NanoVibronix has announced the completion of the pilot phase of its UroShield clinical trial at the University of Michigan, marking a significant step toward potential U.S. commercialization. UroShield is a disposable ultrasound device designed to prevent catheter-associated urinary tract infections (UTIs) by preventing bacterial colonization and biofilm formation on indwelling urinary catheters.
The pilot phase, involving 30 patients, primarily focused on refining recruitment and retention strategies, as well as assessing the effectiveness of intervention and data collection methods. Dr. Lona Mody, professor of internal medicine at the University of Michigan, stated that the team "achieved the goals of the pilot phase."
The core technology behind UroShield involves the generation of low-intensity ultrasonic surface acoustic waves throughout the catheter. NanoVibronix reports that these waves interfere with bacterial attachment by creating an "acoustic shield," thereby preventing biofilm formation. Biofilm formation is a key factor in the development of UTIs, often caused by bacteria such as Escherichia coli.
Brian Murphy, CEO of NanoVibronix, indicated that the successful completion of the pilot phase allows the research team at the University of Michigan to advance to the full randomized controlled trial, expected to commence in 2025. The full study aims to enroll approximately 300 participants.
UroShield is already CE marked and available on England’s National Health Service (NHS). The NHS watchdog, the National Institute for Health and Care Excellence (NICE), has acknowledged the device's potential for cost savings, particularly in patients with recurrent infections or catheter blockages. However, NICE previously called for further research to strengthen the evidence base for clinical effectiveness.
NanoVibronix is preparing for the potential U.S. launch of UroShield, contingent upon 510K clearance from the U.S. Food and Drug Administration (FDA). The upcoming study at the University of Michigan is expected to run concurrently with these preparations.
