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RCS - Ondine Biomedical - New study confirms nose is key source of infection

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RNS Number : 8356L  Ondine Biomedical Inc.  25 April 2024

Non-regulatory announcement

ONDINE BIOMEDICAL INC.

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

New study confirms nose is key source of infection

Findings include 86% of surgical site infections ("SSIs") caused by bacteria
from the patients' own nose, skin, or gut and nearly 60% of infections are
resistant to antibiotics

Ondine Biomedical Inc. (LON: OBI), the Canadian life sciences company
pioneering light-activated antimicrobial treatments, announces new independent
research published in the journal Science Translational Medicine showing that
86% of surgical site infections (SSIs)(!) after spinal surgery are caused by
bacteria from the patient's own nose, skin, or gut. The study, "Contribution
of the patient microbiome to surgical site infection and antibiotic
prophylaxis failure in spine surgery
(https://www.science.org/doi/10.1126/scitranslmed.adk8222) ", was undertaken
by researchers from the University of Washington School of Medicine in Seattle
and reinforces the findings of previous studies that have shown that nasal and
skin decolonization result in significantly lower rates of SSIs
(https://www.canjsurg.ca/content/66/6/E550) .

Over a 12-month period, the University of Washington researchers sampled
bacteria living in the nose, skin and stool of over 200 patients prior to
spine surgery. There was then a follow-up at 90 days to compare those samples
with any post-surgical infections that occurred. The study showed that 86% of
the bacteria causing infections after spine surgery were genetically matched
to bacteria the patient carried before surgery. Researchers also discovered
that bacteria colonizing the upper back around the neck and shoulders are more
similar to those found in the nose, and those normally colonizing the lower
back are more similar to those found in the gut and stool.

Another key finding of the study was that 59% of infections were resistant to
the antibiotic used to prevent surgical site infections (SSIs), the antiseptic
used to clean the skin before surgery, or both. Rising rates of resistant
bacteria pose a fundamental threat to the safety of all types of surgery.
There were an estimated 1.27 million deaths attributable to bacterial
antimicrobial resistance (AMR) in 2019, and the two pathogens associated with
the most AMR-related deaths - Escherichia coli and Staphylococcus aureus - are
also the cause of most post-operative infections.( 1 )

SSIs are serious complications that can occur following surgery, and are the
most common type of healthcare-associated infection (HAI). Spine SSIs can
affect up to 18% of patients who then require long, complex and costly
treatment.( 2 ) Nasal decolonization is now deemed an essential practice prior
to major surgeries, including spine and cardiac surgery, by the Society for
Healthcare Epidemiology of America (SHEA).( 3 ) SSIs involving drug-resistant
pathogens are associated with significantly increased length of
hospitalization and costs.( 4 )

Lead authors Dustin Long, Assistant Professor of Anesthesiology, School of
Medicine, University of Washington and Chloe Bryson-Cahn, Associate Professor
of Allergy and Infectious Diseases, School of Medicine, University of
Washington, commented: "Surgical site infections occur following about one in
30 procedures, typically with no explanation. While rates of many other
medical complications have shown steady improvement over time, data from the
Agency for Healthcare Research and Quality and the Centers for Disease Control
and Prevention show that the problem of surgical site infection is not getting
better."

The University of Washington research demonstrates the benefits of focusing on
novel solutions for nasal decolonization like Ondine Biomedical's
light-activated antimicrobial, Steriwave®. Unlike traditional antibiotics,
Steriwave is immediately effective with a single five-minute treatment and
does not trigger antimicrobial resistance (AMR), making it an excellent
alternative to the traditional antibiotics that many healthcare facilities use
to prevent HAIs.

**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 Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian life sciences company and leader
innovating 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 the UK 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 many other
indications.

About Steriwave®

Ondine's Steriwave® nasal photodisinfection system is a patented technology
using a proprietary light-activated antimicrobial (photosensitizer) to destroy
bacteria, viruses, and fungi colonizing the nose. 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 red laser 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%( 5 )-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,( 6 ) and the Society for Healthcare
Epidemiology of America (SHEA) guidelines, published in May 2023, recommend
nasal decolonization for major surgical procedures.( 7 )

 1  Murray CJ, Ikuta KS, Sharara F, Swetschinski L, Robles Aguilar G, Gray A
et al.  Global burden of bacterial antimicrobial resistance in 2019: a
systematic analysis. Lancet 2022;399:629-655.

 2  Chahoud J, Kanafani Z, Kanj SS. Surgical site infections following spine
surgery: eliminating the controversies in the diagnosis. Front Med (Lausanne).
2014 Mar 24;1:7. doi: 10.3389/fmed.2014.00007.

 3  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

 4  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

 5  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

 6 
https://cdn.who.int/media/docs/default-source/integrated-health-services-(ihs)/ssi/fact-sheet-staphylococcus-web.pdf?sfvrsn=7e7266ed_2

 7  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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