RCS - Ondine Biomedical - Steriwave use expanded following successful pilot

Ondine BiomedicalAnnouncement

31/10/2023 09:00

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RNS Number : 8585R  Ondine Biomedical Inc.  31 October 2023

31 October 2023

ONDINE BIOMEDICAL INC.

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

Steriwave use expanded following successful pilot

·    Alberta Health Services has expanded its use of Steriwave nasal
photodisinfection to reduce the incidence of surgical site infections (SSIs)
in orthopedic surgery following a successful pilot at the Mazankowski Alberta
Heart Institute.

·    SSIs, the most common of healthcare-associated infections (HAIs), are
a significant burden to healthcare systems as well as to patients, with the
estimated cost of a prosthetic hip or knee infection ranging from C$31,000 to
more than C$100,000. 1  (#_edn1)

Ondine Biomedical Inc (AIM: OBI), the Canadian life sciences company
developing non-antibiotic photodisinfection therapies to prevent and treat
healthcare-associated and drug-resistant infections announces that Alberta
Health Services has confirmed that it is expanding its use of Ondine's
Steriwave® nasal photodisinfection following early data from its pilot
introduction at the Mazankowski Alberta Heart Institute, which saw significant
reductions in surgical site infections following cardiac surgery. The Royal
Alexandra Hospital in Edmonton, Canada, will use Steriwave nasal
photodisinfection prior to its c. 3,000 orthopedic surgeries over the next
year.

Ondine has pioneered nasal photodisinfection as a rapid, non-antibiotic method
for decolonizing the nose of the pathogens carried by patients that can lead
to HAIs. Steriwave uses a proprietary red light-activated agent to eliminate
infection-causing bacteria, viruses, and fungi in the nose, a major reservoir
of germs 2  (#_edn2) , without causing resistance. At the Mazankowski Alberta
Heart Institute, Steriwave replaced the previous standard of care, the
antibiotic mupirocin. Mupirocin is commonly used for nasal decolonization to
prevent SSIs, but has poor rates of patient compliance and reported resistance
rates as high as 81%. 3  (#_edn3)

Ondine Biomedical's CEO Carolyn Cross said:

"We are very pleased to be collaborating with Alberta Health Services to
reduce the incidence of SSIs in Alberta without generating antibiotic
resistance. The successful initial implementation of Steriwave into the
pre-surgical treatment protocols at the Mazankowski Alberta Heart Institute
has driven rapid adoption of Steriwave for orthopedic surgeries at the Royal
Alexandra Hospital.

"The rising rate of antimicrobial resistance (AMR) makes it more important
than ever to have cost-effective, non-antibiotic methods for preventing HAIs.
Alongside growing global concerns about the consequences of AMR, we are seeing
more hospitals looking to move away from topical antibiotic nasal
decolonization. In addition to growing resistance, topical antibiotics require
patient compliance with twice daily treatments for five days to achieve
efficacy on a limited number of bacterial species as compared to five minutes
for photodisinfection to eradicate a broad spectrum of bacteria, viruses and
fungi just prior to surgery. Photodisinfection's rapid eradication of
potentially harmful pathogens gives healthcare professionals better control
over patient outcomes."

Rising rates of AMR are making infections more difficult to prevent and treat,
as some commonly used antibiotics are now ineffective. 4  (#_edn4) Many
hospitals are adapting their infection prevention protocols to combat
drug-resistant pathogens. As many as one in 19 deaths in Canada is now
attributable to antibiotic-resistant infections, 5  (#_edn5) and the cost of
AMR to the Canadian healthcare sector is also projected to increase to $7.6
billion per year by 2050.(( 6  (#_edn6) )) SSIs, the most common of HAIs, are
a big burden to healthcare systems as well as to patients, with the estimated
cost of a prosthetic hip or knee infection ranging from C$31,000 to more than
C$100,000. 7  (#_edn7)

Steriwave is already in use in major hospitals across Canada, including
Vancouver General and UBC Hospitals in BC, The Ottawa Hospital (Ontario),
Montreal Heart Institute, Sherbrooke Fleurimont (Quebec), and the Queen
Elizabeth II Health Sciences Centre (Nova Scotia). In 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, lower rates of antibiotic prescribing and
significant cost savings. 8  (#_edn8) (, 9  (#_edn9) , 10  (#_edn10) )

**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 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. 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). Nasal decolonization is
recommended in the 2016 WHO Global guidelines for the prevention of surgical
site infections, 11  (#_edn11) and the Society for Healthcare Epidemiology of
America (SHEA) guidelines, published in May 2023, recommend nasal
decolonization for major surgical procedures. 12  (#_edn12) 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 Alberta Health Services

Alberta Health Services (AHS) is proud to be part of Canada's first and
largest provincewide, integrated health system, responsible for delivering
health services to more than 4.4 million people living in Alberta, as well as
to some residents of Saskatchewan, B.C. and the Northwest Territories.

AHS has 106 acute care hospitals, five stand-alone psychiatric facilities,
8,523 acute care beds, 28,360 continuing care beds/spaces and 3,077 addiction
and mental health beds/spaces, plus equity partnership in 40 primary care
networks. Programs and services are offered at more than 900 facilities
throughout the province, including hospitals, clinics, continuing care
facilities, cancer centres, mental health facilities and community health
sites.

 1  (#_ednref1) Rennert-May ED, Conly J, Smith S, et al. The cost of managing
complex surgical site infections following primary hip and knee arthroplasty:
A population-based cohort study in Alberta, Canada. Infection Control &
Hospital Epidemiology. 2018;39(10):1183-1188. doi:10.1017/ice.2018.199

 2  (#_ednref2) Liu Z, Norman G, Iheozor-Ejiofor Z, Wong JK, Crosbie EJ,
Wilson P. Nasal decontamination for the prevention of surgical site infection
in Staphylococcus aureus carriers. Cochrane Database Syst Rev. 2017 May
18;5(5):CD012462. doi: 10.1002/14651858.CD012462.pub2. PMID: 28516472; PMCID:
PMC6481881.

 3  (#_ednref3) 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

 4  (#_ednref4) Poovelikunnel T, Gethin G, Humphreys H. Mupirocin resistance:
clinical implications and potential alternatives for the eradication of MRSA.
J Antimicrob Chemother. 2015 Oct;70(10):2681-92. doi: 10.1093/jac/dkv169. Epub
2015 Jul 3.

 5  (#_ednref5) Healthcare-associated infections and antimicrobial resistance
in Canadian acute care hospitals, CCDR 49(5) - Canada.ca

 6  (#_ednref6) Healthcare-associated infections and antimicrobial resistance
in Canadian acute care hospitals, CCDR 49(5) - Canada.ca

 7  (#_ednref7) Rennert-May ED, Conly J, Smith S, et al. The cost of managing
complex surgical site infections following primary hip and knee arthroplasty:
A population-based cohort study in Alberta, Canada. Infection Control &
Hospital Epidemiology. 2018;39(10):1183-1188. doi:10.1017/ice.2018.199

 8  (#_ednref8) 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.

 9  (#_ednref9)
https://www.londonstockexchange.com/news-article/OBI/ottawa-hospital-presents-steriwave-study-
results/15860312

 10  (#_ednref10) 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

 11  (#_ednref11)
https://cdn.who.int/media/docs/default-source/integrated-health-services-(ihs)/ssi/fact-sheet-staphylococcus-web.pdf?sfvrsn=7e7266ed_2

 12  (#_ednref12) 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

 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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