Steriwave receives UAE Regulatory Approval

Ondine Biomedical Inc.

18 October 2024

 

ONDINE BIOMEDICAL INC.

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

Steriwave receives UAE Regulatory Approval

Ondine receives regulatory approval for Steriwave light-activated antimicrobial technology in the United Arab Emirates

Ondine Biomedical Inc. (LON: OBI), a Canadian life sciences company pioneering light-activated antimicrobial treatments, announces that it has received regulatory approval to market Steriwave^® nasal decolonization to reduce healthcare-associated infections (HAIs) in patients undergoing surgery in the United Arab Emirates (UAE).

The UAE, with its population of 9.4 million, represents an important and growing market in the Middle East. It is becoming a center of medical excellence, drawing medical tourists from across the Middle East and Asia. Wellness tourists spend an estimated $5.4 billion, up from $2.1 billion in 2020.[1]

Carolyn Cross, CEO of Ondine Biomedical, commented:

"We are looking forward to bringing the infection-reducing benefits of Steriwave nasal decolonization to the United Arab Emirates and other Middle Eastern Markets. We believe that adding Steriwave to current presurgical and ICU protocols can help these countries to address the growing threat from antimicrobial resistant infections in hospitals."

HAIs remain a critical challenge across the world, resulting in significant costs, avoidable deaths, and human suffering. HAIs rank as the fifth most frequent cause of mortality in acute-care hospitals in the United States.^[2] Post-surgical infections, in particular, extend recovery times and often require prolonged antibiotic treatment, which governments, such as in the UK, are actively seeking to reduce.^[3] In the U.S., the average hospital cost per surgical site infection (SSI) is approximately $20,000.^[4]

Nasal decolonization is recommended in the 2016 WHO Global guidelines for the prevention of surgical site infections,^[5] and the Society for Healthcare Epidemiology of America (SHEA) guidelines, published in May 2023, recommend nasal decolonization for major surgical procedures.^[6]

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, 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.

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%[7] - is that pathogens do not develop resistance to the therapy.

Enquiries:

Ondine Biomedical Inc.
Carolyn Cross, CEO	+001 604 669 0555
Singer Capital Markets (Nominated Adviser, Joint Broker)
Phil Davies, Sam Butcher	[phone]
RBC Capital Markets (Joint Broker)
Rupert Walford, Kathryn Deegan	[phone]
Vane Percy & Roberts (Media Contact)	[phone]
Simon Vane Percy, Amanda Bernard

---

[1] According to the Global Wellness Economy Monitor - https://www.thenationalnews.com/news/uae/2024/04/08/how-the-uae-has-become-one-of-the-worlds-fastest-growing-medical-tourism-destinations/

[2] Klevens RM, Edwards JR, Richards CL Jr, Horan TC, Gaynes RP, Pollock DA, et al. Estimating health care-associated infections and deaths in U.S. hospitals, 2002. Public Health Rep 2007;122(2):160-166. doi:10.1177/003335490712200205.

[3] See the UK's  5-year action plan for antimicrobial resistance, published in May 2024.

[4] Ban et al. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. Journal of the American College of Surgeons, 2017; 224 (1): 59.

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

[6] 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)

[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. (link)

 

END