Ondine Biomed Regulatory News (OBI)

ONDINE BIOMEDICAL INC.

("Ondine Biomedical", "Ondine" or the "Company")

Progress Update

Ondine Biomedical Inc. (LON:OBI) a Canadian life sciences company, announces a progress update including operational highlights from the first quarter of 2023. Ondine is the world leader in the development of photodisinfection, a non-antibiotic technology which kills all types of resistant and non-resistant pathogens (including viruses, bacteria, and fungi) without itself causing antimicrobial resistance. The Company has seven applications of this technology in its pipeline, with the lead indication focused on reducing healthcare-associated infections via nasal photodisinfection prior to surgery. In Canadian hospitals, Ondine's Steriwave™ technology has been proven to reduce the incidence of surgical site infections (SSIs) in major surgery by more than 50%.[1]

Ondine has made substantial progress on the preparation of its Phase 3 clinical study in support of the commercialization of Steriwave in the US. In addition, several clinical deployments of the technology in core target markets with existing regulatory approval outside the US have been initiated.

Clinical development for US market approval

· In addition to the primary Phase 2 clinical study conducted in 2022, Ondine has completed a second smaller study designed to support upcoming regulatory submissions and to inform Phase 3 trial design.

· Phase 3 preparations continue to be the primary focus for the Company. Considerable progress has been made towards the necessary project management, clinical trial site identification, HCA Healthcare operational integration and recruitment planning. CRO and regulatory consultants have also been identified, with a goal of initiating the study in the second half of the year.

· Ondine has invested considerable resources into the next generation of efficient, injection-molded, disposable light activator units. These medical devices reduce disposable material footprint, significantly reduce cost of goods, and enhance performance. The design is compatible with the medication management and dispensing units employed in large hospital operations.

Additional clinical data and endorsement

· Clinical pilot outcomes of a six-month study at The Ottawa Hospital, Ottawa, Ontario were reported in March 2023, confirming substantial reductions in patient readmission rates (51% fewer readmissions vs. pre-intervention period) and significant reduction in length of hospital stay (48% fewer days among treated vs. non-treated) in spine surgery patients. Patient safety was also confirmed during this pilot study.[2] For this work, the infection control team at The Ottawa Hospital was recognized with a Quality Improvement Award from the Ontario Surgical Quality Improvement Network.[3]

· Clinical trial results demonstrating a significant decrease in viral infectivity in predominantly vaccinated COVID-19 patients were published in Frontiers in Cellular and Infection Microbiology in January 2023.[4] This University of Navarra (Spain) COVID-19 trial represented the first randomized, placebo-controlled, blinded clinical study of nasal photodisinfection to treat an upper respiratory illness and paved the way for a future role in pandemic preparedness planning.

· A physician-sponsored press conference in Toronto was held March 6, 2023, during which a number of prominent Canadians discussed their experiences with Steriwave nasal decolonization in enterprise (non-hospital) settings over the past year. The conference was joined by Ondine's advisory board member Professor Trevor M. Jones CBE, whose remarkable career included development of the world-class antiviral drugs Zovirax (anti-herpetic) and Retrovir (AZT, anti-AIDS), among others. Finally, the Manager of the rock band KISS presented on the band's extensive use of Steriwave nasal decolonization in international touring locations, where the band was exposed to constant threat of SARS-CoV-2 infection from large audiences with mixed vaccination status. Steriwave was credited with helping the band to stay largely free of COVID-19, thereby enabling their highly successful year-long tour.[5]

· Earlier in the year, the successful outcomes of a University Hospital Zurich (USZ) in vitro study were published in the journal Antibiotics.[6] This research demonstrated that Ondine's photodisinfection therapy achieved more than 99.99% eradication (4-7 log10 kill) of the key pathogens in biofilms which are found on the surfaces of failing prosthetic joint implants. The study also demonstrated that photodisinfection did not damage or cause any relevant surface modification on any of the different prosthesis materials, a key step in proving the therapy safe to use in this new approach to recovering failing implants in human patients.

Commercial progress

· Ondine has expanded further into the Canadian hospital market using a clinical pilot model. The number of hospital and medical clinic installations and clinical pilots in Canada now stands at 14 - a substantial increase from last year.

· In addition to the rollout of further pilot installations in Canada, Ondine has initiated commercialization in three further countries - the UK, Spain, and Mexico - which, together with Canada, represent a market of over 270 million people. These countries are medically influential and have sophisticated private medical and academic facilities which serve medical tourists as well as their own populations. 

· During Q1 2023, the Company continued to build up its sales processes, key personnel, organizational infrastructure, and inventory to support commercial growth objectives. Ondine has established a network of local distributors in target markets discussed above, in order to leverage existing relationships and boost distribution and aftermarket support infrastructure. The Company is working with leading key opinion leaders (KOLs) in these territories across the main therapy areas where SSIs induce the greatest economic burden. These approaches are designed to foster broad adoption of Steriwave, as well as to generate additional data for other key market initiatives.

· When COVID-19 interrupted Ondine's Canadian healthcare commercialization efforts, the Company was able to use its existing capacity to serve the needs of a large meat processing plant in Manitoba, Canada. Approximately 1,500 meat processing workers used Ondine's Steriwave therapy on a weekly basis over the year, which was credited with protecting essential workers and substantially reducing outbreaks in the plant.[7] Safety data collected during this large-scale and multi-use deployment, which ended in August 2021, are expected to support regulatory filings. Outcomes of this deployment have now been submitted for peer review and publication.

Ondine's CEO, Carolyn Cross, said:

"I am very pleased to be able to report that Ondine has taken significant steps forward in our clinical development and commercialization strategy over the past year. We have also made substantial progress towards initiating the US Phase 3 trial of our Steriwave nasal photodisinfection technology. We look forward to providing further updates on our clinical and commercial activity in due course as Ondine enters this exciting stage in its growth."

**ENDS**

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian headquartered company innovating in the field of photodisinfection therapies. Ondine has a pipeline of investigational products, based on its proprietary photodisinfection platform, in various stages of development. Products beyond nasal photodisinfection include therapies for a variety of medical indications such as chronic sinusitis, ventilator-associated pneumonia, burns, and other indications. 

About photodisinfection

Ondine's photodisinfection is a patented technology using a proprietary photosensitizer (non-antibiotic, light-activated solution) to destroy pathogens. When illuminated with a specific wavelength of light, the photosensitizer is activated, causing an oxidative burst that is lethal to all types of pathogens.

Ondine's nasal photodisinfection system has a CE mark and is approved in Canada and several other countries under the name Steriwave™. It has been used in Canada for over ten years, with no serious adverse events reported. In the US, it is currently undergoing clinical trials for regulatory approval.