First commercial adoption of Steriwave by the NHS

Ondine Biomedical Inc.

25 March 2024

 

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014, which is part of UK law by virtue of the European Union (Withdrawal) Act 2018. Upon the publication of this announcement, this inside information is now considered to be in the public domain.

25 March 2024

ONDINE BIOMEDICAL INC.

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

First commercial adoption of Steriwave by the NHS

NHS deal gives patients access to groundbreaking light-activated antimicrobial to combat AMR (antimicrobial resistance)

·      A new light-activated antimicrobial that kills all types of bugs - viruses, bacteria, and fungi - in minutes without generating resistance is being adopted by two NHS hospitals to reduce surgical infections.

Mid Yorkshire Teaching NHS Trust has approved the commercial adoption of Ondine's groundbreaking light-activated antimicrobial, Steriwave®. The approval will see the use of Steriwave expanded across hip and knee surgery patients at Pontefract and Pinderfields NHS Hospitals to reduce the incidence of surgical site infections (SSIs). This adoption as standard-of-care for orthopedic patients follows a successful, initial deployment that is being used to evaluate Steriwave at Pontefract Hospital.

Dr Stuart Bond, Consultant antimicrobial pharmacist and Director of Innovation at Mid Yorkshire Teaching NHS Trust, commented:

"We are very pleased to be the first NHS Trust to be giving patients access to this important new technology. SSIs can have a devastating effect on patients and their families, and we are pleased that we have demonstrated the feasibility of using Steriwave in our Orthopaedic Centre of Excellence at Pontefract Hospital. It is a real step forward to making Steriwave more widely available across the Trust."

The CEO of Ondine Biomedical, a world leader in light-activated antimicrobial technology, Carolyn Cross, said:

"We are delighted to see the first two NHS hospitals adopt Steriwave, particularly as NHS is seen around the world as a leader in antibiotic stewardship in response to the growing threat of AMR (antimicrobial resistance). This is not only a significant milestone for Ondine, but Mid Yorks's accelerated decision to adopt suggests that Steriwave has been well received by patients, surgeons, and nurses."

As announced on 5 March 2024, Ondine Biomedical, Mid Yorkshire Teaching NHS Trust, and Health Innovation Yorkshire & Humber have partnered to sponsor a health economic analysis with the York Health Economics Consortium (YHEC). The full findings of this study [are expected to be reported on later this year and] will be used to support the further spread and adoption of Steriwave across the NHS and across additional surgical applications.

SSIs are one of the most common healthcare-associated infections (HAIs) and affect one in every 20 patients who undergo a surgical procedure in the NHS.[1] SSIs can cost up to £100,000 per patient,[2] and the overall cost of HAIs to NHS England is over £2 billion a year.[3] These costs are expected to rise as growing rates of antimicrobial resistance (AMR) make the current standard of care - the antibiotic mupirocin -  less effective.[4]

Steriwave is a light-activated antimicrobial that uses a specific wavelength of red light to destroy pathogens that colonise the nose and can spread to cause harmful infections. Crucially, unlike traditional antibiotics, Steriwave is immediately effective with a single five-minute treatment and does not trigger antimicrobial resistance (AMR). Nasal decolonization - eliminating harmful pathogens from the nasal cavities - is recommended by WHO and NICE prior to surgery as a key approach to preventing SSIs.[5]

Steriwave has been used in over 150,000 patient treatments, including at major hospitals across Canada, including Vancouver General Hospital (VGH), The Ottawa Hospital (TOH), and the Mazankowski Alberta Heart Institute. Research recently published by VGH in the Canadian Journal of Surgery showed that the use of Steriwave in patients undergoing spine surgery resulted in a 66.5% reduction in post-surgical infection rates and almost $2600 per spine surgery patient, representing $2.5 million in annual savings for Vancouver General Hospital's spine group.[6] No serious adverse events have ever been reported from Steriwave treatment.

**ENDS**

Enquiries:

Ondine Biomedical Inc.
Carolyn Cross, CEO	+001 [phone]
Singer Capital Markets (Nominated Adviser and Joint Broker)
Aubrey Powell, Asha Chotai, Sam Butcher	[phone]
RBC Capital Markets (Joint Broker)
Rupert Walford, Kathryn Deegan	[phone]
Vane Percy & Roberts (Media Contact)
Simon Vane Percy, Amanda Bernard	[phone]

About Ondine Biomedical Inc.

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

Ondine's nasal decolonisation light-activated technology 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. Light-activated antimicrobial products in development include therapies for a variety of medical indications such as chronic sinusitis, ventilator-associated pneumonia, burns, and other indications.

About Steriwave®

Ondine's Steriwave is a patented technology using a proprietary light-activated antimicrobial (photosensitizer) to destroy bacteria, viruses, and fungi colonizing the nose - a major reservoir of pathogens. The 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 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%^[7], 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,^[8] and the Society for Healthcare Epidemiology of America (SHEA) guidelines, published in May 2023, recommend nasal decolonisation for major surgical procedures.^[9]

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[1] National Institute for Health and Care Excellence, Surgical site infections: prevention and treatment NICE guideline [NG125], 2019, https://www.nice.org.uk/guidance/ng125/chapter/Context)

[2] Getting it Right First Time, SSI National Survey, April 2019, https://gettingitrightfirsttime.co.uk/wp-content/uploads/2017/08/SSI-Report-GIRFT-APRIL19e-FINAL.pdf)

[3] Guest JF, Keating T, Gould D, et al Modelling the annual NHS costs and outcomes attributable to healthcare-associated infections in England BMJ Open 2020; 10:e033367. https://doi.org/10.1136/bmjopen-2019-033367

[4] Naylor NR, Evans S, Pouwels KB, Troughton R, Lamagni T, Muller-Pebody B, Knight GM, Atun R, Robotham JV. Quantifying the primary and secondary effects of antimicrobial resistance on surgery patients: Methods and data sources for empirical estimation in England. Front Public Health. 2022 Aug 8;10:803943. doi: 10.3389/fpubh.2022.803943. PMID: 36033764; PMCID: PMC9413182.

[5] https://www.nice.org.uk/guidance/ng125/chapter/recommendations

[6] Eryck Moskven, Daniel Banaszek, Eric C. Sayre, Aleksandra Gara, Elizabeth Bryce, Titus Wong, Tamir Ailon, Raphaële Charest-Morin, Nicolas Dea, Marcel F. Dvorak, Charles G. Fisher, Brian K. Kwon, Scott Paquette and John T. Street. Can J Surg November 15, 2023 66 (6) E550-E560; DOI: https://doi.org/10.1503/cjs.016922

[7] 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

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

[9] 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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