RCS - Ondine Biomedical - Steriwave authorized for use by HCA UK

Ondine BiomedicalAnnouncement

10/04/2024 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240410:nRSJ9581Ja&default-theme=true

RNS Number : 9581J  Ondine Biomedical Inc.  10 April 2024

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
(https://ondinebio.com/media/steriwave-prevents-sinonasal-ssis/?portfolioCats=68)

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.
 Carolyn Cross, CEO                                           +001 (604) 665 0555

 Singer Capital Markets (Nominated Adviser and Joint Broker)
 Aubrey Powell, Asha Chotai, 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)
 Simon Vane Percy, Amanda Bernard                             +44 (0)77 1000 5910

 

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 )

 

 i  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

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

 iii  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

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAXKLLBZZLFBBD