Ondine Biomedical's US $11M Fundraise Enables a Q4 2024 Start of Its Pivotal Phase 3 US Trial

VANCOUVER, British Columbia--(BUSINESS WIRE)--Canadian life sciences company Ondine Biomedical announces that it is accelerating its final preparations for a Q4 2024 start to its key pivotal US Phase 3 trial following its recent successful raise of Cdn $16 million (£9m, US $11m).

Alongside strong support from existing institutional shareholders, Ondine added a number of significant new shareholders, including M&G Investment Management Limited, which corner-stoned the recent financing. Ondine is also in discussions with a major U.S. healthcare group regarding a further potential investment of up to Cdn $5.5 (US$4 m,£3.1 m).

The Company is pioneering the development of cost-effective, light-activated antimicrobials that kill all types of pathogens – viruses, bacteria and fungi – in minutes without causing the development of resistant strains of microbes. The company is presently focused on nasal decolonization prior to surgery to reduce hospital-associated infections through its proven Steriwave® technology. Hospitals deploying the Company’s unique, painless, infection control therapy have seen significant reductions in surgical site infection rates, patient re-admission numbers, length of stay, and antibiotic usage.

Ondine's Steriwave technology is now used in many hospitals across Canada and in several UK NHS hospital trusts, including Mid Yorks, Leeds Teaching Hospitals, and Kings College London. The Company plans to expand its product reach outside North America through its recently announced distribution partnership with Mölnlycke Health Care.

Carolyn Cross, CEO of Ondine, commented: “With this key financing behind us, we are able to move forward with our plans for our key Phase 3 clinical trial in the USA in support of FDA approval and US market access. The capital raised enables us to advance our goal to have the first patient treated in December 2024.

“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).”

Ondine's is conducting its Phase 3 trial in close collaboration with its US clinical trial partner HCA Healthcare, the largest healthcare provider in the United States.ⁱ The 5,000-patient group-randomised crossover study will be carried out at 14 HCA hospital sites. It will compare standard-of-care infection prevention practices with and without Ondine's nasal photodisinfection (branded as Steriwave® outside the US).

Recruitment of the first patient is now due by the end of 2024, with the final patient expected in mid-2025, and an early data readout anticipated in Autumn 2025.

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian life sciences company and leader innovating light-activated antimicrobial therapies (also known as 'photodisinfection'). Ondine's nasal photodisinfection system has a CE mark in Europe and the UK and is approved in Canada and several other countries under the name Steriwave®. In the US, it is currently undergoing clinical trials for regulatory approval.

ⁱ https://www.definitivehc.com/blog/top-10-largest-health-systems