REG - Ondine Biomedical - Photodisinfection recommended as Standard of Care

Ondine BiomedicalAnnouncement

16/11/2023 07:00

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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® 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" (https://www.canjsurg.ca/content/66/6/E550) 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®. 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."

**END**

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

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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)
(https://www.cdc.gov/drugresistance/biggest-threats.html) and the World Health
Organization (WHO)
(https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed)
, 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®.
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
(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
(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
(https://www.londonstockexchange.com/news-article/OBI/steriwave-proven-effective-against-xdr-bacteria/16124940)

 

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