NanoVibronix Announces Commencement of UroShield Clinical Study at the University of Michigan

NanoVibronix, Inc. (Nasdaq: NAOV), a medical device company that produces the UroShield, PainShield and WoundShield Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced that the University of Michigan will begin the pilot phase of its clinical trial of UroShield this week. The “pilot” phase of the study is the first component of the broader study.

As previously announced on November 28, 2023, the company signed a Research Agreement with the Regents of the University of Michigan for a Randomized Control Trial (“RCT”) study of UroShield to further advance clinical evidence of the efficacy of UroShield. This link will take you to the company’s previous press release.

Brian Murphy, Chief Executive Officer of NanoVibronix, Inc., said, “Entering into the pilot phase of the UroShield study at the University of Michigan is an important step towards our goal of applying for permanent FDA clearance or approval for the UroShield product. The experienced and highly accomplished team of researchers at Michigan is studying the impact UroShield may have on reducing urinary tract infections, catheter blockage pain and improving the quality of life of the patients studied. The pilot portion of the study will include up to 30 patients, while the full study is expected to encompass an estimated 300 patients, primarily nursing home residents.”

About NanoVibronix

NanoVibronix, Inc. (Nasdaq: NAOV) is a medical device company headquartered in Elmsford, New York, with research and development in Nesher, Israel, focused on developing medical devices utilizing its patented low intensity surface acoustic wave (SAW) technology. The proprietary technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including for disruption of biofilms and bacterial colonization, as well as for pain relief. The devices can be administered at home without the assistance of medical professionals. The Company’s PainShield product is a portable device suitable for administration at home without assistance of medical professionals. Additional information about NanoVibronix is available at: www.nanovibronix.com.