Canadian life sciences company Ondine Biomedical announced it is accelerating its final preparations for a fourth quarter start to its key pivotal US Phase 3 trial following its recent successful raise of C$16 million. Along with strong support from existing institutional shareholders, Ondine added several significant new shareholders, such as M&G Investment Management Limited. Plus, Ondine is also in discussions with a major U.S. healthcare group regarding a further potential investment of up to C$5.5 million.
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 focuses on nasal decolonization before surgery to reduce hospital-associated infections through its proven Steriwave technology. Hospitals deploying the company’s painless and infection control therapy have significantly reduced 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, such as 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.
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. And 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). The 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.
KEY QUOTES:
“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).”
– Carolyn Cross, CEO of Ondine
