RCS - Ondine Biomedical - 66.5% reduction in spine surgery infection rate

Ondine BiomedicalAnnouncement

23/10/2023 07:15

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RNS Number : 9232Q  Ondine Biomedical Inc.  23 October 2023

23 October 2023

ONDINE BIOMEDICAL INC.

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

66.5% reduction in spine surgery infection rate

Pre-surgical Steriwave® nasal photodisinfection protocol contributed to 66.5%
reduction in spine surgery infection rates and $2.5 million annual savings in
Vancouver General Hospital

Canadian life sciences company, Ondine Biomedical Inc. (OBI: LON), reports new
independent research findings from Vancouver General Hospital which were
presented at the IP2023 conference in Liverpool, England.

·    Canada's British Columbia-based hospitals, Vancouver General &
University of British Columbia (UBC) Hospitals, pioneered the universal
pre-surgical nasal photodisinfection and chlorhexidine gluconate (CHG) wipes
protocol and were the first hospitals to adopt this approach as a standard of
care, reducing post-surgical infection rates without generating resistance.

·    66.5% reduction in surgical site infection rate in spine patients
(7.98% vs 2.67%, p<0.001) despite rising anti-microbial resistance.

·    $19.9 million net cost savings over the 8-year study period between
2011 and 2019 from reduced infection rates.

·    Demonstration of long-term safety - no complications or adverse
events specific to the administration of nasal photodisinfection.

With the inclusion of Steriwave nasal photodisinfection in its presurgical
quality improvement protocols, researchers at Vancouver General Hospital (VGH)
were able to demonstrate a 66.5% reduction in its surgical site infection
(SSI) rate in spine surgery patients.  The VGH spine group, led by Dr. John
Street, presented its research findings showing a significant and sustained
reduction of surgical site infections (SSIs) in spine surgery patients using
this universal pre-surgical protocol.

In collaboration with UBC Hospital, the new decolonization protocol pioneered
by the Vancouver Coastal Health Infection Control team included Steriwave
nasal photodisinfection alongside skin cleansing with chlorhexidine gluconate
(CHG) wipes to prevent SSIs in patients undergoing major surgeries. As one of
Canada's largest tertiary hospitals, the VGH spine group also estimated that
the prevented SSIs over the 8-year study period between 2011-2019 resulted in
institutional cost savings of $19.9 million, a net annual cost saving of $2.49
million.

The poster, presented by Dr. Eryck Moskven, concludes that the universal
presurgical protocol involving nasal photodisinfection and CHG skin
decolonization "is a simple, safe, and clinically effective preventative
strategy for reducing the incidence of SSI following emergent or elective
spine surgery." Moreover, no performance impact from resistance generation was
observed during the study period.

Surgical site infections are serious complications that can occur following
surgery. Spine SSIs can affect up to 18% of patients who then require long,
complex and costly treatment.( 1  (#_edn1) )

The full poster is available for viewing here
(https://ondinebio.com/wp-content/uploads/2023/10/IPS2023-VCH-poster-Effectiveness-of-Prophylactic-Intranasal-Photodynamic-Disinfection-scaled.jpg)
.

**END**

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

 Singer Capital Markets (Nominated Adviser and Joint Broker)
 Aubrey Powell, Asha Chotai, 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 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 Steriwave Nasal Photodisinfection

Nasal photodisinfection is a non-antibiotic method for nasal decolonization
that uses a proprietary light-activated agent (photosensitizer) to destroy
pathogens in minutes without causing resistance. 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 pathogens. In this single, 5-minute treatment, Steriwave eliminates
infection-causing bacteria, viruses, and fungi in the nose - a major reservoir
of pathogens.( 2  (#_edn2) )

Pre-operative nasal decolonization has been found to significantly decrease
SSIs caused by the infection-causing pathogen S. aureus.( 3  (#_edn3) ) The
Society for Healthcare Epidemiology of America (SHEA) updated guidelines to
elevate nasal decolonization from a recommended practice to essential for
orthopaedic (including spine) and cardiothoracic surgical procedures.( 4 
(#_edn4) )

Rising rates of antimicrobial resistance are a serious concern: the reported
resistance rates for the antibiotic commonly used for nasal decolonization,
mupirocin, are as high as 81%.( 5  (#_edn5) ) SSIs involving resistant
pathogens are associated with significant increases in the length of
hospitalization and costs.( 6  (#_edn6) ) Unlike currently used topical
antibiotics, Steriwave can eradicate pathogens including extensively
drug-resistant (XDR) bacteria, viruses (including coronaviruses), and fungi
such as Candida auris.( 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 Photodisinfection Protocol used at Vancouver Coastal Health:

Photodisinfection-based nasal decolonization therapy was first introduced at
Vancouver Coastal Health for universal pre-surgical decolonization to reduce
surgical site infections. In 2011, Dr. Elizabeth Bryce, Regional Medical
Director for Infection Control at Vancouver Coastal Health Acute, led a
multidisciplinary team involving the Division of Medical Microbiology and
Infection Prevention, the Department of Orthopaedics and the Peri-operative
Care groups at Vancouver General Hospital and University of British
Columbia Hospital. The original Vancouver Coastal Health decolonization team
included:

·      Surgery: Bas Masri; Gary Redekop

·      Perioperative Services: Debbie Jeske; Claire Johnston; Kelly
Barr; Shelly Errico; Anna- Marie MacDonald; Tammy Thandi; Lorraine
Haas; Pauline Goundar; Lucia Allocca; Dawn Breedveld; Steve Kabanuk

·      Infection Control: Elizabeth Bryce; Chandi Panditha; Leslie
Forrester; Diane Louke; Tracey Woznow

·      Medical Microbiology: Diane Roscoe; Titus Wong

·      Patient Safety: Linda Dempster

·      Quality Assurance, Training: Shelagh Weatherill

Having demonstrated significant patient safety outcomes and cost savings with
the first ever deployment of universal nasal Photodisinfection, the VCH team
received the 2013 Innovation Award of Excellence from the International
Conference for Prevention and Infection Control (ICPIC), which is endorsed by
the World Health Organization.

 

 1  (#_ednref1) 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.

 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) 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.

 4  (#_ednref4) 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

 5  (#_ednref5) 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  (#_ednref6) 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)

 7  (#_ednref7) 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)

 

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