RCS - Ondine Biomedical - Steriwave evaluation at major heart institute

Ondine BiomedicalAnnouncement

12/09/2023 09:00

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RNS Number : 1541M  Ondine Biomedical Inc.  12 September 2023

12 September 2023

ONDINE BIOMEDICAL INC.

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

Steriwave evaluation at major heart institute

Canadian life sciences company Ondine Biomedical Inc. (LON: OBI) has launched
an eight-month evaluation of its Steriwave(®) nasal photodisinfection
technology at the University of Alberta's Mazankowski Alberta Heart Institute
in Edmonton, Canada, a world-leading centre for complex cardiac care and
surgery. The evaluation will include around 1000 cardiac surgery patients
treated with Steriwave to further reduce post-surgical infection risk.

Surgical site infections (SSIs) are one of the most significant complications
in cardiac surgery patients and are strongly associated with poorer prognosis,
longer hospitalization, higher medical costs, and high mortality.( 1 )
Universal pre-operative nasal decolonization has been found to significantly
decrease SSIs caused by the infection-causing pathogen S. aureus following
cardiac procedures.( 2 )

Ondine Biomedical's CEO Carolyn Cross said:

"Ondine is delighted to be working with one of the top cardiac healthcare
facilities in the world to further reduce the risk of infections following
cardiac surgery. The consequences of a post-surgical infection can be
catastrophic and can be especially hard for a patient and their family if the
procedure itself has been successful. The team at the Mazankowski Alberta
Heart Institute has been fantastic and welcomed the addition of Steriwave
nasal photodisinfection to their infection prevention protocols. We are very
pleased to help and look forward to sharing results from this evaluation next
year."

Ondine's nasal photodisinfection treatment kills all types of pathogens -
viruses, bacteria, and fungi - in minutes without causing resistance and is
already in use in major hospitals across Canada, including Vancouver General
Hospital and The Ottawa Hospital.

In these hospital settings, pre-surgical use of Steriwave has resulted in
significant improvement in post-surgical outcomes including lower rates of
infection, reduced patient length of stay, fewer readmissions, and lower rates
of antibiotic prescribing.( 3 )(,)( 4 )(,)( 5 ) In Ondine's US Phase 2 trial,
a single, five-minute nasal photodisinfection treatment was found to eliminate
or significantly decrease Staphylococcus aureus (S. aureus) in 86% of
carriers.( 6 )

**ENDS**

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian headquartered company innovating in the
field of photodisinfection therapies. Ondine has a pipeline of investigational
products, based on its proprietary photodisinfection platform, in various
stages of development. Products beyond nasal photodisinfection include
therapies for a variety of medical indications such as chronic sinusitis,
ventilator-associated pneumonia, burns, and other indications.

About Nasal Photodisinfection

Ondine's nasal photodisinfection is a patented technology using a proprietary
photosensitizer (non- antibiotic, light-activated agent) to destroy pathogens.
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 laser light for less
than five minutes. The light activates the photosensitizer, causing an
oxidative burst that is lethal to all types of pathogens. A key benefit of
this approach, unlike with antibiotics, is that pathogens do not develop
resistance to the therapy.

Nasal decolonization with antibiotics is already standard practice in many
hospitals prior to surgery, as pathogens in a patient's nasal cavities are a
major cause of surgical site infections (SSIs). However, there is a growing
need to reduce antibiotic use and find non-antibiotic methods of nasal
decolonization as resistance rates have been reported as high as 81%.( 7 
(#_edn7) )

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®.
It has been used in Canada for over ten years, with no serious adverse events
reported. In the US, it is currently undergoing clinical trials for regulatory
approval.

About The Mazankowski Alberta Heart Institute

The Mazankowski Alberta Heart Institute in Edmonton is a world leader in
complex cardiac care and surgery. With a collaborative approach, its team of
highly skilled cardiologists, cardiovascular surgeons, cardiac care
professionals, researchers and educators are advancing the prevention,
detection, treatment and study of cardiovascular disease.

 1  Zukowska A, Zukowski M. Surgical Site Infection in Cardiac Surgery. J Clin
Med. 2022 Nov 26;11(23):6991. doi: 10.3390/jcm11236991. PMID: 36498567; PMCID:
PMC9738257.

 2  Lemaignen A, Armand-Lefevre L, Birgand G, et al. Thirteen-year experience
with universal Staphylococcus aureus nasal decolonization prior to cardiac
surgery: a quasi-experimental study. J Hosp Infect. 2018;100(3):322-328.
doi:10.1016/j.jhin.2018.04.023.

 3  Banaszek D, Inglis T, Tamir Ailon T, Charest-Morin R, Dea N, Fisher C,
Kwon B, Paquette S, Street J. The efficacy and cost-effectiveness of
photodynamic therapy in prevention of surgical site infection. The Spine
Journal, Volume 19, Issue 9, Supplement, 2019, Page S138.

 4 
https://www.londonstockexchange.com/news-article/OBI/ottawa-hospital-presents-steriwave-study-
results/15860312
(https://www.londonstockexchange.com/news-article/OBI/ottawa-hospital-presents-steriwave-study-%20results/15860312)

 5  Bryce E, Wong T, Forrester L, et al. Nasal photodisinfection and
chlorhexidine wipes decrease surgical site infections: a historical control
study and propensity analysis [published correction appears in J Hosp Infect.
2015 Sep;91(1):93]. J Hosp Infect. 2014;88(2):89-95.
doi:10.1016/j.jhin.2014.06.017

 6 
https://www.londonstockexchange.com/news-article/OBI/ondine-reports-full-results-from-phase-2-trial/15740894
(https://www.londonstockexchange.com/news-article/OBI/ondine-reports-full-results-from-phase-2-trial/15740894)

 7  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

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