Ondine Biomedical Inc Announces Corporate and Trading Update

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Corporate and Trading Update

Significant revenue growth and commercial momentum

VANCOUVER, BC / ACCESSWIRE / April 24, 2024 / Ondine Biomedical (LON:OBI), a leading provider of light-activated antimicrobial technology to treat and prevent hospital infections, provides an update on its recent developments, strategic priorities and 2024 corporate plans.

Commercial

In 2023, revenues nearly doubled to $1.2 million ($0.6 million in 2022), driven by significant growth in the number of hospitals deploying Steriwave®. Ondine ended the year with 16 hospital deployments, up from six at the prior year end. This momentum has continued with eight additional hospital deployments in Q1 2024, bringing the total to 24 hospitals, 50% up from the previous year-end and four times the number at the beginning of 2023.

During the last quarter, several hospitals announced expansions to include other surgical indications. The Company is also benefitting from significantly reduced sales cycle times, lower new client acquisition costs and improved margins resulting from lower cost of goods and higher product pricing. Retention of hospital accounts added to date is at 100%.

Of the eight new hospital placements in the first quarter of 2024, five of these were located internationally:

In the UK, strategic inroads were made into the NHS in England with the accelerated adoption by two hospitals in the Mid Yorkshire NHS Teaching Trust (the "Trust") for orthopedic surgeries as a result of a strong early pilot data in one of them, and high levels of enthusiasm for the new technology by both healthcare professionals and patients. The Trust created a 12-month budget for the use of Steriwave for patients undergoing hip and knee surgery. Ondine is now partnering with the Trust and Health Innovation Yorkshire and Humber to conduct a health economic analysis to further support Steriwave adoption across the NHS. In the private sector, HCA Healthcare UK has approved Steriwave for use in its UK-based private hospitals, at the discretion of the clinician. HCA UK, a leading private healthcare provider in the UK with 30 facilities, is a subsidiary of HCA Healthcare (USA).

In Spain, the first three hospitals are now implementing Steriwave, including the prestigious Hospital Universitario La Paz (HULP). HULP is a large tertiary hospital in Madrid with 1,308 beds. The Hospital Universitario La Paz is recognized as a centre of reference and health excellence and is considered one of the top three public hospitals with the best reputation in Spain.

In Australia, Ondine has achieved its first hospital deployment in Australia at Mater Hospital, North Sydney, a 233-bed private hospital in New South Wales. The hospital is part of the St. Vincent's Health Australia Group, Australia's largest not-for-profit provider of health and aged care services. This follows the recent Australian Spine Society Conference held from 5-7 April 2024, at which Dr. John Street, Co-Medical Director of the Complex Spine Program at Vancouver General Hospital, presented his research study findings on Steriwave as keynote speaker.

Distribution Partnership(s) to accelerate growth: As a result of Ondine's positive clinical data, growing sales momentum and recent commercial success, the Company has been approached by several multinational companies in the hospital supply, wound care, and infection control industries. The Company is currently in a process of progressing discussions on distribution collaborations with potential partners. While these discussions have been constructive, there is no certainty that a distribution agreement will materialize from any of these discussions. Management believes that distribution partnerships have the potential to generate earlier income for Ondine in the form of time-based territorial license payments and to accelerate sales and income generation for the Company through faster market penetration and greater geographical reach. The Company's 2023 investments in manufacturing capacity upgrades combined with a significant COGS reduction program support larger-scale rollout and increased gross margins required by any potential partners. The latest generation light diffuser is reducing the cost of goods for our Steriwave testing kits by 46 per cent.

Expansion into Intensive Care Units (ICU): Ondine is accelerating its plans to enter the ICU market to take advantage of interest by hospitals to replace the commonly used antibiotic mupirocin. Mupirocin, the topically applied antibiotic used in the nose over 5 days, requires lengthy administration times and generates antibiotic resistance. Having established a solid safety and efficacy profile in over 150,000 patients in pre-surgical and industrial settings, the Company estimates that the ICU application represents an opportunity to expand the total addressable market for Steriwave significantly. As ICUs have the highest hospital rates of infection and mortality, they represent an opportunity to accelerate new hospital adoption at a point of major unmet need both in terms of improving patient outcomes and reducing cost of care and length of stay. Further announcements will be made in due course.

US Phase 3 Clinical Trial Plans

Following a Type C meeting with the US Food & Drug Administration ("FDA") last September, the design and budget for the clinical trial program has been finalized in close collaboration with HCA Healthcare ("HCA"), Ondine's US clinical trial partner. The trial will run at 14 HCA hospital sites with a circa 5,000-patient group-randomized crossover study, comparing Ondine's nasal photodisinfection added to standard-of-care infection prevention practices versus standard-of-care alone. The Company is targeting to commence the trial in the third quarter of this year. Data from the trial will inform the Company's planned FDA submission and approval would facilitate adoption of Steriwave in the US.

Funding Position and Support

The Company has received indications of support from its founder CEO and substantial shareholder, Carolyn Cross, and from other existing shareholders, to provide near-term funding to extend the Company's runway. Discussions are currently underway with HCA's investment arm, Health Insight Capital, for its funding support of the key Phase 3 clinical trial. The Company is confident in its ability to secure longer-term financing to execute on the growth opportunities described above. Further announcements will be made in due course.

**ENDS**

Enquiries:

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian life sciences company and leader innovating light-activated antimicrobial therapies (also known as 'photodisinfection'). Ondine has a pipeline of investigational products, based on its proprietary photodisinfection technology, in various stages of development.

Ondine's nasal photodisinfection system has a CE mark in Europe and the UK and is approved in Canada and several other countries under the name Steriwave®. In the US, it has been granted Qualified Infectious Disease Product designation and Fast Track status by the FDA and is currently undergoing clinical trials for regulatory approval. Products beyond nasal photodisinfection include therapies for a variety of medical indications such as chronic sinusitis, ventilator-associated pneumonia, burns, and many other indications.

About Steriwave®

Ondine's Steriwave® nasal photodisinfection system is a patented technology using a proprietary light-activated antimicrobial (photosensitizer) to destroy bacteria, viruses, and fungi colonizing the nose. The photodisinfection treatment is carried out by a trained healthcare professional and is an easy to use, painless, two-step process. The photosensitizer is applied to each nostril using a nasal swab, followed by illumination of the area with a specific wavelength of red laser light for less than five minutes. The light activates the photosensitizer, causing an oxidative burst that is lethal to all types of pathogens without causing long-term adverse effects on the nasal microbiome. A key benefit of this approach-unlike with antibiotics, which have resistance rates reported as high as 81%^[i]-is that pathogens do not develop resistance to the therapy.

Nasal decolonization is recommended in the 2016 WHO Global guidelines for the prevention of surgical site infections,^[ii] and the Society for Healthcare Epidemiology of America (SHEA) guidelines, published in May 2023, recommend nasal decolonization for major surgical procedures.^[iii]

^[i] Poovelikunnel T, Gethin G, Humphreys H. Mupirocin resistance: clinical implications and potential alternatives for the eradication of MRSA. J Antimicrob Chemother. 2015;70(10):2681-2692. doi:10.1093/jac/dkv169

^[ii] https://cdn.who.int/media/docs/default-source/integrated-health-services-(ihs)/ssi/fact-sheet-staphylococcus-web.pdf?sfvrsn=7e7266ed_2

^[iii] Calderwood MS, Anderson DJ, Bratzler DW, et al. Strategies to prevent surgical site infections in acute-care hospitals: 2022 Update. Infect Control Hosp Epidemiol. 2023;44(5):695-720. doi:10.1017/ice.2023.67

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SOURCE: Ondine Biomedical Inc