Strategic therapeutic areas
Bactiguard focuses on five strategic therapeutic areas where the risk of infection has important consequences that has exposed a significant unmet medical need for infection prevention. These areas include Orthopedics, Cardiology, Neurology, Urology, and Vascular Access, altogether representing a significant market potential for Bactiguard.
Orthopedics
External fixators and hardware implants are commonly used in orthopedic operations and procedures to treat patients with joint disorders and fractures, and early mobility and functionality are key for complete and full recovery. Both during and after these procedures, externally fixed or implantable devices are susceptible to infections. Current infection rates vary depending on the procedure, with primary implant infections occurring in 1 to 5 percent of cases, revision surgeries ranging from 8 to 22 percent, and fracture-related infections from 5 to 40 percent. Avoiding infections and consequential revision surgery by using infection prevention technologies can reduce patient distress and save healthcare system resources.
Cardiology
Implantable cardiovascular medical devices, including pacemakers, implantable cardiac defibrillators (ICDs), and ventricular assist devices (VADs), are essential for managing conditions such as heart failure and arrhythmias. However, these devices are also susceptible to infections, with reported infection rates ranging from 1 to 7 percent for cardiac implantable electronic devices (CIEDs) and 19 to 39 percent for ventricular assist devices. Over the past two decades, advancements in the design of VAD devices have significantly improved patient outcomes. However, infection-related mortality remains a major challenge, as infections often lead to device failure, necessitating surgical removal or replacement. This, in turn, has a substantial impact on patient recovery and healthcare resources.
Neurology
Neurological medical devices, including shunts, deep brain stimulators (DBS), spinal cord stimulators (SCS), sacral nerve stimulators (SNS), vagus nerve stimulators (VNS), and peripheral nerve stimulators (PNS), play a vital role in treating neurological disorders such as hydrocephalus, Parkinson’s disease and other movement disorders, epilepsy, incontinence, and chronic pain. However, these devices are vulnerable to infections, with reported infection rates ranging from 1 to 15 percent for neuromodulation devices and 5 to 13 percent for shunts. Patients are at an increased risk of infection both during and after neurosurgical procedures. Infections can lead to device failure, the need for revision surgery, and prolonged hospital stays, significantly impacting patient recovery and healthcare resources.
Urology
Urinary tract infections (UTIs) are the most common healthcare-associated infections (HAIs), with a significant proportion caused by indwelling urinary catheters, known as catheter-associated UTIs (CAUTIs). Bacteria colonize the catheter surface and form biofilm, leading to infection. The risk of CAUTI increases with each day of catheterization. Among patients catheterized for more than two days, CAUTI incidence ranges from 9–21 percent, heightening the risk of prolonged hospital stays and additional complications. A urinary tract infection can cause significant discomfort and pain, and can progress to severe bacterial complications such as urosepsis.
Vascular access
Patients with co-morbidities and compromised immunity are at a higher risk of infection, particularly in intensive care unit settings. Central line-associated bloodstream infections (CLABSI) occur in 2 to 10 percent of patients with a central line in place for more than two days, further increasing the risk of severe complications. In addition, there is substantial risk of cross contamination within the care unit. An infection in a patient who is already critically ill is serious and leads to higher mortality. Preventing infections can save lives.