TIDMOBI
RNS Number : 6789T
Ondine Biomedical Inc.
16 November 2023
16 November 2023
ONDINE BIOMEDICAL INC.
("Ondine Biomedical", "Ondine" or the "Company")
Photodisinfection recommended as Standard of Care
Peer-reviewed publication involving 13,493 patients reports
66.5% decrease in spine surgery infection rate sustained over 8
years with the use of Steriwave (R) nasal photodisinfection
Canadian life sciences company, Ondine Biomedical Inc. (OBI:
LON), reports that an independent, peer-reviewed research paper,
"Effectiveness of prophylactic intranasal photodynamic disinfection
therapy and chlorhexidine gluconate body wipes for surgical site
infection prophylaxis in adult spine surgery" from Vancouver
General Hospital ("VGH") has been published in the Canadian Journal
of Surgery. The study spanned an eight-year period and involved
13,493 patients with 8823 patients receiving Steriwave (R) . The
paper concludes that nasal photodisinfection should be the standard
of care for all patients undergoing emergent or elective spine
surgeries.
The eight-year study showed a 66.5% reduction (7.98% vs 2.67%,
p<0.001) in surgical site infections (SSIs) following spine
surgery when Ondine's Steriwave nasal photodisinfection (nPDT) was
implemented in the universal pre-surgical infection prevention
protocol. The study also found that the hospital saved $19.9
million net over the study period (2011 to 2019), an average net
annual cost saving of $2.49 million.
The research was conducted by the Vancouver General Hospital
spine group, led by Professor John Street. Professor Street is the
Director of the Integrated Ambulatory Spine program at VGH, one of
Canada's largest referral centres for complex spinal trauma and
spine disorder cases. Professor Street is the creator of the SAVES
quality improvement programme (Spine Adverse Events System). The
SAVES programme has more than 100 peer-reviewed publications and
has received numerous national and international awards.
The study's authors concluded that:
"Preoperative bundled nPDT-CHG is a clinically effective
strategy for reducing the incidence of SSIs after emergent or
elective spine surgery. It is an affordable intervention and is
associated with significant institutional savings for every SSI
prevented in this high-risk population. Given its rapid action,
minimal risk of antimicrobial resistance, broad-spectrum activity,
and high compliance rate, preoperative bundled nPDT-CHG
decolonization should be the standard of care for all patients
undergoing emergent or elective spine surgery."
Ondine Biomedical CEO Carolyn Cross said:
"With our this simple, 5-minute, painless intervention our
Steriwave treatment makes a life-saving impact - in this case, 468
spine surgery patients saved from potentially lethal infections -
more than enough to fill a 747 plane. We are truly grateful to
Professor Street and the research staff at VGH for their pursuit of
better patient outcomes. Postoperative spine infection can be a
devastating and expensive complication after spine surgery, with
patients at high risk for chronic pain, paralysis, return to the
operating room, poor long-term outcomes, and even death. This study
conclusively demonstrates that Steriwave is setting a new standard
for safety and performance in infection control."
****
Ondine Biomedical Inc.
+001 (604) 665
Carolyn Cross, CEO 0555
Singer Capital Markets (Nominated Adviser
and Joint Broker)
+44 (0)20 7496
Aubrey Powell, Asha Chotai, Sam Butcher 3000
RBC Capital Markets (Joint Broker)
+44 (0)20 7653
Rupert Walford, Kathryn Deegan 4000
Vane Percy & Roberts (Media Contact)
+44 (0)77 1000
Simon Vane Percy, Amanda Bernard 5910
About Surgical Site Infections
Surgical site infections are serious complications that can
occur following surgery, and SSIs following spine surgery can
affect up to 18% of patients who may then require long, complex and
costly treatment .([1]) 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).([2]) However, the topical antibiotic typically used
for nasal decolonization before surgery, mupirocin, has shown
antimicrobial resistance rates as high as 81%.([3]) SSIs involving
drug-resistant pathogens are associated with significantly
increased length of hospitalization and costs.([4])
About Ondine Biomedical Inc.
Ondine Biomedical Inc. is a Canadian life science company
pioneering 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 using 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 a localized oxidative burst
that is lethal to pathogens. In this single short treatment,
Steriwave eliminates infection-causing bacteria, viruses, and fungi
in the nose - a major reservoir of pathogens associated with
hospital-acquired infections.([5]) The speed of application and
sustained decolonization potential is of great importance in
enhancing hospital workflows.
Pre-operative nasal decolonization has been found to
significantly decrease SSIs caused by the infection-causing
pathogen Staphylococcus aureus.([6]) The Society for Healthcare
Epidemiology of America (SHEA) recently updated guidelines to
elevate nasal decolonization from a recommended practice to an
essential requirement for orthopaedic (including spine) and
cardiothoracic surgical procedures.([7])
According to the Centers for Disease Control and Prevention
(CDC) and the World Health Organization (WHO) , rising rates of
antimicrobial resistance are of serious worldwide concern. The
reported resistance rates for the antibiotic commonly used for
nasal decolonization, mupirocin, are as high as 81%.([8]) SSIs
involving resistant pathogens are associated with significant
increases in the length of hospitalization and costs.([9]) Unlike
currently used topical antibiotics, Steriwave relies on
multi-target mechanisms of action that can eradicate pathogens
including extensively drug-resistant (XDR) bacteria, viruses
(including coronaviruses such as SARS-CoV-2), and fungi such as
Candida auris.([10])
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(R). 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.
[1] 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] 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
[3] 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] 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] 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.
[6] 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 .
[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
[8] 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
[9] 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
[10] 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
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