Non-regulatory
announcement
ONDINE BIOMEDICAL INC.
("Ondine Biomedical",
"Ondine" or the "Company")
Steriwave authorized for use
by HCA UK
Light-activated
antimicrobial that does not generate antimicrobial resistance (AMR)
approved for use in healthcare facilities operated by leading
private healthcare provider HCA Healthcare UK
Leading private healthcare provider, HCA Healthcare
UK, has approved the Steriwave® light-activated antimicrobial
developed by Ondine Biomedical Inc. (LON:OBI) for use in its
healthcare facilities to prevent healthcare-associated infections
(HAIs) and reduce the use of antibiotics. HCA Healthcare is the
largest private healthcare provider in the world, and one of the
leading private healthcare providers in the UK, where it operates
over 30 healthcare facilities.
Antimicrobial resistance (AMR) is a growing concern
for healthcare providers around the world, particularly in the
prevention and treatment of HAIs. Steriwave is a light-activated
antimicrobial with a distinct mechanism of action from traditional
antibiotics, allowing it to be used without fear of generating AMR.
Its broad-spectrum efficacy destroys bacteria, viruses, and fungi
in a single, 5-minute treatment.
Steriwave has already been
successfully used in a small patient population in HCA Healthcare
UK hospitals, but this approval will allow additional hospitals and
healthcare facilities to adopt the technology more widely at the
discretion of the clinician.
Professor Claire Hopkins, Professor
of Rhinology at King's College London and Consultant ENT Surgeon at
Guy's & St Thomas' NHS Foundation Trust and London Bridge
Hospital, has used Steriwave routinely to nasally decolonise her
endoscopic sinus surgery patients at HCA Healthcare UK's London
Bridge Hospital since 2021. A retrospective study showed that using
Steriwave in endoscopic sinus surgery patients led to antibiotic
use across all her patients dropping from 22% to less than
5% - a 77% reduction.
Professor Hopkins commented: "I was
amazed that studies show that by treating the nose you can reduce
spinal surgical site infections - so it seemed an ideal way to
reduce the risk of post-operative infection after nasal surgery. I
have seen a significant reduction in post-operative infections
requiring antibiotics, which is good for the patients, reducing the
risk of antibiotic-related side effects, and important to help
prevent ever-increasing antibiotic resistance. It needs formal
controlled studies to further evaluate the effectiveness, but I am
impressed with the difference that I have seen in my
practice."
Interview with Professor
Hopkins:
Steriwave prevents sinonasal SSIs
Carolyn Cross, Ondine Biomedical CEO, commented: "We
are delighted that Steriwave has now been authorized for use across
HCA Healthcare UK's healthcare facilities. We are already working
closely with HCA Healthcare in the US on our US Phase 3 trial and
the FDA regulatory submission for Steriwave, so it is fantastic to
be getting such good support from them in the UK as well. The study
undertaken at London Bridge Hospital has demonstrated Steriwave's
potential for addressing the threat of AMR by preventing infections
and reducing antibiotic use."
HCA Healthcare is partnering with Ondine in the
United States to conduct a US Phase 3 clinical trial with the
ultimate goal of obtaining FDA approval to bring Ondine's nasal
photodisinfection into the US market. HCA Healthcare operates 184
hospitals and over 2,000 sites of care across the United States,
making it the largest healthcare system in the US.
***ENDS***
Enquiries:
Ondine Biomedical
Inc.
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Carolyn Cross, CEO
|
+001 (604) 665 0555
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|
|
Singer Capital Markets (Nominated Adviser and Joint
Broker)
|
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Aubrey Powell, Asha Chotai, Sam
Butcher
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+44 (0)20 7496 3000
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RBC
Capital Markets (Joint Broker)
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Rupert Walford, Kathryn
Deegan
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+44 (0)20 7653 4000
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Vane Percy & Roberts (Media Contact)
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Simon Vane Percy, Amanda
Bernard
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+44 (0)77 1000 5910
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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%[i]-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,[ii]
and the Society for Healthcare Epidemiology of America (SHEA)
guidelines, published in May 2023, recommend nasal decolonisation
for major surgical procedures.[iii]