1 August 2023

ONDINE BIOMEDICAL INC.

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

Ondine commences first NHS Steriwave® pilot

Mid Yorkshire Teaching NHS Trust will be using Ondine's nasal photodisinfection therapy prior to orthopaedic surgeries at Pontefract Hospital over a six-month pilot

·    Surgical site infections (SSIs) are the leading cause of readmission to hospital and three percent of patients who contract an SSI will die.^[i]

·    SSIs are estimated to cost the NHS £700 million per year.^[ii]

·    A patient with a surgical site infection will, on average, spend seven days more in hospital.^[iii]

Mid Yorkshire Teaching NHS Trust has this week started the first UK pilot evaluation of Ondine Biomedical's Steriwave® nasal photodisinfection for the prevention of surgical site infections (SSIs). The six-month pilot will see 500 elective hip and knee surgery patients nasally decolonized using Steriwave prior to their surgery.

Steriwave is already in use at a number of hospitals across Canada, including Vancouver General Hospital and The Ottawa Hospital, and has demonstrated significant improvement in post-surgical outcomes including lower rates of infection, reduced patient length of stay, fewer readmissions, and lower rates of antibiotic prescribing.^{[iv],[v],[vi]}

Nasal decolonization is recommended by NICE to eliminate pathogens in a patient's nasal cavities, like MRSA, which are major causes of SSIs.^[vii] A patient with a surgical site infection will, on average, spend 7 to 11 days more in hospital, significantly increasing costs and lengthening patients' recovery.^[viii] Nasal mupirocin, an antibiotic, is usually used for nasal decolonization, however, there are serious concerns about its antimicrobial resistance rates which have been reported as high as 81%.^[ix]

Dr Stuart Bond, Consultant Antimicrobial Pharmacist & Director of Innovation at Mid Yorkshire Teaching NHS Trust commented: "We are very pleased to be the first NHS Trust in the UK to pilot this exciting, non-antibiotic method of preventing infections after surgery. Although infections after hip and knee surgeries are rare, we know that they lengthen patients' stay in hospital, complicate the recovery process, and cause significant pain and suffering. We look forward to sharing the results of the Steriwave pilot in due course."

Nasal photodisinfection is a non-antibiotic method for nasal decolonization that uses a proprietary light-activated agent to destroy pathogens. First, the agent is applied to each nostril using a nasal swab, then the area is illuminated with a specific wavelength of light. The light activates the photodynamic agent, causing an oxidative burst that destroys pathogens. In this single, 5-minute treatment, Steriwave eliminates infection-causing bacteria, viruses and fungi in the nose.^[x]

Ondine is in discussions with a number of other NHS Trusts about initiating additional Steriwave pilots.

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.  

About HAIs

·    There is no national surveillance programme for hospital-acquired infections in the UK, so much of the available data relies on self-reporting from NHS hospitals. However, data modelling studies can provide estimates of the impact of HAIs.

·    Over 10 million operations are performed in England each year, and the average operating theatre will see over 1,200 procedures a year.^[xi]

·    Pre-surgical nasal decolonization to prevent certain types of HAIs is recommended by the World Health Organisation (WHO), the Health Research & Educational Trust (HRET), the Society for Healthcare Epidemiology of America (SHEA), and the Centers for Disease Control and Prevention (CDC).

·    The NHS saw an estimated 834,000 healthcare-associated infections in 2016/2017 costing £2.7 billion, and accounting for 28,500 patient deaths, and 7.1 million occupied hospital bed days (equivalent to 21% of the annual number of all bed days across all NHS hospitals in England).^[xii]

·    The United States has two HAI surveillance systems, the National Healthcare Safety Network (NHSN) and the Emerging Infections Program Healthcare-Associated Infections - Community Interface (EIP HAIC).

·    In American hospitals alone, the Centers for Disease Control (CDC) estimates that HAIs account for an estimated 1.7 million infections and 99,000 associated deaths each year.^[xiii]

·    On any given day in the United States, about one in 31 hospital patients has at least one healthcare-associated infection.^[xiv]