Full Press Release Details
TYLER, Texas, Sept. 09, 2026 (GLOBE NEWSWIRE) -- ENvue Medical, Inc. (NASDAQ: FEED) (“ENvue” or the “Company”), a commercial-stage medical device company focused on real-time guided bedside feeding tube placement and therapeutic technologies, today announced that it has resumed commercial shipments of PainShield®, manufactured in the United States, and has begun fulfilling open orders from Ultra Pain Products, Inc. (“UPPI”), the Company’s exclusive U.S. distribution partner for the product.
The resumption of shipments marks an important commercial and operational milestone following the transfer of NanoVibronix manufacturing operations from Israel to the United States. With U.S. production now operational, the Company is restoring commercial supply of PainShield and fulfilling existing distributor orders.
“Restoring PainShield production and commercial shipments was an immediate priority for us following a manufacturing disruption,” said Doron Besser, MD, Chief Executive Officer of ENvue. “With U.S. production now operational, we are shipping product against existing orders and restoring supply to our commercial channel. Our focus now is straightforward: support our distribution partners, meet customer demand and rebuild growth in the NanoVibronix business.”
The transition of NanoVibronix manufacturing to the United States is part of ENvue’s broader effort to strengthen supply continuity, streamline operations and establish a more efficient operating structure. Research and development for the NanoVibronix product portfolio remains based in Tel Aviv, Israel.
About PainShield PainShield® is a wearable, non-invasive therapeutic ultrasound device designed for the treatment of pain and related conditions. The device delivers low-frequency, low-intensity ultrasound through a treatment patch placed over or adjacent to the treatment area and is designed to enable extended-duration treatment outside of a traditional clinical setting. PainShield is available by prescription in the United States.
About ENvue Medical, Inc. ENvue Medical, Inc. (NASDAQ: FEED) is a medical technology company specializing in the advancement of intelligent, non-invasive solutions for enteral care across clinical and home care settings. Headquartered in Tyler, Texas, with research and development in Tel-Aviv and Nesher, Israel, the Company focuses on two distinct technology platforms:
• ENvue™ Navigation Platform, developed and operated by ENvue Medical Inc., 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.
• ENvue Medical 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.
• 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.
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 anticipated benefits of the transition of the Company's NanoVibronix manufacturing operations to the United States, the Company’s ability to maintain U.S. manufacturing operations and supply continuity, the anticipated timing and extent of the fulfillment of existing and future distributor orders, the Company’s ability to maintain adequate inventory levels and support its distribution partners and customers, the anticipated operational efficiencies associated with U.S. manufacturing, the resumption and continuation of commercial shipments of PainShield, expected demand for and commercial growth of PainShield, the Company’s ability to convert product availability into recurring sales and revenue growth, and the Company’s plans and expectations regarding the future growth of the NanoVibronix business. 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.