20 December 2021

Ondine Biomedical Inc.

Ondine Biomedical Inc. and University of Navarra in Spain initiate clinical trial deploying nasal photodisinfection for a new variant-agnostic approach to stop SARS-CoV-2 replication in high-risk viral carriers

·    Nasal decolonisation therapy, Steriwave™, destroys all pathogen classes, including SARS-CoV-2, without producing resistance.

·    Recent in vitro and in vivo SARS-CoV-2 studies using nasal photodisinfection against SARS-Cov-2 received an ICPIC Innovation Award of Excellence, Geneva (Sept 2021).

·    Ondine Biomedical Inc. is developing an inexpensive COVID-19 treatment which is designed to inhibit viral replication and reduce transmission between carriers.

Ondine Biomedical Inc. (LON: OBI), "the Company," has initiated a clinical trial of its Steriwave™ photodisinfection technology for nasal disinfection in COVID-19 patients. The study will evaluate the impact of nasal decolonization on asymptomatic SARS-CoV-2 infected individuals.

The single-center, randomized, placebo-controlled study is being conducted at the Central Unit for Clinical Trials at the University of Navarra in Pamplona, Spain and will involve up to 100 PCR-positive asymptomatic individuals. Researchers at the Center for Applied Medical Research of the University of Navarra previously conducted in vitro studies demonstrating the efficacy of Steriwave against SARS-CoV-2. This work resulted in an Innovation of Excellence Award at the 2021 Infection Consortium of Prevention and Infection Control (ICPIC) in Geneva.

"The continuing emergence of SARS-CoV-2 variants such as Omicron, demonstrates that this research is more important than ever. Ondine Biomedical Inc.'s laboratory work, as well as that of researchers at the University of Navarra, have demonstrated that our photodisinfection technology is extremely effective against SARS-CoV-2," stated Carolyn Cross, Ondine Biomedical Inc.'s CEO. "Our Steriwave nasal photodisinfection technology has been successfully used in Canadian hospitals for more than ten years, significantly reducing surgical site infections. Eliminating a broad spectrum of pathogens from the nose prior to surgery has proven to be a major factor in reducing hospital acquired infections. Given our preliminary research, we believe that Steriwave's broad spectrum decolonization efficacy will reduce the number of COVID-19 transmissions and COVID-19 related hospitalizations, as well as accelerate rates of recovery in affected patients.

Our goal is to be able to offer an effective, economical COVID-19 treatment to help our communities deal with emerging SARS-CoV-2 variants. We are enormously grateful for the Spanish team's expertise, facilities and their extraordinary support to accelerate this important work."

All patients in the study's treatment arm will receive Steriwave nasal photodisinfection treatments, followed by a post-treatment PCR test to evaluate the anti-viral efficacy of nasal photodisinfection. These patients will be followed up for two weeks to track their COVID-19 symptoms and hospitalization rates. Patients in the control arm will receive matched interventions and follow-up, but without the active photosensitizer.

Ondine Biomedical Inc.'s nasal photodisinfection is a patented platform technology. The photodisinfection treatment is carried out by a trained healthcare professional and is an easy to use, painless, two-step process. A light-activated agent is applied to each nostril using a nasal swab followed by a few minutes of illumination with a specific wavelength and power level of light.

Photodisinfection is a painless process that works by causing an oxidative burst which rapidly targets and destroys pathogens. A key benefit of this approach is that targeted pathogens do not develop resistance to the treatment.  Steriwave has received the CE mark and is approved in Canada and number of other countries. In the US, it is currently undergoing clinical trials for regulatory approval.

About the Central Unit for Clinical Trials at the University of Navarra

The Clinic of the University of Navarra is a non-profit research center that conducts the largest number of clinical trials in Spain. Every year the Center launches approximately 70 new clinical research projects to generate knowledge for changing the course of human diseases. Currently, the Center manages more than 300 clinical trials across 25 medical specialties.

The University of Navarra has consistently been ranked as the best private university in Spain. Through its six campuses (Pamplona, San Sebastián, Madrid, Barcelona, Munich, and New York City), the University confers 35 official degrees, 13 dual degrees and more than 38 master's programs in 14 faculties, 2 university schools, 17 institutes, its graduate business school, IESE, ISSA and other centers and institutions. The university also runs a teaching hospital, the Clinic of the University of Navarra, where 2,045 qualified professionals manage more than 100,000 patients each year, and the Center for Applied Medical Research, CIMA, that focuses on four main areas: Oncology, Neuroscience, Cardiovascular Sciences, and Gene Therapy and Hepatology.

For more information, please visit: https://www.unav.edu/en/research 

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian medical device company led by founder and CEO Carolyn Cross. The Company has developed a patented, painless, rapid, photodisinfection technology platform which can be used in the development of prevention and treatment therapies for a broad-spectrum of pathogens -including bacterial, viral, and fungal species, multidrug-resistant strains, and emerging threats such as the virulent hospital microbe, Candida auris. Photodisinfection was originally developed by Professor Michael Wilson at University College London.

Ondine Biomedical Inc. has seven products under various stages of development including treatment of chronic rhinosinusitis, treatment of 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 transmission of SARS-CoV-2. Steriwave, the Company's nasal decolonization product, has been safely and effectively used in Canadian hospitals for over ten years in the prevention of hospital-acquired infections.

For more information, please visit:  www.ondinebio.com

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