Replacement: Steriwave deploying in 8 new sites

Ondine Biomedical Inc.

15 March 2024

 

The following amendment(s) has (have) been made to the 'Steriwave deploying in eight new sites' announcement released on 15.03.2024 at 7am under RNS No 9650G.

The final sentence of the fourth paragraph has been amended to include 'million' following '$2.49'.

All other details remain unchanged.

The full amended text is shown below.

ONDINE BIOMEDICAL INC.

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

Steriwave deploying in eight new sites

Ondine Biomedical Inc. (LON:OBI), the Canadian life sciences company pioneering light-activated antimicrobial treatments to prevent and treat healthcare-associated infections (HAIs), has made significant commercial progress to date in 2024, ahead of management's expectations. Ondine's Steriwave® technology is deploying in eight new healthcare facilities, including six new hospitals. This brings the total number of hospitals to 22, representing a 38% increase year-to-date and nearly quadruple the number a year ago. Two orthopedic surgeon group practices in the Toronto area will also shortly begin offering Steriwave to patients undergoing elective orthopedic procedures.

In addition, The Ottawa Hospital (TOH) has confirmed it is significantly expanding its use of Steriwave, building upon the success of its pilot and a comprehensive cost-benefit assessment within spine surgeries. This expansion means that Steriwave will now be used across an additional site, and also extends its application from spinal surgeries to also include TOH's orthopedic and vascular surgery patients. Annually, Steriwave will now be used prior to approximately 2,600 surgical procedures at TOH, a threefold increase from the Steriwave pilot.

Discussions are ongoing with medical device distributors to further expand the commercial reach of Steriwave.

Driving this increase in hospital deployments is the growing need to reduce avoidable hospital costs in an era of rising antibiotic resistance. Recently published findings reported a net saving approaching C$2,600 per spine surgery patient treated with Steriwave nasal photodisinfection and chlorhexidine skin decolonization.[1] Despite case complexity increasing over the study period, the post-surgical infection rate dropped by 67%, resulting in estimated annual cumulative institutional savings of $2.49 million attributable to the use of the bundled protocol with Steriwave.

The new commercial deployments of Steriwave described above beyond the TOH expansion are paid adoptions that have begun or were agreed before the end of February 2024:

·    The first three hospitals in Spain, including the Hospital Universitario La Paz (HULP) in Madrid for a paid pilot of patients undergoing elective orthopedic procedures. As anticipated by a previous announcement, these are the first sign-ups through our distribution partner in Spain.

·    Sturgeon Community Hospital, Alberta, (Alberta Health Services (AHS), Canada's largest integrated health system). Sturgeon Community Hospital is the third AHS hospital to deploy Steriwave. Steriwave has been deployed for the reduction of surgical site infections (SSIs) for patients undergoing breast reconstruction surgeries and elective orthopedic procedures.

·    Nanaimo Regional General Hospital, British Columbia, (Island Health Authority) has deployed Steriwave to reduce HAIs in patients undergoing hip and knee surgeries.

·    Two orthopedic surgeon group practices in the Toronto area will also begin offering Steriwave on a patient-pay basis to patients undergoing elective orthopedic procedures. These groups operate from Toronto Western Hospital, St Mary's General Hospital, and Grand River Hospital all of which are in the Greater Toronto region in Ontario, Canada.

Results presented at the the prestigious SPIE Photonics West conference on 30 January 2024 in San Francisco, California showed that treatment with Ondine's Steriwave® Nasal Photodisinfection System significantly reduces pathogens in the nose without long-term adverse effects on the nasal microbiome. This is an important finding to allay potential concerns as to a possible side-effect of Steriwave treatment, which has been used in over 150,000 patients with no serious adverse events reported.

**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 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%[2]-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,[3] and the Society for Healthcare Epidemiology of America (SHEA) guidelines, published in May 2023, recommend nasal decolonization for major surgical procedures.[4]

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[1] $2,484,856-$2,495,016 average annual net savings divided by 964 mean number of patients per year= $2,582.92 net saving per patient. Moskven E et al. Effectiveness of prophylactic intranasal photodynamic disinfection therapy and chlorhexidine gluconate body wipes for surgical site infection prophylaxis in adult spine surgery. Can J Surg. 2023 Nov;66(6), E550-E560. https://doi.org/10.1503/cjs.016922

[2] 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

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

[4] 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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