RCS - Ondine Biomedical - Steriwave receives UAE Regulatory Approval

Ondine BiomedicalAnnouncement

18/10/2024 07:00

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RNS Number : 6664I  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  (#_edn1)

 

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 
(#_edn2) )) 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  (#_edn3) )) In the U.S., the
average hospital cost per surgical site infection (SSI) is approximately
$20,000.(( 4  (#_edn4) ))

 

Nasal decolonization is recommended in the 2016 WHO Global guidelines for the
prevention of surgical site infections,(( 5  (#_edn5) )) and the Society for
Healthcare Epidemiology of America (SHEA) guidelines, published in May 2023,
recommend nasal decolonization for major surgical procedures.(( 6  (#_edn6) ))

 

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  (#_edn7) - 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                                   +44 (0)20 7496 3000

 RBC Capital Markets (Joint Broker)
 Rupert Walford, Kathryn Deegan                             +44 (0)20 7653 4000

 Vane Percy & Roberts (Media Contact)                      +44 (0)77 1000 5910
 Simon Vane Percy, Amanda Bernard

 

 1  (#_ednref1) 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  (#_ednref2) 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  (#_ednref3) See the UK's  5-year action plan for antimicrobial resistance
(https://www.gov.uk/government/publications/uk-5-year-action-plan-for-antimicrobial-resistance-2024-to-2029)
, published in May 2024.

 4  (#_ednref4) 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  (#_ednref5) Surgical Site Infection Prevention: Key facts on
decolonization of nasal carriers of Staphylococcus aureus. World Health
Organization. (link)

 6  (#_ednref6) 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  (#_ednref7) 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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