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NanoVibronix (Nasdaq: NAOV) announced the start of the pilot phase for the UroShield clinical trial at the University of Michigan. This phase is the initial part of a broader study, following a Research Agreement signed on November 28, 2023. The trial aims to evaluate UroShield's efficacy in reducing urinary tract infections, catheter blockage, and pain, thereby enhancing patient quality of life. The pilot phase involves up to 30 patients, while the full study will involve approximately 300 patients, primarily from nursing homes. The goal is to gather data that will support an application for permanent FDA clearance or approval.
NanoVibronix (NASDAQ: NAOV) issued an update on its business developments and financial performance for Q1 2024. The company reported record first-quarter revenues of $921,000, but also a loss from operations of $568,000. Cash reserves stand at $2.7 million with $2.6 million in inventory. Domestic sales, particularly within the Veterans Affairs (VA) and worker’s compensation markets, are seeing growth, aided by a new General Services Administration (GSA) grant effective May 1, 2024. Internationally, the company has made strides in the UK, Australia, and New Zealand. A significant research study on UroShield by the University of Michigan is underway, potentially bolstering FDA approval efforts. The company is also focused on improving existing products and exploring new opportunities. Key goals include expanding distribution channels and achieving broader market coverage.
NanoVibronix (NASDAQ: NAOV) announced a distribution agreement with CB Medical, a VA-certified and Service-Disabled Veteran-Owned Small Business, for the sale and distribution of UroShield. UroShield, an ultrasound-based device, helps prevent bacterial colonization on urinary catheters, reduces catheter-associated urinary tract infections (CAUTI), and alleviates pain and discomfort. The multi-year agreement allows CB Medical to sell UroShield throughout the VA system in the U.S. Brian Murphy, CEO of NanoVibronix, highlighted the opportunity to expand UroShield's distribution and benefit veterans. Shawn Pinkston, CEO of CB Medical, emphasized the importance of offering effective solutions to veterans, especially those with spinal injuries who use indwelling catheters and are at high risk of infection.
NanoVibronix, Inc. announced that its PainShield product will be included in the U.S. Department of Veteran Affairs’ Federal Supply Schedule (FSS) effective May 1, 2024. The five-year contract awarded to distribution partner Delta Medical, will provide a significant opportunity for NanoVibronix to expand the placement of PainShield devices within the VA healthcare network, serving nine million enrolled veterans annually. The contract aims to address the growing need for non-pharmacological pain management solutions, positioning PainShield as a valuable therapeutic option.