12 December 2022

Ondine Biomedical Inc.

("Ondine Biomedical", "Ondine" or the "Company")

Steriwave receives regulatory approval in Mexico

Photodisinfection kills all types of pathogens, including viruses, bacteria and fungi without using antibiotics

Ondine Biomedical Inc. (LON:OBI): Mexico's Health Authority (COFEPRIS) has approved the sale and use of Ondine Biomedical's Steriwave™ photodisinfection technology, which eliminates nasal pathogens that can cause healthcare-associated infections (HAIs).   

The large and growing Mexican healthcare market is of strategic interest to Ondine. Mexico's healthcare system provides coverage to its 129 million citizens through a combination of public and private entities. The private hospitals and medical facilities serve a large domestic market, together with up to 1 million foreign medical tourists a year-a market estimated to be worth US$6.75 billion in 2021.[1]

Carolyn Cross, CEO of Ondine Biomedical, said:

"With significant global backlogs and high costs of various types of medical procedures, medical tourism is likely to be on the rise over the coming years, as foreign medical tourists seek state of the art medical services at affordable prices. The Mexican healthcare market is of strategic interest to our company and is of personal interest to me. I am thrilled to bring our technology to this important market and to help Mexican healthcare professionals better protect patients from the growing antimicrobial resistance threat.

"The great advantage of our photodisinfection therapy is that it not only spares patients the trauma of an infection, but it can also reduce patient waiting lists by reducing hospital readmissions rates and decreasing the average length of stay in hospital."

Ondine is presently focused on commercialising its Steriwave™ nasal photodisinfection, which eliminates infection-causing bacteria, viruses, and fungi from patients' noses in minutes to prevent HAIs. Disinfection of the nose is recommended prior to surgery as pathogens in a patient's nasal cavities are a major cause of surgical site infections (SSIs).[2] A patient with a surgical site infection will, on average, spend five days more in hospital, significantly increasing the cost and lengthening a patient's recovery. At Vancouver General Hospital (VGH), one of Canada's largest tertiary care hospitals, pre-surgical use of Steriwave has resulted in a 78% reduction in SSIs among spine surgery patients.[3]

A study published in JAMA showed that SSIs are the leading cause of readmissions to hospital following surgery and are a significant cause of post-surgical morbidity and mortality, with a 2- to 11-fold increase in mortality risk.[4] Recent research at VGH found the all-cause crude mortality rate was cut by 59% (13.2 vs. 32.2 deaths/1000 patients, P<0.001) among patients who received nasal photodisinfection before surgery when compared to those who did not.[5] Post-surgical infection treatment can be challenging, especially with rising rates of antimicrobial resistance, but Steriwave provides a comprehensive solution to this problem that can be easily used for all types of surgeries.

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The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014, which is part of UK law by virtue of the European Union (Withdrawal) Act 2018. Upon the publication of this announcement, this inside information is now considered to be in the public domain."

About Nasal Photodisinfection

Ondine's nasal photodisinfection is a patented technology using a proprietary light-activated solution. The photodisinfection treatment is carried out by a trained healthcare professional, and is an easy to use, painless, two-step process.  The light-activated solution 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 solution, causing an oxidative burst that is lethal to pathogens (Watch video here:  www.ondinebio.com/technology). A key benefit of this approach, unlike with antibiotics, is that pathogens do not develop resistance to the therapy.

Ondine's nasal photodisinfection system has a CE mark 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 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.