ENvue Medical, Formerly NanoVibronix, UroShield® Kit Secures Reimbursement in the UK
Rhea-AI Summary
ENvue Medical (NASDAQ:NAOV) announced that the UroShield Kit was added to the UK NHS Drug Tariff Part IX on Dec 18, 2025, establishing a nationwide prescription reimbursement pathway.
The company also secured an initial purchase order from Peak Medical, a UK distributor, providing early commercial demand signal and near-term revenue visibility heading into 2026. The UroShield Actuator was previously included in the Drug Tariff in 2023, and UroShield is intended to reduce catheter-associated urinary tract infections by applying low-frequency ultrasonic energy to catheters.
Positive
- Drug Tariff inclusion on Dec 18, 2025
- Initial purchase order received from Peak Medical (UK)
- Nationwide NHS prescription reimbursement pathway enabled
- Actuator previously included in Drug Tariff in 2023
Negative
- None.
Key Figures
Market Reality Check
Peers on Argus
Peers show mixed moves, with names like TIVC at -2.06%, VERO at -15.74%, and BBLG on the momentum scanner at about -6.75%, suggesting today’s weakness in NAOV is more stock-specific than a broad medical devices rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 19 | Shareholder letter | Positive | -8.8% | Outlined refocus on ENvue system and rebranding to ENvue Medical. |
| Sep 18 | Product launch | Positive | -4.0% | Launched Oscar training aid to support ENvue adoption and new revenue. |
| Sep 16 | Equity offering | Negative | -28.5% | Announced $2.0M registered direct offering to a single institutional investor. |
| Sep 15 | Patent grant | Positive | +64.9% | Secured U.S. patent for insertion device positioning guidance system. |
| Sep 04 | Patent grant | Positive | -4.9% | Announced U.S. patent for real-time imaging overlay navigation technology. |
Good-news announcements have often seen negative or muted price reactions, while dilutive financing and one IP update drew sharp moves, indicating inconsistent alignment between fundamentals and trading.
Over the past six months, the company has focused on building ENvue Medical, highlighted by new U.S. patents on navigation and imaging overlay technologies in early September 2025. A registered direct offering of $2.0 million on September 16, 2025 led to a sharp selloff, while a subsequent patent announcement produced a strong positive move. The November 19, 2025 shareholder letter outlined a strategic refocus and rebranding to ENvue Medical, yet the stock declined. Today’s UK reimbursement milestone fits the shift toward commercial execution in advanced therapeutic systems.
Regulatory & Risk Context
An active S-3/A shelf dated 2025-10-06 covers Series H shares convertible into common stock at $7.01 per share with a floor of $2.02. It lists Alpha Capital Anstalt as a selling stockholder and includes potential dividend shares, indicating capacity for future registered resales or issuances under this shelf.
Market Pulse Summary
This announcement marks a key commercial milestone, adding the UroShield Kit to the NHS Drug Tariff Part IX and enabling prescription reimbursement across UK care settings. It builds on prior strategic steps, including ENvue-focused patents and a corporate rebranding. Investors may track actual order flow from Peak Medical, adoption trends in long-term catheterized patients where prevalence is around 6–7%, and any future use of the existing S-3/A shelf registration as indicators of execution and capital needs.
Key Terms
catheter-associated urinary tract infections medical
biofilm medical
ultrasonic energy technical
AI-generated analysis. Not financial advice.
Peak Medical, ENvue’s Exclusive Distributor in UK, Places Significant Order after Reimbursement Decision, Projecting Future Market Demand for UroShield® Kit
TYLER, Texas, Dec. 18, 2025 (GLOBE NEWSWIRE) -- ENvue Medical, Inc. (NASDAQ: FEED) (NASDAQ: NAOV) (“ENvue,” “ENvue Medical” or the “Company”), a medical technology company specializing in non-invasive therapeutic systems, today announced that the UroShield® Kit has been added to the UK National Health Service (NHS) Drug Tariff Part IX, enabling nationwide prescription reimbursement across the UK.
In parallel with this reimbursement milestone, ENvue Medical has secured an initial purchase order from Peak Medical, a leading UK-based distributor specializing in stoma care and urology medical devices with a vast network of hospitals and community settings, reflecting early commercial demand following NHS Drug Tariff inclusion.
The NHS Drug Tariff Part IX establishes a direct, prescription-based reimbursement pathway, significantly expanding access for the UroShield® Kit, which is used in conjunction with the UroShield® Actuator that was previously included in the NHS Drug Tariff Part IX in the UK in 2023, across community and hospital care settings. Long-term urinary catheterization is common in the UK, with published studies indicating catheter prevalence of approximately 6–
UroShield® is a non-invasive device designed to reduce catheter-associated urinary tract infections (CAUTIs) and catheter blockages by applying low-frequency ultrasonic energy to the catheter, helping to inhibit biofilm formation. CAUTIs are among the most common device-associated healthcare-acquired infections globally.²,³
“This represents a meaningful commercial and reimbursement inflection point for UroShield,” said Doron Besser, MD, Chief Executive Officer of ENvue Medical. “Drug Tariff inclusion removes a major reimbursement barrier and enables scalable NHS prescribing. The initial purchase order provides early revenue visibility heading into 2026 and is a first step in establishing our presence in European markets where reimbursement-driven access models and large catheterized patient populations may support future expansion. Our team will continue to assess reimbursement frameworks and market access pathways in select European countries as part of our longer-term portfolio strategy.”
Auriol Lawson, Managing Director of Peak Medical Ltd., said, “We are excited to partner with ENvue Medical after confirmation of this critically important reimbursement milestone for the UroShield® Kit. The addition to the NHS Drug Tariff Part IX opens up prescription reimbursement access for patients across the UK and allows us to bring to market leading technology that addresses significant challenges of catheter-associated urinary tract infections and side effects in our hospitals and communities. We remain committed to supporting our healthcare system in the UK with innovative, non-invasive solutions to improve patient outcomes such as the UroShield® Kit.”
References
- Czwikla J, et al. Prevalence of indwelling urinary catheters in nursing home residents (Int J Nurs Stud. 2023) - NHS nursing home catheter prevalence: UK ~
6.9% , Germany ~10.2% - Czwikla J, Schmiemann G, Hoffmann F. Use of indwelling urinary catheters in German nursing homes (BMC Urology, 14 Jun 2024) - German catheter prevalence
13.4% - CDC. Catheter-associated urinary tract infection (CAUTI) basics (CDC.gov, updated June 27, 2025) - CAUTIs are one of the most common healthcare-associated infections
About ENvue Medical, Inc.
ENvue Medical, Inc. (NASDAQ: FEED) 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 Tel-Aviv and 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 Holdings, Corp., 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.
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 Company’s proposed name and symbol change, 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
Valter@KCSA.com
SOURCE: ENvue Medical, Inc.
FAQ
What did ENvue Medical (NAOV) announce on Dec 18, 2025 about UroShield?
How does the NHS Drug Tariff Part IX listing affect UroShield access for NAOV?
Did ENvue (NAOV) secure any orders after the UK reimbursement decision?
What clinical problem does UroShield address for NAOV investors?
How does the 2023 actuator listing relate to the Dec 18, 2025 announcement for NAOV?
What near-term commercial impact did ENvue (NAOV) cite from the UK reimbursement?
