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Ondine Biomedical eyes US market expansion 

Posted on May 15, 2025May 15, 2025
ondine biomedical

LONDON: Ondine Biomedical Inc. (LON: OBI), a leader in light-activated antimicrobial therapies, announced significant milestones in its 2024 annual report, positioning the company for accelerated growth in 2025 and beyond. Key achievements include robust commercial expansion, strategic partnerships and the launch of a pivotal Phase 3 clinical trial in the U.S. 

Commercial and Clinical Momentum 

In 2024, Ondine expanded its flagship product, Steriwave®, into 20 hospitals across Canada, including five of the country’s top 10 largest hospitals. The company also secured a listing on the NHS Supply Chain, simplifying access for hospitals in England and Wales. A distribution partnership with Mölnlycke Health Care aims to drive adoption in the UK, EU and Middle East. 

The company successfully raised $217 million in net cash during the year, with an additional $57 million strategic investment from a U.S. healthcare entity post-year-end. These funds are earmarked for advancing the Phase 3 LANTERN trial, which enrolled its first patient in late 2024. Positive results could pave the way for FDA approval and U.S. market entry by 2026. 

Financial Highlights 

– Revenue grew 70% to $2.0 million, driven by hospital deployments and higher product prices. 

– Operating loss narrowed to $19.4 million, reflecting disciplined cost management. 

– Cash reserves stood at $9.9 million at year-end, bolstered by successful fundraising. 

Strategic Priorities for 2025 

1. Phase 3 Trial Completion: Ondine aims to complete enrollment for the LANTERN trial, with data submission to the FDA expected in late 2025. 

2. ICU Expansion: A pilot study at Royal Columbian Hospital will evaluate Steriwave’s use in intensive care units, unlocking a potential $4 billion market. 

3. Manufacturing Scalability: Enhanced production capabilities are expected to improve margins and meet anticipated demand. 

CEO Carolyn Cross emphasized the company’s long-term vision: “Our technology addresses one of healthcare’s greatest challenges — antimicrobial resistance. With Steriwave’s proven efficacy and our Phase 3 trial underway, we’re poised to transform infection prevention globally.” 

The board, chaired by former Canadian Deputy Prime Minister Jean Charest, includes experts in biotech, finance and regulatory affairs. Ondine maintains compliance with the Quoted Companies Alliance governance code, underscoring its commitment to transparency. 

While Ondine acknowledges risks — including clinical trial delays and funding needs — mitigation strategies are in place. The company is exploring non-dilutive financing options and has strengthened its supply chain to support growth. 

Looking Ahead 

Analysts project Ondine’s addressable market could exceed $10 billion if Steriwave expands into ICU and other high-risk settings. With a scalable platform and partnerships in place, the company is well-positioned to capitalize on rising demand for antibiotic-free infection control solutions. 

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