Company Announcements

Patent strengthens ENvue’s IP position as it advances toward pediatric regulatory clearance and expanded clinical use

TYLER, Texas--(BUSINESS WIRE)--Jun. 11, 2025-- NanoVibronix, Inc. (NASDAQ: NAOV) (“NanoVibronix” or the “Company”), a medical technology company specializing in therapeutic devices, announced today, through its ENvue Medical Holdings LLC division (“ENvue Medical” or “ENvue”), a new U.S. patent for its pediatric feeding tube guidance system. U.S. Patent No. 12,324,632, titled “Insertion Device Positioning Guidance System,” further strengthens ENvue Medical’s intellectual property portfolio and reflects the Company’s ongoing commitment to innovation in feeding tube placement technologies.

This newly granted patent covers ENvue’s proprietary system and is designed to assist clinicians in guiding the insertion of feeding tubes in pediatric patients - a population that presents significant anatomical and procedural challenges. This proprietary system is intended to provide real-time navigational data during tube placement, supporting clinical decision-making and potentially reducing reliance on confirmatory imaging.

In the United States alone, approximately 400,000 preterm infants and a large population of additional pediatric patients, including those in intensive care, surgical recovery and chronic care undergo feeding tube placement annually.^1-4 Combined, these high-risk groups account for over 1.5 million procedures per year, representing a single U.S. market opportunity of more than $150 million annually in capital systems and disposables⁵. ENvue’s newly granted patent strengthens its ability to serve this critical segment with real-time, precision-guided navigation.

“We believe the addressable market for our pediatric navigation platform is substantial,” said Dr. Doron Besser, CEO of the Company. “Accordingly, this patent reflects our commitment to addressing this market opportunity by developing more precise, real-time enteral access solutions tailored to the needs of vulnerable patient populations. We continue to innovate with the goal of expanding clinical capabilities and meeting unmet needs in the field of enteral access.”

As part of its broader product development strategy, ENvue Medical is preparing to pursue U.S. Food and Drug Administration (FDA) 510(k) clearance for the pediatric use of its ENvue system. The system is currently FDA-cleared for use in adult patients only.

The newly patented technology builds on the ENvue Enhanced Navigation (EN) platform, which uses electromagnetic tracking to visualize and confirm feeding tube position in real time - without reliance on blind placement or repeated X-rays.

About NanoVibronix, Inc.

NanoVibronix, Inc. (NASDAQ: NAOV) is a medical technology company advancing both non-invasive and minimally invasive solutions across clinical and home care settings. Headquartered in Tyler, Texas, with research and development in Nesher, Israel, the Company focuses on two distinct technology platforms:

• Acoustic-based therapeutic technologies, including PainShield® and UroShield®, which utilize proprietary low-intensity surface acoustic wave (SAW) technology. These devices are intended for use in home or care settings and are designed to treat pain, reduce bacterial colonization, and disrupt biofilms.
• ENvue™ Navigation Platform, developed and operated by ENvue Medical, with offices in Arlington Heights, Illinois, and Tel Aviv, Israel, is a minimally invasive electromagnetic navigation system intended to assist clinicians in placing feeding tubes into the gastrointestinal tract. FDA 510(k) cleared for adult use, ENvue provides real-time bedside visualization of tube movement and supports informed decision-making during the placement procedure. Future platform expansion may include pediatric and vascular access applications.

NanoVibronix aims to advance standards in non-invasive therapy and minimally invasive navigation, with a commitment to patient safety, clinical usability, and technology innovation across a range of healthcare environments.

Forward-Looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or similar words. These forward-looking statements include, but are not limited to: statements regarding the adoption and implementation of the ENvue System and ENvue Medical’s platforms, anticipated commercial expansion and implementation of the ENvue System and ENvue Medical’s platforms in additional medical institutions and markets, market interest in the Company’s technology, including the ENvue System and ENvue Medical’s platforms, and future expectations for strategic growth. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: (i) market acceptance of the Company’s existing and new products; (ii) clinical performance and operational outcomes; (iii) delays or complications in product implementation; (iv) intense competition in the medical device industry; (v) product liability or performance issues; (vi) limitations in manufacturing or supply chain capabilities; (vii) reimbursement limitations; (viii) intellectual property protection; (ix) healthcare regulatory changes in the U.S. and abroad; and (x) the need for additional capital. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Investors and security holders are urged to read these documents free of charge at: www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events, or otherwise, except as required by law.

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Brett Maas, Managing Principal
Hayden IR, LLC
brett@haydenir.com
(646) 536-7331

Source: NanoVibronix, Inc.