Suppression of SARS-CoV-2 replication and infectivity in vaccinated individuals: a clinical study of Ondine Biomedical’s nasal photodisinfection carried out at the Clínica Universidad de Navarra, Spain

Vancouver, British Columbia, Canada – July 19, 2022

Clínica Universidad de Navarra has completed a randomised controlled study of Ondine Biomedical’s nasal photodisinfection technology in fully vaccinated COVID-19 patients with early symptoms of COVID-19.

“Top-line results from this clinical trial suggest that nasal photodisinfection treatment rapidly and substantially suppresses SARS-CoV-2 viral replication and infectivity in the nasal cavity of already-vaccinated individuals. This trial confirms the early work undertaken by Canadian clinicians during the pandemic,” commented Dr.  A. Fernandez-Montero, one of the 3 Principal investigators responsible for the Clínica Universidad de Navarra clinical trial. “We are currently in the process of submitting our results for publication and look forward to being able to discuss these and other important findings from the study in the near future.” 

Photodisinfection rapidly destroys pathogens including viruses, bacteria and fungi including resistant strains.  This broad-spectrum approach targets the primary source of infection as well as bacterial cofactors that may also contribute to substantial comorbidity. Nasal photodisinfection has been deployed over the past decade in Canadian hospitals to significantly reduce hospital-acquired infections. Ondine’s photodisinfection is a platform technology under development for a wide variety of conditions including presurgical decolonisation, and treatment of burns, wounds, ventilator-associated pneumonia, and chronic sinusitis.

“The rising rates of COVID-19 due to rapidly evolving SARS-CoV-2 variants underline the importance of our broad-spectrum nasal decolonisation research. We are pleased to report that top-line results of the Clínica Universidad de Navarra clinical study in vaccinated individuals confirm findings from trials at Sunnybrook Hospital (Toronto) and Coimbra University (Portugal), as well as Canadian meat processing plant installations,” stated Dr. Nicolas Loebel, Ondine’s President.

“Our goal is to be able to offer a cost-effective COVID-19 treatment and prophylaxis to help our communities deal with SARS-CoV-2 variants and other emerging threats. We are grateful to the team at the Clínica Universidad de Navarra for their expertise, facilities, and their extraordinary support in completing this important study during pandemic conditions.  The study contributes to the growing body of evidence demonstrating positive outcomes with nasal photodisinfection in the prevention and treatment of COVID-19.”

Ondine’s nasal photodisinfection, also known as antimicrobial photodynamic disinfection therapy (aPDT), is a patented technology which was originally developed at University College London, UK. The photodisinfection treatment is carried out by a trained healthcare professional, and is an easy to use, painless two-step process.  A laser light-activated compound is applied to each nostril using a nasal swab, and the nostrils then illuminated with a specific wavelength of light using a disposable light radiator for less than five minutes. The laser light excites the photodynamic agent, causing an oxidative burst which rapidly destroys all types of pathogens without harming human tissue. A key benefit of this technology is that pathogens do not develop resistance to the treatment.  

Steriwave has a CE mark and is approved in Canada and a number of other countries. In the US, it is currently undergoing clinical trials for regulatory approval. 

About Ondine Biomedical Inc.

Ondine Biomedical Inc. (LON: OBI) 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, which is not currently approved in the United States, 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.

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