Patent Awarded to ENvue Medical for Pediatric Feeding Tube Guidance Tech

NanoVibronix Inc.’s ENvue Medical Holdings division has won a new U.S. patent for its pediatric feeding tube guidance system. U.S. Patent No. 12,324,632, “Insertion Device Positioning Guidance System,” further strengthens ENvue Medical’s intellectual property portfolio.

The newly granted patent covers ENvue’s proprietary system and aims to help clinicians guide feeding tube insertion in pediatric patients, a population that presents significant anatomical and procedural challenges. This proprietary system intends to provide real-time navigational data during tube placement, supporting clinical decision-making and potentially reducing reliance on confirmatory imaging, according to the company.

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 more than 1.5 million procedures annually, representing a U.S. market opportunity of greater than $150 million a year in capital systems and disposables.⁵ 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,” NanoVibronix CEO Dr. Doron Besser said. “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.

NanoVibronix Inc. is 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 use proprietary low-intensity surface acoustic wave technology. These devices are used in home or care settings to treat pain, reduce bacterial colonization, and disrupt biofilms.

The ENvue Navigation Platform, developed and operated by ENvue Medical, with offices in Arlington Heights, Ill., and Tel Aviv, Israel, is a minimally invasive electromagnetic navigation system to help clinicians place 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.

References
¹ CDC National Center for Health Statistics (NCHS) “Births: Final Data for 2022” (published January 2024)
² American Academy of Pediatrics – Clinical Report on Enteral Nutrition for Preterm infants
³ Parker et al., JPEN, 2019
⁴ Healthcare Cost and Utilization Project (HCUP)
⁵ Based on information available to the company as of the date hereof and internal calculations.