UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the fiscal year ended December 31, 2025
OR
☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from to
Commission
File Number: 001-36445
ENvue
Medical, Inc.
(Exact
name of registrant as specified in its charter)
(Address of principal executive office) (Zip Code)
Registrant’s
telephone number, including area code: (914)233-3004
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol Name of each exchange on which registered
Common stock, par value $0.001 per share FEED NASDAQ Capital Market
Securities
registered pursuant to Section 12(g) of the Act: None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. ☐
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The
aggregate market value of voting stock held by non-affiliates as of June 30, 2025, the last business day of the registrant’s most
recently completed second quarter and based on the closing price of the registrant’s common stock as reported on the Nasdaq Capital
Market, was approximately $7.3 Million.
The
number of shares outstanding of the registrant’s common stock as of April 15, 2026, was 3,700,908 shares.
DOCUMENTS
INCORPORATED BY REFERENCE
None.
TABLE
OF CONTENTS
PART I. 1
ITEM 1: BUSINESS 1
ITEM 1A: RISK FACTORS 41
ITEM 1B: UNRESOLVED STAFF COMMENTS 75
ITEM 1C: CYBERSECURITY 75
ITEM 2: PROPERTIES 76
ITEM 3: LEGAL PROCEEDINGS 77
ITEM 4: MINE SAFETY DISCLOSURES 78
PART II. 79
ITEM 6: [RESERVED] 80
ITEM 7A: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 87
ITEM 8: FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 87
ITEM 9A: CONTROLS AND PROCEDURES 88
ITEM 9B: OTHER INFORMATION 90
ITEM 9C: Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 90
PART III. 91
ITEM 10: DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE 91
ITEM 11: EXECUTIVE COMPENSATION 97
ITEM 14: PRINCIPAL ACCOUNTANT FEES AND SERVICES 113
PART IV.
ITEM 15: EXHIBITS, FINANCIAL STATEMENT SCHEDULES 114
i
EXPLANATORY
NOTE
On
February 14, 2025, subsequent to the end of the fiscal year ended December 31, 2024, the fiscal year to which this Annual Report on Form
10-K relates and as further described herein, pursuant to the terms of that certain Agreement and Plan of Merger, dated as of February
14, 2025 (the “Merger Agreement”), by and among ENvue Medical, Inc. (formerly NanoVibronix, Inc.) (the “Company”)
NVEH Merger Sub I, Inc., a Delaware corporation and a wholly-owned subsidiary of the Company (“First Merger Sub I”), NVEH
Merger Sub II, LLC, a Delaware limited liability company and a wholly-owned subsidiary of the Company (“Second Merger Sub”),
and ENvue Medical Holdings LLC (“Predecessor ENvue”), the Company and Predecessor ENvue effected (i) a merger of First Merger
Sub with and into Predecessor ENvue, with the First Merger Sub ceasing to exist and Predecessor ENvue becoming a wholly-owned subsidiary
of the Company and (ii) the merger of Predecessor ENvue with and into Second Merger Sub (the “Second Merger” and, together
with the First Merger, the “Merger”), with Second Merger Sub being the surviving entity of the Second Merger (“Surviving
Entity”). At the effective time of the Second Merger, the certificate of formation of the Surviving Entity was amended and restated
to, among other things, to change the name of the Surviving Entity to “ENvue Medical Holdings LLC.”
ii
Cautionary
Note Regarding Forward-Looking Statements
This
Annual Report on Form 10-K contains “forward-looking statements,” which include information relating to future events, future
financial performance, financial projections, strategies, expectations, competitive environment and regulation. Words such as “may,”
“should,” “could,” “would,” “predicts,” “potential,” “continue,”
“expects,” “anticipates,” “future,” “intends,” “plans,” “believes,”
“estimates,” and similar expressions, as well as statements in future tense, are intended to identify forward-looking statements.
Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of
when such performance or results will actually be achieved. Forward-looking statements are based on information we have when those statements
are made or our management’s good faith belief as of that time with respect to future events, and are subject to a number of risks,
and uncertainties and assumptions that could cause actual performance or results to differ materially from those expressed in or suggested
by the forward-looking statements. These risks are more fully described in the “Risk Factors” section of this Annual Report
on Form 10-K. Important factors that could cause such differences include, but are not limited to:
● Our history of losses and expectation of continued losses.
● Market acceptance of existing and new products.
● Risks of product liability acclaims and the availability of insurance.
● Our ability to generate internal growth.
● Risks related to computer system failures and cyber-attacks.
● Our ability to obtain regulatory approval in foreign jurisdictions.
● The price of our securities is volatile with limited trading volume.
iii
● The adoption of health policy changes and health care reform.
● Lack of financial resources to adequately support our operations.
● Changes in our relationship with key collaborators.
● Our failure to comply with regulatory guidelines.
● Uncertainty in industry demand and patient wellness behavior.
● Depth of the trading market in our common stock.
The
foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or
risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements.
Please see “Item 1A. Risk Factors” for additional risks which could adversely impact our business and financial performance.
Moreover, new risks regularly emerge, and it is not possible for us to predict or articulate all risks we face, nor can we assess the
impact of all risks on our business or the extent to which any risk, or combination of risks, may cause actual results to differ from
those contained in any forward-looking statements. All forward-looking statements included in this Annual Report on Form 10-K are based
on information available to us on the date hereof. Except to the extent required by applicable laws or rules, we undertake no obligation
to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Unless
the context otherwise indicates or requires, the terms “we,” “our,” “us,”, “ENvue”,
“NanoVibronix,” and the “Company,” as used in this Annual Report on Form 10-K, refer to ENvue Medical, Inc.
and its subsidiaries as a combined entity, except where otherwise stated or where it is clear that the terms mean only ENvue
Medical, Inc. exclusive of its subsidiaries.
Trademarks
We
have proprietary rights to certain trademarks used in this Annual Report on Form 10-K that are important to our business, some of which
are registered under applicable intellectual property laws, including but not limited to UroShieldTM, PainShieldTM MD, PainShieldTM
Plus, WoundShieldTM, UroShield®, PainShield®, PainShield Plus®, WoundShield®, UroShield®, NanoVibronix®,
ENvue Medical, ENsump, ENvue, ENgat, ENvue (wordmark and logo), and ENvue’s logo in key countries, including the U.S., Europe,
and China.
Solely
for convenience, trademarks and trade names referred to in this Annual Report appear without the “®” or “TM”
symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent possible under
applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or
display of other companies’ trademarks, trade names or service marks to imply a relationship with, or endorsement or sponsorship
of us by, any other companies. Each trademark, trade name or service mark of any other company appearing in this Annual Report on Form
10-K is the property of its respective holder.
iv
PART
I
ITEM
1. BUSINESS
Overview
ENvue
Medical, Inc. (the “Company”), formerly known as NanoVibronix, Inc., was incorporated as a Delaware corporation in
October 2003. In December 2025, the Company changed its name from NanoVibronix, Inc. to ENvue Medical, Inc. Prior to such a name
change, on February 14, 2025, the Company consummated and completed its merger (the “Merger”) pursuant to the Agreement
and Plan of Merger, dated as of February 14, 2025 (the “Merger Agreement”), as further described herein. Following the
consummation of the Merger, the Company conducts its operations through two wholly-owned subsidiaries: (i) NanoVibronix Ltd.
(“Nano OpCo”), a private company incorporated under the laws of the State of Israel, which focuses on non-invasive,
biological response-activating medical devices targeting biofilm prevention and pain therapy, designed for home use without the need
for medical professional assistance; and (ii) ENvue Medical Holdings LLC, a Delaware limited liability company, which is a medical
device company engaged in the research, development, production, marketing, and sale of medical devices in the field of enteral
feeding, currently in the initial growth stage of commercialization. Further descriptions of each business division, their
respective products, and business models are set forth below.
The
Merger Agreement
On
February 14, 2025, pursuant to the terms of that certain Agreement and Plan of Merger (as amended, restated, amended and restated, supplemented
or modified from time to time, the “Merger Agreement”), dated as of February 14, 2025, by and among us, NVEH Merger Sub I,
Inc., a Delaware corporation and a wholly-owned subsidiary of the Company (“First Merger Sub”), NVEH Merger Sub II, LLC,
a Delaware limited liability company and a wholly-owned subsidiary of the Company (“Second Merger Sub”), and ENvue Medical
Holdings, Corp. (“Predecessor ENvue” or “ENvue”), the Company and Predecessor ENvue effected (i) a merger of
First Merger Sub with and into Predecessor ENvue, with the First Merger Sub ceasing to exist and Predecessor ENvue becoming a wholly-owned
subsidiary the Company (the “First Merger”, and effective time of such First Merger, the “First Effective Time”)
and (ii) the merger of Predecessor ENvue with and into Second Merger Sub (the “Second Merger” and, together with the First
Merger, the “Merger”), with Second Merger Sub being the surviving entity of the Second Merger (“Surviving Entity”).
At the effective time of the Second Merger, the certificate of formation of the Surviving Entity was amended and restated to, among other
things, to change the name of the Surviving Entity to “ENvue Medical Holdings LLC.” In connection with the Merger Agreement,
we issued (i) 3,318 shares of common stock (the “Merger Shares”), which such number of shares represented no more than 4.9%
(the “Exchange Cap”) of the outstanding shares of common stock as of immediately before the First Effective Time and (ii)
Pre-Funded Warrants to purchase up to 12,526 shares of our common stock (the “Merger Pre-Funded Warrants”) at an exercise
price of $0.001 per share, and (iii) 57,720 shares of Series X Non-Voting Convertible Preferred Stock (the “Series X Preferred
Stock”) in excess of the Exchange Cap to the holders of Predecessor ENvue in consideration for 100% of Predecessor ENvue.
2025
Reverse Stock Splits
On
March 12, 2025, the Company filed a Certificate of Amendment to its Certificate of Incorporation with the Secretary of State of Delaware
to effect a 1-for-11 reverse stock split of the shares of its common stock either issued and outstanding or held by the Company as treasury
stock, effective as of 4:05 p.m. (Delaware time) on March 13, 2025 (the “March 2025 Reverse Stock Split”).
On
August 8, 2025, the Company filed a Certificate of Amendment to its Certificate of Incorporation with the Secretary of State of Delaware
to effect a 1-for-10 reverse stock split of the shares of its common stock either issued and outstanding or held by the Company as treasury
stock, effective as of 4:05 p.m. (Delaware time) on August 11, 2025 (the “August 2025 Reverse Stock Split” and together with
the March 2025 Reverse Stock Split, the “Reverse Stock Splits”).
ENvue’s
Business
ENvue
is a medical device company engaged in the research, development, production, marketing, and sale of medical devices in the field of
enteral feeding and is in the growth stage of commercializing its products. Guided by its mission to be an innovation leader in the field
of enteral feeding, ENvue is focused on improving patient outcomes across the continuum of care, encompassing the development of advanced,
personalized navigation solutions, responding to the challenges of the ever-hanging healthcare environment, while continuously focusing
on the customer. The medical device marketed and sold by ENvue is the FDA 510(k)-cleared ENvue System, which assists in the insertion
of a feeding tube into the digestive system of patients requiring nutrition during hospitalization through intra-body navigation (the
“ENvue System”).
The
most common way to provide nutrition to patients during hospitalization is through a feeding tube inserted through the nose or mouth
into the stomach or small intestine (known as “enteral nutrition”). Around 43 million feeding tubes are inserted annually
worldwide (Enteral feeding devices, Global forecast to 2025; Market & Markets (“Markets & Markets”)). Between 2-5%
of these tubes are placed in the lungs leading to a 30% chance of a collapsed lung or possible fatality (Aguilar-Nascimento, Kudsk, JPEN
J Parenter Enteral Nutr 2007; Bourgault, Margo Halm Am J Crit Care. 2009). Furthermore, between 20-50% of hospital patients (Bellanti,
Francesco, et al. “Malnutrition in hospitalized old patients: screening and diagnosis, clinical outcomes, and management.”
Nutrients 14.4 (2022): 910.), including those in the intensive care unit (“ICU”), are malnourished, with malnutrition having
a significant impact on both clinical outcomes and healthcare systems.
Recognizing
the critical need for early feeding in small bowel and lower the risk of tube misplacement, ENvue applied its expertise in electromagnetic
navigation and enteral feeding to develop the ENvue System. The ENvue System, together with a dedicated feeding tube for the system,
positioning sensors, and other components developed by ENvue, is designed to efficiently and safely insert the feeding tube into the
patient’s digestive system for the purpose of providing nutrition. Furthermore, ENvue’s solution aims to provide faster nutrition
delivery to the patient, potentially improving their condition, and facilitating the insertion of the feeding tube into the small intestine,
which we believe has advantages over insertion into the stomach. ENvue believes that the ENvue System offers an efficient solution for
feeding tube insertion and has the ability to transform enteral feeding tube insertion.
In
February 2019, ENvue received 510(k) market clearance from U.S. Food and Drug Administration for the commercial marketing and sale
of the ENvue System in the United States for use in adults (aged 22 and over)1. During the first quarter of 2020, ENvue
began marketing and selling the ENvue System and its dedicated feeding tubes, and it is currently in the initial growth
commercialization phase of these products in the U.S.
1
According to FDA guidelines, an adult is defined as a person who is 22 years of age or older.
ENvue
Strategy
ENvue’s
strategy is focused on improving the safety, efficiency, and reliability of enteral feeding tube placement and management through the
development and commercialization of navigation-enabled medical devices and related disposable products. The Company is developing a
platform intended to assist clinicians in the real-time placement and verification of enteral feeding tubes, addressing longstanding
clinical challenges associated with traditional placement methods that may rely on blind insertion techniques and subsequent confirmation
procedures.
The
Company’s current commercial efforts are primarily focused on the United States acute care hospital market. ENvue is in the growth
commercialization phase of the ENvue System, a navigation platform designed to provide clinicians with real-time guidance during
feeding tube placement. The system is used in conjunction with proprietary disposable enteral feeding tubes designed to integrate with
the platform.
In
addition to feeding tubes, the Company offers enteral feeding accessories, including syringes and other related products intended to
support enteral feeding procedures. The Company’s business model includes the sale of the navigation system together with recurring
sales of disposable products used in connection with clinical procedures.
As
of the date of this Annual Report on Form 10-K, ENvue has established commercial engagements with multiple hospitals in the United States
for the evaluation, implementation, and clinical use of the ENvue System and related disposable enteral feeding tubes and accessories.
The Company’s commercialization strategy includes expanding its sales, marketing, and clinical education activities to support
increased adoption of the system and its associated disposable products across hospital intensive care units and other clinical settings
where enteral feeding procedures are performed.
Over
time, the Company intends to broaden the capabilities of its navigation platform and expand its product portfolio to address additional
clinical applications related to enteral access and other intrabody navigation procedures. In addition, ENvue may seek to expand its
commercialization activities into additional international markets, subject to obtaining applicable regulatory approvals and establishing
appropriate distribution and commercialization infrastructure.
ENvue
Products
I. Enteral Feeding - General Background
Enteral
feeding is the most common method of providing liquid nutrition and certain types of medications to critically ill patients who are hospitalized
and require nutritional support, such as those on ventilators, post-surgery patients, patients with disabilities or conditions that prevent
them from eating fully or partially, and premature infants (Welch, Teresa D. “Nutrition options in critical care unit patients.”
Critical Care Nursing Clinics 30.1 (2018): 13-27 (“Welch 2018”); Milsom, S. A., et al. “Naso-enteric tube placement:
a review of methods to confirm tip location, global applicability and requirements.” World journal of surgery 39 (2015): 2243-2252
(“Milsom 2015”); de Aguilar-Nascimento, José Eduardo, and Kenneth A. Kudsk. “Use of small-bore feeding tubes:
successes and failures.” Current Opinion in Clinical Nutrition & Metabolic Care 10.3 (2007): 291-296 (“de Aguilar-Nascimento
and Kudsk 2007”); Koyfman, Leonid, et al. “The Placement of Post-pyloric Feeding Tubes Using DRX-Revolution Mobile X-Ray
System in an ICU. A Case Series.” The Journal of Critical Care Medicine 2.3 (2016): 131-134). The prevalence of malnutrition among
critically ill patients ranges from 30% to 50%, with some patients arriving at the hospital already malnourished and others potentially
developing malnutrition during hospitalization (Market & Markets; Barker, Lisa A., Belinda S. Gout, and Timothy C. Crowe. “Hospital
malnutrition: prevalence, identification and impact on patients and the healthcare system.” International journal of environmental
research and public health 8.2 (2011): 514-527; Wischmeyer, Paul E. “Malnutrition in the acutely ill patient: is it more than just
protein and energy?” South African Journal of Clinical Nutrition 24.3 (2011): S1-S7). It should be noted that there are critically
ill patients who, due to their medical condition, are unable to receive regular nutrition for many days.
Delays
in providing nutrition to patients can lead to a deterioration in their condition, as early insertion of the feeding tube and timely
provision of nutrition can, in most cases, reduce the severity of the illness, help preserve the integrity of the intestinal lining,
reduce infections and complications, improve gastrointestinal motility, and enhance immune response (Wang, Honggang, et al. “Early
enteral nutrition reduced postoperative ileus and improved the outcomes in patients with emergency intestinal surgery: results from a
propensity score analysis.” Int J Clin Exp Med 10.4 (2017): 7040-7048). Moreover, early provision of nutrition may improve the
patient’s condition and recovery rate, reduce possible complications, shorten the stay in intensive care, and even lower mortality
rates (Welch 2018). Consequently, early provision of nutrition may also result in significant cost savings for the hospital. Therefore,
in cases where regular nutrition cannot be provided to the patient and enteral feeding is required, it should be provided as soon as
possible (within 24-48 hours).
Enteral
nutrition is administered, among other methods, by inserting a feeding tube through the patient’s nose or mouth into the stomach
or small intestine (Tatsumi, Hiroomi. “Enteral tolerance in critically ill patients.” Journal of intensive care 7.1 (2019):
30 (“Tatsumi 2019”)). Each year, approximately 43 million nasogastric feeding tubes are inserted worldwide (about 14 million
of them in the United States) (Market & Markets). In general, according to FDA guidelines, a feeding tube inserted into a patient
should not remain in place for more than 30 days. However, hospitals tend to remove/replace the tube more frequently (for example, in
cases of tube blockage due to improperly dissolved medications or accidental disconnection of the tube by the patient).
Feeding
through a tube inserted through the patient’s nose or mouth directly into the patient’s small intestine (Post-Pyloric Feeding),
where nutrients are absorbed, requires more precise insertion of the tube, and offers several advantages over gastric feeding. Feeding
directly into the small intestine may reduce the risk of medical complications, involve a lower risk of gastric reflux and respiratory
infections and complications, provide higher caloric intake for the patient, and require a shorter stay in the intensive care unit (Welch
2018; Sajid, M. S., et al. “An integrated systematic review and meta-analysis of published randomized controlled trials evaluating
nasogastric against postpyloris (nasoduodenal and nasojejunal) feeding in critically ill patients admitted in intensive care unit.”
European journal of clinical nutrition 68.4 (2014): 424-432; Jiyong, Jing, et al. “Effect of gastric versus post-pyloric feeding
on the incidence of pneumonia in critically ill patients: observations from traditional and Bayesian random-effects meta-analysis.”
Clinical Nutrition 32.1 (2013): 8-15; Tatsumi 2019. As detailed below, the ENvue System is designed to facilitate the insertion of the
feeding tube through the patient’s nasal or oral route into the stomach or directly into the small intestine with accuracy and
efficiency.
Limitations
of Existing Alternative Enteral Feeding Methods
To
the best of ENvue’s knowledge, the most common method currently used for inserting feeding tubes through the nose or mouth is the
“blind” method, i.e., without visibility inside the patient’s body to facilitate accurate navigation and placement.
While for many years the “blind” insertion method was considered harmless, it has been found that this method can cause serious
and even fatal complications in patients (Market & Markets). Common complications among patients with feeding tubes inserted via
the “blind” method include incorrect insertion of the tube into the respiratory tract instead of the esophagus, aspiration
(entry of food, saliva, or stomach acids into the respiratory tract), lung collapse, sinus injuries, nosebleeds, and more (Rassias, Athos
J., Perry A. Ball, and Howard L. Corwin. “A prospective study of tracheopulmonary complications associated with the placement of
narrow-bore enteral feeding tubes.” Critical Care 2 (1998): 1-4; Prabhakaran, S., et al. “Nasoenteric tube complications.”
Scandinavian Journal of Surgery 101.3 (2012): 147-155 (“Prabhakaran 2012”)). According to studies, of the approximately 43
million feeding tubes inserted worldwide each year, about 1.72 million tubes are mistakenly inserted into patients’ lungs, and
of these, about 40% of patients suffered from pneumothorax (air accumulation in the chest cavity, impairing the breathing process) (de
Aguilar-Nascimento, Jose Eduardo, and Kenneth A. Kudsk. “Clinical costs of feeding tube placement.” Journal of Parenteral
and Enteral Nutrition 31.4 (2007): 269-273 (“de Aguilar-Nascimento 2007”); Burns, Suzanne M., et al. “Detection of
inadvertent airway intubation during gastric tube insertion: capnography versus a colorimetric carbon dioxide detector.” American
Journal of Critical Care 15.2 (2006): 188-195). Due to the high frequency of feeding tube use, experts believe that even a relatively
small percentage of cases where the feeding tube is incorrectly inserted could impact a very large number of people (Prabhakaran 2012).
Incorrect
insertion of the feeding tube into the lungs can have further serious consequences for the patient, including worsening of their medical
condition, which could lead to medical harm and even death, extended hospitalization, significant costs for the hospital, and legal claims
(de Aguilar-Nascimento 2007; Sparks, Dorothy A., et al. “Pulmonary complications of 9931 narrow-bore nasoenteric tubes during blind
placement: a critical review.” Journal of Parenteral and Enteral Nutrition 35.5 (2011): 625-629).
It
should be noted that due to technical failures and the prolonged time required for blind insertion of the feeding tube, attempts to insert
feeding tubes directly into the small intestine can result in delays in providing the necessary nutrition to the patient (as mentioned
above, providing early nutrition to the patient may improve their condition and prevent medical complications).
Given
the difficulties, risks, and possible complications associated with the blind insertion method of feeding tubes, as detailed above, the
duration of insertion, and the challenge of inserting it into the small intestine using this method, there is a noticeable trend towards
using alternative methods for inserting feeding tubes using technological or other means (Koopmann, Matthew C., et al. “A team-based
protocol and electromagnetic technology eliminate feeding tube placement complications.” Annals of surgery 253.2 (2011): 297-302
(“Koopman 2011”)), instead of relying on the blind insertion method, as detailed below.
There
are significant limitations in the existing alternative methods for inserting feeding tubes into patients and the various methods used
to verify that the blindly inserted feeding tube is located in the patient’s digestive system and not in the respiratory tract,
the main ones of which are detailed below.
Methods
for Verifying the Placement of a Blindly Inserted Feeding Tube
Among
the primary methods are measuring the distance of the tube from the insertion site, measuring the volume of aspirate, measuring the pH
level of the liquid aspirated from the tube (to check acidity levels to ensure it is gastric juices), checking the carbon dioxide level
of the air aspirated from the tube (to ensure the tube is not located in the lungs), and using an X-ray (fluoroscopy), with the latter
generally considered more accurate than the others (de Aguilar-Nascimento and Kudsk 2007; Milsom 2015). However, these methods may not
always identify errors accurately and in a timely manner, and they allow correction of incorrect insertion and placement of the tube
in the digestive system only after it has already been inserted into the lung, which may have caused pneumothorax or lung perforation
due to the insertion of the tube into the respiratory tract (Powers, Jan, et al. “Elimination of radiographic confirmation for
small-bowel feeding tubes in critical care.” American Journal of Critical Care 22.6 (2013): 521-527.). Furthermore, the X-ray method
has additional drawbacks, such as additional technical costs, prolonged time consumption, delayed patient nutrition, and radiation exposure.
Additionally, the pH measurement method has various limitations, such as respiratory burden and, primarily, inaccuracies due to medication
or other chemical treatment that affects the acidity level in the patient’s digestive system (Bourgault, Annette M., and Margo
A. Halm. “Feeding tube placement in adults: safe verification method for blindly inserted tubes.” American Journal of Critical
Care 18.1 (2009): 73-76).
II. The ENvue System
The
core application of ENvue’s operations is the ENvue System, which is a system for monitoring and correctly positioning feeding
tubes in patients who require nutritional support during hospitalization. The system includes the main unit (the system body), disposable
(consumable) ENvue Feeding Tubes designed exclusively for use with the system, sensors, and additional components developed by ENvue.
These components, when used together, are intended to facilitate more efficient, faster, and safer insertion of the feeding tube into
the patient’s digestive system. The system uses electromagnetic waves transmitted to the upper torso of the patient, utilizing
sensors embedded in the dedicated feeding tube and sensors attached to the patient’s body during the procedure, enabling monitoring
and control of the feeding tube’s insertion path in an effort to facilitate proper placement into the GI tract bypassing the airways.
It should be noted that using the ENvue System will not guarantee the absence of medical errors or adverse events in connection with
a feeding tube placement. For example, five serious adverse events have been reported in connection with tubes inserted in patients’
lungs or pulmonary airway using the ENvue System. After investigation and review of placement files, ENvue believes the reported serious
adverse events were caused by user error.
Product
Components and Features
The
system components are described in greater detail below:
During
the procedure, the other end of the tube is inserted through the nose into the patient’s body. A passive electromagnetic sensor
embedded in the tube allows the tube’s path within the patient’s body to be tracked on the system’s screen.
As
of now, ENvue’s feeding tube has been cleared in three different diameters: 8 Fr., 10 Fr., and 12 Fr.3
3
Fr. 1 = 0.3 mm.
ENvue
System Usage
The
ENvue System is used as follows: Throughout the feeding tube insertion procedure, the ENvue System emits electromagnetic waves toward
the patient’s upper body. Using the reference sensor connected to the system, the operator marks several anatomical points on the
patient’s upper body and attaches an additional location sensor to the side of the patient’s chest, allowing the system to
remain accurate even when the patient moves or coughs during the procedure. The operator then inserts the dedicated feeding tube for
the system through the patient’s nose or mouth into the esophagus and further into the digestive system (small intestine or stomach)
while viewing the tube’s path on the system’s screen from several angles and receiving real-time alerts if the system detects
the tube entering the patient’s airways, which is intended to enable the operator to immediately correct the tube’s insertion
path.
To
the best of ENvue’s knowledge, using the ENvue System allows the feeding tube insertion procedure to be completed within approximately
5-30 minutes on average, depending on the patient’s condition, the operator’s technical ability, and other factors. In comparison,
the time required for blind insertion of a feeding tube through the nose or mouth, based on ENvue’s estimate and medical research,
may take about 11-60 minutes (approximately 42 minutes on average) (Smithard, David, et al. “Electromagnetic sensor-guided enteral
access systems: a literature review.” Dysphagia 30 (2015): 275-285). Additionally, research shows that the time from blind insertion
of a feeding tube to the start of feeding the patient may take several hours, partly due to the need to verify the tube’s correct
placement in the digestive system using X-rays (Gray, Rebecca, et al. “Bedside electromagnetic-guided feeding tube placement: an
improvement over traditional placement technique?” Nutrition in Clinical Practice 22.4 (2007): 436-444).
Using
alternative methods as mentioned during the use of the ENvue System is not required by the FDA and is subject to the specific hospital’s
policy.
For
illustration purposes, below are diagrams demonstrating the use of the ENvue System:
Transmission
of electromagnetic waves by the system to the patient’s upper body throughout the procedure
Real-time
visualization of the feeding tube’s insertion path within the patient’s body from multiple angles
Receiving
an alert for the detection of improper insertion of the feeding tube
Marketing
Strategy
The
system, including the dedicated feeding tubes, is marketed to hospitals, and was designed and developed after ENvue received feedback
from healthcare professionals in the United States regarding their needs, which helped tailor the system to the market.
Using
the technology on which the system is based, it monitors the precise location of the feeding tube within the patient’s body, from
the moment it is inserted through the patient’s nose or mouth until it reaches the stomach or small intestine, and displays its
location in real-time through an imaging display of the patient’s body from several different angles on a screen. The display of
the patient’s body on the screen is made possible by using a reference sensor and marking anatomical landmarks on the patient’s
body at the beginning of the procedure.
In
cases where the system detects a deviation in the tube’s path towards the patient’s trachea, an immediate alert appears on
the screen. This allows the operator to correct the feeding tube’s insertion path immediately.
As
part of its operations ENvue has marketed the ENvue System to its customers and continuously supplied them with consumable feeding tubes,
which are designed for use exclusively with the system. At the beginning of 2020, ENvue began marketing the system and feeding tubes
to hospitals in the United States, following the FDA clearance received in February 2019 for marketing the product in this territory
for adults (aged 22 and older) only.
The
unique solution developed by ENvue as part of the ENvue System is intended to address, among other things, the risks and costs associated
with existing methods for inserting the feeding tube into the patient and the time required until the start of feeding due to delays
caused by the need to verify the tube’s placement in the patient, as described above. Using the ENvue System, including the dedicated
feeding tube developed by ENvue, it is possible to monitor the feeding tube insertion path into the patient and receive a real-time alert
if the tube is inserted into the patient’s respiratory tract. ENvue believes the system design may allow for accurate, reliable,
and efficient tube insertion for the patient and ease of use for the operator, which could potentially reduce the time required to insert
the feeding tube and thereby reducing the time until nutrition is provided to the patient.
4
The clinical trial lasted about a year, during which ENvue was required to obtain the consent of the patients or their family members
(depending on the patient’s medical condition) for participation in the trial.
Additionally,
ENvue believes using the system may minimize the risk of complications resulting from improper tube insertion and the associated costs
for the hospital, as well as shorten the patient’s hospitalization duration and prevent exposure to radiation from performing multiple
X-ray examinations to verify the tube’s placement. Furthermore, using the system screen that displays the patient’s body
dimensions, ENvue believes it is easier to properly insert the feeding tube into the patient’s small intestine on the first attempt,
which, as mentioned, is preferable to gastric tube insertion.
III. Nutriseal Nasogastric Aspiration Tube
ENvue
also has another product in the field, a tube designed for enteral nutrition called the Nutriseal Nasogastric Aspiration Tube (NGAT).
This tube employs a sealing technique to prevent stomach acid from refluxing into the esophagus and to prevent aspiration of stomach
contents into the respiratory tract. NGAT has been cleared for marketing in the U.S. and was approved in the European Union; however,
as of now, ENvue is not manufacturing or marketing it, and the EU approval is currently not valid.
NGAT
is a feeding tube developed by Nutriseal Limited Partnership (the rights to which were transferred to ENvue shortly after its establishment
in 2017. NGAT is intended to serve as an enteral feeding tube for patients needing nutritional support and for other uses in hospitalized
patients. NGAT’s uniqueness compared to other feeding tubes lies in its sealing technique around the patient’s esophagus,
which can significantly reduce the risks associated with nasoenteral feeding (feeding through a tube inserted through the nose into the
stomach or small intestine), including esophageal reflux (the backflow of stomach acid up the esophagus) and aspiration (inhalation)
of stomach contents and food particles that may enter the lungs and cause severe health complications, including pneumonia.
NGAT
was developed and designed for use in various medical procedures, such as enteral feeding, gastric lavage, and gastric decompression,
while reducing the risk of esophageal reflux or aspiration. It should be noted that NGAT, in its current version, is intended for insertion
without a navigation system, but future iterations, if any, may be able to be used as a feeding tube connected to the ENvue System for
navigation during the tube insertion process, subject to applicable FDA clearance(s). Additionally, ENvue has developed other NGAT-b
components, for which, as of now, ENvue has not submitted applications for regulatory approval.
Product
Components and Features
NGAT
includes a feeding tube composed of a single central internal tube for delivering nutrients into the stomach and six internal suction
tubes surrounding the central internal tube (the “internal suction tubes”). NGAT contains small openings along its length,
which, after the tube is inserted into the patient’s body, are positioned along the esophagus and release low negative air pressure,
creating a suction action that causes the esophageal walls to contract inward, forming a seal around the tube that prevents stomach fluids
from refluxing into the esophagus and aspirating refluxed stomach fluids (the “aspiration mechanism”).
NGAT
is designed with two sealed suction areas located at the end of the tube inserted into the patient’s body, where stomach fluids
accumulate. The internal suction tubes are divided into two sets of three suction tubes each, with each set connected to a different
suction area. The operator can regulate the suction between the two sealed suction areas using a branched valve located at the end of
the tube that remains outside the patient’s body, allowing suction to be applied to one sealed suction area at a time.
NGAT
can be connected to standard hospital suction equipment, and its use does not require special equipment. This connection enables the
operation of the aspiration mechanism as well as performing gastric lavage procedures.
Marketing
Strategy
ENvue
may market NGAT in the U.S. for adult treatment only (aged 22 and above) (FDA clearance in the 510(k) pathway). NGAT also received the
European Union CE Mark for marketing in EU countries, which is not valid as of February 25, 2019, and several patents related to this
product have been registered.
ENvue
is not manufacturing or marketing NGAT as part of its business strategy to focus its operations and marketing efforts in the coming years
on the introduction and integration of the ENvue System into relevant markets. ENvue’s decision regarding the commercialization
of NGAT will be reviewed regularly by management and will be determined, among other factors, by the financial resources available to
ENvue, the pace of ENvue System adoption in the market, and the potential impact of various factors on ENvue’s operations (including
the risk factors to which ENvue is exposed). Therefore, there is currently no certainty regarding the timing of NGAT’s commercialization
by ENvue. It should be noted that NGAT can potentially be used with the ENvue System, subject to the necessary FDA clearance(s), and
ENvue may consider integrating NGAT within the ENvue System’s use and submitting an updated 510(k) notification to FDA if it decides
to commercially manufacture and market NGAT in the future.
IV. New Products
ENvue
Feeding Tube and System for Use in Children and Preterm Infants
This
is a navigation system with dedicated feeding tubes of smaller diameters, designed for use in children and preterm infants. ENvue has
completed the initial product development process and will begin preparations for conducting a clinical trial as part of the FDA clearance
process.
Imaging
Navigation (ENvue Plus)
This
development allows the integration of medical imaging (fluoroscopy, MRI, CT) into the ENvue System, enabling real-time navigation of
the feeding tube based on the patient’s anatomical information. In January 2022, ENvue completed the product development process,
and is planning to initiate a clinical trial to assess the ENvue System’s capability to perform internal tube navigation based
on a chest X-ray image.
Peripherally
Inserted Central Catheter (PICC)
This
is a procedure for inserting a catheter into central blood vessels to ensure the catheter’s proper placement in the patient’s
blood vessels using the electromagnetic navigation technology of the ENvue System. This development is expected to allow ENvue System
users to perform PICC insertion with electromagnetic navigation on X-ray images, with real-time alerts from the ENvue System about incorrect
catheter placement in the patient’s body. Inserting a catheter into central blood vessels is essential for administering medications,
fluids, and nutrition and for taking continuous blood samples from hospitalized patients.
ENfit
Compatible Syringes
In
January 2026, ENvue announced the launch of ENfit compatible syringes designed for use with the ENvue System and enteral feeding tube
placements. ENfit is the internationally recognized connector standard (ISO 80369-3) developed to reduce the risk of misconnections between
enteral feeding devices and non-enteral lines. The ENfit compatible syringes are designed to work seamlessly with ENfit-compliant enteral
feeding tubes and connectors, supporting safe and accurate delivery of nutrition, hydration, and medications to patients requiring enteral
access. The Company believes the introduction of ENfit compatible syringes represents a meaningful expansion of its product portfolio
and supports its broader commercial strategy of providing a comprehensive enteral feeding solution to acute care hospitals in the United
States. In January 2026, ENvue signed a distribution agreement with U-Deliver, a U.S. based supplier of enteral feeding supplies, to
distribute ENvue’s ENFit compatible syringes through non-acute care channels nationwide. The syringes are available over the counter
in four sizes (2.5 mL, 5 mL, 10 mL, and 60 mL), meet ISO 80369-3 global standards, and are designed for reuse for up to seven days or
20 uses. Distribution is through U-Deliver’s website, Amazon storefront, and wholesale channels, targeting home care and long-term
care patients and caregivers. The agreement represents ENvue’s first commercial step into non-acute care channels, complementing
its existing acute care hospital business.
Robotic
Arm (ENvue Drive)
During
the year, the Company initiated development of a next-generation robotic platform within its ENvue Medical division, referred to as ENvue
DriveTM, intended to automate aspects of electromagnetic navigation for enteral and vascular access procedures at the bedside.
The platform is being designed to integrate with the Company’s existing electromagnetic guidance technology used for enteral feeding
tube placement and is intended to support clinician alignment and positional stability during procedures. The system is currently in
the preclinical development phase and has not been submitted to the U.S. Food and Drug Administration (FDA) for regulatory clearance.
Development timelines and commercialization remain subject to engineering progress and applicable regulatory approvals.
Research
and Development
From
its founding, ENvue has engaged in the research and development of the ENvue System it developed—a system based on electromagnetic
navigation technology for inserting a feeding tube. In February 2019, ENvue received FDA clearance for the commercial marketing of the
product in the U.S. for adults (aged 22 and above) only.
ENvue’s
research and development activities have been focused mainly on product development and improvements and upgrades to various components
that make up the ENvue System to develop and improve performance.
II. Clinical Trials
As
part of the FDA clearance process for the system under the 510(k) pathway, ENvue was required to conduct a clinical trial following the
safety alert issued by the FDA regarding the use of the Cortrak*2 Enteral Access System, which is another device that, like the ENvue
System, is intended to facilitate enteral feeding tube placement, but was recalled due to serious adverse events resulting from misplaced
tubes in connection with the use of the system. During the clinical trial conducted by ENvue2, 58 feeding tube insertions
were performed on 57 subjects using the system, during which no feeding tubes were ultimately placed into the patient’s lung, and
no harm was caused to the patient’s lung during the procedure. In two cases, immediate correction of the tube insertion was performed
following the system’s alert of entry into the airways. Additionally, ENvue believes the trial results indicated ease of use of
the system and quick learning of how to operate it.
ENvue
Customers
ENvue’s
current and potential customers are hospitals in the U.S. As of 2023, there are approximately 5,222 hospitals in the U.S. that operate
intensive care units, which constitute the majority of ENvue’s potential customers (Fast Facts on U.S. Hospitals, 2024. American
Hospital Association. https://www.aha.org/statistics/fast-facts-us-hospitals). The primary users of ENvue’s products in these locations
are medical staff, usually nurses and clinical dietitians. As of the date hereof, ENvue’s customers include both hospitals in the
U.S. with which ENvue has signed direct sales agreements and hospitals within the hospital network with which ENvue has contracted under
the agreement detailed below.
ENvue
is in the stage of commercializing its products, and its sales activities in the U.S. were conducted directly with end customers. As
part of ENvue’s strategy to introduce the ENvue System into the U.S. market and expand its marketing efforts, ENvue may, in the
future, consider partnering with a distributor or strategic marketer, in addition to direct sales to customers in the U.S.
In