Mölnlycke(R) and Ondine Join Forces Against HAIs

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Mölnlycke Health Care partners with Ondine for Steriwave distribution collaboration in the key markets of the UK, Europe and the Middle East

VANCOUVER, BC / ACCESSWIRE / September 23, 2024 / Ondine Biomedical Inc. (LON:OBI), a Canadian life sciences company pioneering light-activated antimicrobial treatments, and Mölnlycke Health Care (Gothenburg Sweden), a world-leading MedTech company that specializes in innovative solutions for wound care and surgical procedures, are pleased to announce a strategic partnership to bring Ondine's Steriwave^® nasal decolonization technology to the United Kingdom, EU, and Middle East markets.

This collaboration marks a significant milestone in the fight against healthcare-associated infections (HAIs) and the growing threat of antimicrobial resistance (AMR), as Steriwave safely reduces hospital infections without generating AMR. Steriwave, a non-antibiotic, light-activated nasal decolonization therapy, has been clinically proven ^{[1] - [5]} to reduce harmful pathogens in the nasal passages, a common source of HAIs and cause of higher rates of mortality, length of stay and readmissions. Mölnlycke's established distribution networks, strong brand and market presence in over 100 countries make it an ideal partner to accelerate the adoption of Steriwave.

The first market focus starting later this year, is the pivotal UK market where Steriwave is already deployed several National Health Service (NHS) Trusts, including, Mid Yorkshire Teaching NHS Trust and Leeds Teaching Hospital NHS Trust. Steriwave is also listed with NHS Supply Chain, a national body that manages the sourcing, delivery and supply of healthcare products to the NHS and healthcare organizations in England and Wales. The UK market, with a total addressable market of over 3 million major surgeries annually ^[6] and over 200,000 annual intensive care unit (ICU) admissions, [7] has significant global influence in setting best practice for patient care.

Mölnlycke ^® will incorporate Steriwave as a key product in its infection control portfolio, enhancing its product offerings with a focus on preventing HAIs and reducing AMR. Distribution will commence in the UK in Q4 2024, followed by expansion into the EU and Middle East regions in 2025, leveraging Mölnlycke's extensive market presence to ultimately broaden the impact of this innovative technology on a global scale. Mölnlycke will spearhead sales and marketing efforts across the UK, EU, and Middle East.

Lina Karlsson, Executive Vice President Antiseptics, Mölnlycke, stated: "Mölnlycke's purpose is to revolutionize care for people and planet. In the Antiseptics business area, we do this by making patient skin decolonization manageable and motivational. We believe that Steriwave can improve the lives of millions of people, fitting perfectly with our purpose and mission. The ability to rapidly eliminate multiple drug-resistant pathogens without generating antimicrobial resistance is key to our sustainability initiative, and complements our Hibiwash^® brand skin prep line, enabling us to provide comprehensive 'nose-to-toes' decolonization prior to surgery. Universal decolonization is now a well-accepted practice to improve surgical outcomes and produce significant cost savings to healthcare systems."

Carolyn Cross, CEO of Ondine Biomedical, commented: "We are excited to be partnering with Mölnlycke Health Care, whose global reach, corporate vision and commitment to sustainable healthcare aligns perfectly with our own core values, purpose and mission. The Mölnlycke collaboration represents a transformative step towards our ambitious plans to combat HAIs and antimicrobial resistance globally. We look forward to working with Mölnlycke in these initial key markets and beyond."

HAIs remain a critical challenge across the world, consuming approximately 6% of European public sector budgets ^[8] and resulting in significant costs, avoidable deaths, and human suffering. Post-surgical infections, in particular, extend recovery times and often require prolonged antibiotic treatment, something the UK government is actively seeking to reduce as part of its , published in May 2024.

Nasal decolonization is recommended in the 2016 WHO Global guidelines for the prevention of surgical site infections, ^[9] and the Society for Healthcare Epidemiology of America (SHEA) guidelines, published in May 2023, recommend nasal decolonization for major surgical procedures. ^[10]

Steriwave uses a patented light-activated agent to rapidly eliminate infection-causing pathogens in a single, 5-minute treatment. The process works so rapidly that pathogens do not have the opportunity to develop resistance, [11] making it an effective alternative to antibiotics. Hospitals using Steriwave have reported high levels of staff and patient compliance. Steriwave has also been proven to be highly effective against drug-resistant pathogens. A 2023 study showed that Steriwave is highly effective (>99.99% kills in 20 seconds) against both moderately drug-resistant (MDR) and extensively drug-resistant (XDR) pathogens.

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About Mölnlycke Health Care

Mölnlycke Health Care is a world-leading MedTech company that specializes in innovative solutions for wound care and surgical procedures. Mölnlycke products and solutions are used daily by hospitals, health care providers and patients in over 100 countries around the world. Founded in 1849, Mölnlycke is owned by Investor AB and headquartered in Sweden. www.molnlycke.com

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian life sciences company and leader innovating light-activated antimicrobial therapies (also known as 'photodisinfection'). In addition to Steriwave, Ondine has a pipeline of 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 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 antibiotics, which have resistance rates reported as high as 81% ^{[12] -} is that pathogens do not develop resistance to the therapy.

Enquiries:

^[1] Bryce E, Wong T, Forrester L, et al. Nasal photodisinfection and chlorhexidine wipes decrease surgical site infections: a historical control study and propensity analysis [published correction appears in J Hosp Infect. 2015 Sep;91(1):93]. J Hosp Infect. 2014;88(2):89-95. (link)

^[2] Moskven E, Banaszek D, Sayre EC, 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;66(6):E550-E560. (link)

^[3] Ondine Biomedical's nasal photodisinfection cuts surgical site infections by 66%. Press release 18 April 2023 (link)

^[4] Pre-op Nasal Decolonization via Photodisinfection: A Pilot Study in Spinal Surgery Procedures at the Ottawa Hospital. Poster presentation at IPAC Canada 2023 National Conference. (link)

^[5] Street C, Pedigo L, Gibbs A, et al. Antimicrobial photodynamic therapy for the decolonization of methicillin-resistant Staphylococcus aureus from the anterior nares. In: Kessel DH, editor. Photodynamic therapy: back to the future. 12th World Congress of the International Photodynamic Association. Vol. 7380 of Proceedings series. Bellingham (WA): SPIE; 2009. (link)

^[6] Surgical Procedure Volumes in UK from 2021-2029. Life Science Intelligence; 2023 Jan. Volume 23.

^[7] Hospital Admitted Patient Care Activity, 2011-22. Secondary Care Analytical Team, NHS Digital. Health and Social Care Information Centre. 22 Sep 2022. (link)

^[8] OECD/European Union (2020), Health at a Glance: Europe 2020: State of Health in the EU Cycle, OECD Publishing, Paris. (link)

^[9] Surgical Site Infection Prevention: Key facts on decolonization of nasal carriers of Staphylococcus aureus. World Health Organization. (link)

^[10] 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. (link)

^[11] Pedigo LA, Gibbs AJ, Scott RJ, et al. Absence of bacterial resistance following repeat exposure to photodynamic therapy. Proc. SPIE 7380, Photodynamic Therapy: Back to the Future, 73803H (2009). (link)

^[12] 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. (link)

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SOURCE: Ondine Biomedical Inc