RCS - Ondine Biomedical - Montreal Heart Institute pilots Steriwave

Ondine BiomedicalAnnouncement

21/09/2023 07:00

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RNS Number : 1438N  Ondine Biomedical Inc.  21 September 2023

21 September 2023

ONDINE BIOMEDICAL INC.

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

Montreal Heart Institute pilots Steriwave

·    The world-renowned Montreal Heart Institute and Hôpital Fleurimont,
University of Sherbrooke (CHUS) in Sherbrooke, Quebec are piloting nasal
photodisinfection to prevent post-operative infections in an era of rising
antibiotic resistance.

·    2022 SHEA guidelines elevated nasal decolonization to an essential
practice for orthopedic and cardiothoracic surgical procedures.

·    The topical antibiotic commonly used for nasal decolonization has
bacterial resistance rates reported as high as 81%.

Two of Quebec's leading hospitals, Montreal Heart Institute (MHI), Canada's
largest cardiology research centre, and the Hôpital Fleurimont, affiliated
with the Centre de Recherche (CHUS), University of Sherbrooke, are piloting
Ondine's proprietary Steriwave® nasal photodisinfection in an effort to stay
ahead of increasing antibiotic resistance. MHI is evaluating patient outcomes
in elective cardiac surgical procedures and Hôpital Fleurimont is evaluating
outcomes in elective spine surgeries.

The Steriwave nasal photodisinfection treatment, developed by Canadian life
sciences company Ondine Biomedical Inc. (LON: OBI), uniquely kills all types
of pathogens - viruses, bacteria, and fungi - in minutes without causing
resistance. Pre-surgical use of Steriwave in hospital settings has resulted in
significant improvement in post-surgical outcomes including lower rates of
surgical site infections (SSIs), reduced patient length of stay, fewer
readmissions, and lower rates of antibiotic prescribing.( 1  (#_edn1) )(,( 2 
(#_edn2) )),( 3  (#_edn3) )

Surgical site infections (SSIs) are serious complications that can occur
following surgery and made worse by the growing resistance to antibiotics.
Certain types of infection, such as deep sternal infections, can be a serious
threat,  increasing a patient's mortality risk by 40% as surgeons have to
reopen the sternum to prevent the infection from spreading to internal
organs.( 4  (#_edn4) ) Cardiac SSIs are strongly associated with poorer
prognosis, longer hospitalization, higher medical costs, and high
mortality.( 5  (#_edn5) ) Post-surgical infections are also a greater risk for
spinal surgeries, affecting up to 17% of patients and treatment can be
particularly challenging. ( 6  (#_edn6) )(,( 7  (#_edn7) ))

Universal pre-operative nasal decolonization has been found to significantly
decrease SSIs caused by the infection-causing pathogen S. aureus.( 8  (#_edn8)
) The Society for Healthcare Epidemiology of America (SHEA) updated guidelines
elevate nasal decolonization from a recommended practice to essential for
orthopedic (including spine) and cardiothoracic surgical procedures.( 9 
(#_edn9) )

Rising rates of antimicrobial resistance are also a serious concern for both
cardiac and spine surgery patients. The reported resistance rates for the
antibiotic commonly used for nasal decolonization, mupirocin, are as high as
81%.( 10  (#_edn10) ) SSIs involving resistant pathogens are associated with
significant increases in the length of hospitalization and costs.( 11 
(#_edn11) ) Unlike currently used topical antibiotics, Steriwave can eradicate
pathogens including extensively drug-resistant (XDR) bacteria, viruses
(including coronaviruses), and fungi such as Candida auris.( 12  (#_edn12) )

Ondine Biomedical's CEO Carolyn Cross said:

"We are very pleased to be working with the Montreal Heart Institute, an
innovation leader in cardiac research and care. Steriwave offers a powerful
alternative to traditional antibiotic-based nasal decolonization, which is
undermined by a narrow range of efficacy, antibiotic resistance, and patient
compliance issues. For patients, preventing a post-surgical infection can be
the difference between life and death. With its immediate, broad-spectrum
efficacy-including against extensively drug-resistant (XDR) bacteria, the
novel coronavirus, and the emerging fungal threat, Candida auris-without
generating resistance, we believe that pre-surgical use of Steriwave can
become the new standard of care for improved protection against serious
post-surgical multi-drug resistant infections."

Ondine's nasal photodisinfection is already in use in or under evaluation at
other major hospitals across Canada, including Vancouver General Hospital, The
Ottawa Hospital, and the Mazankowski Alberta Heart Institute.

 

**ENDS**

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

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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%.( 13 
(#_edn13) )

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 Montreal Heart Institute

An ultra-specialized hospital centre, the Montreal Heart Institute is
dedicated to care, research, teaching, prevention, rehabilitation, and the
assessment of new technologies in cardiology. Always on the cutting-edge, the
MHI is a leader in its field and plays a leading role in Quebec, Canada and
the world, and performs thousands of cardiac surgical procedures every year.
It is affiliated with Université de Montréal.

About the Hôpital Fleurimont du Centre Hospitalier Univesitaire de Sherbrooke

HÔPITAL FLEURIMONT is affiliated with the Centre de Recherche (CHUS),
University of Sherbrooke. The CHUS offers general, specialized and
sub-specialized medicine and is the teaching hospital in the administrative
regions of Estrie, Centre-du-Québec, and the eastern portion of
the Montérégie. With 6,244 employees, 649 doctors and pharmacists, and more
than 3,700 students, the CHUS is an academic and economic hub in southeastern
Quebec and is the second largest employer in the Estrie region. The HÔPITAL
FLEURIMONT performs between 500 and 600 spine surgeries a year (elective and
trauma).

 

 1  (#_ednref1) 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.

 2  (#_ednref2)
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)

 3  (#_ednref3) 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

 4  (#_ednref4)
https://www.dicardiology.com/article/rethinking-heart-surgery-surgical-site-infection-prevention
(https://www.dicardiology.com/article/rethinking-heart-surgery-surgical-site-infection-prevention)

 5  (#_ednref5) 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.

 6  (#_ednref6) Merkow RP, Ju MH, Chung JW, Hall BL, Cohen ME, Williams MV,
Tsai TC, Ko CY, Bilimoria KY. Underlying reasons associated with hospital
readmission following surgery in the United States. JAMA. 2015 Feb
3;313(5):483-95. doi: 10.1001/jama.2014.18614.

 7  (#_ednref7) Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, Fry DE,
Itani KM, Dellinger EP, Ko CY, Duane TM. American College of Surgeons and
Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J
Am Coll Surg. 2017 Jan;224(1):59-74.

 8  (#_ednref8) 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.

 9  (#_ednref9) 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

 10  (#_ednref10) 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

 11  (#_ednref11) Weigelt JA, Lipsky BA, Tabak YP, Derby KG, Kim M, Gupta V
(2010) Surgical site infections: causative pathogens and associated outcomes.
Am J Infect Control 38:112-120. https://doi.org/10.1016/j.ajic.2009.06.010
(https://doi.org/10.1016/j.ajic.2009.06.010)

 12  (#_ednref12) Ondine Biomedical Inc. (2023, September 14). Steriwave
proven highly effective against XDR bacteria [Press release].
https://www.londonstockexchange.com/news-article/OBI/steriwave-proven-effective-against-xdr-bacteria/16124940
(https://www.londonstockexchange.com/news-article/OBI/steriwave-proven-effective-against-xdr-bacteria/16124940)

 13  (#_ednref13) 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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