NanoVibronix (Nasdaq:NAOV) has announced the successful completion of the initial phase in a randomized controlled trial for its UroShield device. This study was conducted by researchers at the University of Michigan.
UroShield, a compact ultrasonic therapeutic tool, implements innovative low-intensity surface acoustic wave (SAW) technology. This facilitates the generation of low-frequency ultrasound waves, applicable in multiple medical treatments.
The UroShield system includes a disposable single-use clip along with a portable power unit to activate the clip. Once powered, the clip emits ultrasonic waves that form a protective acoustic barrier on catheter surfaces, disrupting bacterial adhesion and biofilm development, thereby potentially reducing infection risks. Additionally, it may decrease or eliminate the necessity for antibiotics. This versatile device is compatible with all external urinary tract catheters, offering potential relief from spasms and catheter-related discomfort.
Research headlined by NanoVibronix involved mainly nursing home residents, focusing on evaluating UroShield’s effects on life quality. The objective was to explore its capability in reducing urinary tract infections, catheter obstructions, and pain associated with the prolonged use of urinary catheters.
“Conducting the first study phase has provided an essential validation before proceeding to a comprehensive study,” stated Brian Murphy, CEO of NanoVibronix. “Completion of this phase allows researchers at UM to progress into the subsequent phase, which involves expanding the randomized controlled trial to include more participants. We are looking forward to starting the full trial in 2025.”
Recently, NanoVibronix has launched UroShield in the European market, as mentioned by Murphy. The subsequent phase of this study is anticipated to align with the preparations for its introduction in the U.S., contingent upon obtaining FDA clearance.