Photodisinfection recommended as Standard of Care

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" 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."

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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) 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®. 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.

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[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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