21 September 2023
ONDINE BIOMEDICAL INC.
("Ondine Biomedical", "Ondine" or the "Company")
Montreal Heart Institute pilots Steriwave
· The world-renowned Montreal Heart Institute and Hôpital Fleurimont, University of Sherbrooke (CHUS) in Sherbrooke, Quebec are piloting nasal photodisinfection to prevent post-operative infections in an era of rising antibiotic resistance.
· 2022 SHEA guidelines elevated nasal decolonization to an essential practice for orthopedic and cardiothoracic surgical procedures.
· The topical antibiotic commonly used for nasal decolonization has bacterial resistance rates reported as high as 81%.
Two of Quebec's leading hospitals, Montreal Heart Institute (MHI), Canada's largest cardiology research centre, and the Hôpital Fleurimont, affiliated with the Centre de Recherche (CHUS), University of Sherbrooke, are piloting Ondine's proprietary Steriwave® nasal photodisinfection in an effort to stay ahead of increasing antibiotic resistance. MHI is evaluating patient outcomes in elective cardiac surgical procedures and Hôpital Fleurimont is evaluating outcomes in elective spine surgeries.
The Steriwave nasal photodisinfection treatment, developed by Canadian life sciences company Ondine Biomedical Inc. (LON: OBI), uniquely kills all types of pathogens - viruses, bacteria, and fungi - in minutes without causing resistance. Pre-surgical use of Steriwave in hospital settings has resulted in significant improvement in post-surgical outcomes including lower rates of surgical site infections (SSIs), reduced patient length of stay, fewer readmissions, and lower rates of antibiotic prescribing.[1],[2],[3]
Surgical site infections (SSIs) are serious complications that can occur following surgery and made worse by the growing resistance to antibiotics. Certain types of infection, such as deep sternal infections, can be a serious threat, increasing a patient's mortality risk by 40% as surgeons have to reopen the sternum to prevent the infection from spreading to internal organs.[4] Cardiac SSIs are strongly associated with poorer prognosis, longer hospitalization, higher medical costs, and high mortality.[5] Post-surgical infections are also a greater risk for spinal surgeries, affecting up to 17% of patients and treatment can be particularly challenging. [6],[7]
Universal pre-operative nasal decolonization has been found to significantly decrease SSIs caused by the infection-causing pathogen S. aureus.[8] The Society for Healthcare Epidemiology of America (SHEA) updated guidelines elevate nasal decolonization from a recommended practice to essential for orthopedic (including spine) and cardiothoracic surgical procedures.[9]
Rising rates of antimicrobial resistance are also a serious concern for both cardiac and spine surgery patients. The reported resistance rates for the antibiotic commonly used for nasal decolonization, mupirocin, are as high as 81%.[10] SSIs involving resistant pathogens are associated with significant increases in the length of hospitalization and costs.[11] Unlike currently used topical antibiotics, Steriwave can eradicate pathogens including extensively drug-resistant (XDR) bacteria, viruses (including coronaviruses), and fungi such as Candida auris.[12]
Ondine Biomedical's CEO Carolyn Cross said:
"We are very pleased to be working with the Montreal Heart Institute, an innovation leader in cardiac research and care. Steriwave offers a powerful alternative to traditional antibiotic-based nasal decolonization, which is undermined by a narrow range of efficacy, antibiotic resistance, and patient compliance issues. For patients, preventing a post-surgical infection can be the difference between life and death. With its immediate, broad-spectrum efficacy-including against extensively drug-resistant (XDR) bacteria, the novel coronavirus, and the emerging fungal threat, Candida auris-without generating resistance, we believe that pre-surgical use of Steriwave can become the new standard of care for improved protection against serious post-surgical multi-drug resistant infections."
Ondine's nasal photodisinfection is already in use in or under evaluation at other major hospitals across Canada, including Vancouver General Hospital, The Ottawa Hospital, and the Mazankowski Alberta Heart Institute.
**ENDS**
| Ondine Biomedical Inc. |
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| Carolyn Cross, CEO | +001 (604) 665 0555 |
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| Singer Capital Markets (Nominated Adviser and Joint Broker) |
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| Aubrey Powell, Asha Chotai, Sam Butcher | +44 (0)20 7496 3000 |
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| RBC Capital Markets (Joint Broker) |
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| Rupert Walford, Kathryn Deegan | +44 (0)20 7653 4000 |
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| 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 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 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). 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]
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 Montreal Heart Institute
An ultra-specialized hospital centre, the Montreal Heart Institute is dedicated to care, research, teaching, prevention, rehabilitation, and the assessment of new technologies in cardiology. Always on the cutting-edge, the MHI is a leader in its field and plays a leading role in Quebec, Canada and the world, and performs thousands of cardiac surgical procedures every year. It is affiliated with Université de Montréal.
About the Hôpital Fleurimont du Centre Hospitalier Univesitaire de Sherbrooke
HÔPITAL FLEURIMONT is affiliated with the Centre de Recherche (CHUS), University of Sherbrooke. The CHUS offers general, specialized and sub-specialized medicine and is the teaching hospital in the administrative regions of Estrie, Centre-du-Québec, and the eastern portion of the Montérégie. With 6,244 employees, 649 doctors and pharmacists, and more than 3,700 students, the CHUS is an academic and economic hub in southeastern Quebec and is the second largest employer in the Estrie region. The HÔPITAL FLEURIMONT performs between 500 and 600 spine surgeries a year (elective and trauma).
[1] 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.
[2] https://www.londonstockexchange.com/news-article/OBI/ottawa-hospital-presents-steriwave-study- results/15860312
[3] 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
[4] https://www.dicardiology.com/article/rethinking-heart-surgery-surgical-site-infection-prevention
[5] Zukowska A, Zukowski M. Surgical Site Infection in Cardiac Surgery. J Clin Med. 2022 Nov 26;11(23):6991. doi: 10.3390/jcm11236991. PMID: 36498567; PMCID: PMC9738257.
[6] Merkow RP, Ju MH, Chung JW, Hall BL, Cohen ME, Williams MV, Tsai TC, Ko CY, Bilimoria KY. Underlying reasons associated with hospital readmission following surgery in the United States. JAMA. 2015 Feb 3;313(5):483-95. doi: 10.1001/jama.2014.18614.
[7] Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, Fry DE, Itani KM, Dellinger EP, Ko CY, Duane TM. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2017 Jan;224(1):59-74.
[8] 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.
[9] 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
[10] 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
[11] 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
[12] 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
[13] 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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