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What changed in ENvue Medical, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of ENvue Medical, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+606 added−917 removedSource: 10-K (2026-04-15) vs 10-K (2025-03-31)

Top changes in ENvue Medical, Inc.'s 2025 10-K

606 paragraphs added · 917 removed · 395 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

165 edited+68 added−285 removed283 unchanged
Biggest changeThe issuance in the Exchange of the 3(a)(9) Shares, the January 2025 Warrant, the January 2025 Pre-Funded Warrant and the shares of common stock issuable upon the exercise thereof pursuant to the Exchange Agreement was made in reliance on an exemption from registration under Section 3(a)(9) of the Securities Act Nano OpCo’s Business Nano OpCo’s primary products, which are in various stages of clinical and market development, currently consist of: ● UroShield, an ultrasound-based product that is designed to prevent bacterial colonization and biofilm in urinary catheters, increase antibiotic efficacy and decrease pain and discomfort associated with urinary catheter use, which has been, and is being marketed in the U.S. under FDA’s policy of enforcement discretion which was effectuated during the COVID-19 pandemic and is currently undergoing clinical testing that will, hopefully, support 510(k) clearance; ● UroShield Ultra, is similar to UroShield, but is designed to prevent bacterial colonization and biofilm formation in urinary catheters to increase antibiotic efficacy and decrease pain and discomfort associated with urinary catheter use, utilizing two separate transducers which provide ultrasound energy to both sides of an indwelling catheter. ● PainShield, a patch-based therapeutic ultrasound technology to treat pain, muscle spasm and joint contractures by delivering a localized ultrasound effect to treat pain and induce soft tissue healing in a targeted area.
Biggest changeNano OpCo’s Business Nano OpCo’s primary products, which are in various stages of clinical and market development, currently consist of: ● PainShield, a patch based therapeutic ultrasound technology designed to treat pain, muscle spasms and joint contractures by delivering localized ultrasound energy that promotes pain relief and supports soft tissue healing in targeted areas, including PainShield MD, a single use patch-based device utilizing this technology. ● UroShield, an ultrasound-based product that is designed to prevent bacterial colonization and biofilm in urinary catheters, increase antibiotic efficacy and decrease pain and discomfort associated with urinary catheter use.
However, if we are unable to obtain widespread insurance coverage and reimbursement for PainShield, its acceptance as a pain management treatment would likely be hindered, as patients may be reluctant to pay for the product out-of-pocket. 17 CMS approved PainShield for reimbursement for Medicare beneficiaries on a national basis in January 2020 although we have never received a reimbursement value.
However, if we are unable to obtain widespread insurance coverage and reimbursement for PainShield, its acceptance as a pain management treatment would likely be hindered, as patients may be reluctant to pay for the product out-of-pocket. CMS approved PainShield for reimbursement for Medicare beneficiaries on a national basis in January 2020 although we have never received a reimbursement value.
We order certain component parts on an as-needed basis, generally from the manufacturer that provides us with the most competitive pricing. Our most significant suppliers for these components are B Star, Inc and Plastic One. We do not have written agreements with any of these suppliers, but we believe anyone could be easily replaced if necessary.
We order certain component parts on an as-needed basis, generally from the manufacturer that provides us with the most competitive pricing. Our most significant suppliers for these components are B Star, Inc and Plastic One. We do not have written agreements with any of these suppliers, but we believe anyone could be replaced if necessary.
Through their size, effectiveness and ease of use, these products are intended to eliminate the need for technicians and medical personnel to manually administer ultrasound treatment through large transducers, thereby promoting patient independence and enabling more cost-effective home-based care. PainShield MD is currently cleared for marketing in the United States by the FDA.
Through their size, effectiveness and ease of use, these products are intended to eliminate the need for technicians and medical personnel to manually administer ultrasound treatment using large transducers, thereby promoting patient independence and enabling more cost effective home based care. PainShield MD is currently cleared for marketing in the United States by the FDA.
After investigation and review of placement files, ENvue believes the reported serious adverse events were caused by user error. 30 Product Components and Features The system components are described in greater detail below: System Body The system body includes several components, including a screen displaying the feeding tube’s position and an electromagnetic field generator mounted on an adjustable arm.
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: System Body The system body includes several components, including a screen displaying the feeding tube’s position and an electromagnetic field generator mounted on an adjustable arm.
Approved PMAs can include post-approval conditions and post-market surveillance requirements, analogous to some of the special controls that may be imposed on Class II devices. WoundShield, PainShield and ENvue System are classified as Class II medical devices and require U.S. Food and Drug Administration authorization prior to marketing, by means of 510(k) clearance.
Approved PMAs can include post-approval conditions and post-market surveillance requirements, analogous to some of the special controls that may be imposed on Class II devices. PainShield and the ENvue System are classified as Class II medical devices and require U.S. Food and Drug Administration authorization prior to marketing, by means of 510(k) clearance.
In addition, HIPAA mandates that HHS conduct periodic compliance audits of HIPAA covered entities and their business associates for compliance. Many states also have laws that protect the privacy and security of sensitive and personal information, including health information. These laws may be similar to or even more protective than HIPAA and other federal privacy laws.
In addition, HIPAA mandates that HHS conduct periodic compliance audits of HIPAA covered entities and their business associates for compliance. 36 Many states also have laws that protect the privacy and security of sensitive and personal information, including health information. These laws may be similar to or even more protective than HIPAA and other federal privacy laws.
We believe these grants both help promote alignment between our employees and our stockholders and provide retention benefits, as the awards generally vest over a three-year period. We do not have any employees that are represented by a labor union or that have entered into a collective bargaining agreement with the Company.
We believe these grants both help promote alignment between our employees and our stockholders and provide retention benefits, as the awards generally vest over a three-year period. 38 We do not have any employees that are represented by a labor union or that have entered into a collective bargaining agreement with the Company.
The announcements published so far have generated media interest and have been covered in commercial media, national media, and technology publications. ● Participation in Events and Conferences : ENvue participates in selected events in the healthcare and technology industries to meet with influencers and decision-makers in the field. ENvue believes it is not dependent on any of its marketing channels.
The announcements published so far have generated media interest and have been covered in commercial media, national media, and technology publications. ● Participation in Events and Conferences : ENvue participates in selected events in the healthcare and technology industries to meet with influencers and decision-makers in the field. 12 ENvue believes it is not dependent on any of its marketing channels.
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. 35 NGAT can be connected to standard hospital suction equipment, and its use does not require special equipment.
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.
The health care laws that may be applicable to our business or operations include: ● The federal Anti-Kickback Statute, which prohibits the offer, payment, solicitation or receipt of any form of remuneration in return for referring, ordering, leasing, purchasing or arranging for, or recommending the ordering, purchasing or leasing of, items or services payable by Medicare, Medicaid or any other federal health care program. 55 ● Federal false claims laws and civil monetary penalty laws, including the False Claims Act, that prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other government health care programs that are false or fraudulent, or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. ● The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which prohibits knowingly and wilfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretences, representations, or promises, any of the money or property owned by, or under the custody or control of, any health care benefit program, and for knowingly and wilfully falsifying, concealing or covering up a material fact or making any materially false statements in connection with the delivery of or payment for health care benefits, items or services. ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and its implementing regulations, which also impose obligations and requirements on health care providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform certain services for them that involve the use or disclosure of individually identifiable health information, with respect to safeguarding the privacy and security of certain individually identifiable health information. ● The federal transparency requirements under the Affordable Care Act, including the provision commonly referred to as the Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid or Children’s Health Insurance Program to report annually to Centers for Medicare and Medicaid Services, or CMS, information related to payments and other transfers of value to physicians and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members. ● Analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may be broader in scope and apply to referrals and items or services reimbursed by both governmental and non-governmental third-party payers, including private insurers, many of which differ from each other in significant ways and often are not pre-empted by federal law, thus complicating compliance efforts.
The health care laws that may be applicable to our business or operations include: ● Federal false claims laws and civil monetary penalty laws, including the False Claims Act, that prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other government health care programs that are false or fraudulent, or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. ● The federal Anti-Kickback Statute, which prohibits the offer, payment, solicitation or receipt of any form of remuneration in return for referring, ordering, leasing, purchasing or arranging for, or recommending the ordering, purchasing or leasing of, items or services payable by Medicare, Medicaid or any other federal health care program ● The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which prohibits knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any health care benefit program, and for knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statements in connection with the delivery of or payment for health care benefits, items or services. ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and its implementing regulations, which also impose obligations and requirements on health care providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform certain services for them that involve the use or disclosure of individually identifiable health information, with respect to safeguarding the privacy and security of certain individually identifiable health information. ● The federal transparency requirements under the Affordable Care Act, including the provision commonly referred to as the Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid or Children’s Health Insurance Program to report annually to Centers for Medicare and Medicaid Services, or CMS, information related to payments and other transfers of value to physicians and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members. ● Analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may be broader in scope and apply to referrals and items or services reimbursed by both governmental and non-governmental third-party payers, including private insurers, many of which differ from each other in significant ways and often are not pre-empted by federal law, thus complicating compliance efforts.
Additionally, there is a need for suitable marketing and distribution channels to handle institutional bodies such as hospitals, which can compete against large companies operating in the field of ENvue’s products. ● Rate of Market Penetration - Penetrating the target market in the field of activity requires a long time, partly due to the entry barriers described above. https://patientsafetymovement.org/clinical/enteral-tube-safety/enteral-tube-safety-nasogastric-tube-ngt-placement-and-verification And also: https://patientsafetyj.com/index.php/patientsaf/article/view/misplaced-nasogastric-tubes/219 43 Competition for ENvue System ENvue industry is competitive and has been evolving rapidly with the introduction of new products and technologies as well as the market activities of industry participants.
Additionally, there is a need for suitable marketing and distribution channels to handle institutional bodies such as hospitals, which can compete against large companies operating in the field of ENvue’s products. ● Rate of Market Penetration - Penetrating the target market in the field of activity requires a long time, partly due to the entry barriers described above. https://patientsafetymovement.org/clinical/enteral-tube-safety/enteral-tube-safety-nasogastric-tube-ngt-placement-and-verification And also: https://patientsafetyj.com/index.php/patientsaf/article/view/misplaced-nasogastric-tubes Competition for ENvue System ENvue industry is competitive and has been evolving rapidly with the introduction of new products and technologies as well as the market activities of industry participants.
Furthermore, the rapid spread of the COVID-19 virus worldwide, especially the increase in morbidity in the USA, heightened the need to improve patient nutrition, leading to increased demand for nasal enteral feeding means. In 2023, hospitals were the primary users of enteral nutrition means (approximately 58.3% of global usage) (Grand View Research).
Furthermore, the rapid spread of the COVID-19 virus worldwide, especially the increase in morbidity in the USA, heightened the need to improve patient nutrition, leading to increased demand for nasal enteral feeding means. 13 In 2023, hospitals were the primary users of enteral nutrition means (approximately 58.3% of global usage) (Grand View Research).
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.
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. 9 IV.
Therefore, patients and clinicians have shown increased interest in alternative pain therapy using medical devices that do not carry these side effects. The currently available ultrasound treatments for chronic pain have generally been accepted by the medical community as standard treatment for pain management.
Therefore, patients and clinicians have shown increased interest in alternative pain therapy using medical devices that do not carry these side effects. 25 The currently available ultrasound treatments for chronic pain have generally been accepted by the medical community as standard treatment for pain management.
Projections indicate that in the USA, this population is expected to remain the primary group using enteral nutrition means, with an expected growth rate of approximately 6.7% from 2020 to 2025 and a market value of approximately $3.9 billion by 2025. 41 II.
Projections indicate that in the USA, this population is expected to remain the primary group using enteral nutrition means, with an expected growth rate of approximately 6.7% from 2020 to 2025 and a market value of approximately $3.9 billion by 2025. II.
The decision to file an MDR involves a judgment by the manufacturer. If the FDA disagrees with the manufacturer’s determination, the FDA can take enforcement action. 53 Additionally, the FDA has the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture.
The decision to file an MDR involves a judgment by the manufacturer. If the FDA disagrees with the manufacturer’s determination, the FDA can take enforcement action. Additionally, the FDA has the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture.
The ENvue System is indicated for use in adults 22 and over years of age to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 8 Fr, 10 Fr, and 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding.
The ENvue System is indicated for use in adults 22 and over years of age to aid qualified operators in the placement of the ENvue Medical Enteral Feeding Tube of 8 Fr, 10 Fr, and 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding.
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 in-body navigation (the “ENvue System”).
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”).
In addition to obtaining approval for each product, in many cases each device manufacturing facility must be audited on a periodic basis by the notified body. Further inspections may occur over the life of the product. U.S.
In addition to obtaining approval for each product, in many cases each device manufacturing facility must be audited on a periodic basis by the notified body. Further inspections may occur over the life of the product. 35 U.S.
Such legal proceedings may negatively impact our business and financial position, result in brand or reputational harm, and divert the attention of our management from core operations of our business. 59 Protrade Proceeding On February 26, 2021, Protrade Systems, Inc.
Such legal proceedings may negatively impact our business and financial position, result in brand or reputational harm, and divert the attention of our management from core operations of our business. Protrade Proceeding On February 26, 2021, Protrade Systems, Inc.
The targeted reimbursement would be based upon specific indications, where study data serves as justification for payment. 18 PainShield Sales and Marketing PainShield was introduced in 2009 as a treatment for pain, such as tendonitis, sports injuries, pelvic pain, and neurologic pain, depending on the scope of the approval or clearance from each applicable jurisdiction, and we have sold over 8,000 units since its introduction.
The targeted reimbursement would be based upon specific indications, where study data serves as justification for payment. 26 PainShield Sales and Marketing PainShield was introduced in 2009 as a treatment for pain, such as tendonitis, sports injuries, pelvic pain, and neurologic pain, depending on the scope of the approval or clearance from each applicable jurisdiction, and we have sold over 8,000 units since its introduction.
As part of efficiency processes and cost-cutting measures in Predecessor ENvue, as of July 2023, Predecessor ENvue ceased its research and development activities. The activities were resumed following the purchase of by Envizion Holdings Corp.
As part of efficiency processes and cost-cutting measures in Predecessor ENvue, as of July 2023, Predecessor ENvue ceased its research and development activities. The activities were resumed following the purchase by ENvue Holdings Corp.
For the year ended December 31, 2024, our largest customer was Ultra Pain Products Inc, to whom our sales of products to them comprised approximately 31% of our total revenues. We are currently in discussions with several distribution companies with access to various markets in the United States, Europe, and Asia, as well as the Veterans Health Care network facilities.
For the year ended December 31, 2025, our largest customer was Ultra Pain Products Inc, to whom our sales of products to them comprised approximately 31% of our total revenues. We are currently in discussions with several distribution companies with access to various markets in the United States, Europe, and Asia, as well as the Veterans Health Care network facilities.
The SEC maintains an internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov . The contents of these websites are not incorporated into this filing. Further, the Company’s references to website URLs are intended to be inactive textual references only. 61
The SEC maintains an internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov . The contents of these websites are not incorporated into this filing. Further, the Company’s references to website URLs are intended to be inactive textual references only. 40
From time to time, we have had interest from strategic companies in the catheter market to partner, license or acquire the UroShield technology. These strategic partners are active in the urology market and may be interested in integrating UroShield as an accessory, into their respective range of products. Discussions with these partners are ongoing.
UroShield Sales and Marketing From time to time, we have had interest from strategic companies in the catheter market to partner, license or acquire the UroShield technology. These strategic partners are active in the urology market and may be interested in integrating UroShield as an accessory, into their respective range of products. Discussions with these partners are ongoing.
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 approval process.
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.
Such reports and other information filed by the Company with the SEC are available free of charge on the Company’s website at www.nanovibronix.com , as soon as reasonably practicable after we have electronically filed with, or furnished to, the SEC.
Such reports and other information filed by the Company with the SEC are available free of charge on the Company’s website at www.envuemed.com , as soon as reasonably practicable after we have electronically filed with, or furnished to, the SEC.
It also does not require special expertise and can be operated by a trained care provider. These advantages pose a challenge for competitors who struggle to achieve the same level of reliability and stability in products and services in the field of activity, including the unique and effective electromagnetic navigation method, which is partly patented. 4 U.S.
It also does not require special expertise and can be operated by a trained care provider. These advantages pose a challenge for competitors who struggle to achieve the same level of reliability and stability in products and services in the field of activity, including the unique and effective electromagnetic navigation method, which is partly patented.
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 everchanging healthcare environment, while continuously focusing on the customer.
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.
Patent and Trademark Office. III. Trade Secrets ENvue also relies on trade secrets relating to its products and technology, including its data processing algorithms, and maintains the confidentiality of such proprietary information to protect aspects of its business that are not amenable to, or that ENvue does not consider appropriate for, patent protection.
Trade Secrets ENvue also relies on trade secrets relating to its products and technology, including its data processing algorithms, and maintains the confidentiality of such proprietary information to protect aspects of its business that are not amenable to, or that ENvue does not consider appropriate for, patent protection.
In addition, state and federal privacy laws subject to frequent change.
In addition, state and federal privacy laws are subject to frequent change.
Regulatory Strategy PainShield received 510(k) clearance from the FDA in August 2008 as an ultrasonic diathermy device intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions, such as relief of pain, muscle spasms, and joint contractures.
Regulatory Strategy PainShield received 510(k) clearance from the FDA in August 2008 as an ultrasonic diathermy device intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions, such as relief of pain, muscle spasms, and joint contractures. PainShield received CE Mark approval in July 2008.
Safety and Wellness At NanoVibronix, we believe that health matters to everyone, and the safety health, and wellness of our employees is one of our top priorities.
Safety and Wellness At ENvue, we believe that health matters to everyone, and the safety health, and wellness of our employees is one of our top priorities.
CN 101431940 B, and Israeli Patent No. 193600. 46 These patents are directed to our proprietary surface acoustic wave (SAW) technology, including our commercialized PAINSHIELD, PAINSHIELD PLUS, WOUNDSHIELD and UROSHIELD devices.
CN 101431940 B, and Israeli Patent No. 193600. These patents are directed to our proprietary surface acoustic wave (SAW) technology, including our commercialized PAINSHIELD, WOUNDSHIELD, and UROSHIELD devices and the previously commercialized PAINSHIELD PLUS.
We also offer paid leave as mandated by government regulations, flexible work schedules, and other benefits as mandated by government regulations. We also offer key employees the benefit of equity ownership in NanoVibronix through stock option grants.
We also offer paid leave as mandated by government regulations, flexible work schedules, and other benefits as mandated by government regulations. We also offer employees the benefit of equity ownership in ENvue through stock option grants.
This technology allows us to treat pain by securing our transducers to the skin with a separate adhesive patch, and portable self-adhering acoustic patch, thereby eliminating the need for technicians and medical personnel to manually administer ultrasound therapy, which should reduce the cost of therapy.
This technology allows us to treat pain by securing our transducers to the skin with a separate adhesive patch, thereby eliminating the need for technicians and medical personnel to manually administer ultrasound therapy, which should reduce the cost of therapy.
Feeding Tube with Electromagnetic Sensor - Feeding tubes that include an electromagnetic sensor and a wire that runs along the length of the tube. Country Status Japan Granted United States Granted (3 patents) 7.
Feeding Tube with Electromagnetic Sensor - Feeding tubes that include an electromagnetic sensor and a wire that runs along the length of the tube. Country Status Japan Granted United States Granted (3 patents and 1 allowed application) 7.
Country Status Israel Pending Japan Pending 49 II. Trademarks As of February 6, 2024, ENvue owns the following trademarks: Envizion Medical, ENsump, ENvue, ENgat, Envizion (wordmark and logo), and ENvue’s logo in key countries, including the U.S., Europe, and China.
Country Status Israel Pending Japan Allowed United States Pending II. Trademarks As of February 6, 2024, ENvue owns the following trademarks: Envizion Medical, ENsump, ENvue, ENgat, Envizion (wordmark and logo), and ENvue’s logo in key countries, including the U.S., Europe, and China.
Once the controller is purchased by the end user, recurring revenue will be realized by purchases of replacement disposables to the extent that the end user continues treatment with our product. Nano OpCo’s products are intended to be distributed directly by the us, independent distributors, and potential licensees.
Once the controller is purchased by the end user, recurring revenue will be realized by purchases of replacement disposables to the extent that the end user continues treatment with our product. Nano OpCo’s products are intended to be distributed directly by either the dedicated sales force, independent distributors, and potential licensees.
Country Status Europe (Validated in AT, CH/LI, DE, ES, FR, GB, and IT) Granted China 1 Granted, 1 pending Japan Granted United States Granted (2 patents) 8.
Country Status Europe (Validated in AT, CH/LI, DE, ES, FR, GB, and IT) Granted China Granted (2 patents) Japan Granted United States Granted (3 patents) 8.
Country Status China 2 Pending Applications Japan Granted United States Granted (3 patents) 9. Insertion Device Positioning Guidance System and Method - A device, system, and method for guiding the insertion and positioning of an insertion tube within the patient’s body based on sensing of changes in an electromagnetic field. Country Status Israel Pending Japan Pending 10.
Country Status China 2 Pending Applications Japan Granted United States Granted (4 patents) 30 9. Insertion Device Positioning Guidance System and Method - A device, system, and method for guiding the insertion and positioning of an insertion tube within the patient’s body based on sensing of changes in an electromagnetic field.
Additionally, the system features a processor that collects and processes all data to create a three-dimensional anatomical map of the patient’s upper body, all of which functions independently of patient movement and various deviations. Country Status China Allowed Japan Granted United States Granted (4 patents and 1 allowed application) 48 6.
Additionally, the system features a processor that collects and processes all data to create a three-dimensional anatomical map of the patient’s upper body, all of which functions independently of patient movement and various deviations. Country Status China Granted Japan Granted United States Granted (5 patents) 6.
Nasogastric Tube - A system that includes a tube for insertion through the patient’s nose, containing a feeding mechanism, a suction mechanism, and a gastric decompression mechanism. Country Status Europe (Validated in AT, CH/LI, DE, ES, FR, GB, and IT) Granted 4.
Country Status Israel Granted United States Granted 3. Nasogastric Tube - A system that includes a tube for insertion through the patient’s nose, containing a feeding mechanism, a suction mechanism, and a gastric decompression mechanism. Country Status Europe (Validated in AT, CH/LI, DE, ES, FR, GB, and IT) Granted United States Allowed 29 4.
As of 2023, most enteral nutrition use was in North America (32.0%), Europe (29.0%), and Asia (24.0%) (“Enteral Feeding Formulas Markt Size, Share, and Trends 2025 to 2034”; available at: https://www.precedenceresearch.com/enteral-feeding-formulas-market). 40 The global enteral feeding devices market size was valued at $4.3 billion in 2023 (Enteral Feeding Devices Market Trends; Grand View Research; available at: https://www.grandviewresearch.com/industry-analysis/enteral-feeding-devices-industry “Grand View Research”) (of which about $2.84 billion was in the USA) (U.S.
As of 2023, most enteral nutrition use was in North America (32.0%), Europe (29.0%), and Asia (24.0%) (“Enteral Feeding Formulas Markt Size, Share, and Trends 2025 to 2034”; available at: https://www.precedenceresearch.com/enteral-feeding-formulas-market). The global enteral feeding devices market size was valued at $4.62 billion in 2025 (Enteral Feeding Devices Market Trends; Grand View Research; available at: https://www.grandviewresearch.com/industry-analysis/enteral-feeding-devices-industry “Grand View Research”).
For illustration purposes, below are diagrams demonstrating the use of the ENvue System: 32 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 33 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 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. 6 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 7 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.
Of import with respect to diabetic wounds, in which a prolonged inflammatory phase occurs, vibration vasodilation has generated an indirect anti-inflammatory action, mainly by suppression of nuclear factor-kβ, the key gene for inflammatory mediators (Sackner, M.A., “Nitric Oxide is released into circulation with whole-body, periodic acceleration”, Chest 2005;127;30-39). 6 Urinary catheter usage is associated with pain and discomfort caused by the friction between the catheter surface and the urethral tissue.
Of import with respect to diabetic wounds, in which a prolonged inflammatory phase occurs, vibration vasodilation has generated an indirect anti-inflammatory action, mainly by suppression of nuclear factor-kβ, the key gene for inflammatory mediators (Sackner, M.A., “Nitric Oxide is released into circulation with whole-body, periodic acceleration”, Chest 2005;127;30-39).
Predecessor ENvue has since resumed all activities. Available Information The Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments thereto, are filed with the Securities and Exchange Commission (the “SEC”).
Available Information The Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments thereto, are filed with the Securities and Exchange Commission (the “SEC”).
Therefore, we are continuing our practice of investing in obtaining appropriate legal protection for our innovations whenever possible and have adopted a more fully integrative approach to the management of our intellectual property that mutually aligns with our ongoing R&D strategies, commercial opportunities based on market analyses, and longer-term business objectives.
Therefore, we are continuing our practice of investing in obtaining appropriate legal protection for our innovations whenever possible and have adopted a more fully integrative approach to the management of our intellectual property that mutually aligns with our ongoing R&D strategies, commercial opportunities based on market analyses, and longer-term business objectives. 27 From our patented technologies to our trademarked brands, we believe our intellectual property has substantial value and has significantly contributed to our success to date.
The FDA regulations govern, among other things, the development, testing, manufacturing, labelling, safety, storage, record-keeping, market clearance or approval, advertising and promotion, import and export, marketing and sales, distribution and market withdrawal and recalls of medical devices and pharmaceutical products. PainShield MD and PainShield MD Plus have each already obtained 510(k) marketing clearance by the FDA.
The FDA regulations govern, among other things, the development, testing, manufacturing, labelling, safety, storage, record-keeping, market clearance or approval, advertising and promotion, import and export, marketing and sales, distribution and market withdrawal and recalls of medical devices and pharmaceutical products.
Additionally, ENvue believes the trial results indicated ease of use of the system and quick learning of how to operate it. 34 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.
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.
Pending patent applications related to PAINSHIELD, PAINSHIELD PLUS, WOUNDSHIELD devices are directed to Transdermal Patch of a Portable Ultrasound-Generating System for Improved Delivery of Therapeutic Agents and Associated Methods of Treatment and Portable Ultrasound System and Methods of Treating Facial Skin by Application of Surface Acoustic Waves .
Pending patent applications related to PAINSHIELD, PAINSHIELD PLUS, WOUNDSHIELD devices are directed to Transdermal Patch of a Portable Ultrasound-Generating System for Improved Delivery of Therapeutic Agents and Associated Methods of Treatment (US Patent Application no. 17/025,969) and Portable Ultrasound System and Methods of Treating Facial Skin by Application of Surface Acoustic Waves ) US Patent Application number 17/646,753, in restoration process.
We continue to focus on the foundational aspects of each respective product, including the design and performance of each, the reimbursement, regulatory status, and quality control, in order to strengthen our position with prospective partners.
Nano OpCo’s business plan continues to focus on these types of transactions/agreements. We continue to focus on the foundational aspects of each respective product, including the design and performance of each, the reimbursement, regulatory status, and quality control, in order to strengthen our position with prospective partners.
Ultrasound Technology and Nano OpCo’s Products As noted above, Nano OpCo’s primary products are based on the use of low frequency ultrasound, which delivers energy through mechanical vibrations in the form of sound waves. Ultrasound has long been used in physical therapy, physical medicine, rehabilitation and sports medicine.
Ultrasound Technology and Nano OpCo’s Products As noted above, Nano OpCo’s primary products are based on the use of low frequency ultrasound, which delivers energy through mechanical vibrations in the form of sound waves.
These orders are made according to the customer’s needs and generally on a monthly basis, with the consideration determined by the price of the feeding tube agreed upon by the parties within the agreement. 39 EnVue Sales and Marketing Until the suspension of marketing activities, which resumed in July 2024, ENvue worked to build awareness of its products among hospitals and the U.S. medical community in several ways, the main ones being detailed below: ● Conducting Demonstrations for Potential Customers : As part of ENvue’s marketing activities, ENvue’s sales agents periodically meet with hospital procurement officials, demonstrate (Demo) the system, and allow the medical staff to experience the system through several procedures of feeding tube insertion in patients. ● Engagements with Group Purchasing Organizations (GPOs) : A GPO is an entity that helps healthcare providers, such as hospitals, nursing homes, and home health agencies, achieve savings and efficiency by aggregating purchasing volume and leveraging that to negotiate discounts with manufacturers, distributors, and suppliers.
EnVue Sales and Marketing ENvue is continuously working to build awareness of its products among hospitals and the U.S. medical community in several ways, the main ones being detailed below: ● Conducting Demonstrations for Potential Customers : As part of ENvue’s marketing activities, ENvue’s sales agents periodically meet with hospital procurement officials, demonstrate (Demo) the system, and allow the medical staff to experience the system through several procedures of feeding tube insertion in patients. ● Engagements with Group Purchasing Organizations (GPOs) : A GPO is an entity that helps healthcare providers, such as hospitals, nursing homes, and home health agencies, achieve savings and efficiency by aggregating purchasing volume and leveraging that to negotiate discounts with manufacturers, distributors, and suppliers.
To the best of ENvue’s knowledge, the ENvue System is technologically distinct from the Cortrak device in several respects, including: (1) performing a registration to the patient’s body that allows for the display of the patient-specific chest contour according to individual dimensions on the system screen; (2) providing a graphical and textual alert for feeding tube entry into the patient’s airway; (3) using the patient’s anatomical landmarks for the navigation process; (4) additional sensors that enable accurate insertion of the feeding tube even if the patient moves (without the need to place a device on the patient’s body); (5) a sensor embedded within the feeding tube; (6) three simultaneous vies; and (7) responsive real time display of the tube tip pathway (40 image per second refresh rate) and more. 3 To the best of ENvue’s knowledge, Avanos Medical acquired the product in 2016. 44 Further, in recent years, reports have been received of incorrect insertion of feeding tubes using Cortrak device, and in January 2018, the FDA issued a Safety Alert 4 following reports of cases where feeding tubes inserted using the Cortrak device were inserted into the lungs, despite the device indicating placement in the stomach.
To the best of ENvue’s knowledge, the ENvue System is technologically distinct from the Cortrak device in several respects, including: (1) performing a registration to the patient’s body that allows for the display of the patient-specific chest contour according to individual dimensions on the system screen; (2) providing a graphical and textual alert for feeding tube entry into the patient’s airway; (3) using the patient’s anatomical landmarks for the navigation process; (4) additional sensors that enable accurate insertion of the feeding tube even if the patient moves (without the need to place a device on the patient’s body); (5) a sensor embedded within the feeding tube; (6) three simultaneous vies; and (7) responsive real time display of the tube tip pathway (40 image per second refresh rate) and more.
Government Regulation U.S. Food and Drug Administration Regulation Each of our products must be approved, cleared by, or registered with the U.S. Food and Drug Administration (“FDA”) before they can be marketed in the United States, and they can only be marketed consistently with their respective approved or cleared indication(s) of use.
Food and Drug Administration (“FDA”) before they can be marketed in the United States, and they can only be marketed consistently with their respective approved or cleared indication(s) of use.
Intellectual Property Intellectual Property Related to Nano OpCo’s Business Stemming from a combination of patent, copyright, trademark and trade secret laws, as well as non-disclosure agreements and other contracts, our intellectual property rights represent a vital resource to the management of our company.
We continue to work toward a favorable reimbursement rate with outside legal counsel and reimbursement consultants. Intellectual Property Intellectual Property Related to Nano OpCo’s Business Stemming from a combination of patent, copyright, trademark and trade secret laws, as well as non-disclosure agreements and other contracts, our intellectual property rights represent a vital resource to the management of our company.
Patent No. 9,585,977 directed to “System and Method for Surface Acoustic Waves Treatment of Skin” (expiring on August 20, 2033). Foreign counterparts include: European Patent No. EP 1991129 B1, Chinese Patent No.
Patent No. 9,028,748 to “System and Method for Surface Acoustic Wave Treatment of Medical Devices” (expiring on July 11, 2030); and (3) U.S. Patent No. 9,585,977 directed to “System and Method for Surface Acoustic Waves Treatment of Skin” (expiring on August 20, 2033). Foreign counterparts include: European Patent No. EP 1991129 B1, Chinese Patent No.
Even though our ability to assemble our products has not been affected by the current political environment, we cannot predict if future events may cause delays. Our 2023 production run established an ample supply of devices and monthly disposable kits. The completed products can be used as a platform for either PainShield or UroShield.
Even though our ability to assemble our products has not been affected by the current political environment, we cannot predict if future events may cause delays. Our 2025 production run established an ample supply of devices and monthly disposable kits.
On March 21, 2023, the court denied the motion to re-argue and renew. On July 10, 2023, the Company filed its appeal with the Appellate Division, Second Department. That appeal is now fully briefed.
On March 21, 2023, the court denied the motion to re-argue and renew. 39 On July 10, 2023, the Company filed its appeal with the Appellate Division, Second Department. That appeal is now fully briefed. In February 2025, the Second Department informed counsel for the Company that the Second Department was beginning to process the appeal for calendaring.
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. 29 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).
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).
In order to address the potential risks and complications associated with the “blind” insertion method of feeding tubes and the drawbacks of standard methods for verifying the placement of the feeding tube, several products have been developed over the years using technological tools to enable real-time monitoring of the feeding tube’s placement within the patient’s body.
ENvue competes against other companies that have developed similar devices in the market for enteral feeding devices for hospitalized patients needing nutritional support. 15 In order to address the potential risks and complications associated with the “blind” insertion method of feeding tubes and the drawbacks of standard methods for verifying the placement of the feeding tube, several products have been developed over the years using technological tools to enable real-time monitoring of the feeding tube’s placement within the patient’s body.
Some third -party payers must also pre-approve coverage for new or innovative devices or therapies before they will reimburse health care providers who use the products or therapies.
In addition, third party payers are increasingly challenging the prices charged for medical products and services. Some third -party payers must also pre-approve coverage for new or innovative devices or therapies before they will reimburse health care providers who use the products or therapies.
We believe that UroShield creates an acoustic envelope on the surfaces of the catheter, which decreases friction and tissue trauma, pain and discomfort caused by the catheter.
See the discussion of our Heidelberg 1 trial below. ● Decreased Catheter Associated Pain and Discomfort. We believe that UroShield creates an acoustic envelope on the surfaces of the catheter, which decreases friction and tissue trauma, pain and discomfort caused by the catheter.
There are also harmonized standards relating to design and manufacture. While not mandatory, compliance with these standards is viewed as the easiest way to satisfy the essential requirements as a practical matter.
There are also harmonized standards relating to design and manufacture. While not mandatory, compliance with these standards is viewed as the easiest way to satisfy the essential requirements as a practical matter. Compliance with a standard developed to implement an essential requirement also creates a rebuttable presumption that the device satisfies that essential requirement.
Therefore, looking beyond just pain management and urology, our patent applications relate to, inter alia: novel transdermal patches uniquely configured to work with our ultrasound technology to additionally provide for improved absorption and transdermal delivery of therapeutic agents during treatment; cosmetic applications of our ultrasound technology to provide anti-aging benefits; and certain new or improved stand-alone therapeutic medical devices or so-called “indwelling medical devices” (e.g., catheters, intravenous (IV) needle assemblies, and percutaneous endoscopic gastronomy (PEG) tubes) that include our SAW-generating technology to provide the accompanying antimicrobial effect for preventing infections typically associated with available indwelling devices.
Therefore, looking beyond just pain management and urology, our patent applications relate to, inter alia: novel transdermal patches uniquely configured to work with our ultrasound technology to additionally provide for improved absorption and transdermal delivery of therapeutic agents during treatment; cosmetic applications of our ultrasound technology to provide anti-aging benefits; and certain new or improved stand-alone therapeutic medical devices or so-called “indwelling medical devices” (e.g., catheters, intravenous (IV) needle assemblies, and percutaneous endoscopic gastronomy (PEG) tubes) that include our SAW-generating technology to provide the accompanying antimicrobial effect for preventing infections typically associated with available indwelling devices. 28 We intend to further grow our patent portfolio by continuing to patent new technology as it is developed, to defend intellectual property as we believe necessary by actively pursuing any infringements, to pursue commercial opportunities our patents provide for our innovations, and to continue to develop our brands and trademarks.
By embracing differences, we aim to foster an environment of respect and trust in an effort to facilitate creativity, spark passion, and help us achieve better outcomes for all those who work at the Company.
Diversity and Inclusion We believe that an inclusive culture is required to understand and develop products that benefit all patients. By embracing differences, we aim to foster an environment of respect and trust in an effort to facilitate creativity, spark passion, and help us achieve better outcomes for all those who work at 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 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 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”).
(“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”).
Our proprietary PainShield technology consists of a small, thin (1 millimeter) transducer that is capable of transmitting ultrasonic acoustic waves onto treatment surfaces with a radius of up to 10 centimeters beyond the transducer.
Ultrasound has long been used in physical therapy, physical medicine, rehabilitation and sports medicine. 18 Our proprietary PainShield technology consists of a small, thin (1 millimeter) transducer that is capable of transmitting ultrasonic acoustic waves onto treatment surfaces with a radius of up to 10 centimeters beyond the transducer.
It should also be noted that several companies with a global presence provide similar services to those of the current manufacturer, and ENvue previously estimated that, if necessary, it could replace or expand the existing assembly capabilities within 6-9 months without significant cost changes.
It should also be noted that several companies with a global presence provide similar services to those of the current manufacturer, and ENvue previously estimated that, if necessary, it could replace or expand the existing assembly capabilities within 6-9 months without significant cost changes. customers. 37 Additionally, there are only a few manufacturers worldwide that produce feeding tubes (made of polyurethane) used by ENvue to produce the specialized feeding tubes for the ENvue System.
Our current agreements stipulate that distributors will be responsible for carrying out local marketing activities and sales. We are responsible for training, providing marketing guidance, marketing materials, and technical guidance. In addition, in most cases, all sales costs, including sales representatives, incentive programs, and marketing trials, will be borne by the distributor.
Our current agreements stipulate that distributors will be responsible for carrying out local marketing activities and sales. In addition, in most cases, all sales costs, including sales representatives, incentive programs, and marketing trials, will be borne by the distributor. We expect any future distribution agreements to contain substantially similar stipulations.
To the extent we provide services that require the use of PHI, we may be business associates of such covered entities and directly subject to HIPAA. 56 State attorneys general also have the right to prosecute HIPAA violations committed against residents of their states, and HIPAA standards have been used as the basis for the duty of care in state civil suits, such as those for negligence or recklessness in misusing personal information.
State attorneys general also have the right to prosecute HIPAA violations committed against residents of their states, and HIPAA standards have been used as the basis for the duty of care in state civil suits, such as those for negligence or recklessness in misusing personal information.
In the United States, PainShield is only cleared to treat pain, muscle spasms, and joint contractures associated with or caused by various conditions or diseases. It has also been used to treat pelvic and abdominal pain. To date, to the best of our knowledge, the primary treatment options for several of these conditions are pain medication and surgery.
Picture of PainShield with Patch In the United States, PainShield is only cleared to treat pain, muscle spasms, and joint contractures associated with or caused by various conditions or diseases. It has also been used to treat pelvic and abdominal pain.
We expect any future distribution agreements to contain substantially similar stipulations. Under our current agreements, distributors purchase our products from us at a fixed price. Our current agreements with distributors are generally for a term of approximately two to three years and automatically renew for additional annual terms unless modified by either party.
Under our current agreements, distributors purchase our products from us at a fixed price. Our current agreements with distributors are generally for a term of approximately two to three years and automatically renew for additional annual terms unless modified by either party. We also service patients directly as a result of independent sales agents.
Due to its nature and the lack of existing predicate devices on the market, UroShield is automatically classified as a Class III device for which a PMA is required, unless our request for De Novo reclassification is successful, in which case, it will be classified as a Class II device and subject to the same post market framework as 510(k)-cleared devices. 51 To request marketing authorization by means of a 510(k) clearance, we must submit a pre-market notification demonstrating that the proposed device is substantially equivalent to a legally marketed medical device (referred to as a “predicate device”).
Due to its nature and the lack of existing predicate devices on the market, UroShield is automatically classified as a Class III device for which a PMA is required, unless our request for De Novo reclassification is successful, in which case, it will be classified as a Class II device and subject to the same post market framework as 510(k)-cleared devices.
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.
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. 8 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.
As part of its operations (up until the initiation of insolvency proceedings), 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.
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.
Pending patent applications related to UROSHIELD devices are directed to Multiple Frequency Surface Acoustic Waves for Internal Medical Device and System, Device, and Method for Mitigating Bacterial Biofilms Associated with Indwelling Medical Devices , PCT application (PCT/US2024/018759).
Pending patent applications related to UROSHIELD devices are directed to Multiple Frequency Surface Acoustic Waves for Internal Medical Device (US Patent Application number 19/163,046) and System, Device, and Method for Mitigating Bacterial Biofilms Associated with Indwelling Medical Devices ,) US Patent Application number 17/646,715, in restoration process).
Nano OpCo’s Business Model All of Nano OpCo’s products consist of a reusable controller device and a disposable component, which includes a transducer, and in the case of PainShield, a 30-day supply of adhering patches.
Nano OpCo’s Business Model All of Nano OpCo’s products consist of a reusable controller device and a disposable component, which includes a transducer, and in the case of PainShield, a 30-day supply of adhering patches. The components are purchased by either the distributor or end user for use in any of the intended applications.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeInternational sales of our products and any of our product candidates that we commercialize are subject to the regulatory requirements of each country in which the products are sold. Accordingly, the introduction of our product candidates in markets outside the United States where we do not already possess regulatory approval will be subject to regulatory approvals in those jurisdictions.
Biggest changeAccordingly, the introduction of our products in markets outside the United States where we do not already possess regulatory approval will be subject to regulatory approvals in those jurisdictions. The regulatory review process varies from country to country. Many countries impose product standards, packaging and labelling requirements, and import restrictions on medical devices.
Risks Related to ENvue Legal, Regulatory and Compliance Matters ● Complying with regulations enforced by FDA and other regulatory authorities is expensive and time consuming, and failure to comply could result in substantial penalties. ● We may not receive the necessary authorizations to market future versions, if any, of our ENvue System or any future new product candidates, and any failure to timely do so may adversely affect our ability to grow our business. ● Certain modifications to our products may require new 510(k) clearance or other marketing authorizations.
Risks Related to ENvue Legal, Regulatory and Compliance Matters ● Complying with regulations enforced by the FDA and other regulatory authorities is expensive and time consuming, and failure to comply could result in substantial penalties. ● We may not receive the necessary authorizations to market future versions, if any, of our ENvue System or any future new product candidates, and any failure to timely do so may adversely affect our ability to grow our business. ● Certain modifications to our products may require new 510(k) clearance or other marketing authorizations.
On February 24, 2025, we obtained approval from our stockholders to file a certificate of amendment to our Certificate of Incorporation to effectuate the 2025 Reverse Stock Split, among others, and on March 13, 2025, the 2025 Reverse Stock Split became effective.
On February 24, 2025, we obtained approval from our stockholders to file a certificate of amendment to our Certificate of Incorporation to effectuate the March 2025 Reverse Stock Split, among others, and on March 13, 2025, the March 2025 Reverse Stock Split became effective.
In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities.
In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities.
We began our marketing and sales activities in the beginning of 2020, and as of the date of this filing, we have not yet begun large-scale production and marketing. Accordingly, the use of the ENvue System has not yet been tested and proven on a large commercial scale.
We began our marketing and sales activities of ENvue System in the beginning of 2020, and as of the date of this filing, we have not yet begun large-scale production and marketing. Accordingly, the use of the ENvue System has not yet been tested and proven on a large commercial scale.
As we continue to engage with target GPOs to increase adoption of and utilization our ENvue System, we expect to face competition in the market from competing technologies, as well as competition from new companies that may enter the market or introduce new technologies in the future.
As we continue to engage with target GPOs to increase adoption and utilization of our ENvue System, we expect to face competition in the market from competing technologies, as well as competition from new companies that may enter the market or introduce new technologies in the future.
The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of FDA or another governmental authority, could have a negative impact on us.
The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.
We are required to timely file various reports with FDA, including reports required by the medical device reporting regulations which require us to report to FDA when we receive or become aware of information that reasonably suggests that one of our products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur in the device or a similar device that we market, could cause or contribute to a death or serious injury.
We are required to timely file various reports with the FDA, including reports required by the medical device reporting regulations which require us to report to the FDA when we receive or become aware of information that reasonably suggests that one of our products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur in the device or a similar device that we market, could cause or contribute to a death or serious injury.
FDA and certain foreign regulatory bodies have the authority to require the recall of commercialized products under certain circumstances. A government-mandated or voluntary recall by us could occur as a result of an unacceptable risk to health, component failures, malfunctions, labeling or design deficiencies, packaging defects, or other deficiencies, or failures to comply with applicable regulations.
The FDA and certain foreign regulatory bodies have the authority to require the recall of commercialized products under certain circumstances. A government-mandated or voluntary recall by us could occur as a result of an unacceptable risk to health, component failures, malfunctions, labeling or design deficiencies, packaging defects, or other deficiencies, or failures to comply with applicable regulations.
We may initiate voluntary withdrawals, removals, or corrections for our products in the future that we determine do not require notification of FDA because no material compliance issue or safety risk is involved. If FDA disagrees with our determinations, it could require us to report those actions and we may be subject to enforcement action.
We may initiate voluntary withdrawals, removals, or corrections for our products in the future that we determine do not require notification of the FDA because no material compliance issue or safety risk is involved. If the FDA disagrees with our determinations, it could require us to report those actions and we may be subject to enforcement action.
In addition, FDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent, limit, or delay regulatory clearance or approval of our future products. For example, in November 2018, FDA announced that it plans to develop proposals to drive manufacturers utilizing the 510(k) pathway toward the use of newer predicates.
In addition, the FDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent, limit, or delay regulatory clearance or approval of our future products. For example, in November 2018, the FDA announced that it plans to develop proposals to drive manufacturers utilizing the 510(k) pathway toward the use of newer predicates.
We also cannot predict the likelihood, nature, or extent of government regulation that may arise from future legislation or administrative or executive action, either in the U.S. or abroad. For example, the Trump Administration previously enacted several executive actions that could impose significant burdens on, or otherwise materially delay, FDA’s ability to engage in routine regulatory and oversight activities.
We also cannot predict the likelihood, nature, or extent of government regulation that may arise from future legislation or administrative or executive action, either in the U.S. or abroad. For example, the Trump Administration previously enacted several executive actions that could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight activities.
Patent and Trademark Office, or the USPTO, for the entire time prior to issuance as a U.S. patent. Patent applications filed in countries outside of the United States are not typically published until at least 18 months from their first filing date. Similarly, publication of discoveries in the scientific or patent literature often lags behind actual discoveries.
Patent and Trademark Office, or the USPTO, for the entire time prior to issuance as a U.S. patent. Patent applications filed in countries outside of the United States are not typically published until at least 18 months from their first filing date. Similarly, publication of discoveries in scientific or patent literature often lags behind actual discoveries.
The new regulations, among other things: ● strengthen the rules on placing devices on the market and reinforce surveillance once they are available; ● establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market; ● improve the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number; ● set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the European Union; and ● strengthen rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.
The new regulations, among other things: ● strengthen the rules on placing devices on the market and reinforce surveillance once they are available; ● establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market; 54 ● improve the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number; ● set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the European Union; and ● strengthen rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.
It is possible that there will be further or longer military reserve duty call-ups in the future, which may affect our business due to a shortage of skilled labor and loss of institutional knowledge, and necessary mitigation measures we may take to respond to a decrease in labor availability, such as overtime and third-party outsourcing, for example, which may have unintended negative effects and adversely impact our results of operations, liquidity or cash flows.
It is possible that there will be further military reserve duty call-ups in the future, which may affect our business due to a shortage of skilled labor and loss of institutional knowledge, and necessary mitigation measures we may take to respond to a decrease in labor availability, such as overtime and third-party outsourcing, for example, which may have unintended negative effects and adversely impact our results of operations, liquidity, or cash flows.
Such policy, statutory, or regulatory changes could impose additional requirements upon us that could delay our ability to obtain new 510(k) clearances, increase the costs of compliance, or restrict our ability to maintain our current marketing authorizations. We received our European CE mark, indicating that we affirm our product’s conformity with European health, safety and environmental protection standards, in 2021.
Such policy, statutory, or regulatory changes could impose additional requirements upon us that could delay our ability to obtain new 510(k) clearances, increase the costs of compliance, or restrict our ability to maintain our current marketing authorizations. 52 We received our European CE mark, indicating that we affirm our product’s conformity with European health, safety and environmental protection standards, in 2021.
Food and Drug Administration approval or clearance before our product candidates may be marketed and after approval or clearance and during the marketing of our products. ● UroShield has not been cleared or approved by the FDA, nor has it undergone the same type of review as an FDA-approved or cleared device. ● Failure to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our products abroad. ● We are uncertain regarding the success of our clinical trials for our products in development. ● Healthcare reform measures could adversely affect our business and financial results. 62 Risks Related to NanoVibronix’s Operations in Israel ● We conduct our operations in Israel and therefore our results may be adversely affected by political, economic and military instability in Israel and its region. ● Because a certain portion of our expenses is incurred in currencies other than the U.S. dollar, our results of operations may be harmed by currency fluctuations and inflation.
Food and Drug Administration approval or clearance before our product candidates may be marketed and after approval or clearance and during the marketing of our products. ● UroShield has not been cleared or approved by the FDA, nor has it undergone the same type of review as an FDA-approved or cleared device. ● Failure to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our products abroad. ● We are uncertain regarding the success of our clinical trials for our products in development. ● Healthcare reform measures could adversely affect our business and financial results. 41 Risks Related to NanoVibronix’s Operations in Israel ● We conduct our operations in Israel and therefore our results may be adversely affected by political, economic and military instability in Israel and its region. ● Because a certain portion of our expenses is incurred in currencies other than the U.S. dollar, our results of operations may be harmed by currency fluctuations and inflation.
Hiring a significant number of additional employees, particularly those at the management level, would increase our expenses significantly. Moreover, if we fail to expand and enhance its operational, financial and management systems in conjunction with its potential future growth, such failure could have a material adverse effect on our business, financial condition and results of operations.
Hiring a significant number of additional employees, particularly those at the management level, would increase our expenses significantly. Moreover, if we fail to expand and enhance our operational, financial and management systems in conjunction with our potential future growth, such failure could have a material adverse effect on our business, financial condition and results of operations.
Management has substantial doubt about the Company’s ability to continue as a going concern. ● Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security. Risks Related to the Regulation of NanoVibronix’s Products ● We are subject to extensive governmental regulation, including the requirement of U.S.
Management has substantial doubt about our ability to continue as a going concern. Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security. Risks Related to the Regulation of NanoVibronix’s Products ● We are subject to extensive governmental regulation, including the requirement of U.S.
Risks Related to NanoVibronix’s Organization and NanoVibronix’s Securities ● The price of our securities may be volatile, and the market price of our securities may drop below the price you pay. ● We have a significant number of warrants and options, and future sales of our common stock upon exercise of these options or warrants, or the perception that future sales may occur, may cause the market price of our common stock to decline, even if our business is doing well. ● Although our shares of common stock are listed on Nasdaq, we currently have a limited trading volume, which results in higher price volatility for, and reduced liquidity of, our common stock. ● If we fail to comply with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted. ● If we fail to maintain effective internal control over financial reporting, our business, financial condition or results of operations may be adversely affected.
Risks Related to ENvue’s Organization and Securities ● The price of our securities may be volatile, and the market price of our securities may drop below the price you pay. ● We have a significant number of warrants and options, and future sales of our common stock upon exercise of these options or warrants, or the perception that future sales may occur, may cause the market price of our common stock to decline, even if our business is doing well. ● Although our shares of common stock are listed on Nasdaq, we currently have a limited trading volume, which results in higher price volatility for, and reduced liquidity of, our common stock. ● If we fail to comply with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted. ● If we fail to maintain effective internal control over financial reporting, our business, financial condition or results of operations may be adversely affected.
There are also criminal penalties, including imprisonment and criminal fines, for making or presenting false, fictitious or fraudulent claims to the federal government; 99 ● Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payers, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements or representations, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of, or payment for, healthcare benefits, items or services.
There are also criminal penalties, including imprisonment and criminal fines, for making or presenting false, fictitious or fraudulent claims to the federal government; 55 ● the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payers, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements or representations, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of, or payment for, healthcare benefits, items or services.
Food and Drug Administration approval or clearance before our product candidates may be marketed and after approval or clearance and during the marketing of our products. The process of obtaining FDA approval is lengthy, expensive and uncertain, and we cannot be sure that our additional product candidates will be approved in a timely fashion, or at all.
Food and Drug Administration approval or clearance before NanoVibronix product candidates may be marketed and after approval or clearance and during the marketing of our products. The process of obtaining FDA approval is lengthy, expensive and uncertain, and we cannot be sure that our additional product candidates will be approved in a timely fashion, or at all.
Risks Related to NanoVibronix’s Business ● We have a history of losses, and we expect to continue to incur losses and may not achieve or maintain profitability ● If we are unable to raise additional capital, our clinical trials and product development will be limited and our long-term viability will be threatened; however, if we do raise additional capital, your percentage ownership as a stockholder could decrease and constraints could be placed on the operations of our business. ● If we fail to obtain an adequate level of reimbursement for our approved products by third party payers, there may be no commercially viable markets for our approved products or the markets may be much smaller than expected. ● We face the risk of product liability claims and may not be able to obtain insurance. ● Our product candidates may not be developed or commercialized successfully. ● Our need to increase the size of our organization in order to successfully manage our growth. ● Our failure to protect our intellectual property rights could diminish the value of our solutions, weaken our competitive position and reduce our revenue. ● The Company’s financial statements have been prepared on a going concern basis, and do not include adjustments that might be necessary if the Company is unable to continue as a going concern.
Risks Related to NanoVibronix’s Business ● We have a history of losses, and we expect to continue to incur losses and may not achieve or maintain profitability. ● If we are unable to raise additional capital, our clinical trials and product development will be limited and our long-term viability will be threatened; however, if we do raise additional capital, your percentage ownership as a stockholder could decrease and constraints could be placed on the operations of our business. ● If we fail to obtain an adequate level of reimbursement for our approved products by third party payers, there may be no commercially viable markets for our approved products or the markets may be much smaller than expected. ● We face the risk of product liability claims and may not be able to obtain insurance. ● Our product candidates may not be developed or commercialized successfully. ● Our need to increase the size of our organization in order to successfully manage our growth. ● Our failure to protect our intellectual property rights could diminish the value of our solutions, weaken our competitive position and reduce our revenue. ● Our financial statements have been prepared on a going concern basis, and do not include adjustments that might be necessary if we are unable to continue as a going concern.
If we fail to comply with our reporting obligations, FDA or other governmental authorities could take action, including warning letters, untitled letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our device clearance, seizure of our products, or delay in clearance of future products.
If we fail to comply with our reporting obligations, the FDA or other governmental authorities could take action, including warning letters, untitled letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our device clearance, seizure of our products, or delay in clearance of future products.
Our ability to grow and to manage our growth effectively will require us to hire, train, retain, manage and motivate additional employees and to implement and improve its operational, financial and management systems. These demands also may require the hiring of additional senior management personnel or the development of additional expertise by our senior management personnel.
Our ability to grow and to manage our growth effectively will require us to hire, train, retain, manage and motivate additional employees and to implement and improve our operational, financial and management systems. These demands also may require the hiring of additional senior management personnel or the development of additional expertise by our senior management personnel.
As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. 106 We may be subject to claims challenging the inventorship of our patents and other intellectual property.
As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. We may be subject to claims challenging the inventorship of our patents and other intellectual property.
Accordingly, on April 13, 2022, the Company submitted an application for the correction of the award which the arbitrator denied on June 22, 2022. 73 On April 5, 2022, Protrade filed a Petition with the Supreme Court of New York Nassau County seeking to confirm the Award.
Accordingly, on April 13, 2022, the Company submitted an application for the correction of the award which the arbitrator denied on June 22, 2022. On April 5, 2022, Protrade filed a Petition with the Supreme Court of New York Nassau County seeking to confirm the Award.
Any of these risks coming to fruition could have a material adverse effect on our business, results of operations, financial condition and prospects. 105 Our failure to secure trademark registrations could adversely affect our ability to market our products and operate our business.
Any of these risks coming to fruition could have a material adverse effect on our business, results of operations, financial condition and prospects. Our failure to secure trademark registrations could adversely affect our ability to market our products and operate our business.
Due to the breadth of these laws, the narrowness of statutory exceptions and regulatory safe harbors available, and the range of interpretations to which they are subject, it is possible that some of our current or future practices might be challenged under one or more of these laws. 100 Certain enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry.
Due to the breadth of these laws, the narrowness of statutory exceptions and regulatory safe harbors available, and the range of interpretations to which they are subject, it is possible that some of our current or future practices might be challenged under one or more of these laws. 56 Certain enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry.
On December 26, 2024, we received the Decision Letter from the Panel granting a limited extension of time for us to demonstrate compliance with the Bid Price Rule and the Equity Rule for continued listing on Nasdaq, subject to the following conditions: (i) on or before February 27, 2025, we will have obtained stockholder approval to effect a reverse stock split of our common stock; (ii) on or before March 31, 2025, we shall have effected a reverse stock split and, thereafter, maintain a $1.00 closing bid price of our common stock for a minimum of ten consecutive trading days; (iii) on or before March 31, 2025, we are required to demonstrate compliance with the Equity Rule by filing public disclosure with the SEC and demonstrate long-term compliance with the Equity Rule; and (iv) on or before March 31, 2025, we are required to demonstrate compliance with all continued listing requirements for Nasdaq.
On December 26, 2024, we received a letter (the “Decision Letter”) from the Panel granting a limited extension of time for us to demonstrate compliance with the Bid Price Rule and the Equity Rule for continued listing on Nasdaq, subject to the following conditions: (i) on or before February 27, 2025, we will have obtained stockholder approval to effect a reverse stock split of our common stock; (ii) on or before March 31, 2025, we shall have effected a reverse stock split and, thereafter, maintain a $1.00 closing bid price of our common stock for a minimum of ten consecutive trading days; (iii) on or before March 31, 2025, we are required to demonstrate compliance with the Equity Rule by filing public disclosure with the SEC and demonstrate long-term compliance with the Equity Rule; and (iv) on or before March 31, 2025, we are required to demonstrate compliance with all continued listing requirements for Nasdaq.
We are a continuous process of receiving feedback from product users, developing, and improving products, distributing the improved products, and continuously reviewing our training procedures and quality control.
We are in a continuous process of receiving feedback from product users, developing, and improving products, distributing the improved products, and continuously reviewing our training procedures and quality control.
They may have more established sales and marketing programs than we do and have greater name recognition. In addition to competing for market share, competitors may develop or acquire patents or other rights that may limit our ability to compete. We believe that the competitive advantages of our ENvue System will be important factors in our future success.
They may have more established sales and marketing programs than we do and have greater name recognition. In addition to competing for market share, competitors may develop or acquire patents or other rights that may limit our ability to compete. W e believe that the competitive advantages of our ENvue System will be important factors in our future success.
ITEM 1A. RISK FACTORS Investing in our common stock involves a high degree of risk. Before investing in our securities, you should carefully consider the following risks, together with the financial and other information contained in this Annual Report on Form 10–K for the year ended December 31, 2024, and our other periodic filings with the SEC.
ITEM 1A. RISK FACTORS Investing in our common stock involves a high degree of risk. Before investing in our securities, you should carefully consider the following risks, together with the financial and other information contained in this Annual Report on Form 10–K for the year ended December 31, 2025, and our other periodic filings with the SEC.
While our ENvue System received 510(k) clearance in February 2019, we may in the future apply for 510(k) clearance for updated components of our ENvue System, which must, then, be found by the FDA to be substantially equivalent to the cleared ENvue System and, thus, may not be lawfully marketed in the U.S. until FDA make a substantial equivalence determination and issues the requisite 510(k) clearance for the updated ENvue System.
While our ENvue System received 510(k) clearance in February 2019, we may in the future apply for 510(k) clearance for updated components of our ENvue System, which must, then, be found by the FDA to be substantially equivalent to the cleared ENvue System and, thus, may not be lawfully marketed in the U.S. until the FDA makes a substantial equivalence determination and issues the requisite 510(k) clearance for the updated ENvue System.
Additionally, there is no assurance that we will maintain compliance with such minimum listing requirements if we regain compliance with all applicable requirements for continued listing on Nasdaq.
There is no assurance that we will maintain compliance with such minimum listing requirements if we regain compliance with all applicable requirements for continued listing on Nasdaq.
If we are unable to successfully drive interest in our ENvue System, our business, financial condition and results of operations would be harmed. Our commercial success and revenues will depend in large part on the future adoption of the ENvue System into patient work streams in facilities and other healthcare settings.
Our commercial success and revenues will depend on the future adoption of the ENvue System into patient work streams in facilities and other healthcare settings. If we are unable to successfully drive interest in our ENvue System, our business, financial condition and results of operations would be harmed.
Although our shares of common stock are listed on Nasdaq under the symbol “NAOV,” trading volume in our common stock has been limited and an active trading market for our shares of common stock may never develop or be maintained. The absence of an active trading market increases price volatility and reduces the liquidity of our common stock.
Although our shares of common stock are listed on Nasdaq under the symbol “FEED,” trading volume in our common stock has been limited and an active trading market for our shares of common stock may never develop or be maintained. The absence of an active trading market increases price volatility and reduces the liquidity of our common stock.
We are subject to the risks that: ● the FDA or a foreign regulatory authority finds our product candidates ineffective or unsafe; ● we do not receive necessary regulatory approvals; ● the regulatory review and approval process may take much longer than anticipated, requiring additional time, effort and expense to respond to regulatory comments and/or directives; ● we are unable to get our product candidates in commercial quantities at reasonable costs; and ● the patient and physician community does not accept our product candidates.
We are subject to the risks that: ● the FDA or a foreign regulatory authority finds our products ineffective or unsafe; ● we do not receive necessary regulatory approvals; ● the regulatory review and approval process may take much longer than anticipated, requiring additional time, effort and expense to respond to regulatory comments and/or directives; ● we are unable to get our products in commercial quantities at reasonable costs; and ● the patient and physician community does not accept our products.
While we do not have any customer or direct supplier relationships in either country at this time, the current military conflict, and related sanctions, as well as export controls or actions that may be initiated by nations including the United States, the European Union or Russia (e.g., potential cyberattacks, disruption of energy flows, etc.) and other potential uncertainties could adversely affect our business and/or our supply chain, business partners, employees or customers, and interrupt our ability to supply products, or otherwise adversely impact our business.
While we do not have any customer or direct supplier relationships in impacted areas at this time, the current military conflict, and related sanctions, as well as export controls or actions that may be initiated by nations including the United States, the European Union or Russia (e.g., potential cyberattacks, disruption of energy flows, etc.) and other potential uncertainties could adversely affect our business and/or our supply chain, business partners, employees or customers, and interrupt our ability to supply products, or otherwise adversely impact our business.
Broad market and industry factors, as well as general economic, political and market conditions such as recessions or interest rate changes, may seriously affect the market price of the combined company’s common stock, regardless of the actual operating performance of NanoVibronix.
Broad market and industry factors, as well as general economic, political and market conditions such as recessions or interest rate changes, may seriously affect the market price of the combined company’s common stock, regardless of our actual operating performance.
The consolidated financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
The consolidated financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should we be unable to continue as a going concern.
We subsequently timely requested a hearing before the Panel, which was held on December 5, 2024. 81 On November 19, 2024, we received an additional deficiency notice from the Staff indicating that we no longer satisfied the $2.5 million stockholders’ equity requirement set forth in the Equity Rule for continued listing on Nasdaq.
We subsequently and timely requested a hearing before the Panel, which was held on December 5, 2024. 66 On November 19, 2024, we received an additional deficiency notice from the Staff indicating that we no longer satisfied the $2.5 million stockholders’ equity requirement set forth in the Equity Rule for continued listing on Nasdaq.
We currently have 4 full-time employees, including 4 employees who are members of senior management, as well as engagements with 5 contractors, who are located in and/or reside in Israel. As a result, our business and operations are directly affected by economic, political, geopolitical and military conditions in Israel.
We currently have 12 full-time employees, including 5 employees who are members of senior management, as well as engagements with 2 contractors, who are located in and/or reside in Israel. As a result, our business and operations are directly affected by economic, political, geopolitical and military conditions in Israel.
As a result, NanoVibronix may be forced to later write-down or write-off assets, restructure operations, or incur impairment or other charges that could result in losses. Even if due diligence successfully identifies certain risks, unexpected risks may arise, and previously known risks may materialize in a manner not consistent with NanoVibronix’s preliminary risk analysis.
As a result, we may be forced to later write-down or write-off assets, restructure operations, or incur impairment or other charges that could result in losses. Even if due diligence successfully identifies certain risks, unexpected risks may arise, and previously known risks may materialize in a manner not consistent with our preliminary risk analysis.
In February 2025, the Second Department informed counsel for the Company that the Second Department was beginning to process the appeal for calendaring.” As of December 31, 2024, and 2023, the Company accrued the amount of the arbitration award to Protrade of approximately $2.1 and $2.0 million, respectively, including interest which is classified in “Other accounts payable and accrued expenses”.
In February 2025, the Second Department informed counsel for the Company that the Second Department was beginning to process the appeal for calendaring. As of December 31, 2025, and 2024, the Company accrued the amount of the arbitration award to Protrade of approximately $2.3 and $2.1 million, respectively, including interest which is classified in “Other accounts payable and accrued expenses”.
The discovery of a defect, error or security vulnerability in our products, software applications or IT systems, incompatibility with future customers’ computer operating systems and hardware configurations with a new release or upgraded version or the failure of our products or primary IT systems may cause adverse consequences, including: delay or loss of revenues, significant remediation costs, delay in market acceptance, loss of data, disclosure of financial, health or other personal information of any customers or patients, product recalls, damage to our reputation, or increased service costs, any of which could have a material effect on our business, financial condition or results of our operations and the operations of our potential customers or our business partners. 85 Our operations and financial performance depend on global and regional economic conditions.
The discovery of a defect, error or security vulnerability in our products, software applications or IT systems, incompatibility with future customers’ computer operating systems and hardware configurations with a new release or upgraded version or the failure of our products or primary IT systems may cause adverse consequences, including: delay or loss of revenues, significant remediation costs, delay in market acceptance, loss of data, disclosure of financial, health or other personal information of any customers or patients, product recalls, damage to our reputation, or increased service costs, any of which could have a material effect on our business, financial condition or results of our operations and the operations of our potential customers or our business partners.
The Company will need to raise additional capital to finance its losses, debt obligations, and negative cash flows from operations and may continue to be dependent on additional capital raising as long as our products do not reach commercial profitability. There are no assurances that the Company would be able to raise additional capital on terms favorable to it.
We will need to raise additional capital to finance our losses, debt obligations, and negative cash flows from operations and may continue to be dependent on additional capital raising as long as our products do not reach commercial profitability. There are no assurances that we would be able to raise additional capital on terms favorable to it.
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to the relevant patent agencies in several stages over the lifetime of the patents and /or applications. The relevant patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent application process.
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to the relevant patent agencies in several stages over the lifetime of the patents and /or applications. The relevant patent agencies require compliance with a number of procedures, documentation, fee payment and other provisions during the patent application process.
We may, in the future, be involved in one or more lawsuits, claims or other proceedings. These suits could concern issues including contract disputes, employment actions, employee benefits, taxes, environmental, health and safety, fraud and abuse, personal injury and product liability matters. On February 26, 2021, Protrade Systems, Inc.
We face risks associated with litigation and claims. We may, in the future, be involved in one or more lawsuits, claims or other proceedings. These suits could concern issues including contract disputes, employment actions, employee benefits, taxes, environmental, health and safety, fraud and abuse, personal injury and product liability matters. On February 26, 2021, Protrade Systems, Inc.
These regulations vary from country to country but cover, among other things, the following activities with respect to medical devices: ● design, development and manufacturing; ● testing, labeling, content and language of instructions for use and storage; ● product storage and safety; ● marketing, sales and distribution; ● pre-market clearance or approval; ● record keeping procedures; ● advertising and promotion; ● recalls and field safety corrective actions; 93 ● post-market surveillance; ● post-market approval studies; and ● product import and export.
These regulations vary from country to country but cover, among other things, the following activities with respect to medical devices: ● design, development and manufacturing; ● testing, labeling, content and language of instructions for use and storage; ● product storage and safety; ● marketing, sales and distribution; ● pre-market clearance or approval; ● record keeping procedures; ● advertising and promotion; ● recalls and field safety corrective actions; ● post-market surveillance; ● post-market approval studies; and ● product import and export. 51 The regulations to which we are subject are complex.
There is no assurance that, following any such acquisition, the combined company will achieve the synergies expected to justify the transaction, which could result in a material adverse effect on the combined company’s business and prospects. 74 Certain stockholders could attempt to influence changes within NanoVibronix, which could adversely affect NanoVibronix ’ s operations, financial condition and the value of NanoVibronix ’ s common stock.
There is no assurance that, following any such acquisition, the combined company will achieve the synergies expected to justify the transaction, which could result in a material adverse effect on our business and prospects. Certain stockholders could attempt to influence changes within the Company, which could adversely affect our operations, financial condition and the value of our common stock.
In addition to the factors discussed in this “Risk Factors” section and elsewhere in this Annual Report, these factors include: ● progress, or lack of progress, in developing and commercializing our products; ● favorable or unfavorable decisions about our products or intellectual property from government regulators, insurance companies or other third-party payers; ● our ability to recruit and retain qualified regulatory and research and development personnel; ● changes in investors’ and securities analysts’ perception of the business risks and conditions of our business; ● changes in our relationship with key collaborators; ● changes in the market valuation or earnings of our competitors or companies viewed as similar to us; ● changes in key personnel; ● depth of the trading market in our common stock; ● changes in our capital structure, such as future issuances of securities or the incurrence of additional debt; ● the granting or exercise of employee stock options or other equity awards; ● realization of any of the risks described under this section entitled “Risk Factors”; and ● general market and economic conditions. 80 In recent years, the stock markets, in general, have experienced extreme price and volume fluctuations especially in the biotechnology sector.
In addition to the factors discussed in this “Risk Factors” section and elsewhere in this Annual Report, these factors include: ● progress, or lack of progress, in developing and commercializing our products; ● favorable or unfavorable decisions about our products or intellectual property from government regulators, insurance companies or other third-party payers; ● our ability to recruit and retain qualified regulatory and research and development personnel; ● changes in investors’ and securities analysts’ perception of the business risks and conditions of our business; ● changes in our relationship with key collaborators; ● changes in the market valuation or earnings of our competitors or companies viewed as similar to us; ● changes in key personnel; ● depth of the trading market in our common stock; ● changes in our capital structure, such as future issuances of securities or the incurrence of additional debt; ● the granting or exercise of employee stock options or other equity awards; ● realization of any of the risks described under this section entitled “Risk Factors”; and ● general market and economic conditions.
We are aiming to increase awareness about our ENvue System, work with medical professionals in the United States to raise awareness among the medical community and grow the number of facilities that utilize our ENvue System, but there can be no assurance that we will succeed. 88 The commercial success of our ENvue System will continue to depend on a number of factors, including the following: ● the actual and perceived effectiveness and clinical benefit, of our ENvue System; ● the prevalence and severity of any adverse patient events involving our ENvue System; ● our ability to provide earlier awareness of and education about our ENvue System to GPOs; ● the degree to which medical professionals and GPOs adopt our ENvue System; ● the availability, relative cost and perceived advantages and disadvantages of alternative technologies or treatment methods for cognitive disorders; ● the results of future clinical and other studies relating to the health, economic or other benefits of our ENvue System; ● whether key thought leaders in the medical community accept that our future clinical utility is sufficiently meaningful to influence their decision to adopt our ENvue System; ● the extent to which we are successful in educating medical professionals, GPOs and patients about the benefits of our ENvue System; ● our reputation among GPOs and medical professionals; ● our ability to predict product performance; ● the strength of our marketing and distribution infrastructure, including our ability to drive adoption and utilization of our ENvue System; ● our ability to obtain, maintain, protect, enforce and defend our intellectual property rights, including those covering our ENvue System; ● our ability to maintain compliance with all legal and regulatory requirements, including FDA medical device postmarket surveillance regulations applicable to our ENvue System; and ● our ability to continue to attract and retain key talent.
The commercial success of our ENvue System will continue to depend on a number of factors, including the following: ● the actual and perceived effectiveness and clinical benefit, of our ENvue System; ● the prevalence and severity of any adverse patient events involving our ENvue System; ● our ability to provide earlier awareness of and education about our ENvue System to GPOs; ● the degree to which medical professionals and GPOs adopt our ENvue System; ● the availability, relative cost and perceived advantages and disadvantages of alternative technologies or treatment methods for cognitive disorders; ● the results of future clinical and other studies relating to the health, economic or other benefits of our ENvue System; ● whether key thought leaders in the medical community accept that our future clinical utility is sufficiently meaningful to influence their decision to adopt our ENvue System; ● the extent to which we are successful in educating medical professionals, GPOs and patients about the benefits of our ENvue System; ● our reputation among GPOs and medical professionals; 71 ● our ability to predict product performance; ● the strength of our marketing and distribution infrastructure, including our ability to drive adoption and utilization of our ENvue System; ● our ability to obtain, maintain, protect, enforce and defend our intellectual property rights, including those covering our ENvue System; ● our ability to maintain compliance with all legal and regulatory requirements, including FDA medical device postmarket surveillance regulations applicable to our ENvue System; and ● our ability to continue to attract and retain key talent.
Because the Company does not have sufficient resources to fund our operations for the next twelve months from the date of this filing, management has substantial doubt about the Company’s ability to continue as a going concern. In addition, the Company has incurred additional short-term debt related to the merger transaction.
Because we do not have sufficient resources to fund our operations for the next twelve months from the date of this filing, management has substantial doubt about our ability to continue as a going concern. In addition, we have incurred additional short-term debt related to the Merger.
A product liability claim or series of claims brought against us would decrease our cash and could reduce our value or marketability. 70 Our product candidates may not be developed or commercialized successfully.
A product liability claim or series of claims brought against us would decrease our cash and could reduce our value or marketability. 46 Our products may not be developed or commercialized successfully.
The current business of NanoVibronix differs from that of ENvue in important respects and, accordingly, the results of operations of the combined company and the market price of our common stock following the Merger may be affected by factors different from those currently affecting the results of operations of NanoVibronix.
Our NanoVibronix business differs from that of ENvue Holdings in important respects and, accordingly, the results of operations of the combined company and the market price of our common stock following the Merger may be affected by factors different from those affecting our results of operations prior to the Merger.
The failure to procure such required financing could have a material adverse effect on our business, financial condition and results of operations, or threaten our ability to continue as a going concern. 68 A variety of factors could impact the timing and amount of any required financings, including, without limitation: ● unforeseen developments during our clinical trials; ● delays in our receipt of required regulatory approvals; ● delayed market acceptance of our products; ● unanticipated expenditures in our acquisition and defense of intellectual property rights, and/or the loss of those rights; ● the failure to develop strategic alliances for the marketing of some of our product candidates; ● unforeseen changes in healthcare reimbursement for any of our approved products; ● lack of financial resources to adequately support our operations; ● difficulties in maintaining commercial scale manufacturing capacity and capability; ● unanticipated difficulties in operating in international markets; ● unanticipated financial resources needed to respond to technological changes and increased competition; ● unforeseen problems in attracting and retaining qualified personnel; ● enactment of new legislation or administrative regulations; ● the application to our business of new regulatory interpretations; ● claims that might be brought in excess of our insurance coverage; ● the failure to comply with regulatory guidelines; ● the uncertainty in industry demand; and ● the delisting of our common stock from Nasdaq.
A variety of factors could impact the timing and amount of any required financings, including, without limitation: ● unforeseen developments during our clinical trials; ● delays in our receipt of required regulatory approvals; ● delayed market acceptance of our products; ● unanticipated expenditures in our acquisition and defense of intellectual property rights, and/or the loss of those rights; ● the failure to develop strategic alliances for the marketing of some of our product candidates; ● unforeseen changes in healthcare reimbursement for any of our approved products; ● lack of financial resources to adequately support our operations; ● difficulties in maintaining commercial scale manufacturing capacity and capability; ● unanticipated difficulties in operating in international markets; ● unanticipated financial resources needed to respond to technological changes and increased competition; ● unforeseen problems in attracting and retaining qualified personnel; ● enactment of new legislation or administrative regulations; ● the application to our business of new regulatory interpretations; ● claims that might be brought in excess of our insurance coverage; ● the failure to comply with regulatory guidelines; ● the uncertainty in industry demand; and ● the delisting of our common stock from Nasdaq.
Our product candidates are based on a technology that has not been used previously in the manner we propose and must compete with more established treatments currently accepted as the standards of care. Market acceptance of our products will largely depend on our ability to demonstrate their relative safety, efficacy, cost-effectiveness and ease of use.
Our products are based on technologies that have not been used previously in the manner we propose and must compete with more established treatments currently accepted as the standards of care. Market acceptance of our products will largely depend on our ability to demonstrate their relative safety, efficacy, cost-effectiveness and ease of use.
As a result of the foregoing, NanoVibronix may be unable to realize the full strategic and financial benefits currently anticipated from the Merger, and NanoVibronix cannot assure you that the Merger will be accretive to NanoVibronix in the near term or at all.
As a result of the foregoing, we may be unable to realize the full strategic and financial benefits previously anticipated from the Merger, and we cannot assure you that the Merger will be accretive to us in the near term or at all.
Even though these charges may be non-cash items and may not have an immediate impact on liquidity, the fact that NanoVibronix reports charges of this nature could contribute to negative market perceptions about NanoVibronix or its securities. In addition, charges of this nature may make future financing difficult to obtain on favorable terms or at all.
Even though these charges may be non-cash items and may not have an immediate impact on liquidity, the fact that we report charges of this nature could contribute to negative market perceptions about us or our securities. In addition, charges of this nature may make future financing difficult to obtain on favorable terms or at all.
FDA can delay, limit, or deny 510(k) clearance, or approval or reclassification, of a device for many reasons, including: ● we may be unable to demonstrate to FDA’s satisfaction that the product candidate or modifications are substantially equivalent to a proposed predicate device or safe and effective for their intended uses; ● we may be unable to demonstrate that the clinical and other benefits of the device outweigh the risks; and ● the applicable regulatory authority may identify deficiencies in our submissions or in the facilities or processes of our third party contract manufacturers. 94 Any delay or failure to obtain necessary regulatory clearances or approvals could harm our business.
FDA can delay, limit, or deny 510(k) clearance, or approval or reclassification, of a device for many reasons, including: ● we may be unable to demonstrate to FDA’s satisfaction that the product candidate or modifications are substantially equivalent to a proposed predicate device or safe and effective for their intended uses; ● we may be unable to demonstrate that the clinical and other benefits of the device outweigh the risks; and ● the applicable regulatory authority may identify deficiencies in our submissions or in the facilities or processes of our third party contract manufacturers.
Our product, the ENvue System (for which we have obtained FDA 510(k) clearance), and our future products are considered medical devices and, accordingly, are subject to rigorous regulation by government agencies in the U.S. and other countries in which we intend to sell our products.
In addition, ENvue Holdings’ product, the ENvue System (for which we have obtained FDA 510(k) clearance) is, and future ENvue Holdings products can be considered medical devices and, accordingly, are subject to rigorous regulation by government agencies in the U.S. and other countries in which we intend to sell our products.
Our inability to do so could harm our competitive position. 103 We rely on our portfolio of issued and pending patent applications in the U.S. and other countries to protect a large part of our intellectual property and our competitive position; however, our currently pending or future patent filings may not result in the issuance of patents.
We rely on our portfolio of issued and pending patent applications in the U.S. and other countries to protect a large part of our intellectual property and our competitive position; however, our currently pending or future patent filings may not result in the issuance of patents.
Failure to comply with applicable requirements could result in, among other things, any of the following actions: ● FDA issuance of Form 483 or Warning Letters, which may be made public and may lead to further regulatory or enforcement actions, or similar letters by other regulatory authorities; ● fines and other monetary penalties; ● unanticipated expenditures; ● delays in FDA approval and clearance, or FDA refusal to approve or clear a product candidate; ● product recall or seizure; ● interruption of manufacturing or clinical trials; ● operating restrictions; ● injunction or other restrictions imposed on our operations, including closing our facilities or our contract manufacturers’ facilities; or ● criminal prosecutions.
Failure to comply with applicable requirements could result in, among other things, any of the following actions: ● FDA issuance of Form 483 or Warning Letters, which may be made public and may lead to further regulatory or enforcement actions, or similar letters by other regulatory authorities; ● fines and other monetary penalties; ● unanticipated expenditures; ● delays in FDA approval and clearance, or FDA refusal to approve or clear a product candidate; ● product recall or seizure; ● interruption of manufacturing or clinical trials; ● operating restrictions; ● injunction or other restrictions imposed on our operations, including closing our facilities or our contract manufacturers’ facilities; or ● criminal prosecutions. 50 In addition to the approval and clearance requirements, numerous other regulatory requirements apply, both before and after approval or clearance, to us, our products and product candidates, and our suppliers and contract manufacturers.
On April 5, 2017, the European Parliament passed the Medical Devices Regulation (Regulation 2017/745), which repeals and replaces the EU Medical Device Directive and became effective on May 26, 2021.
On April 5, 2017, the European Parliament passed the MDR which repeals and replaces the EU Medical Device Directive and became effective on May 26, 2021.
On March 21, 2023, the court denied the motion to re-argue and renew. On July 10, 2023, the Company filed its appeal with the Appellate Division, Second Department. That appeal is now fully briefed.
On the same day, the Company also filed a notice of appeal with the Appellate Division, Second Department. On March 21, 2023, the court denied the motion to re-argue and renew. On July 10, 2023, the Company filed its appeal with the Appellate Division, Second Department. That appeal is now fully briefed.
If we are unable to raise additional capital, our clinical trials and product development will be limited and our long-term viability will be threatened; however, if we do raise additional capital, your percentage ownership as a stockholder could decrease and constraints could be placed on the operations of our business.
Any of these events could materially affect our business and operating results. 44 If we are unable to raise additional capital, our clinical trials and product development will be limited and our long-term viability will be threatened; however, if we do raise additional capital, your percentage ownership as a stockholder could decrease and constraints could be placed on the operations of our business.
NanoVibronix may encounter numerous difficulties in developing, manufacturing, and marketing any new products resulting from a strategic alliance or acquisition that delay or prevent it from realizing their expected benefits or enhancing its business.
We may encounter numerous difficulties in developing, manufacturing, and marketing any new products resulting from a strategic alliance or acquisition that delay or prevent us from realizing their expected benefits or enhancing our business.
Our continued success depends on, among other things, our ability to: ● successfully engage with GPOs to increase adoption of and utilization our ENvue System; ● attract and retain skilled research, development, sales, marketing and clinical personnel; ● continue to innovate in order to improve our ENvue System and enhance the patient and provider experience; ● adequately predict and respond to product performance and safety; ● obtain and maintain regulatory clearances, including for expanded indications; ● cost-effectively market and sell our ENvue System; ● obtain, maintain, protect, enforce and defend our intellectual property rights and operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of others; and ● acquire products or technologies complementary to or necessary for our business.
Our continued success depends on, among other things, our ability to: ● successfully engage with GPOs to increase adoption of and utilization our ENvue System; ● attract and retain skilled research, development, sales, marketing and clinical personnel; ● continue to innovate in order to improve our ENvue System and enhance the patient and provider experience; ● adequately predict and respond to product performance and safety; ● obtain and maintain regulatory clearances, including for expanded indications; ● cost-effectively market and sell our ENvue System; ● obtain, maintain, protect, enforce and defend our intellectual property rights and operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of others; and ● acquire products or technologies complementary to or necessary for our business. 72 The medical device industry is intensely competitive, subject to rapid change and significantly affected by new product introductions and other market activities of industry participants.
Legislative and governmental activity in the privacy area may result in new laws or regulations that are applicable to us and that may hinder our business, for example, by restricting use or sharing of patient data, limiting our ability to provide certain data to our customers, limiting our ability to develop or modify our AI systems, or otherwise regulating AI and machine learning, including the use of algorithms and automated processing in ways that could materially affect our business, or which may lead to significant increases in the cost of compliance.
Legislative and governmental activity in the privacy area may result in new laws or regulations that are applicable to us and that may hinder our business, for example, by restricting use or sharing of patient data, limiting our ability to provide certain data to our customers, limiting our ability to develop or modify our AI systems, or otherwise regulating AI and machine learning, including the use of algorithms and automated processing in ways that could materially affect our business, or which may lead to significant increases in the cost of compliance. 65 Risks Related to Our Organization and Securities The price of our securities may be volatile, and the market price of our securities may drop below the price you pay.
We intend to protect our intellectual property rights, including our AI technology and related algorithms, through a combination of patent, trademark, copyright, and trade secret laws, as well as third-party confidentiality and assignment agreements.
We intend to protect our intellectual property rights, including our AI technology and related algorithms, through a combination of patent, trademark, copyright, and trade secret laws, as well as third-party confidentiality and assignment agreements. Our inability to do so could harm our competitive position.
NanoVibronix’s stockholders may from time to time seek to acquire a controlling stake in NanoVibronix, engage in proxy solicitations, advance stockholder proposals or otherwise attempt to effect changes.
Our stockholders may from time to time seek to acquire a controlling stake in the Company, engage in proxy solicitations, advance stockholder proposals or otherwise attempt to effect changes.
Although NanoVibronix has conducted due diligence on ENvue, there can be no assurances that our diligence revealed all material issues that may be present in ENvue’s business, that all material issues through a customary amount of due diligence will be uncovered, or that factors outside of NanoVibronix’s control will not later arise.
Although we have conducted due diligence on ENvue Holdings, there can be no assurances that our diligence revealed all material issues that may be present in ENvue Holdings’ business, that all material issues through a customary amount of due diligence will be uncovered, or that factors outside of our control will not later arise.
This could cause a number of delays and/or issues for our operations, including delay of the review of our product candidates by regulatory agencies, which in turn would have a material adverse impact on our ability to commercialize our product candidates. Additionally, members of our management and employees are located and reside in Israel.
This could cause a number of delays and/or issues for our operations, including delay of the review of our product candidates by regulatory agencies, which in turn would have a material adverse impact on our ability to commercialize our product candidates.
Our business could be adversely affected by unstable economic and political conditions within the United States and foreign jurisdictions and geopolitical conflicts, such as the conflict between Russia and Ukraine.
Our business could be adversely affected by unstable economic and political conditions within the United States and foreign jurisdictions and geopolitical conflicts, such as the conflicts in Venezuela, between Russia and Ukraine or in the Middle East.
This could also result in litigation, fines, penalties, and adverse publicity that could cause reputational harm and loss of patient trust, which could have an adverse effect on our business.
This could also result in litigation, fines, penalties, and adverse publicity that could cause reputational harm and loss of patient trust, which could have an adverse effect on our business. Risks Related to Our Operations in Israel We conduct our operations in Israel.
Issues with product development or enhancements, IT system integration, implementation, updates and upgrades could disrupt our operations and have a material impact on our business and operating results.
Our products and information technology systems are critical to our business. Issues with product development or enhancements, IT system integration, implementation, updates and upgrades could disrupt our operations and have a material impact on our business and operating results.
Further, consumers can bring private false-advertising lawsuits, including class actions, against us for any material misrepresentations and/or deceptive or unsubstantiated claims (among other similar causes of action) in our promotional materials or other advertising.
Further, consumers can bring private false-advertising lawsuits, including class actions, against us for any material misrepresentations and/or deceptive or unsubstantiated claims (among other similar causes of action) in our promotional materials or other advertising. Any of the foregoing could have a material adverse effect on our business.
Any such access, inappropriate disclosure of confidential or proprietary information or other loss of information, including our data being breached at third-party providers, could result in legal claims or proceedings, liability or financial loss under laws that protect the privacy of personal information, disruption of our operations or our product development programs and damage to our reputation, which could adversely affect our business.
Any such access, inappropriate disclosure of confidential or proprietary information or other loss of information, including our data being breached at third-party providers, could result in legal claims or proceedings, liability or financial loss under laws that protect the privacy of personal information, disruption of our operations or our product development programs and damage to our reputation, which could adversely affect our business. 49 We may acquire businesses or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions.
We face competition from established medical device companies, such as Neurometrix Inc., Zetrox, (a subsidiary of the 3M Company) and Smith & Nephew plc, manufacturers of certain portable ultrasound devices capable of self-administered use, as well as from academic institutions, government agencies, and private and public research institutions in the United States and abroad.
We face competition from established medical device companies, such as (i) with respect to our NanoVibronix business, Neurometrix Inc., Zetrox (a subsidiary of the 3M Company), Smith & Nephew plc, manufacturers of certain portable ultrasound devices capable of self-administered use and (ii) with respect to ENvue Holdings business, Cardinal Health and Avanos Medical, as well as from academic institutions, government agencies, and private and public research institutions in the United States and abroad.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeAs of the date of this report, no cybersecurity incident (or aggregation of incidents) or cybersecurity threat has materially affected our results of operations or financial condition. However, an actual or perceived breach of our security could damage our reputation, and cause existing clients/customers to discontinue.
Biggest changeMaterial incidents are escalated to the Chief Executive Officer and reported to the Nominating and Corporate Governance Committee in accordance with our incident response procedures. As of the date of this report, no cybersecurity incident (or aggregation of incidents) or cybersecurity threat has materially affected our results of operations or financial condition.
The committee receives interim reports and updates from the senior management, and management has committed to updating the full Board on a quarterly basis with respect to the management of risks from cybersecurity threats. Such reports cover the Company’s information technology security program, including its current status, capabilities, objectives and plans, as well as the evolving cybersecurity threat landscape.
The Committee receives interim reports and updates from senior management, and management has committed to updating the full Board on a quarterly basis with respect to the management of risks from cybersecurity threats. Such reports cover our information technology security program, including its current status, capabilities, objectives, and plans, as well as the evolving cybersecurity threat landscape.
The program outlines governance, policies and procedures, and technology we use to oversee and identify risks from cybersecurity threats and is informed by previous cybersecurity incidents we have observed both within the Company and in our industry.
The program outlines governance, policies and procedures, and technology controls we use to oversee and identify risks from cybersecurity threats, and is informed by cybersecurity incidents we have observed both within the Company and in our industry.
ITEM 1C. CYBERSECURITY We operate in the biotechnology sector, which is subject to various cybersecurity risks that could adversely affect our business, financial condition, and results of operations, including intellectual property theft; fraud; extortion; harm to employees or customers; violation of privacy laws and other litigation and legal risk; and reputational risk.
CYBERSECURITY Cybersecurity Risk Management and Governance We operate in the medical device and healthcare technology sector, which is subject to various cybersecurity risks that could adversely affect our business, financial condition, and results of operations, including intellectual property theft; fraud; extortion; harm to employees or customers; violation of privacy laws and other litigation and legal risk; and reputational risk.
For further information, see “Risk Factors- Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security ” in Item 1A of this Annual Report on Form 10-K.
For further information, see “Risk Factors-Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security” in Item 1A of this Annual Report on Form 10-K. We currently carry a cyber liability insurance policy.
As well as prevent us from attracting new clients/customers, and interfere with the progress of our clinical trials, or interfere with our efforts to pursue regulatory approvals for our product candidates, or subject us to third-party lawsuits, regulatory fines or other actions or liabilities, any of which could adversely affect our business, operating results or financial condition.
However, an actual or perceived breach of our security could damage our reputation, cause existing clients and customers to discontinue their relationships with us, prevent us from attracting new clients and customers, interfere with the progress of our clinical trials, or interfere with our efforts to pursue regulatory approvals for our product candidates, or subject us to third party lawsuits, regulatory fines, or other actions or liabilities, any of which could adversely affect our business, operating results, or financial condition.
We recognize the critical importance of developing, implementing, and maintaining robust cybersecurity measures to safeguard our information systems and protect the confidentiality, integrity, and availability of our data. We currently have security measures in place to protect our clients, patients, customers, employees,‌ and vendor information and prevent data loss and other security breaches, including a cybersecurity risk assessment program.
We recognize the critical importance of developing, implementing, and maintaining cybersecurity measures to safeguard our information systems and protect the confidentiality, integrity, and availability of our data. Cybersecurity Risk Assessment Program Our cybersecurity risk assessment program consists of an annual review of our risks and policies.
Our General Manager, who is responsible for overseeing our business operations, with oversight from senior management and the nominating and the Corporate Governance Committee of our Board are responsible for day-to-day assessment and management of risks from cybersecurity threats, including the prevention, mitigation, detection, and remediation of cybersecurity incidents.
We seek to ensure that our policies and controls are applied consistently across both locations. Management and Board Oversight Our Chief Operating Officer, with oversight from the Chief Executive Officer and senior management, is responsible for the day-to-day assessment and management of risks from cybersecurity threats, including the prevention, mitigation, detection, and remediation of cybersecurity incidents.
In addition, we maintain business continuity, contingency, and recovery plans for use in the event of a cybersecurity incident by the administering of local and cloud based back up of files. and emails.
We maintain business continuity, contingency, and recovery plans for use in the event of a cybersecurity incident, including local and cloud based backup of files and emails. Third Party Service Provider Risk We have implemented processes to oversee and identify cybersecurity risks associated with our use of third party service providers .
We also use the services of an outside consulting firm to monitor activity and advise the company of cybersecurity protocols. The Nominating and Corporate Governance Committee of the Board is responsible for oversight of risks from cybersecurity threats in conjunction with management.
Day-to-day operational cybersecurity activities are managed by our IT Manager in coordination with external IT support. The Audit Committee of the Board of Directors is responsible for oversight of risks from cybersecurity threats in conjunction with management.
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We also only use third party software for accounting, billing and payroll that have successful SOC 1 type 2 compliance.
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We are adopting formal policies governing information security, acceptable use, and data retention, which are reviewed and updated on at least an annual basis. 75 We have engaged a third party virtual Chief Information Security Officer (CISO) to assist in assessing, developing, and maintaining our cybersecurity program.
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Both management and the Board are actively involved in the continuous assessment of risks from cybersecurity threats, including prevention, mitigation, detection, and remediation of cybersecurity incidents. 108 O ur current cybersecurity risk assessment program consists of an annual review of our risks and policies.
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Among other things, this engagement includes periodic evaluations of our workstations and on site storage equipment. We maintain and constantly improve security measures designed to protect client, patient, customer, employee, and vendor information and to prevent data loss and other security breaches.
Removed
Additionally, the Nominating and Corporate Governance Committee considers risks from cybersecurity threats as part of its oversight of the Company’s business strategy, risk management, and financial oversight by requiring quarterly updates from management at its Board meetings. We routinely undertake activities to prevent, detect, and minimize the effects of cybersecurity incidents, including an annual risk review, policy reviews and revisions.
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These processes include vendor due diligence prior to engagement, contractual requirements for security standards where appropriate, and ongoing monitoring of compliance with applicable protocols. We require that third party software providers used for accounting, billing, and payroll maintain SOC 1 compliance, and we monitor their continued adherence to those standards.
Removed
We engaged and used the advice of a third-party consultant to help us assess and identify risks from cybersecurity threats, including the threat of a cybersecurity incident, and manage our risk assessment program.
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Cross-Border Operations We maintain operations in both the United States (Tyler, Texas, Arlington Heights, Illinois) and Israel (Tel Aviv), including through our subsidiary NanoVibronix Ltd. (Nesher, Tel-Aviv) Our cybersecurity program is designed to address the risks associated with cross-border data flows and the applicable data protection requirements in each jurisdiction, including Israeli privacy law.
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Among other things, these providers have recommended installation of Check Point Firewall and ESET Protect Advanced cloud based anti-virus, as well as site periodic evaluations of the work stations and onsite storage equipment.
Added
The Nominating and Corporate Governance Committee considers risks from cybersecurity threats as part of its oversight of the Company’s business strategy, risk management, and financial oversight. Materiality Assessment In determining whether a cybersecurity incident is material, senior management evaluates the nature and scope of the incident, the data or systems affected, potential financial impact, regulatory implications, and any operational disruption.
Removed
We also engaged third party consultants to prepare policies and procedures to oversee and identify the risks from cybersecurity threats associated with our use of third-party service providers and we continue to monitor that all third-party software providers remain in compliance with SOC 1 protocols.
Removed
We currently do not carry a cyber liability insurance policy, but are evaluating whether to acquire one to mitigate any financial impact of a cybersecurity breach.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeIn March 2024, we entered into a new three year lease for an office and manufacturing facility in Nesher for approximately $2,500 per month, with the option to terminate the lease anytime with four months notice after the first twelve months. The space is approximately 180 square meters. We paid approximately $4,200 per month under our former lease.
Biggest changeThe lease provides for monthly rent of approximately $2,500 and covers approximately 180 square meters. The lease includes an option to terminate the agreement at any time after the first twelve months upon four months’ prior written notice. We also maintain an office in Tyler, Texas, for which we pay approximately $1,200 per month.
ITEM 2. PROPERTIES We lease an office and manufacturing facility in Nesher, Israel and maintain an office in Tyler, Texas. Our lease, for a space of approximately 284 square meters, for the facility in Nesher expired on December 31, 2023, and we decided not to renew the lease.
ITEM 2. PROPERTIES We lease office and manufacturing facilities in Nesher, Israel, maintain a corporate office in Tel Aviv, Israel through ENvue, and maintain an office in Tyler, Texas. 76 In March 2024, we entered into a three-year lease for an office and manufacturing facility in Nesher, Israel.
Removed
We pay $1,200 per month for our Tyler, Texas office, although we do not have a lease. We believe that our facilities are adequate to meet our current and proposed needs. ENvue has previously entered into a lease agreement for its headquarters office in Israel (Tel Aviv).
Added
This arrangement is currently on a month-to-month basis and is not subject to a formal long-term lease agreement. We also have ENvue’s offices and facilities in Tel Aviv, Israel, consisting of approximately 490 square meters, with monthly rent of approximately $4,900.
Removed
Additionally, ENvue has entered into an agreement for storage, inventory management, order processing, and shipping services in the U.S. (Arlington Heights, Illinois). 109
Added
In addition, ENvue has an agreement for offices and facilities located in Arlington Heights, Illinois, for storage, inventory management, order processing, and shipping services within the United States, for which we pay approximately $4,000 per month. We believe our existing facilities and logistics arrangements are adequate to meet our current operational needs and anticipated near-term growth.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeIn February 2025, the Second Department informed counsel for the Company that the Second Department was beginning to process the appeal for calendaring.” As of December 31, 2024, and 2023, the Company accrued the amount of the arbitration award to Protrade of approximately $2.1 and $2.0 million, respectively, including interest which is classified in “Other accounts payable and accrued expenses”.
Biggest changeAs of December 31, 2025, and 2024, the Company accrued the amount of the arbitration award to Protrade of approximately $2.3 and $2.1 million, respectively, including interest which is classified in “Other accounts payable and accrued expenses”. See also “Item 8. Financial Statements and Supplementary Data - Note 12.
On April 13, 2022, the Company submitted an application to the ICA seeking to correct an error in the award based on the evidence that the Company only sold 2-3 reusable patches per device contrary to the 33 reusable patches claimed by Protrade. The same arbitrator who issued the award, denied the application.
On April 13, 2022, the Company submitted an application to the ICA seeking to correct an error in the award based on the evidence that the Company only sold 2-3 reusable patches per device contrary to the 33 reusable patches claimed by Protrade.
On July 22, 2022, the Company filed a cross-motion seeking to vacate arbitration award on the grounds that the arbitrator exceeded her authority, that the award was procured by fraud, and that the arbitrator failed to follow procedures established by New York law.
The same arbitrator who issued the award, denied the application. 77 On July 22, 2022, the Company filed a cross-motion seeking to vacate arbitration award on the grounds that the arbitrator exceeded her authority, that the award was procured by fraud, and that the arbitrator failed to follow procedures established by New York law.
On March 21, 2023, the court denied the motion to re-argue and renew. On July 10, 2023, the Company filed its appeal with the Appellate Division, Second Department. That appeal is now fully briefed.
On March 21, 2023, the court denied the motion to re-argue and renew. On July 10, 2023, the Company filed its appeal with the Appellate Division, Second Department. That appeal is now fully briefed. In February 2025, the Second Department informed counsel for the Company that the Second Department was beginning to process the appeal for calendaring.
See also “Item 8. Financial Statements and Supplementary Data - Note 12. Commitments and Contingencies,” which information is incorporated herein by reference, for a description of pending and recent litigation.
Commitments and Contingencies,” which information is incorporated herein by reference, for a description of pending and recent litigation.
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On March 30, 2026, the Appellate Division of the Second Department issued a decision and order which affirmed the judgment of the Supreme Court, Nassau County in its entirety and dismissed the appeal, stating inter alia that “NanoVibronix failed to establish that the arbitration award violated a strong public policy, was irrational, procured by fraud, or clearly exceeded a specifically enumerated limitation of the arbitrator’s power”.
Added
It further held that NanoVibronix had not demonstrated that it had shown sufficient new facts to the court on the motion to renew. The decision was conclusory and did not analyze the facts as argued by NanoVibronix nor did it distinguish them specifically. The Company is currently reviewing the decision and considering its available alternatives.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changePrior to April 10, 2015, there was no established public trading market for our common stock. Related Stockholder Matters As of March 31, 2025, we had 759,297 issued and outstanding shares of common stock and 57,720 shares of Series X Non-Voting Convertible Preferred Stock.
Biggest changeRelated Stockholder Matters As of March 31, 2026, we had 1,100,413 issued and outstanding shares of common stock, 820 issued and outstanding shares of Series G Preferred Stock, 11,111 issued and outstanding shares of Series H Preferred Stock and 53,100 issued and outstanding shares of Series X Non-Voting Convertible Preferred Stock.
On August 17, 2021, the Company’s stockholders voted to approve an amendment to our Amended and Restated Certificate of Incorporation to increase the number of shares of our common stock authorized for issuance from 24,109,635 shares to 40,000,000 shares. As of March 31, 2025, there were no shares of our Series C Preferred Stock issued and outstanding.
On August 17, 2021, the Company’s stockholders voted to approve an amendment to our Amended and Restated Certificate of Incorporation to increase the number of shares of our common stock authorized for issuance from 24,109,635 shares to 40,000,000 shares. As of March 31, 2026, there were no shares of our Series C Preferred Stock issued and outstanding.
Recent Sales of Unregistered Securities All sales of unregistered securities during the year ended December 31, 2024, were previously disclosed in a Quarterly Report on Form 10-Q or a Current Report on Form 8-K. Issuer Purchases of Equity Securities We did not purchase any of our registered equity securities during the period covered by this Annual Report.
Recent Sales of Unregistered Securities All sales of unregistered securities during the year ended December 31, 2025, were previously disclosed in a Quarterly Report on Form 10-Q or a Current Report on Form 8-K. Issuer Purchases of Equity Securities We did not purchase any of our registered equity securities during the period covered by this Annual Report.
This limitation may be waived upon not less than 61 days’ prior written notice to us. As of March 31, 2025, there were no shares of our Series E Preferred Stock issued and outstanding.
This limitation may be waived upon not less than 61 days’ prior written notice to us. As of March 31, 2026, there were no shares of our Series E Preferred Stock issued and outstanding.
This limitation may be waived upon not less than 61 days’ prior written notice to us. As of March 31, 2025, there were no shares of our Series D Preferred Stock outstanding.
This limitation may be waived upon not less than 61 days’ prior written notice to us. As of March 31, 2026, there were no shares of our Series D Preferred Stock outstanding.
This limitation may be waived upon not less than 61 days’ prior written notice to us. 111 As of March 31, 2025, there were no shares of our Series F Preferred Stock issued and outstanding.
This limitation may be waived upon not less than 61 days’ prior written notice to us. As of March 31, 2026, there were no shares of our Series F Preferred Stock issued and outstanding.
The common stock was held by 101 holders of record and the Series X Preferred Stock was held by 1 holders of record. The actual number of holders of our common stock is greater than the number of record holders, and includes stockholders who are beneficial owners, but whose shares are held in street names by brokers or other nominees.
The actual number of holders of our common stock is greater than the number of record holders, and includes stockholders who are beneficial owners, but whose shares are held in street names by brokers or other nominees.
Except as otherwise provided in the Series X Certificate of Designations, or as required by the DGCL, the Series X Preferred Stock shall have no voting rights.
Except as otherwise provided in the Series H Certificate of Designations or as otherwise required by law, the Series H Preferred Stock shall have no voting rights.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock is listed on Nasdaq under the symbol “NAOV” since November 8, 2017. Prior to that date, our common stock was quoted on the OTCQB over-the-counter marketplace under the symbol “NAOV” since April 10, 2015.
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock is listed on Nasdaq under the symbol “FEED.” Prior to December 12, 2025, our common stock was listed on Nasdaq under the symbol “NAOV.” Prior to listing on Nasdaq, our common stock was quoted on the OTCQB over-the-counter marketplace under the symbol “NAOV” since April 10, 2015.
The Series F Preferred Stock is not entitled to vote on any other matter, except to the extent required under the Delaware General Corporation Law. As of March 31, 2025, there were 57,720 shares of our Series X Preferred Stock issued and outstanding. The conversion price for each share of Series X Preferred Stock shall be $0.6063.
The Series F Preferred Stock is not entitled to vote on any other matter, except to the extent required under the Delaware General Corporation Law. 79 As of March 31, 2026, there were 62,220 shares of Series X Preferred Stock authorized and 53,100 shares of our Series X Preferred Stock issued and outstanding.
Added
Prior to April 10, 2015, there was no established public trading market for our common stock.
Added
The common stock was held by 103 holders of record, the Series G Preferred Stock was held by 1 holder of record, the Series H Preferred Stock was held by 1 holder of record and the Series X Preferred Stock was held by 6 holders of record.
Added
As of March 31, 2026, the conversion price for each share of Series X Preferred Stock is $20.40.
Added
Except as otherwise provided in the Series X Certificate of Designations, or as required by the DGCL, the Series X Preferred Stock shall have no voting rights. As of December 31, 2025, there were 820 shares of our Series G Preferred Stock issued and outstanding.
Added
The Series G Preferred Stock is convertible into shares of common stock at a current conversion price equal to $17.77 per share of common stock, subject to adjustment as provided in the Series G Certificate of Designations, at any time at the option of the holder prior to the fifth anniversary of the date of issuance, at which time all shares of outstanding Series G Preferred Stock shall automatically and without any further action by the holder be converted into shares of common stock at the then effective conversion price.
Added
The holders of Series G Preferred Stock are entitled to receive cumulative dividends at the rate per share of 9% per annum of the stated value per share, until the fifth anniversary of the date of issuance of the Series G Preferred Stock.
Added
The five year 9% per annum dividend will be paid upon conversion of the Series G Preferred Stock irrespective of the timing of conversion such that upon conversion, the conversion price will incorporate the five-year 9% dividend.
Added
Except as otherwise provided in the Series G Certificate of Designations or as otherwise required by law, the Series G Preferred Stock shall have no voting rights. As of December 31, 2025, there were 11,111 shares of our Series H Preferred Stock issued and outstanding.
Added
The Series H Preferred Stock were initially convertible into the common stock at the election of the holder at any time at an initial conversion price of $10.10 per share, and following the additonal investment right consummated in March 24, 2026 and as March 31, 2026, at the current conversion price of $1.0422 per share (the “Series H Conversion Price”).
Added
The Series H Conversion Price is subject to customary adjustments for stock dividends, stock splits, reclassifications, stock combinations and the like (subject to certain exceptions) and subject to price-based adjustment in the event of any issuances of common stock, or securities convertible, exercisable or exchangeable for common stock, at a price below the then-applicable Series H Conversion Price (subject to certain exceptions).

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

41 edited+62 added−69 removed15 unchanged
Biggest changeJanuary 2025 3(a)(9) Exchange On January 7, 2025, we entered into a securities exchange agreement (the “Exchange Agreement”) with a certain institutional investor pursuant to which we agreed to issue an aggregate of (i) 41,498 shares of common stock (the “3(a)(9) Shares”), (ii) a warrant to purchase up to 158,562 shares of common stock (the “January 2025 Warrant”), and (iii) a pre-funded warrant to purchase up to 178,132 shares of common stock (the “January 2025 Pre-Funded Warrant”), in exchange for the A-1 Warrant held by the Holder to purchase up to 264,271 shares of common stock at an exercise price of $16,17 per share (the “Exchange”).
Biggest changeSeptember 2025 Registered Direct Offering On September 16, 2025, the Company entered into a securities purchase agreement with a single institutional investor, pursuant to which the Company agreed to issue and sell (i) 74,114 shares of common stock, and (ii) pre-funded warrants to purchase up to 217,090 shares of common stock in a registered direct offering for $2.04 million, pursuant to an effective shelf registration statement on Form S-3 (the “September 2025 Registered Direct Offering”).
On December 26, 2024, we received a decision letter (the “Decision Letter”) from the Panel granting a limited extension of time for us to demonstrate compliance with the Bid Price Rule and the Equity Rule for continued listing on Nasdaq, subject to the following conditions: (i) on or before February 27, 2025, we will have obtained stockholder approval to effect the Reverse Stock Split; (ii) on or before March 31, 2025, we shall have effected the Reverse Stock Split and, thereafter, maintain a $1.00 closing bid price of the our common stock for a minimum of ten consecutive trading days; (iii) on or before March 31, 2025, we are required to demonstrate compliance with the Equity Rule by filing public disclosure with the SEC and demonstrate long-term compliance with the Equity Rule; and (iv) on or before March 31, 2025, we are required to demonstrate compliance with all continued listing requirements for Nasdaq.
On December 26, 2024, we received a decision letter (the “Decision Letter”) from the Panel granting a limited extension of time for us to demonstrate compliance with the Bid Price Rule and the Equity Rule for continued listing on Nasdaq, subject to the following conditions: (i) on or before February 27, 2025, we will have obtained stockholder approval to effect a reverse stock split; (ii) on or before March 31, 2025, we shall have effected a reverse stock split and, thereafter, maintain a $1.00 closing bid price of our common stock for a minimum of ten consecutive trading days; (iii) on or before March 31, 2025, we are required to demonstrate compliance with the Equity Rule by filing public disclosure with the SEC and demonstrate long-term compliance with the Equity Rule; and (iv) on or before March 31, 2025, we are required to demonstrate compliance with all continued listing requirements for Nasdaq.
The second step is to measure the tax benefit as the largest amount that is more than 50% (cumulative basis) likely to be realized upon ultimate settlement. We recognize interest and penalties related to uncertain tax positions on the income tax expense line in the accompanying consolidated statement of operations.
The second step is to measure the tax benefit as the largest amount that is more than 50% (cumulative basis) likely to be realized upon ultimate settlement. 83 We recognize interest and penalties related to uncertain tax positions on the income tax expense line in the accompanying consolidated statement of operations.
While our significant accounting policies are more fully described in Note 3 in the “Notes to Financial Statements”, we believe the following accounting policies are critical to the process of making significant estimates in preparation of our financial statements. Inventory Inventories are stated at the lower of cost or net realizable value.
While our significant accounting policies are more fully described in Note 3 – Summary of Significant Accounting Policies in the “Notes to Financial Statements”, we believe the following accounting policies are critical to the process of making significant estimates in preparation of our financial statements. Inventory Inventories are stated at the lower of cost or net realizable value.
As previously disclosed, on April 10, 2024, we received a letter (the “Letter”) from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC indicating that, based upon the closing bid price of our Common Stock for the 30 consecutive business days between February 27, 2024 and April 9, 2024, we did not meet the minimum bid price of $1.00 per share required for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).
Nasdaq Minimum Stockholder’s Bid Price Requirement and Minimum Stockholder’s Equity Requirement As previously disclosed, on April 10, 2024, we received a letter (the “Letter”) from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC indicating that, based upon the closing bid price of our Common Stock for the 30 consecutive business days between February 27, 2024 and April 9, 2024, we did not meet the minimum bid price of $1.00 per share required for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).
Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. Cost is determined using the “first-in, first-out” method. Inventory write-offs are provided to cover risks arising from slow-moving items or technological obsolescence.
Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. Cost is determined using the “first-in, first-out” method. Inventory write-offs are provided to cover risks arising from slow-moving items and obsolete items.
(“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 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”).
(“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 and (ii) the merger of Predecessor ENvue with and into Second Merger Sub (the “Second Merger” and, together with the First Merger, the “ENvue Merger”), with Second Merger Sub being the surviving entity of the Second Merger (“Surviving Entity”).
As of December 31, 2024, we have no off-balance sheet transactions, arrangements, obligations (including contingent obligations), or other relationships with unconsolidated entities or other persons that have, or may have, a material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources. Summary of Cash Flow General .
As of December 31, 2025, we have no off-balance sheet transactions, arrangements, obligations (including contingent obligations), or other relationships with unconsolidated entities or other persons that have, or may have, a material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.
Research and development expenses as a percentage of total revenues were approximately 36% and 8% for the years ended December 31, 2024, and 2023, respectively.
Research and development expenses as a percentage of total revenues were approximately 69% and 36% for the years ended December 31, 2025, and 2024, respectively.
Our cash requirements are generally for product development, research and development costs, marketing and sales activities, general and administrative costs, capital expenditures and general working capital. Cash used in our operating activities was approximately $2,516,000 for the years ended December 31, 2024, and approximately $3,602,000 for the same period in 2023.
Our cash requirements are generally for product development, research and development costs, marketing and sales activities, general and administrative costs, capital expenditures and general working capital. Cash used in our operating activities was approximately $9,372 for the years ended December 31, 2025, and approximately $2,516 for the same period in 2024.
Revenue recognition It is the Company’s policy that revenues from product sales is recognized in accordance with ASC 606 “Revenue Recognition.” Five basic steps must be followed before revenue can be recognized; (1) identifying the contract(s) with a customer that create(s) enforceable rights and obligations; (2) identifying the performance obligations in the contract, such as promising to transfer goods or services to a customer; (3) determining the transaction price, meaning the amount of consideration in a contract to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer; (4) allocating the transaction price to the performance obligations in the contract, which requires the company to allocate the transaction price to each performance obligation on the basis of the relative standalone selling prices of each distinct good or services promised in the contract; and (5) recognizing revenue when (or as) the entity satisfies a performance obligation by transferring a promised good or service to a customer.
Changes in the estimated fair value of the warrants are recognized in Financial expenses or income in the unaudited interim condensed consolidated statements of operations. 82 Revenue recognition Revenues from product and services are recognized in accordance with ASC 606 “Revenue Recognition.” Five basic steps must be followed before revenue can be recognized; (1) Identifying the contract(s) with a customer that create(s) enforceable rights and obligations; (2) Identifying the performance obligations in the contract, such as promising to transfer goods or services to a customer; (3) Determining the transaction price, meaning the amount of consideration in a contract to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer; (4) Allocating the transaction price to the performance obligations in the contract, which requires the company to allocate the transaction price to each performance obligation on the basis of the relative standalone selling prices of each distinct good or services promised in the contract; and (5) Recognizing revenue when (or as) the entity satisfies a performance obligation by transferring a promised good or service to a customer.
Although we received proceeds from the exercise of certain prefunded warrants amounting to $1,000 and had a cash balance of just over $752,000 as of December 31, 2024, we expect to continue to incur losses and negative cash flows from operating activities, and therefore, we do not have sufficient resources to fund our operation for the next twelve months from the date of this filing causing us to have substantial doubt of our ability to continue as a going concern.
Although we had a cash balance of just over $4,254 as of December 31, 2025, we expect to continue to incur losses and negative cash flows from operating activities, and therefore, we do not have sufficient resources to fund our operation for the next twelve months from the date of this filing causing us to have substantial doubt of our ability to continue as a going concern.
As of December 31, 2024, we had cash of approximately $752,000, compared to approximately $3,283,000 as of December 31, 2023. We have historically met our cash needs through a combination of issuance of equity, borrowing activities and sales.
As of December 31, 2025, we had cash of approximately $4,241, net compared to approximately $752 as of December 31, 2024. We have historically met our cash needs through a combination of issuance of equity, borrowing activities and sales.
The Company periodically evaluates the quantities on hand relative to current and historical selling prices and historical and projected sales volume. Based on this evaluation, provisions are made when required to write-down inventory to its net market value. As of December 31, 2024, and 2023, there was no allowance on inventory.
The Company periodically evaluates the quantities on hand relative to current and historical selling prices and historical and projected sales volume. Based on this evaluation, provisions are made when required to write-down inventory to its net market value.
The Merger Agreement On February 14, 2025, pursuant to the terms of that certain Agreement and Plan of Merger, dated as of February 14, 2025 (the “Merger Agreement”), by and among the Company, NVEH Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of NVEH Merger Sub I, Inc.
Agreement and Plan of Merger On February 14, 2025, pursuant to the terms of that certain Agreement and Plan of Merger (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.
Gross profit as a percentage of revenues were approximately 59% and 67% for the years ended December 31, 2024, and 2023, respectively. The increase in gross profit as a percentage of revenues is mainly due to the reasons described above. Research and Development Expenses .
The increase in gross profit as a percentage of revenues is mainly due to the reasons described above. 84 Research and Development Expenses . For the years ended December 31, 2025 and 2024, research and development expenses were approximately $1,762 and $909, respectively, representing an increase of approximately $853, or 94%.
We also had negative cash flow from operating activities of $2,516,000 for the year ended December 31, 2024.
We also had negative cash flow from operating activities of $9,372 for the year ended December 31, 2025.
There are no assurances that we are able to raise additional capital, as required, on terms favorable to us. We do not have any material commitments to capital expenditures as of December 31, 2024, and we are not aware of any material trends in capital resources that would impact our business.
However, there can be no assurance that we will be able to raise additional capital, when needed, on terms favorable to us, or at all. 85 We do not have any material commitments to capital expenditures as of December 31, 2025, and we are not aware of any material trends in capital resources that would impact our business.
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) 1,734,995 shares of common stock (the “Merger Shares”), which such number of shares represented no more than 19.9% (the “Exchange Cap”) of the outstanding shares of common stock as of immediately before the First Effective Time and (ii) 57,720 shares of Series X Non-Voting Convertible Preferred Stock, par value $0.001 per share (the “Series X Preferred Stock”) in excess of the Exchange Cap to the holders of Predecessor ENvue in consideration for 100% of Predecessor ENvue.
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% 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”).
Accordingly, there can be no guarantee that we will be able to maintain our Nasdaq listing. 117 Critical Accounting Policies and Significant Estimates This management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. GAAP.
Critical Accounting Policies and Significant Estimates This management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. GAAP.
General and administrative expenses as a percentage of total revenues were approximately 135% and 172% for the years ended December 31, 2024, and 2023, respectively. Interest expense . For the years ended December 31, 2024, and 2023, our interest expenses were $135,000 and $135,000, respectively.
General and administrative expenses as a percentage of total revenues were approximately 299% and 135% for the years ended December 31, 2025, and 2024, respectively. Goodwill and Intangible Assets Impairment Expense.
Our future capital requirements and the adequacy of our available funds will depend on many factors, including our ability to successfully commercialize our products, our development of future products and competing technological and market developments as well as our ability to overcome obstacles that may be presented due to developments caused by the coronavirus outbreak.
Our future capital requirements and the adequacy of available funds will depend on many factors, including our ability to successfully commercialize our products, our development of future products and competing technological and market developments.
The decrease in net loss resulted primarily from the factors described above. Liquidity and Capital Resources We have incurred net losses of approximately $3,705,000 during the year ended December 31, 2024, which primarily consisted of increased revenues and increased gross margins offset by our operating expenses.
Our net loss increased by approximately $14,480 or 391%, to approximately $18,185 for the year ended December 31, 2025, from approximately $3,705 during the same period in 2024. The increase in net loss resulted primarily from the factors described above. Liquidity and Capital Resources We have incurred net losses of approximately $18,185 during the year ended December 31, 2025.
Cash used in our investing activities was approximately $3,000 and $1,000 for the years ended December 31, 2024, and 2023, respectively, from purchases of fixed assets. Cash provided by financing activities during the year ended December 31, 2024, was approximately $1,000, which was primarily composed of the net proceeds received from the exercise of prefunded warrants.
Cash provided by (used in) our investing activities was approximately $148 and ($3) for the years ended December 31, 2025, and 2024, respectively, from cash acquired in the ENvue Merger and purchases of fixed assets.
On February 24, 2025, we obtained approval from our stockholders to file a certificate of amendment to our Certificate of Incorporation to effectuate the 2025 Reverse Stock Split, among others, and on March 13, 2025, the 2025 Reverse Stock Split became effective.
On February 24, 2025, we obtained approval from our stockholders to file a certificate of amendment to our Certificate of Incorporation to effectuate the Reverse Stock Split, among others, and on March 13, 2025, the Reverse Stock Split became effective. 81 On April 9, 2025, we received a letter (the “April Letter”) from the Staff notifying us that we had demonstrated compliance with the Bid Price Rule and the Equity Rule as required by the Panel pursuant to the Decision Letter.
Selling and marketing expenses as a percentage of total revenues were approximately 28% and 38% for the years ended December 31, 2024, and 2023, respectively.
Selling and marketing expenses as a percentage of total revenues were approximately 98% and 28% for the years ended December 31, 2025, and 2024, respectively. Selling and marketing expenses consist mainly of payroll expenses to direct sales and marketing employees, travel expenses, conventions, advertising and marketing expenses, rent and facilities expenses associated with and allocated to selling and marketing activities.
For the years ended December 31, 2024, and 2023, the portion of our revenues that was derived from our largest direct medical equipment distributor, Ultra Pain Products LLC, were 31% and 38%, respectively, and customers introduced by our sales representatives were 67% and 41%, respectively. 119 Gross Profit .
For the year ended December 31, 2024, the percentage of revenues attributable to our products was: PainShield and monthly kits – 99% and UroShield – 1%. For the years ended December 31, 2025, and 2024, the portion of our revenues that was derived from our largest direct medical equipment distributor, were 31% and 36%, respectively. Gross Profit .
Accrued interest and penalties are included on the related tax liability line in the consolidated balance sheet. Recently issued accounting standards In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740) – Improvements to Income Tax Disclosures (ASU 2023-09).
Accrued interest and penalties are included on the related tax liability line in the consolidated balance sheet.
Our future capital requirements and the adequacy of available funds will depend on many factors, including our ability to successfully commercialize our products, our development of future products and competing technological and market developments. 121 Factors That May Affect Future Operations We believe that our future operating results will continue to be subject to quarterly variations based upon a wide variety of factors, including the ordering patterns of our distributors, timing of regulatory approvals, the implementation of various phases of our clinical trials and manufacturing efficiencies due to the learning curve of utilizing new materials and equipment as well issues that may continue to occur due to the development of the coronavirus outbreak.
Factors That May Affect Future Operations We believe that our future operating results will continue to be subject to quarterly variability based on a number of factors, including the ordering patterns of our distributors, the timing of regulatory approvals, the progress and implementation of clinical trials, and manufacturing efficiencies associated with the adoption of new materials and equipment.
Impairment of Long-Lived Assets Management reviews for impairment whenever events or changes in circumstances indicate that the carrying amount of property and equipment may not be recoverable under the provisions of accounting for the impairment of long-lived assets.
Impairment of long-lived assets The long-lived assets of the Company, including finite-lived intangible assets, are reviewed for impairment in accordance with ASC No. 360, “Property, Plant and Equipment”, whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
Revenue from product sales is recorded at the net sales price, or “transaction price,” which includes estimates of variable consideration that result from coupons, discounts, chargebacks and distributor fees, processing fees, as well as allowances for returns and government rebates. The Company constrains revenue by giving consideration to factors that could otherwise lead to a probable reversal of revenue.
The Company’s performance obligation is generally the sale and delivery of its products. Revenues from product sales is recorded at the net sales price, or “transaction price,” which includes estimates of variable consideration that result from discounts as well as allowances for returns.
We expect to continue to incur losses and negative flows from operations. We intend to use the proceeds generated from equity financings, or strategic alliances with third parties, either alone or in combination with equity financing to meet our short-term liquidity requirements as well as to advance our long-term plans.
We expect to continue to incur losses and negative cash flows from operations. We intend to fund our operations through a combination of equity financings and potential strategic alliances with third parties.
Business - Cautionary Note Regarding Forward-Looking Statement; Risk Factors Summary” included elsewhere in this Annual Report on Form 10 -K. Overview We are a medical device company focusing on non-invasive biological response-activating devices that target wound healing and pain therapy and can be administered at home, without the assistance of medical professionals.
Nano OpCo focuses on non-invasive biological response-activating devices that target biofilm prevention, pain therapy, and wound healing and can be administered at home, without the assistance of medical professionals.
For the years ended December 31, 2024, and 2023, research and development expenses were approximately $909,000 and $185,000, respectively, an increase of approximately 391%, or $724,000 between the periods.
For the years ended December 31, 2025 and 2024, selling and marketing expenses were approximately $2,493 and $720, respectively, representing an increase of approximately $1,773, or 246%.
Our operating results could also be impacted by the hostilities in Israel, and the Middle East, including the interruption or curtailment of trade within Israel or between Israel and its trading partners, or the ability to ship our products overseas or a weakening of the Euro and strengthening of the New Israeli Shekel, or NIS, both against the U.S. dollar.
Our operating results may also be impacted by geopolitical developments, including hostilities in Israel and the broader Middle East, which could disrupt trade, impact our ability to ship products, or affect our operations and those of our partners.
Results of Operations Year Ended December 31, 2024, Compared to Year Ended December 31, 2023 Revenues . For the years ended December 31, 2024, and 2023, our revenues were approximately $2,558,000 and $2,283,000, respectively, an increase of approximately 12%, or $275,000, between the periods.
For the years ended December 31, 2025 and 2024, revenues were approximately $2,553 and $2,558, respectively, representing a decrease of approximately $5, or 0.2%, year over year.
The increase was due to increased revenues from customers from Veteran Administration facilities and through workman’s compensation programs who are referred to us from certain sales representatives, and our largest direct medical equipment distributor in 2024.
The decrease was primarily attributable to the removal of PainShield Ultra from the market, partially offset by revenues generated from ENvue systems, as well as continued revenues from Veterans Administration facilities and workers’ compensation programs and sales through certain sales representatives and our largest direct medical equipment distributor.
For the years ended December 31, 2024, and 2023, gross profit was approximately $1,508,000 and $1,537,000, respectively, a decrease of approximately 2% or $29,000. The increase was mainly due to the increase in revenues in 2024.
For the years ended December 31, 2025, and 2024, gross profit was approximately $153 and $1,508, respectively, a decrease of approximately 90% or $1,355. Gross margin was also significantly impacted, declining primarily due to the removal of PainShield Ultra from the market, which historically generated higher margins, as well as inventory write-downs associated with PainShield Ultra.
During the year ended December 31, 2024, we met our short-term liquidity requirements from our existing cash reserves.
During the year ended December 31, 2025, we met our short-term liquidity requirements from our existing cash reserves and equity financings. Our future capital requirements and the adequacy of our available funds will depend on many factors, including our ability to successfully commercialize our products, advance development of new products, and respond to evolving technological and market conditions.
For the years ended December 31, 2024, and 2023, general and administrative expenses were approximately $3,461,000 and $3,924,000, respectively, a decrease of approximately 12%, or $463,000 between the periods. The decrease was mainly due to a decrease of legal fees related to securities and litigation matters, as well as accounting fees incurred.
General and Administrative Expenses . For the years ended December 31, 2025 and 2024, general and administrative expenses were approximately $7,633 and $3,461, respectively, representing an increase of approximately $4,172, or 121%.
The tax expense is computed by multiplying income before taxes at our Israeli subsidiary by the appropriate tax rate. 120 Net Loss . Our net loss decreased by approximately 6,000 or less than 1%, to approximately $3,705,000 for the year ended December 31, 2024, from approximately $3,711,000 during the same period in 2023.
For the year ended December 31, 2024, our income tax expense was approximately $19. For 2025 and 2024 we recorded tax expense at our Israeli subsidiary based on the appropriate tax rate and in addition for 2025 we recorded a change in the valuation allowance Net Loss .
Removed
Our WoundShield, PainShield and UroShield products are backed by novel technology which relates to ultrasound delivery through surface acoustic waves.
Added
Business - Cautionary Note Regarding Forward-Looking Statement; Risk Factors Summary” included elsewhere in this Annual Report on Form 10 -K. Overview We were organized as a Delaware corporation in October 2003. On February 14, 2025, we completed the Merger pursuant to the Merger Agreement, as further described below.
Removed
Reverse Stock Splits On February 8, 2023, we effected a reverse stock split of our common stock at a ratio of 1-for-20 (the “2023 Reverse Stock Split”, and on February 13, 2025, we effected a reverse stock split of our common stock at a ratio of 1-for11 (the “2025 Reverse Stock Split” and together with the 2023 Reverse Stock Split, the Reverse Stock Splits”) pursuant a Certificate of Amendment to our Amended and Restated Certificate of Incorporation.
Added
Following the consummation of the Merger, NanoVibronix will conduct its operations through its two wholly-owned subsidiaries: (i) NanoVibronix Ltd., a private company incorporated under the laws of the State of Israel (“Nano OpCo”) and (ii) ENvue Medical Holdings LLC, a Delaware limited liability company (together with its respective subsidiaries, “ENvue”).
Removed
At the effective time of the 2023 Reverse Stock Split and the 2025 Reverse Stock Split, every 20 and 11 shares, respectively, of our issued and outstanding common stock were converted automatically into one issued and outstanding share of common stock without any change in the par value per share.
Added
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 are in the initial stage of commercializing our products.
Removed
Any fractional share of a stockholder resulting from the Reverse Stock Splits was rounded up to the nearest whole number of shares. Proportional adjustments were made to the number of shares of our common stock issuable upon exercise or conversion of the Company’s equity awards, warrants and other convertible securities, as well as the applicable exercise or conversion price thereof.
Added
In addition, the Company issued 3,626 shares of Series X Preferred Stock to a service provider of ENvue, replacing its equity interest in ENvue, resulting in a total of 61,346 shares of Series X Preferred Stock outstanding after the Merger.
Removed
Except as otherwise indicated, all share and per-share figures in this Annual Report on Form 10-K have been adjusted to reflect the Reverse Stock Splits.
Added
Pursuant to the April Letter, we are subject to a mandatory panel monitor for a period of one year from the date of the April Letter.
Removed
Recent Developments 2025 Reverse Stock Split On March 13, 2025, at 4:05 p.m., Eastern Time, pursuant to a Certificate of Amendment to our Amended and Restated Certificate of Incorporation, as amended, 2025 Reverse Stock Split became effective. Our common stock began trading on Nasdaq on a split-adjusted basis on March 14, 2025. See “Reverse Stock Splits” above.
Added
If, within that one-year monitoring period, Staff finds us again out of compliance with the Equity Rule that was subject of the exception, notwithstanding Rule 5810(c)(2), we will not be permitted to provide the Staff with a plan of compliance with respect to that deficiency and Staff will not be permitted to grant additional time for us to regain compliance with respect to that deficiency, nor will the company be afforded an applicable cure or compliance period pursuant to Rule 5810(c)(3).
Removed
(“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.
Added
Instead, Staff will issue a Delist Determination Letter and we will have an opportunity to request a new hearing with the Panel or a newly convened Hearings Panel if the initial Panel is unavailable.
Removed
Each share of Series X Preferred Stock will be convertible into 1,000 shares of our common stock, subject to and contingent upon the affirmative vote of a majority of the shares of common stock present or represented and entitled to vote at a meeting of stockholders of Company to approve, for purposes of the Nasdaq Listing Rules, the issuance of shares of our common stock to the stockholders of Predecessor ENvue upon conversion of any and all shares of Series X Preferred Stock in accordance with the terms of the Certificate of Designation for the Series X Preferred Stock.
Added
The recoverability of assets to be held and used is measured by a comparison of the carrying amount of an assets to the future undiscounted cash flows expected to be generated by the assets. If such review indicates that the carrying amount of long-lived assets is not recoverable, the carrying amount of such assets is reduced to fair value.
Removed
The Merger was consummated and completed on February 14, 2025. 113 After giving effect to the Merger, pursuant to the terms and conditions of the Merger Agreement: (i) the holders of the outstanding equity of Predecessor ENvue immediately prior to the effective time of the First Merger (“First Effective Time”) own 19.9% of the common stock of the Company and 85.0% of the outstanding equity of the Company (assuming the Series X Preferred Stock is converting at a ratio of 1,000:1) immediately following the First Effective Time, which following stockholder approval will allow the Series X Preferred Stock to convert to common stock of the Company which may result in the holders of Predecessor ENvue to own 85% of the common stock of the Company, and (ii) the holders of our outstanding equity immediately prior to the First Effective Time own 80.1% of the common stock of the Company and 15.0% of the outstanding equity of the Company (assuming the Series X Preferred Stock is converting at a ratio of 1,000:1) immediately following the First Effective Time, which following stockholder approval which will allow the Series X Preferred Stock to convert to common stock of the Company which may result in our holders owning 15% of common stock of the Company.
Added
During the years ended December 31, 2025 and 2024, the Company recorded a long-lived asset impairment charge of $645 and $0, respectively. See Note 21 Goodwill impairment Management also evaluates goodwill for impairment at least annually, or more frequently if events or changes in circumstances indicate that the carrying value may not be recoverable.
Removed
Debenture Financing and Senior Convertible Debenture On February 13, 2025, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with an institutional investor (the “Investor”), pursuant to which we sold in a private placement, a senior convertible debenture (the “Debenture”) due the earlier of (i) the date that is the 30-day anniversary of the effective date of stockholder approval (the “Debenture Stockholder Approval”) of the issuance of the shares of common stock upon the conversion of the debenture (the “Debenture Financing”) and (ii) the date that is nine months following the date of issuance of the Debenture (“Maturity Date”), having an aggregate principal amount of $500,000.
Added
Any impairment loss is recognized in the Consolidated Statements of Operations. Business combination The Company applies the provisions of ASC 805, “Business Combination” and allocates the fair value of purchase consideration to the tangible assets acquired, liabilities assumed, and intangible assets acquired based on their estimated fair values.
Removed
The closing of the Debenture Financing occurred on February 14, 2025. On March 26, 2025 we amended and restated the Debenture to increase the Principal Amount to $1,300,000 to provide for the funding by Alpha Capital Anstalt (the “Investor”) to our subsidiary ENvue Medical Holdings, Corp.
Added
The excess of the fair value of purchase consideration over the fair values of these identifiable assets and liabilities is recorded as goodwill. Goodwill generated from a business combination is primarily attributable to synergies. When determining the fair values of assets acquired and liabilities assumed, management makes significant estimates and assumptions, especially with respect to intangible assets.
Removed
(“ ENvue ”), a wholly owned subsidiary of the Company of (i) an aggregate of $250,000 by the Investor to ENvue on February 6, 2025, (ii) an aggregate of $250,000 by the Investor to ENvue on March 4, 2025, and (iii) and an aggregate of $300,000 by the Investor to ENvue on March 26, 2025.
Added
Significant estimates in valuing certain intangible assets include but are not limited to future expected cash flows from acquired technology and acquired customer relationships from a market participant perspective, useful lives and discount rates.
Removed
On the Maturity Date, we shall pay the Investor in cash or, at the option of the Investor, in the form of conversion shares, or a combination thereof, the entire outstanding principal amount of the Debenture, together with accrued and unpaid interest thereon, the applicable exit fee and any other amounts due thereunder.
Added
Management’s estimates of fair value are based upon assumptions believed to be reasonable, but which are inherently uncertain and unpredictable and, as a result, actual results may differ from estimates.
Removed
Following the receipt of Debenture Stockholder Approval, the Debenture shall be convertible, in whole or in part, into shares of common stock, at the option of the Investor, at the initial conversion price of $4.8906 (the “Conversion Price”), which is subject to customary anti-dilution adjustments, and which such Conversion Price shall not be lower than the floor price of $0.97812.
Added
During the measurement period, which may extend up to one year from the acquisition date, the Company may record adjustments to the provisional fair values of the assets acquired and liabilities assumed, with a corresponding offset to goodwill.
Removed
The Debenture bears interest at the rate of 8.0% per annum, payable on the Maturity Date. On February 13, 2025, as amended on March 26, 2025, in connection with the Purchase Agreement and issuance of the Debenture, we entered into that certain Registration Rights Agreement (the “Registration Rights Agreement”) with the Investor.
Added
Upon the earlier of the end of the measurement period or the final determination of the fair values of the assets acquired and liabilities assumed, any subsequent adjustments are recorded in earnings. Acquisition-related expenses are recognized separately from the business combination and are expensed as incurred. See Note 4 Merger, for further information.
Removed
Pursuant to the Registration Rights Agreement, the Company is required to prepare and file a resale registration statement with the SEC within 30 calendar days following the closing date of the amended Debenture Financing (the “Filing Deadline”).
Added
Warrants The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance.
Removed
The Company shall use its commercially reasonable efforts to cause such registration statement to be declared effective by the SEC within 60 calendar days of the Filing Deadline (or within 90 calendar days if the SEC reviews the resale registration statement).
Added
The assessment considers whether the warrants are freestanding financial instruments, meet the definition of a liability under ASC 480, and meet all of the requirements for equity classification, including whether the warrants are indexed to the Company’s own common stock and whether the warrants meet the required conditions for equity classification.
Removed
We cancelled the A-1 Warrant reacquired in the Exchange and the A-1 Warrant will not be reissued.
Added
This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent reporting period end date while the warrants are outstanding. Warrants that meet all the criteria for equity classification, are required to be recorded as a component of additional paid-in capital.
Removed
The January 2025 Warrant has substantially the same terms as the A-1 Warrant, except that the shares of common stock issuable upon exercise of the January 2025 Warrant are subject to stockholder approval pursuant to the applicable rules and regulations of the Nasdaq, is exercisable for a term of five and one half years from the date such stockholder approval is received and deemed effective under Delaware law, and has an exercise price of $6.8296 per share. 114 Subsequent to the Exchange, the holder of the January 2025 Pre-Funded Warrant exercised the January 2025 Pre-Funded Warrant in full on a cashless basis in full for an aggregate of 228,354 shares of common stock.
Added
Warrants that do not meet all the criteria for equity classification, are required to be recorded as liabilities at their initial fair value on the date of issuance and remeasured to fair value at each balance sheet date thereafter. The liability-classified warrants are recorded under non-current liabilities.
Removed
The issuance in the Exchange of the 3(a)(9) Shares, the January 2025 Warrant, the January 2025 Pre-Funded Warrant and the shares of common stock issuable upon the exercise thereof pursuant to the Exchange Agreement was made in reliance on an exemption from registration under Section 3(a)(9) of the Securities Act Our operations in Israel Because we are incorporated under the laws of the state of Israel and our operations are conducted in Israel, our business and operations are directly affected by economic, political, geopolitical, and military conditions in Israel.

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