NanoVibronix Completes UroShield® Pilot Study at University of Michigan
NanoVibronix, Inc. (NASDAQ: NAOV), a medical device company specializing in portable ultrasonic therapeutic devices such as UroShield®, PainShield®, and WoundShield®, has announced the successful completion of the first phase of a randomized control trial (RCT) of UroShield® at the University of Michigan. The study, which is part of a larger trial, was conducted primarily with nursing home residents and focused on evaluating the potential benefits of UroShield® in improving patient quality of life. Specifically, the research aimed to determine the device’s effectiveness in reducing urinary tract infections (UTIs), catheter blockages, and pain associated with long-term use of urinary catheters.
“We have successfully achieved the goals of this pilot phase,” said Dr. Lona Mody, Professor of Internal Medicine at the University of Michigan. “This phase involved refining our recruitment and retention strategies, delivering the intervention, and developing tools for data collection. We look forward to moving into the next phase of the trial.”
Brian Murphy, CEO of NanoVibronix, expressed his satisfaction with the progress made in the study. “The first phase of the trial served as a validation pilot ahead of the full study. With this phase now complete, researchers at the University of Michigan can advance to the next stage, which will include a larger cohort of patients in a full randomized controlled trial. We expect the full study to begin in 2025,” said Murphy. He also emphasized the positive trajectory of UroShield® and the continued validation the product is receiving through independent research.
Murphy further highlighted the significant progress NanoVibronix is making toward expanding the commercialization of UroShield®. “This research builds on previously completed studies and product launches in the U.K., Australia, New Zealand, and our recent introduction of UroShield® in Europe. As we move forward, we are also preparing for the U.S. launch of UroShield®, pending 510(k) clearance from the U.S. Food and Drug Administration (FDA).”
The pilot phase was an essential first step in advancing UroShield®’s clinical development. The study has provided valuable insights into refining the recruitment process, enhancing patient retention, and optimizing the data collection methods for the full-scale trial. With the first phase completed, the next steps involve broadening the patient population and further analyzing UroShield®’s effectiveness in preventing UTIs, reducing catheter-related complications, and improving comfort for patients who rely on long-term catheter use.
The device’s primary focus is to alleviate the challenges faced by patients who use urinary catheters over extended periods. Chronic catheter use is often associated with complications such as urinary tract infections, pain, and blockages, leading to reduced quality of life for many patients. UroShield® utilizes NanoVibronix’s proprietary surface acoustic wave (SAW) technology, which generates low-frequency ultrasound waves that aim to disrupt bacterial colonization and biofilm formation on catheters, potentially preventing infections and improving patient comfort.
NanoVibronix’s expanding portfolio also includes PainShield®, which targets pain relief, and WoundShield®, aimed at promoting wound healing. The company’s devices are designed to be used at home, offering patients a more convenient and accessible way to manage their conditions without needing continuous professional intervention.
NanoVibronix’s UroShield® product has already received recognition in several international markets, and with the success of the current trial phase and preparations for future U.S. market approval, the company is poised for significant growth. The company is committed to its mission of improving patient outcomes through innovative medical technologies that address unmet needs in healthcare.
About NanoVibronix, Inc.
NanoVibronix, Inc. (NASDAQ: NAOV) is a medical device company headquartered in Tyler, Texas, with research and development operations in Nesher, Israel. The company is dedicated to developing medical devices using its patented surface acoustic wave (SAW) technology. This technology generates low-frequency ultrasound waves that have various medical applications, such as disrupting biofilms and bacterial colonization, as well as providing pain relief. NanoVibronix’s primary products, including PainShield® and UroShield®, are designed for home use, enabling patients to manage their conditions independently or in any care setting without continuous medical supervision.
Please find the related post
