Ondine completes US Phase II trial recruitment
8th August 2022
Ondine Biomedical Inc.
("Ondine Biomedical", "Ondine" or the "Company")
Ondine completes US Phase II trial recruitment
Ondine Biomedical Inc. (LON: OBI), has recruited the final patient to its nasal photodisinfection exploratory Phase 2 trial. The trial is evaluating how effectively Ondine's nasal photodisinfection technology eradicates pathogens - specifically Staphylococcus aureus - in the nose.
The single-center, BENEFIT-aPDT open-label study is being carried out at HCA Healthcare's Memorial Health University Medical Center in Savannah, Georgia, and has recruited over 300 patients. Recruited patients undergo a pre-surgery nasal culture to determine the prevalence of Staphylococcus aureus, the main cause of surgical site infections.
Each patient then receives Ondine's nasal photodisinfection (investigational product) followed by a post-treatment culture, enabling evaluation of the efficacy of nasal photodisinfection across a wide range of patients and surgery types.
Carolyn Cross, Ondine's CEO commented "Completing patient recruitment on this Phase II trial is an important step in our clinical development, and we look forward to being able to share the trial results in due course. We appreciate HCA's support throughout the trial, and their focus on the importance of reducing SSIs. Ours is a truly novel approach to nasal disinfection, and we believe that our technology has the potential to have a significant effect on combatting SSIs, complications, and extended hospital stays."
SSIs are the leading cause of readmissions to hospital following surgery and a significant cause of post-surgical morbidity and mortality, with approximately 3% of patients who contract an SSI dying as a consequence. Post-operative infections occur in up to 300,000 patients per year in the United States and cost the US healthcare system tens of billions of dollars a year[i].
Ondine's nasal photodisinfection is a patented platform technology involving a two-step process: the application of a light-activated agent to each nostril using a nasal swab, followed by illumination of the area with a specific wavelength of laser light for less than five minutes.
The photodisinfection process works by the light exciting the photodynamic agent, causing an oxidative burst that destroys pathogens - bacteria, viruses, and fungi. A key benefit of this approach is that pathogens do not develop resistance to the therapy.
Ondine's nasal photodisinfection has a CE mark for use in the EU and is approved in Canada and number of other countries under the name Steriwave™. In the United States, it has received Qualified Infectious Disease Product status and been granted Fast Track by the FDA.The Phase 2 trial is part of the US FDAregulatory application.
**ENDS**
About Ondine Biomedical Inc.
Ondine Biomedical Inc. is a Canadian headquartered company led by founder and CEO, Carolyn Cross. Ondine has developed a patented, photodisinfection technology platform used in treatment and prevention therapies for a broad-spectrum of pathogens - including multidrug-resistant strains. Photodisinfection is a targeted antimicrobial which uses non-thermal light to activate a photosensitive agent. In a few minutes, this light-based therapy destroys the pathogens through an oxidative burst without any impact on human tissue.
Ondine has a pipeline of investigational products, based on its proprietary photodisinfection platform, in various stages of development. Products include treatment of chronic rhinosinusitis, decolonization of infections in burns and wounds, disinfection of endotracheal tubes to reduce the incidence of ventilator-associated pneumonia and most recently, the development of topical antiviral therapy for the upper respiratory tract to reduce viral titres and transmission of respiratory viruses (e.g., SARS-CoV-2, influenza, RSV, etc.). Ondine's technology is approved in a number of jurisdictions and has been awarded the CE mark, as well as Qualified Infectious Disease Product and Fast Track status in the US by the FDA.
For more information, please visit: www.ondinebio.com or contact:
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Ondine Biomedical Inc. |
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Carolyn Cross, CEO |
+001 (1) 604 669 0555 |
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Strand Hanson Limited (Nominated and Financial Adviser) |
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James Harris, James Dance, Richard Johnson |
+44 (0) 20 7409 3494 |
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Arden Partners plc (Broker) |
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Ruari McGirr (Corporate), Seb Wykeham (Sales) |
+44 (0) 20 7614 5900 |
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Vane Percy & Roberts (Media Contact) |
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Simon Vane Percy, Amanda Bernard |
+44 (0) 77 1000 5910 |
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