TYLER, Texas, April 16, 2026 (GLOBE NEWSWIRE) -- ENvue Medical, Inc. (NASDAQ:FEED) ("ENvue," "ENvue Medical" or the "Company"), a medical technology company specializing in the advancement of intelligent, non-invasive solutions for enteral care across clinical and home care settings, today issued the following stockholder letter and corporate update:

Dear Stockholders,

2025 was a transformative year for ENvue Medical. Today, our Company is a commercially active medtech business trading on the Nasdaq Capital Market under the ticker "FEED." ENvue's mission is to improve patient safety and clinical workflow through proprietary technologies that deliver real-time guidance, intelligent navigation, and non-invasive therapeutic solutions.

Over the past twelve months, we believe we have strengthened our leadership team, deepened our clinical footprint, advanced our intellectual property portfolio, and sharpened our strategic focus.

We entered 2026 with two differentiated proprietary technology platforms:

ENvue Navigation Platform for enteral access and future hospital applications; and
Acoustic Therapeutic Platform for non-invasive treatment and biofilm-related applications.

We believe this dual-platform structure will provide us with both growth opportunities and business diversification, strengthening our go-to-market strategy and positively impacting revenue prospects.

Our ENvue Navigation Platform is now commercially deployed across 39 U.S. hospitals, generating recurring revenue and becoming embedded in the daily workflows of clinicians who rely on it. We also continue to advance our Acoustic Therapeutic Platform through PainShield® and UroShield®, preserving valuable technology, commercial relationships and future optionality for stockholders.

Why This Market? Why Now?

Feeding tube placement is one of the most commonly performed procedures in hospitals, occurring more than 13 million times annually in the United States alone, yet 85% of placements in the United States are performed blindly, without any real-time visual guidance.¹ Currently, clinicians advance the feeding tube down the trachea to place it in the stomach and then wait for an X-ray to be performed and for the radiology department to confirm proper placement before patient nutrition can begin. In modern hospitals, this process represents a substantial drain on both time and financial resources, driving efforts to minimize each.

The clinical and operational strain on hospitals is building and compounding:

Patient safety mandates are tightening. Pulmonary misplacement, where a tube enters the lung mistakenly instead of the stomach, is a preventable, but potentially fatal event. Hospitals are under growing pressure to eliminate these types of adverse outcomes.

Staffing shortages mean more procedures are performed by less experienced clinicians, with less oversight at the bedside, making technique-dependent placements inherently more variable in outcome. Tools that reduce technique-dependence and support consistent outcomes are a clinical necessity.

Imaging bottlenecks are slowing patient care. When X-ray confirmation is required after every blind placement, radiology queues grow and patients wait hours before feeding can begin. That delay has measurable consequences for recovery.

Cost pressure is unrelenting. Complications from misplaced tubes drive extended hospital stays, require repeat imaging, and potentially additional procedures. Anything that reduces complication rates and streamlines workflow contributes directly to a hospital's bottom line.

ENvue believes it addresses all four of these challenges through a single, real-time electromagnetic guidance platform providing clinicians continuous, bedside visualization of tube position throughout the placement, not after. We reduce the need to wait for radiology and repeat X-rays.

"The ENvue machine takes away the anxiety of placing feeding tubes. With ENvue, I have total confidence where the tube is at all times." - SWAT Rapid Response, ICU RN, U.S. Hospital

Building the Foundation for the Future

We believe we took the necessary steps in 2025 to build our foundation for the next phase of growth:

First, we strengthened our leadership: Building a commercial-stage medtech company requires the right people to launch the right technology. In January 2026, we appointed Marc Waldman as Vice President, Commercial, bringing experienced medtech leadership to drive our U.S. sales expansion. In 2025, we welcomed David Johnson as Chairman of the Board, adding deep healthcare industry expertise at the corporate governance level.

Second, we grew our installed base: The ENvue Navigation Platform is now commercially deployed across 40 U.S. hospitals. We believe that each installation represents a potential long-term clinical relationship, and recurring orders from existing accounts continue to validate the product's stickiness and the workflow value it delivers.

Third, we built a robust sales pipeline: Translating clinical interest into signed hospital agreements takes time and effort. Over the past year, we have built the pipeline infrastructure, sales methodology, and funnel management discipline that positions us to convert 2026 opportunities efficiently.

Fourth, we secured a significant IP milestone: In February 2026, the USPTO issued a Notice of Allowance for our patent covering a feeding tube design that integrates electromagnetic navigation with a distal-tip camera, enabling both positional guidance and direct internal visualization in a single device. We believe this represents the next generation of intelligent, visualized placement, and it meaningfully strengthens our IP position.

A Business Model Built for Compounding Growth

As ENvue's installed base grows, our revenue model grows with it, and it does so in a way that becomes more predictable and, we believe, durable over time.

Each system ENvue places in a hospital is designed to establish a long-term customer relationship. Our feeding tubes are uniquely designed for the ENvue Navigation Platform, so every feeding tube procedure performed using that system is expected to drive recurring demand for our single-use consumable feeding tube products. The more procedures, the more consumables. The more hospitals are covered by our network, the broader that recurring base becomes.

This is the same underlying logic behind well-known platform business models where the installed asset creates a durable, ongoing revenue stream tied directly to customer utilization. In our case, the clinical need is not discretionary. Patients require enteral feeding. Clinicians perform these procedures every day. On our platform, the consumables become an inherent part of that workflow.

As utilization grows within existing accounts and new hospitals come online, the compounding effect of this model is expected to become increasingly powerful. We anticipate that, over time, recurring revenue will become more visible, more predictable and more resilient.

Expanding the Platform: Multiple Growth Levers Ahead

We believe the long-term power of ENvue's system is centered in our software capabilities: we are able to upgrade capabilities within existing, already deployed hardware. While our immediate focus is scaling the core adult enteral access business, our technology has significant expansion potential:

Pediatric and neonatal applications. We are advancing development of a 5/6 FR feeding tube with ENvue's electromagnetic sensing technology, designed for pediatric and neonatal patients, which is a segment with its own substantial clinical need and currently no comparable real-time guidance solution.
X-ray navigation and PICC line guidance. We have cleared X-ray navigation capabilities and are advancing clinical validation for PICC line navigation, thereby expanding the addressable use cases for our platform within the hospital setting.

Beyond the Hospital

Patients often continue enteral support after discharge. To support continuity of care, we recently launched our over-the-counter ENFit Syringe line through our distribution partnership with U-Deliver, expanding the ENvue brand into non-acute channels and home care settings.

2026 Priorities

1. Accelerate ENvue Navigation Platform Adoption

With Marc Waldman leading our commercial team, our current priority is converting our pipeline of hospital opportunities into signed deployments and driving deeper utilization within our existing installed base. We plan to expand our geographic reach, grow within existing healthcare systems, and generate new business through clinical education and KOL engagement.

2. Advance Regulatory Milestones

We plan to continue to advance submissions for pediatric and PICC indications, initiate clinical validation studies for X-ray navigation capabilities, and engage key opinion leaders to build clinical momentum ahead of clearance milestones. Each new indication is expected to expand the total addressable opportunity for our existing installed base.

3. Scale At-Home and Non-Acute Enteral Solutions

The U-Deliver partnership is a major step in building ENvue's presence beyond the hospital. We will continue to pursue distribution partnerships and grow volume for our ENFit Syringe line, extending the ENvue brand into a market that serves patients after hospital discharge.

Acoustic Therapeutic Device Portfolio Diversifies Geographic and Product Sales

ENvue Medical operates an established acoustic therapeutic device portfolio, comprising PainShield® and UroShield®, which utilize our proprietary surface acoustic wave (SAW) technology to treat pain, reduce bacterial colonization, and disrupt biofilms. PainShield® is commercially sold in the U.S. and UroShield® is sold in the U.K. through select distributors. ENvue achieved a meaningful milestone in 2025 with the addition of the UroShield® Kit to the UK National Health Service Drug Tariff Part IX, enabling nationwide prescription reimbursement and supporting our initial commercial entry into the UK market through our exclusive distributor, Peak Medical.

We believe that maintaining and advancing the Acoustic Therapeutic Platform is strategically important. It broadens our product and geographic diversification, preserves valuable proprietary know-how, and creates additional commercial optionality, all of which we believe contribute to long-term stockholder value.

In conclusion, we believe ENvue Medical is positioned in 2026 to become a stronger company with clearer focus, expanding commercial traction, two proprietary technology platforms, and a disciplined strategy for growth. Our navigation platform addresses a meaningful clinical need in a large market; our acoustic platform adds diversification and strategic optionality, and our team remains focused on execution.

We are grateful for your continued support and look forward to updating you on our progress throughout the year.

Sincerely,

Doron Besser, MD

Chief Executive Officer

ENvue Medical, Inc.

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 adoption and implementation of ENvue Medical's platforms, anticipated commercial expansion, growth, scalability, and implementation of ENvue Medical's products, the success of ENvue's programs, market interest in the Company's technology, 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.

Investor Contact:

KCSA Strategic Communications

Valter Pinto, Managing Director

PH: (212) 896-1254

envue@kcsa.com

Media Contact:

KCSA Strategic Communications

Raquel Cona, Vice President

PH: (516) 779-2630

envue@kcsa.com

¹ Based on Company internal market analysis. The 13 million annual procedure estimate is derived from nasoenteral feeding tube sales data sourced from IQVIA (2022) and the American Hospital Association Annual Survey (2022). The 85% blind placement estimate is based on internal analysis of clinical practice patterns across U.S. hospital settings.

ENvue Issues Stockholder Letter & Provides Corporate Update