Ondine Biomed Regulatory News (OBI)

17/01/2023

ONDINE BIOMEDICAL INC.

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

New photodisinfection study published

Photodisinfection was found to eradicate biofilms associated with periprosthetic joint infections

· Periprosthetic joint infections are life-threatening and extremely hard-to-treat.

· The annual cost of treating periprosthetic joint infections in the US is $1.62 billion, with costs projected to rise to $1.85 billion by 2030 for hip and knee replacements alone.[1]

A new study published in the journal Antibiotics found that antimicrobial photodisinfection therapy (aPDT), using Ondine Biomedical Inc.'s (AIM: OBI) proprietary methylene blue-based photosensitizer in combination with a specific wavelength of light, effectively eradicated pathogen biofilms commonly associated with periprosthetic joint infections ("PJIs").

The results of this study suggest that photodisinfection could be used as an effective treatment method for PJIs, replacing current, more invasive approaches and potentially shortening antibiotic treatment. This would not only improve patients' quality of life, but also reduce morbidity, mortality, antibiotic resistance, and the high healthcare costs associated with treating these infections.

The in vitro study, conducted by a research team from University Hospital Zurich, found that photodisinfection achieved 100% kill of the key pathogens in biofilms associated with PJIs. These included the ESKAPE pathogens Staphylococcus aureus and Escherichia coli and also Staphylococcus epidermidis, and Cutibacterium acnes, with no regrowth.

The photodisinfection treatment did not cause any relevant surface modification on any of the different prosthesis materials, suggesting that the therapy does not harm the material and is safe to use in vivo.

Lead author and Senior Physician for Internal Medicine and Infectious Diseases at Zollikerberg Hospital, Dr. Yvonne Achermann, commented:

"This is the first study to show that photodisinfection, also known as photodynamic therapy (PDT), could be an effective novel treatment for periprosthetic joint infections. This is particularly exciting as it provides a much-needed alternative to antibiotics as resistance in biofilm-forming bacteria continues to grow. We [the research team at University Hospital Zurich] are planning a clinical safety study to further explore the potential of photodisinfection to treat and even prevent PJIs."

Patients undergoing major surgeries like hip or knee replacements face the risk of life-threatening infections with the majority of these related to the patients' own microflora, or bacteria naturally present on the body. PJIs are typically extremely hard to treat,[2] often requiring surgical intervention and prolonged treatment with high-dose antibiotics. In the US alone, the annual cost of treating PJIs is estimated at $1.62 billion.[3]

The full research paper can be accessed here. The University Hospital Zurich research team is planning further clinical studies of photodisinfection for the treatment of PJIs, starting with a clinical safety study.

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. Ondine's nasal photodisinfection technology is approved in several jurisdictions under the brand name Steriwave™. It has been awarded the CE mark and, in the US, has been granted Qualified Infectious Disease Product designation and Fast Track status in the US by the FDA. Products beyond nasal photodisinfection include therapies for a variety of medical indications such as nasal disinfection, sinusitis, ventilator-associated pneumonia, burns, and other indications.

About University Hospital Zurich

The University Hospital Zurich (USZ) is open to all patients every day and provides fundamental medical care and cutting-edge medicine in a central location in Zurich. We use our superior academic knowledge to treat a wide range of health issues, taking a personal touch and utilizing highly specialized and up-to-date research.

www.usz.ch/en/about-university-hospital-zurich/