nasal cavity — 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: Hospital deployments are expanding across NHS Hospital Trusts and Canadian provincial healthcare networks under existing national regulatory clearances.
- Latin America: Clinical evaluations are underway across three private hospitals within two major healthcare networks.
- Continental Europe & Switzerland: Hospital research and clinical evaluation pilots are ongoing at major academic centers, including LMU University Hospital Munich (Germany) and University Hospital Zürich (Switzerland).
A growing body of independent, investigator-led clinical research in authorized markets (Canada and the UK) continues 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 from 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
Why it matters
Ondine’s raise shows investors are willing to fund the costly, uncertain path to US approval even before regulators have weighed in, a bet resting on a Phase 3 trial that reported a 40.5% lower risk of surgical site infections. If the FDA process stays on schedule toward a mid-2027 NDA submission, Steriwave could move from a niche international product into the world’s largest hospital market — while the broader fight against antimicrobial resistance adds urgency to non-antibiotic alternatives.
