Gathering Additional Clinical Evidence to Support Application to FDA for Permanent Clearance

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 it has signed a Research Agreement with the Regents of the University of Michigan for a Randomized Control Trial ("RCT") study of UroShield.

Brian Murphy, Chief Executive Officer of NanoVibronix, Inc., said, "We are partnering with a team of distinguished researchers at the University of Michigan to further advance clinical evidence of the efficacy of UroShield. UroShield is cleared under the U.S. Food and Drug Administration's ('FDA') Enforcement Discretion, and we hope positive outcomes from this independent study will support an application to the FDA for permanent clearance. RCTs are considered the 'gold standard' in clinical research, and we are pleased to be working with the team at the University of Michigan."

Murphy continued, "The research, which is being led by the Center for Research and Innovations in Special Populations (CRIISP), an experienced and highly accomplished research team, will be conducted primarily with nursing home residents and is aimed at studying the impact UroShield may have on reducing urinary tract infections, catheter blockages and pain and improving the quality of life of the patients studied. The first phase of the study will include a validation pilot of 20 patients in advance of the full study. The full study is expected to include more than 300 patients. We look forward to receiving the researchers' conclusions and hope for positive outcomes for patients in the study. The study is expected to commence in the first half of 2024."