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RCS - Ondine Biomedical - 32% Fewer SSIs After Steriwave Replaced Mupirocin

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RNS Number : 5332K  Ondine Biomedical Inc.  15 April 2024

Non-regulatory announcement

ONDINE BIOMEDICAL INC.

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

32% Fewer SSIs After Steriwave Replaced Mupirocin

New data shows reduced cardiac infections and significant cost savings after
the light-activated antimicrobial, Steriwave, replaced the antibiotic standard
of care at the Mazankowski Alberta Heart Institute

Ondine Biomedical Inc. (LON: OBI), the Canadian life sciences company
pioneering light-activated antimicrobial treatments, announces that an
independent study undertaken at the world renowned Mazankowski Alberta Heart
Institute demonstrated a 32% reduction in cardiac surgical site infections
(SSIs) following the implementation of Steriwave as a replacement for the
antibiotic Mupirocin. Researchers from the University of Alberta presented
this data in a poster at the AMMI Canada-CACMID annual conference
(https://ammi-cacmidconference.ca/) , a major conference on clinical
microbiology and infectious diseases.

In June 2023, Steriwave was implemented on a pilot basis as a replacement for
the antibiotic Mupirocin, which has resistance rates as high as 81% and is
used by many hospitals as the standard of care for the prevention of
SSIs.( 1 ) The average SSI rate prior to the implementation of Steriwave was
1.67 per 100 surgeries, and the final rate following the implementation of
Steriwave was 0.7 per 100 surgeries. The researchers estimated that this
reduction in SSIs represented a $56,000 cost saving during the quarter. The
compliance rate for Steriwave was 94%, and treatment was well-tolerated with
no adverse reactions reported.

Lead author Dr. Stephanie Smith, Director of Hospital Infection Prevention and
Control at the University of Alberta Hospital and the Mazankowski Alberta
Heart Institute, commented: "We are very pleased to be able to share these
initial results from the Steriwave pilot.  To see a reduction in SSIs in
excess of the already low rate we had when using Mupirocin is fantastic,
particularly as many hospitals are looking to reduce their use of Mupirocin
because of challenges with compliance and concerns about antibiotic
resistance."

SSIs are one of the most significant complications in cardiac surgery patients
and are strongly associated with poorer prognosis. SSIs can complicate up to
27% of cardiac surgery procedures( 2 ) and result in substantially higher
costs because of the need for additional treatments and extended patient
recovery time. Nasal decolonization has been found to significantly decrease
SSIs caused by the infection-causing pathogen S. aureus following cardiac
procedures.( 3 )

Steriwave is a broad-spectrum light-activated antimicrobial that uses a
patented photosensitizer and associated red activating light to destroy
pathogens in the nose. The nose is a major reservoir of bacteria, fungi and
viruses which can spread and cause serious infections. Unlike traditional
antibiotics, Steriwave is immediately effective with a single five-minute
treatment and does not trigger antimicrobial resistance (AMR).

Mupirocin, as well as having high resistance rates, tends to have a low
compliance rate less than 40%, as patients need to self-administer in the five
days leading up to their surgery. Both these factors led to Alberta Health
Services' previously announced decision to expand its use of Steriwave.
(https://www.londonstockexchange.com/news-article/OBI/steriwave-use-expanded-following-successful-pilot/16189436)

About the pilot:

The Mazankowski Alberta Heart Institute pilot commenced in June 2023. Between
June 2023 and February 2024, Steriwave was used to nasally decolonize 828
patients prior to cardiac surgery. The Steriwave compliance rate was 94%, and
it was well-tolerated with no adverse reactions reported. The results
presented at the AMMI Canada-CACMID annual conference were based on data
including the first three months of the pilot.

**ENDS**

Enquiries:

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

 Singer Capital Markets (Nominated Adviser and Joint Broker)
 Aubrey Powell, Sam Butcher                                   +44 (0)20 7496 3000

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

 Vane Percy & Roberts (Media Contact)
 Simon Vane Percy, Amanda Bernard                             +44 (0)77 1000 5910

 

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, our team of
highly skilled cardiologists, cardiovascular surgeons, cardiac care
professionals, researchers and educators are advancing the prevention,
detection, treatment and study of cardiovascular disease.

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian life science company and a world leader
in the development and clinical use of light-activated antimicrobial therapies
(also known as 'photodisinfection'). Based on its proprietary light-activated
technology, Ondine has a pipeline of investigational products in various
stages of development.

Ondine's nasal decolonisation light-activated technology has a CE mark in
Europe and the UK-CA mark, 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. Light-activated
antimicrobial products in development include therapies for a variety of
medical indications such as chronic sinusitis, ventilator-associated
pneumonia, burns, and other indications.

About Steriwave®

Ondine's Steriwave is a patented technology using a proprietary
light-activated antimicrobial (photosensitizer) to destroy bacteria, viruses,
and fungi colonizing the nose - a major reservoir of pathogens. The 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 red light for less than five minutes. The light activates the
photosensitizer, causing an oxidative burst that is lethal to all types of
pathogens without causing long-term adverse effects on the nasal microbiome. A
key benefit of this approach, unlike with antibiotics which have resistance
rates reported as high as 81%,(1) is that pathogens do not develop resistance
to the therapy.

Nasal decolonization is recommended in the 2016 WHO Global guidelines for the
prevention of surgical site infections,( 4 ) and the Society for Healthcare
Epidemiology of America (SHEA) guidelines, published in May 2023, recommend
nasal decolonisation for major surgical procedures.( 5 )

 1  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

 2  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.

 3  Lemaignen A, Armand-Lefevre L, Birgand G, Mabileau G, Lolom I, Ghodbane W,
Dilly MP, Nataf P, Lucet JC. Thirteen-year experience with universal
Staphylococcus aureus nasal decolonization prior to cardiac surgery: a
quasi-experimental study. J Hosp Infect. 2018 Nov;100(3):322-328. doi:
10.1016/j.jhin.2018.04.023. Epub 2018 May 5.

 4 
https://cdn.who.int/media/docs/default-source/integrated-health-services-(ihs)/ssi/fact-sheet-staphylococcus-web.pdf?sfvrsn=7e7266ed_2

 5  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

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