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Ondine Biomedical Advances Phase 3 Trial of Steriwave for HAI Reduction with $16 Million Funding

• Ondine Biomedical secures C$16 million to accelerate Phase 3 trial of Steriwave, a light-activated antimicrobial technology, targeting healthcare-associated infections (HAIs). • The Phase 3 trial will enroll 5,000 patients across 14 HCA Healthcare sites, comparing standard infection prevention with and without Steriwave nasal photodisinfection. • Steriwave aims to reduce surgical site infections, patient readmissions, and antibiotic usage by eradicating pathogens without inducing antimicrobial resistance. • Initial data from the trial, which is expected to begin enrolling patients in late 2024, is anticipated to be available in Autumn 2025.

Ondine Biomedical has announced it is moving forward with its pivotal US Phase 3 trial of Steriwave, a light-activated antimicrobial technology, after successfully raising C$16 million. The trial will assess Steriwave's effectiveness in reducing healthcare-associated infections (HAIs). With funding secured, the company plans to begin treating the first patient in December 2024.

Trial Design and Objectives

The Phase 3 trial is a group-randomized crossover study involving 5,000 patients across 14 HCA Healthcare hospital sites. The study will compare standard-of-care infection prevention practices with and without Ondine’s nasal photodisinfection, branded as Steriwave outside the US. Patient recruitment is scheduled to begin by the end of 2024, with final patient enrollment expected by mid-2025, and an early data readout anticipated in Autumn 2025.

Steriwave Technology

Steriwave employs a light-activated antimicrobial approach to eliminate viruses, bacteria, and fungi within minutes, without promoting antimicrobial resistance. The technology has already been implemented in numerous hospitals across Canada and within several UK NHS hospital trusts. According to Ondine, hospitals using Steriwave have observed significant reductions in surgical site infection rates, patient readmission numbers, length of stay, and antibiotic usage.

Addressing Antimicrobial Resistance

Carolyn Cross, CEO of Ondine, emphasized the importance of this trial in the context of rising antimicrobial resistance (AMR). "The robust interest we have had in this fundraise is testament to the excitement around our groundbreaking light-activated antimicrobial technology, particularly in the context of the growing death toll caused by antimicrobial resistance (AMR)." The company's focus is on nasal decolonization before surgery to reduce hospital-associated infections through its Steriwave technology.

Market and Future Expansion

Steriwave received a CE mark in Europe in 2020 and is currently used in the UK National Health Service (NHS) trusts. Ondine plans to expand its product reach outside North America through a distribution partnership with Mölnlycke Health Care.
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Reference News

[1]
Ondine Biomedical: Life Sciences Company Raises C$16 Million - Pulse 2.0
pulse2.com · Nov 8, 2024

Ondine Biomedical accelerates final preparations for its US Phase 3 trial, raising C$16 million. The company develops li...

[2]
Ondine accelerates pivotal antimicrobial trial after $11m financing - Clinical Trials Arena
clinicaltrialsarena.com · Nov 5, 2024

Ondine Biomedical plans to start a Phase III trial of its light-activated antimicrobial technology, Steriwave, to reduce...

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