Researchers at the University of Michigan completed the first phase of the trial for UroShield, a portable ultrasonic therapeutic device. UroShield utilizes patented low-intensity surface acoustic wave (SAW) technology. This allows for the creation of low-frequency ultrasound waves for a variety of medical applications.
UroShield features a disposable clip intended for single use, plus a portable driver unit that provides power to the clip. The clip generates ultrasonic waves that create an acoustic shield on the surfaces of a catheter. This interferes with the attachment of bacteria to prevent bacterial biofilm formation and the development of infections. It also may eliminate or reduce the need for antibiotics. The device can be attached to all external urinary tract catheters providing potential relief from spasm and catheter pain.
NanoVibronix said researchers conducted the first phase of the trial primarily with nursing home residents. It aimed to study the impact of UroShield on quality of life through its potential to reduce urinary tract infections, catheter blockages and pain caused by the long-term use of urinary catheters.
“The first phase of the study served as a validation pilot in advance of a full study,” said Brian Murphy, NanoVibronix CEO. “With this phase now complete, researchers at UM can advance to the next phase, a full randomized controlled trial of additional patients. We expect the full trial to commence in 2025.”
NanoVibronix company recently introduced UroShield to the European market, Murphy added. He expects the next phase of this study to take place concurrently with preparations for a U.S. launch. That remains subject to FDA clearance.
