Ondine Biomedical Inc Announces C$4.91 Raise Supports Ongoing Commercialisation

Successful C$4.91 raise supports ongoing commercialisation

· Ondine met its 2023 target and more than doubled the number of hospitals using its groundbreaking photodisinfection technology to reduce healthcare-associated infections (HAIs)

· According to the NIH, HAIs affect more than 2 million patients a year in the US, leading to over 90,000 deaths and incurring costs exceeding $30 billion a year.^[1]

VANCOUVER, BC / ACCESSWIRE / December 13, 2023 / Following its successful fundraising of C$4.91 million (US$3.62), Canadian life sciences company Ondine Biomedical Inc. (AIM:OBI) will continue accelerating commercialisation of its proven nasal photodisinfection technology. This cutting-edge technology replaces topical antibiotics for the prevention of healthcare-associated infections (HAIs) and kills all types of pathogens - bacteria, viruses and fungi - without causing antimicrobial resistance.

The Company has confirmed that it has more than doubled the number of Steriwave® deployments in 2023 and is in discussions with more than 75 hospitals in the UK, Mexico, Spain, and Canada. The growing global emphasis on preventing HAIs post-surgery, coupled with the escalating challenge of antimicrobial resistance, has spurred heightened interest in Ondine's photodisinfection technology.

The deployments are in areas of major surgery, including spinal, orthopedic, and cardiovascular. The antibiotic mupirocin has been used for nasal decolonization for the prevention of HAIs since the 1980s. However, mupirocin has resistance rates of up to 81%,^[2] and very poor compliance.^[3]

Carolyn Cross, CEO of Ondine, commented, "We have put great efforts into improving our commercial activity sales process, which has increased the speed of the average sales cycle from contact to deployment by 50%. We have appointed distributors in the UK, Spain, and Mexico and are gaining real momentum. What is particularly encouraging is that many hospitals are recommending Steriwave to other hospitals. We believe this momentum will continue to increase, and commercial sales will become more significant in 2024."

The five-minute Steriwave nasal decolonization procedure is seamlessly integrated into preoperative protocols, receiving positive feedback from patients for its simplicity and comfort. There have been no reports of serious side effects as a result of Steriwave usage. Steriwave has been used by more than 150,000 patients, including at Vancouver General Hospital where its use has been associated with a significant reduction in HAIs across major surgeries.^[4],[5]

As well as growing its commercial activities, the Company continues to work closely with HCA - the largest hospital group in the United States - to prepare for the Phase 3 trial in circa 14 HCA hospitals as part of its Ondine's submission to the FDA for approval. The Company already has approval for Steriwave in Canada, the UK, the EU, and Mexico.

Implementing nasal decolonization prior to major surgery to reduce HAIs is recommended by leading medical bodies, including the World Health Organization,^[6] the Society for Healthcare Epidemiology of America (SHEA),^[7] and NICE.^[8] The nose is the major reservoir of pathogens and the majority of surgical site infections (SSIs) and bloodstream infections have been traced back to bacteria in the patient's nose.^[9] A patient with a surgical site infection (SSI) will, on average, spend 7 to 11 days longer in the hospital, significantly increasing costs and lengthening patients' recovery.^[10]

While currently focusing on nasal decolonization, Ondine's proprietary photodisinfection technology holds promise for broader applications in preventing and treating various topical infections.

Enquiries:

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 healthcare-associated infections.^[11] The speed of application and broad-spectrum efficacy 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.^[12] 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.⁶

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%.² SSIs involving resistant pathogens are associated with significant increases in the length of hospitalization and costs.^[13] Unlike currently used topical antibiotics, Steriwave can eradicate pathogens including extensively drug-resistant (XDR) bacteria, viruses (including coronaviruses such as SARS-CoV-2), and fungi such as Candida auris.^[14]

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] Stone PW. Economic burden of healthcare-associated infections: an American perspective. Expert Rev Pharmacoecon Outcomes Res. 2009 Oct;9(5):417-22. doi: 10.1586/erp.09.53. PMID: 19817525; PMCID: PMC2827870.

^[2] 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

^[3] Hansen D, Patzke PI, Werfel U, Benner D, Brauksiepe A, Popp W. Success of MRSA eradication in hospital routine: depends on compliance. Infection. 2007 Jun;35(4):260-4. doi: 10.1007/s15010-007-6273-y. Epub 2007 Jul 23. PMID: 17646910.

^[4] Bryce E, Wong T, Forrester L, Masri B, Jeske D, Barr K, Errico S, Roscoe D. Nasal photodisinfection and chlorhexidine wipes decrease surgical site infections: a historical control study and propensity analysis. J Hosp Infect. 2014 Oct;88(2):89-95. doi: 10.1016/j.jhin.2014.06.017. Epub 2014 Aug 1. Erratum in: J Hosp Infect. 2015 Sep;91(1):93. PMID: 25171975.

^[5] Moskven E, Banaszek D, Sayre E, Gara A, Bryce E, Wong T, Ailon T, Charest-Morin R, Dea N., Dvorak M, Fisher C, Kwon B, Paquette S, Street J. Effectiveness of prophylactic intranasal photodynamic disinfection therapy and chlorhexidine gluconate body wipes for surgical site infection prophylaxis in adult spine surgery. Can J Surg. 2023 Nov;66(6), E550-E560. https://doi.org/10.1503/cjs.016922

^[6] World Health Organization. Global Guidelines for the Prevention of Surgical Site Infection. World Health Organization; 2016. Available at: https://www.who.int/publications/i/item/9789241550475. Accessed December 12, 2023.

^[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] National Institute for Health and Care Excellence (NICE). NICE Surgical Site Infections: Prevention and Treatment. NICE; 2019. Available at: https://www.nice.org.uk/guidance/ng125. Accessed December 12, 2023.

^[9] von Eiff C, Becker K, Machka K, Stammer H, Peters G. Nasal carriage as a source of Staphylococcus aureus bacteremia. Study Group. N Engl J Med. 2001 Jan 4;344(1):11-6. doi: 10.1056/NEJM200101043440102. PMID: 11136954.

^[10] Seidelman JL, Mantyh CR, Anderson DJ. Surgical Site Infection Prevention: A Review. JAMA. 2023;329(3):244-252. doi:10.1001/jama.2022.24075

^[11] 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.

^[12] 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.

^[13] 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

^[14] 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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SOURCE: Ondine Biomedical Inc