RCS - Ondine Biomedical - Nasal photodisinfection US market potential

Ondine BiomedicalAnnouncement

19/02/2025 07:15

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RNS Number : 6005X  Ondine Biomedical Inc.  19 February 2025

ONDINE BIOMEDICAL INC.

 

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

 

Innovative light-activated antimicrobial treatment has potential to become
first FDA-approved nasal decolonization treatment for prevention of surgical
site infections

 

·    Ondine's light-activated antimicrobial therapy for nasal
decolonization would apply to more than 35 million major surgical procedures
in the USA annually.

·    Surgical site infections ("SSIs") account for 20% of all
hospital-associated infections ("HAIs") and are linked with up to an 11-fold
increase in the risk of mortality, with 75% of SSI-associated deaths directly
attributable to the infection itself. 1  (#_edn1)

·    HAI costs represent 6% of public sector health budgets in the EU. 2 
(#_edn2) Significant SSI reductions would have immediate cost-saving benefits,
reduce surgical waitlists, and provide better patient outcomes.

Ondine's innovative light-activated antimicrobial treatment has the potential
to become the first FDA-approved nasal decolonization treatment for the
prevention of surgical site infections. The treatment is presently undergoing
a pivotal phase 3 trial (LANTERN) in US hospitals.

The most commonly used approach to combat Staphylococcus aureus in the nose is
off-label use of the topical antibiotic mupirocin. However, mupirocin is
associated with poor patient compliance due to its demanding regimen -
patients are required to apply an oily compound into each nostril twice a day
for 5 days prior to surgery.  Difficulty with use has led to compliance rates
as low as 39% in major studies, (which was demonstrated in the STOP-SSI
study), and because the agent is an antibiotic, resistance rates as high as
81%. 3  (#_edn3)

Ondine intends to replace mupirocin and other nasal agents with a single
5-minute light based antimicrobial treatment just prior to surgery. In
addition to rapid decolonization, which eliminates the requirement for at-home
compliance with a 5-day regimen, Steriwave is effective against the numerous
pathogens which inhabit the nose - fungi, viruses and bacteria (including
Gram-negative bacteria). Administered by a healthcare professional prior to
surgery, the process involves applying a proprietary photosensitive agent to
each nostril with a swab, followed by exposure to a specific wavelength of red
light. The light activates the photosensitive agent, triggering an oxidative
burst that eradicates pathogens in a single treatment.

Dr Simon Sinclair, Ondine's Chief Medical Officer, commented:

"We have successfully treated over 200,000 patients in Canada and the UK, and
as Steriwave kills more pathogens than just S. aureus, both patients and
clinicians have embraced the added protection Steriwave provides against
infection risks. Patients appreciate the reassurance of enhanced safety, while
clinicians value having a fast, easy-to-implement solution to help prevent
potentially devastating post-surgical infections. By seamlessly integrating
into nursing workflows, Steriwave gives surgeons confidence that nasal
decolonization has been achieved, significantly lowering the risk of surgical
site infections."

There is a large unmet need for rapid, broad-spectrum nasal decolonization
without contributing to antimicrobial resistance. According to the Centers for
Disease Control and Prevention (CDC), surgical site infections remain a
significant cause of morbidity, prolonged hospitalization, and mortality in
the United States. SSIs account for 20% of all HAIs and are associated with a
2- to 11-fold increase in mortality, with 75% of SSI-related deaths directly
attributed to the infection.(1) Moreover, SSIs are the most expensive type of
HAI, costing the healthcare system an estimated US$3.3 billion annually,
extending hospital stays by an average of 9.7 days, and increasing
hospitalization costs by more than US$20,000 per admission.¹

Ondine's nasal photodisinfection has been in use in Canadian hospitals for the
past ten years and is now being used in several UK NHS Trusts. Recently,
Ondine announced its partnership with Mölnlycke Health Care, a global leader
in MedTech specialising in wound care and surgical solutions, to distribute
its technology across the UK, EU, and Middle East markets.

 

 

Enquiries:

 Ondine Biomedical Inc.                                                                             www.ondinebio.com (http://www.ondinebio.com)
 Carolyn Cross, CEO                                                                                 Via Vane Percy & Roberts

 Strand Hanson Limited (Nominated & Financial Adviser)
 James Harris, Richard Johnson                                                                      +44 (0) 20 7409 3494

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

 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 in
light-activated antimicrobial therapies (also known as 'photo disinfection').
Based on its proprietary photo disinfection technology, Ondine has a pipeline
of investigational products in various stages of development.

 

Ondine's nasal photodisinfection system has a CE mark in Europe 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.

 

 1  (#_ednref1) Centers for Disease Control and Prevention. Surgical Site
Infection (SSI) Event. National Healthcare Safety Network (NHSN), n.d. (link
(https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf) )

 2  (#_ednref2) Healthcare expenditure and financing. OECD.Stat. Accessed
March 20, 2023.

 3  (#_ednref3) 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
(https://academic.oup.com/jac/article/70/10/2681/829798?login=false) )

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