ONDINE BIOMEDICAL INC.

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

Leeds Teaching Hospitals NHS Trust to use Steriwave

Ondine Biomedical Inc. (LON: OBI), the Canadian life sciences company pioneering light-activated antimicrobial treatments, and Iskus Health announce that Leeds Teaching Hospitals NHS Trust will begin using its Steriwave^® nasal decolonization technology later this month. Leeds Teaching Hospitals NHS Trust is one of the largest and busiest acute hospital trusts in the country, treating 1.5 million patients every year.

Steriwave will be used as part of a quality improvement (QI) initiative to prevent infections in patients undergoing surgery to remove tumours from the base of the brain or top of the spine via the nose (endonasal endoscopic anterior skull base surgery). The key endpoints for the QI initiative will be reducing post-operative antibiotic use 30 days after surgery, and reducing the need for outpatient follow-up appointments to treat infections.

Post-surgical infections prolong recovery times, with even minor infections requiring more follow-up appointments, and treatment often requires prolonged use of antibiotics. Reducing antibiotic use is also a key aspect of the UK's 5-year action plan for antimicrobial resistance, which was published in May 2024.

Paul Nix, Rhinology and Anterior Skull Base Surgeon at Leeds Teaching Hospitals NHS Trust, will lead the Steriwave QI initiative. He says: "There are great advantages to going through the nose to operate on skull base tumours because of the minimally invasive access and the fact that patients have a better quality of life after surgery. However, there is a risk of infection because we access the surgical site through the nose - a well-known reservoir for pathogens - and we risk introducing those pathogens into the brain. Luckily, we have a very low rate of infections, but if a patient gets an infection like meningitis it can be life-threatening.

"Decolonizing the nose is particularly important for us as, unlike with more conventional surgeries, we are not able to clean the skin around the incision. Antibiotics can be used to decolonize the nose but need to be applied by patients at home for five days before surgery, and patients may not be able to do this, not to mention the concerns around rising levels of antimicrobial resistance. The great advantage of Steriwave is that it can be administered once a patient has been admitted or at short notice for an emergency surgery and works instantly."

Steriwave is a groundbreaking antimicrobial treatment that uses a light-activated agent to rapidly eliminate infection-causing pathogens. First, the agent is applied to each nostril using a nasal swab, then the area is illuminated with a red light laser. The light activates the photodynamic agent, causing an oxidative burst that destroys pathogens. This eliminates infection-causing bacteria, viruses and fungi in a single, 5-minute treatment. The process works so rapidly that pathogens do not have the opportunity to develop resistance, making it an effective alternative to antibiotics.

In March 2024, Mid Yorkshire Teaching NHS Trust became the first in the UK to commercially adopt Steriwave as the standard of care for hip and knee surgery patients to prevent surgical site infections (SSIs). In June 2024, was added to the NHS Supply Chain, making it significantly easier for NHS hospitals in England and Wales to purchase. The NHS Supply Chain is a national body which manages the sourcing, delivery and supply of healthcare products to the NHS and healthcare organizations in England and Wales.

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About Leeds Teaching Hospitals NHS Trust

Leeds Teaching Hospitals NHS Trust is one the largest and busiest acute hospital trusts in the country. We are the local hospital for Leeds and provide specialist services for our local communities, the Yorkshire and Humber region and beyond.

Leeds Teaching Hospitals has a budget of more than £1.9 billion and a 21,000-strong staff. Last year, we treated more than 1.6 million patients, including 97,000 inpatient admissions, 1.2 million outpatient attendances and 344,000 attendances in our Emergency Departments.  

Our care and clinical expertise is delivered from seven hospitals on five sites, and they are all joined by our vision to be the best for specialist and integrated care. 

Find out more on our website: Leeds Teaching Hospitals NHS Trust (leedsth.nhs.uk)

About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a clinical Canadian life sciences company and leader in light-activated antimicrobial therapies (also known as 'photodisinfection'). Ondine has a pipeline of investigational products, based on its proprietary photodisinfection technology, in various stages of development.

Ondine's nasal photodisinfection system has a CE mark in Europe, the UK-CA mark, and is approved in Canada and several other countries under the name Steriwave®. In the US, it has been granted Qualified Infectious Disease Product designation and Fast Track status by the FDA and is currently undergoing clinical trials for regulatory approval. 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^®

Ondine's Steriwave nasal photodisinfection system is a patented technology using a proprietary light-activated antimicrobial (photosensitizer) to destroy bacteria, viruses, and fungi colonizing the nose. 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 red laser light for less than five minutes. The light activates the photosensitizer, causing an oxidative burst that is lethal to all types of pathogens without causing long-term adverse effects on the nasal microbiome. A key benefit of this approach-unlike with antibiotics, which have resistance rates reported as high as 81%^[1]-is that pathogens do not develop resistance to the therapy.

Nasal decolonization is recommended in the 2016 WHO Global guidelines for the prevention of surgical site infections,^[2] and the Society for Healthcare Epidemiology of America (SHEA) guidelines, published in May 2023, recommend nasal decolonization for major surgical procedures.^[3]