TYLER, Texas, April 16, 2026 (GLOBE NEWSWIRE) — ENvue Clinical, Inc. (NASDAQ: FEED) (“ENvue,” “ENvue Medical” or the “Company”), a clinical era corporate focusing on the development of clever, non-invasive answers for enteral care throughout scientific and residential care settings, nowadays issued the next stockholder letter and company replace:
Expensive Stockholders,
2025 used to be a transformative yr for ENvue Clinical. As of late, our Corporate is a commercially lively medtech industry buying and selling at the Nasdaq Capital Marketplace beneath the ticker “FEED.” ENvue’s project is to strengthen affected person protection and scientific workflow thru proprietary applied sciences that ship real-time steering, clever navigation, and non-invasive healing answers.
Over the last three hundred and sixty five days, we imagine we’ve got reinforced our management staff, deepened our scientific footprint, complicated our highbrow assets portfolio, and sharpened our strategic center of attention.
We entered 2026 with two differentiated proprietary era platforms:
ENvue Navigation Platform for enteral get entry to and long term clinic programs; andAcoustic Healing Platform for non-invasive remedy and biofilm-related programs.
We imagine this dual-platform construction will supply us with each expansion alternatives and industry diversification, strengthening our go-to-market technique and definitely impacting earnings potentialities.
Our ENvue Navigation Platform is now commercially deployed throughout 39 U.S. hospitals, producing ordinary earnings and turning into embedded within the day-to-day workflows of clinicians who depend on it. We additionally proceed to advance our Acoustic Healing Platform thru PainShield® and UroShield®, holding precious era, advertisement relationships and long term optionality for stockholders.
Why This Marketplace? Why Now?Feeding tube placement is without doubt one of the maximum regularly carried out procedures in hospitals, happening greater than 13 million instances every year in america by myself, but 85% of placements in america are carried out blindly, with none real-time visible steering.1 These days, clinicians advance the feeding tube down the trachea to position it within the abdomen after which look forward to an X-ray to be carried out and for the radiology division to substantiate correct placement sooner than affected person vitamin can start. In fashionable hospitals, this procedure represents a considerable drain on each time and fiscal assets, using efforts to reduce each and every.
The scientific and operational pressure on hospitals is construction and compounding:
Affected person protection mandates are tightening. Pulmonary misplacement, the place a tube enters the lung mistakenly as an alternative of the tummy, is a preventable, however doubtlessly deadly tournament. Hospitals are beneath rising drive to get rid of some of these adversarial results.
Staffing shortages imply extra procedures are carried out by way of much less skilled clinicians, with much less oversight on the bedside, making technique-dependent placements inherently extra variable in end result. Gear that cut back technique-dependence and enhance constant results are a scientific necessity.
Imaging bottlenecks are slowing affected person care. When X-ray affirmation is needed after each blind placement, radiology queues develop and sufferers wait hours sooner than feeding can start. That extend has measurable penalties for restoration.
Value drive is unrelenting. Headaches from out of place tubes power prolonged clinic remains, require repeat imaging, and doubtlessly further procedures. Anything else that reduces complication charges and streamlines workflow contributes without delay to a clinic’s final analysis.
ENvue believes it addresses all 4 of those demanding situations thru a unmarried, real-time electromagnetic steering platform offering clinicians steady, bedside visualization of tube place during the position, no longer after. We cut back the wish to look forward to 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 Fast Reaction, ICU RN, U.S. Clinic
Construction the Basis for the Long run
We imagine we took the vital steps in 2025 to construct our basis for the following section of expansion:
First, we reinforced our management: Construction a commercial-stage medtech corporate calls for the best other people to release the best era. In January 2026, we appointed Marc Waldman as Vice President, Industrial, bringing skilled medtech management to power our U.S. gross sales enlargement. In 2025, we welcomed David Johnson as Chairman of the Board, including deep healthcare business experience on the company governance degree.
2d, we grew our put in base: The ENvue Navigation Platform is now commercially deployed throughout 40 U.S. hospitals. We imagine that each and every set up represents a possible long-term scientific courting, and ordinary orders from present accounts proceed to validate the product’s stickiness and the workflow price it delivers.
3rd, we constructed a powerful gross sales pipeline: Translating scientific hobby into signed clinic agreements takes effort and time. Over the last yr, we’ve got constructed the pipeline infrastructure, gross sales technique, and funnel control self-discipline that positions us to transform 2026 alternatives successfully.
Fourth, we secured a vital IP milestone: In February 2026, the USPTO issued a Understand of Allowance for our patent masking a feeding tube design that integrates electromagnetic navigation with a distal-tip digicam, enabling each positional steering and direct interior visualization in one tool. We imagine this represents the following era of clever, visualized placement, and it meaningfully strengthens our IP place.
A Trade Type Constructed for Compounding Expansion
As ENvue’s put in base grows, our earnings fashion grows with it, and it does so in some way that turns into extra predictable and, we imagine, sturdy over the years.
Every device ENvue puts in a clinic is designed to determine a long-term buyer courting. Our feeding tubes are uniquely designed for the ENvue Navigation Platform, so each feeding tube process carried out the usage of that device is predicted to power ordinary call for for our single-use consumable feeding tube merchandise. The extra procedures, the extra consumables. The extra hospitals are lined by way of our community, the wider that ordinary base turns into.
This is similar underlying common sense in the back of well known platform industry fashions the place the put in asset creates a sturdy, ongoing earnings move tied without delay to buyer usage. In our case, the scientific want isn’t discretionary. Sufferers require enteral feeding. Clinicians carry out those procedures each day. On our platform, the consumables grow to be an inherent a part of that workflow.
As usage grows inside of present accounts and new hospitals come on-line, the compounding impact of this fashion is predicted to grow to be an increasing number of robust. We watch for that, over the years, ordinary earnings will grow to be extra visual, extra predictable and extra resilient.
Increasing the Platform: A couple of Expansion Levers Forward
We imagine the long-term energy of ENvue’s device is targeted in our instrument features: we’re ready to improve features inside of present, already deployed {hardware}. Whilst our quick center of attention is scaling the core grownup enteral get entry to industry, our era has important enlargement doable:
Pediatric and neonatal programs. We’re advancing construction of a 5/6 FR feeding tube with ENvue’s electromagnetic sensing era, designed for pediatric and neonatal sufferers, which is a section with its personal really extensive scientific want and lately no similar real-time steering resolution.X-ray navigation and PICC line steering. Now we have cleared X-ray navigation features and are advancing scientific validation for PICC line navigation, thereby increasing the addressable use instances for our platform inside the clinic surroundings.
Past the Clinic
Sufferers regularly proceed enteral enhance after discharge. To enhance continuity of care, we lately introduced our over the counter ENFit Syringe line thru our distribution partnership with U-Ship, increasing the ENvue logo into non-acute channels and residential care settings.
2026 Priorities
1. Boost up ENvue Navigation Platform AdoptionWith Marc Waldman main our advertisement staff, our present precedence is changing our pipeline of clinic alternatives into signed deployments and using deeper usage inside of our present put in base. We plan to increase our geographic achieve, develop inside of present healthcare methods, and generate new industry thru scientific training and KOL engagement.
2. Advance Regulatory MilestonesWe plan to proceed to advance submissions for pediatric and PICC indications, start up scientific validation research for X-ray navigation features, and have interaction key opinion leaders to construct scientific momentum forward of clearance milestones. Every new indication is predicted to increase the full addressable alternative for our present put in base.
3. Scale At-House and Non-Acute Enteral SolutionsThe U-Ship partnership is a significant step in construction ENvue’s presence past the clinic. We can proceed to pursue distribution partnerships and develop quantity for our ENFit Syringe line, extending the ENvue logo right into a marketplace that serves sufferers after clinic discharge.
Acoustic Healing Instrument Portfolio Diversifies Geographic and Product Gross sales
ENvue Clinical operates a longtime acoustic healing tool portfolio, comprising PainShield® and UroShield®, which make the most of our proprietary floor acoustic wave (SAW) era to regard ache, cut back bacterial colonization, and disrupt biofilms. PainShield® is commercially offered within the U.S. and UroShield® is offered within the U.Ok. thru make a choice vendors. ENvue completed a significant milestone in 2025 with the addition of the UroShield® Equipment to the United Kingdom Nationwide Well being Carrier Drug Tariff Section IX, enabling national prescription repayment and supporting our preliminary advertisement access into the United Kingdom marketplace thru our unique distributor, Top Clinical.
We imagine that keeping up and advancing the Acoustic Healing Platform is strategically essential. It broadens our product and geographic diversification, preserves precious proprietary technology, and creates further advertisement optionality, all of which we imagine give a contribution to long-term stockholder price.
In conclusion, we imagine ENvue Clinical is located in 2026 to grow to be a more potent corporate with clearer center of attention, increasing advertisement traction, two proprietary era platforms, and a disciplined technique for expansion. Our navigation platform addresses a significant scientific want in a big marketplace; our acoustic platform provides diversification and strategic optionality, and our staff stays serious about execution.
We’re thankful on your persevered enhance and stay up for updating you on our growth during the yr.
Sincerely,Doron Besser, MDChief Govt OfficerENvue Clinical, Inc.
About ENvue Clinical, Inc.ENvue Clinical, Inc. (NASDAQ: FEED) is a clinical era corporate focusing on the development of clever, non-invasive answers for enteral care throughout scientific and residential care settings. Headquartered in Tyler, Texas, with analysis and construction in Tel-Aviv and Nesher, Israel, the Corporate makes a speciality of two distinct era platforms:
ENvue™ Navigation Platform, evolved and operated by way of ENvue Clinical Inc., with workplaces in Arlington Heights, Illinois, and Tel-Aviv, Israel, is a minimally invasive electromagnetic navigation device supposed to lend a hand clinicians in hanging feeding tubes into the gastrointestinal tract. FDA 510(ok) cleared for grownup use, ENvue supplies real-time bedside visualization of tube motion and helps knowledgeable decision-making all the way through the position process. Long run platform enlargement might come with pediatric and vascular get entry to programs.ENvue Clinical objectives to advance requirements in non-invasive treatment and minimally invasive navigation, with a dedication to affected person protection, scientific usability, and era innovation throughout a variety of healthcare environments.Acoustic-based healing applied sciences, together with PainShield® and UroShield®, which make the most of proprietary low-intensity floor acoustic wave (SAW) era. Those units are supposed to be used in house or care settings and are designed to regard ache, cut back bacterial colonization, and disrupt biofilms.
Ahead-Having a look StatementsThis press free up accommodates “forward-looking statements.” Such statements is also preceded by way of the phrases “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or identical phrases. Those forward-looking statements come with however don’t seem to be restricted to: statements in regards to the adoption and implementation of ENvue Clinical’s platforms, expected advertisement enlargement, expansion, scalability, and implementation of ENvue Clinical’s merchandise, the luck of ENvue’s techniques, marketplace hobby within the Corporate’s era, and long term expectancies for strategic expansion. Ahead-looking statements don’t seem to be promises of long term efficiency, are in response to positive assumptions, and are topic to more than a few identified and unknown dangers and uncertainties, a lot of that are past the Corporate’s keep watch over and can’t be predicted or quantified; as a result, precise effects might range materially from the ones expressed or implied by way of such forward-looking statements. Such dangers and uncertainties come with, with out limitation: (i) marketplace acceptance of the Corporate’s present and new merchandise; (ii) scientific efficiency and operational results; (iii) delays or headaches in product implementation; (iv) intense festival within the clinical tool business; (v) product legal responsibility or efficiency problems; (vi) barriers in production or provide chain features; (vii) repayment barriers; (viii) highbrow assets coverage; (ix) healthcare regulatory adjustments within the U.S. and in a foreign country; and (x) the desire for extra capital. Extra detailed details about the Corporate and the chance components that can have an effect on the conclusion of forward-looking statements is about forth within the Corporate’s filings with the Securities and Alternate Fee (“SEC”), together with the Corporate’s Annual Document on Shape 10-Ok, Quarterly Studies on Shape 10-Q, and Present Studies on Shape 8-Ok. Traders and safety holders are suggested to learn those paperwork for free at: www.sec.gov. The Corporate assumes no legal responsibility to publicly replace or revise its forward-looking statements on account of new knowledge, long term occasions, or differently, with the exception of as required by way of legislation.
1 In accordance with Corporate interior marketplace research. The 13 million annual process estimate is derived from nasoenteral feeding tube gross sales information sourced from IQVIA (2022) and the American Clinic Affiliation Annual Survey (2022). The 85% blind placement estimate is in response to interior research of scientific apply patterns throughout U.S. clinic settings.
