REG - Ondine Biomedical - Ondine recruits first patient for US Phase 3 trial

Ondine BiomedicalAnnouncement

30/12/2024 07:00

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RNS Number : 5692R  Ondine Biomedical Inc.  30 December 2024

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 27(th), 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  (#_edn1) and the Society for
Healthcare Epidemiology of America (SHEA) guidelines, published in May 2023,
recommend nasal decolonization for major surgical procedures. 2  (#_edn2)

 

 

Enquiries:

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

 RBC Capital Markets (Joint Broker)

 Rupert Walford, Kathryn                                                                                                            +44 (0) 20 7653 4000
 Deegan

 Singer Capital Markets (Nominated Adviser and Joint Broker)
 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.

 

 

 

 1  (#_ednref1)   Surgical Site Infection Prevention: Key facts on
decolonization of nasal carriers of Staphylococcus aureus. World Health
Organization. (link
(https://cdn.who.int/media/docs/default-source/integrated-health-services-(ihs)/ssi/fact-sheet-staphylococcus-web.pdf?sfvrsn=7e7266ed_2)
)

 

 2  (#_ednref2) 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
(https://www.cambridge.org/core/journals/infection-control-and-hospital-epidemiology/article/strategies-to-prevent-surgical-site-infections-in-acutecare-hospitals-2022-update/2F824B9ADD6066B29F89C8A2A127A9DC)
)

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