NanoVibronix Inc. has completed the first phase of a randomized controlled trial of its UroShield Surface Acoustic Wave Portable Ultrasound Therapeutic Device by University of Michigan (UM) researchers.

The trial’s first phase is a precursor to the full study by UM researchers. It was conducted primarily with nursing home residents and was aimed at studying UroShield’s impact on improving patients’ quality of life by 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. With this phase now complete, researchers at UM can advance to the next phase, a full randomized control trial of additional patients. We expect the full trial to commence in 2025,” NanoVibronix CEO Brian Murphy said. “The validation our products continue to receive from independent research and the progress we are making towards further commercializing UroShield is highly encouraging. This research builds on previously concluded studies and product launches in the U.K., Australia and New Zealand and our recent introduction of UroShield to the European market. The next phase of the UM study is expected to be conducted concurrently with our preparations for the launch of UroShield in the U.S., subject to 510K clearance with the U.S. Food and Drug Administration.”

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“Our team has achieved the goals of this pilot phase, including refining our recruitment and retention strategies, delivering the intervention and developing data collection tools. We look forward to the next phase,” stated Dr. Lona Mody, professor of Internal Medicine at the University of Michigan.

NanoVibronix Inc. is a medical device company headquartered in Tyler, Texas, with research and development in Nesher, Israel, focused on developing medical devices using its patented low intensity surface acoustic wave technology. This proprietary technology creates low-frequency ultrasound waves that can be used for various medical applications, including to disrupt biofilms and bacterial colonization, as well as for pain relief. The devices can be administered at home without the continuous assistance of medical professionals. The company’s primary products include PainShield and UroShield, which are portable devices suitable for administration at home or in any care setting.