ONDINE BIOMEDICAL
INC.
("Ondine
Biomedical", "Ondine", or the "Company")
Ondine recruits first patient
for US Phase 3 trial
Ondine Biomedical Inc. (LON: OBI), a
Canadian life sciences company, has enrolled and treated the first
patient in the Light-Activated Antimicrobial Therapy to Prevent
Surgical Site Infections ('LANTERN') Phase 3 clinical trial. The
trial, involving approximately 5,000 patients in 14 hospitals, is
evaluating Ondine's non-antibiotic nasal photodisinfection
technology, branded as Steriwave® outside the US. The
first patient was enrolled at Centennial Medical Center in
Nashville, Tennessee, on Friday December 27th,
2024.
The Phase 3 trial is being conducted
in collaboration with HCA Healthcare, a leading healthcare provider
in the United States. This group-randomized crossover study
will enroll approximately 5,000 surgical patients undergoing
cardiac, orthopaedic, vascular, neurosurgical or radical mastectomy
procedures. The study will compare standard infection prevention
practices with, and without, Ondine's nasal photodisinfection
technology in order to reduce the incidence of surgical site
infections. The final patient is expected
to enroll in mid-2025, and preliminary trial results are projected
for release in Autumn 2025.
Ondine Biomedical's CEO Carolyn
Cross said:
"Our US Phase 3 trial initiation is
an exciting milestone towards making photodisinfection technology
available to healthcare professionals who want to rapidly eliminate
a broad spectrum of infection-causing pathogens without fuelling
drug resistance or relying on patient compliance as is the case
with topical antibiotics."
Ondine's nasal photodisinfection is
a 5-minute, non-invasive procedure that rapidly decolonizes the nose of infection-causing pathogens
without the use of antibiotics. This innovative approach avoids
contributing to antimicrobial resistance (AMR). The process involves applying a proprietary photosensitive
agent to each nostril with a nasal swab, followed by illumination
with a specific wavelength of red light. The light activates the
agent, producing an oxidative burst that destroys bacteria, viruses
and fungi in a single treatment.
Nasal decolonization is recommended
in the 2016 WHO Global guidelines for the prevention of surgical
site infections,[1] and the Society for
Healthcare Epidemiology of America (SHEA) guidelines, published in
May 2023, recommend nasal decolonization for major surgical
procedures.[2]
Enquiries:
|
Ondine Biomedical
Inc.
|
|
|
Carolyn Cross, CEO
|
+001 (604) 665 0555
|
|
RBC
Capital Markets (Joint Broker)
Rupert Walford, Kathryn
Deegan
Singer Capital Markets (Nominated Adviser and Joint
Broker)
|
+44 (0) 20 7653 4000
|
|
Phil Davies, Sam Butcher
|
+44 (0)20 7496 3000
|
|
|
|
|
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 '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 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.
