19 October 2022

Ondine Biomedical Inc.

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

Steriwave™ cuts SSI risk by 47% at major hospital

·    Surgical site infections reduced by an average of 47% across all surgery types.

·    Most significant impact seen in cardiac surgeries - almost 70% reduction.

·    Mortality rate cut by 59% between treated and untreated patients.

·    Average length of stay in hospital reduced by 4 days.

Ondine Biomedical, Inc. (LON:OBI): New research presented at the Infection Prevention Society Conference in Bournemouth, UK, shows that adding Steriwave™ nasal photodisinfection to a presurgical bundle including 2% chlorhexidine (CHG) body wash cloths reduced post-operative surgical site infections (SSIs) by 47% at one of Canada's largest hospitals, Vancouver General Hospital (VGH). Nasal photodisinfection is a quick and simple method of decolonising the nose of dangerous pathogens using a combination of a photosensitizer and a specific wavelength of light.

The retrospective, observational study measured the rate of post-surgical SSIs in over 6,000 patients who underwent both elective and non-elective cardiac, orthopaedic, vascular, spinal, or neurological surgeries between January 3, 2017 and May 1, 2019. The proportion of patients who developed SSIs was approximately half (0.8% vs 1.5%, P=0.01) among those who received nasal photodisinfection before surgery, when compared to those who did not. All-cause crude mortality rate was cut by 59% (13.2 vs 32.2 deaths/1000 patients, P<0.001), and patients treated with nasal photodisinfection spent an average of four days less in hospital compared with non-treated patients (P<0.001).

Jason Hickok, Ondine Biomedical's VP, Medical and Clinical Affairs said:

"This study, conducted in collaboration with researchers at VGH, confirms that nasal photodisinfection before surgery dramatically reduces the rate of SSIs across a broad range of surgery types. Patients treated with Ondine's nasal photodisinfection were discharged an average of four days earlier, reducing the risk of contracting a hospital-acquired infection, and allowing the hospital to care for more patients and therefore reduce surgical wait times. We commend the infection control staff and researchers at VGH for being early adopters of this innovation and adding Steriwave to their pre-operative standard of care."

Pathogens in the nose, like Staphylococcus aureus, are a leading cause of SSIs. Steriwave nasal photodisinfection eliminates nasal bacteria, viruses and fungi with a simple, 5-minute, treatment. The two-step process involves the application of a proprietary light-activated agent to each nostril using a nasal swab, followed by illumination of the area with a specific wavelength of laser light. The light activates the photodynamic agent, causing an oxidative burst that destroys all types of pathogens. A key benefit of this approach is that pathogens do not develop resistance to the therapy.

Steriwave has a CE mark for use in the EU and is approved in Canada, the UK and several other countries. In the US, Ondine's nasal photodisinfection has received Qualified Infectious Disease Product designation and Fast Track status from the FDA and is currently undergoing clinical trials for regulatory approval.

A copy of the full research poster "Surgical Site Infection Reduction With a Pre-surgical Bundle Including Nasal Photodisinfection and Chlorhexidine" can be downloaded here.

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 Infection Prevention Society Annual Conference

The IPS annual conference is the largest infection prevention and control meeting in the UK and attracts over 1,000 renowned infection prevention experts.  The conference is relevant to healthcare delegates, as the issue of infection prevention is becoming increasingly important, as well as to many industry sectors from catering to hospitality and from pharmacy to dentistry. With its high-profile speakers and prestigious reputation within the infection control sector, the conference showcases abstracts, posters and lectures on the latest advances in infection prevention. More information can be found at www.ips.uk.net.

About Nasal Photodisinfection

Ondine's nasal photodisinfection comprises a two-step process: the application of a proprietary light-activated solution 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 photodisinfection process works by light exciting the photodynamic 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. Photodisinfection is also known in the scientific community as antimicrobial photodynamic therapy (aPDT).

Ondine's nasal photodisinfection has a CE mark for use in the EU and is approved in Canada and several other countries, including the UK, under the name Steriwave™. In the US, it has received Qualified Infectious Disease Product designation and Fast Track status from the FDA and is currently undergoing clinical trials for US 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 sinusitis, ventilator-associated pneumonia, burns, and other indications.