What the changes say
- Merger integration and post-merger operations create significant stock volatility and business uncertainties for NanoVibronix and ENvue Holdings.
- Financing restrictions, preferred stock conversions, and cumulative dividend requirements risk severe shareholder dilution.
- Ongoing arbitration awards totaling $2.3 million to Protrade threaten company liquidity and financial condition.
What changed since the prior 10-K
New
- NewRisks Related to Our Business
The intended benefits of the Merger may not be realized
The merger with ENvue Holdings creates integration difficulties, operational differences, and potential stock price volatility for the combined company.
- NewRisks Related to Our Business
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 company accrued an arbitration award of approximately $2.3 million to Protrade as of December 31, 2025, following an affirmed court decision.
- NewRisks Related to Our Regulatory and Compliance Matters
the applicable regulatory authority may identify deficiencies in our submissions or in the facilities or processes of our third party contract manufacturers
Regulatory authorities may identify deficiencies in submissions or contract manufacturer facilities, delaying clearance for the ENvue System and new indications.
- NewRisks Related to Our Organization and Securities
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
A one-year Nasdaq panel monitor subjects the company to immediate delisting without a compliance plan if it breaches the Equity Rule again.
- NewRisks Related to Our Organization and Securities
The Certificate of Designations of the Series H Convertible Preferred Stock (“Series H Certificate of Designations”) provides for the payment of cumulative dividends in shares of our common stock which will require us to have shares of common stock available to pay the dividends
Series H Preferred Stock requires 9% cumulative dividends payable in common stock, risking shareholder dilution and share availability shortages.
- NewRisks Related to Our Organization and Securities
The Series G Certificate of Designations and the Series H Certificate of Designations both contain certain anti-dilution provisions, which may dilute the interests of our stockholders, depress the price of our common stock, and make it difficult for us to raise additional capital
Anti-dilution provisions in Series G and H Preferred Stock may lower conversion prices, depress common stock prices, and hinder equity capital raising.
- NewRisks Related to Our Organization and Securities
Under the Series H Purchase Agreement and the September 2025 Purchase Agreement, we are subject to certain restrictive covenants that may make it difficult to procure additional financing
Restrictive covenants in Series H and September 2025 purchase agreements prohibit variable rate transactions for one year, restricting financing options.
- NewRisks Related to Our Organization and Securities
Mandatory conversion of Series G Preferred Stock on Mandatory Conversion Date can result in substantial dilution to our existing shareholders
Mandatory conversion of Series G Preferred Stock on its fifth anniversary will significantly increase outstanding common shares and dilute existing shareholders.
- NewRisks Related to Our Organization and Securities
Future issuances of preferred stock may adversely affect the market price for our common stock
Future preferred stock issuances or sales may depress common stock market prices and impair future capital-raising ability.
Dropped
- Dropped
NanoVibronix may become involved in securities litigation or stockholder derivative litigation in connection with the Merger, and this could divert the attention of NanoVibronix management and harm the combined company’s business, and insurance coverage may not be sufficient to cover all related costs and damages
Securities or stockholder derivative litigation might arise from the Merger, diverting management attention and resources.
- Dropped
NanoVibronix stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger
Stockholders might experience ownership dilution from the Merger without receiving commensurate strategic and financial benefits.
- Dropped
For U.S. federal income tax purposes, the Merger is intended to qualify as a “reorganization” within the meaning of Section 368(a) of the Code
The Merger might fail to qualify as a tax-free reorganization under Section 368(a) of the Code.
- Dropped
The market price of NanoVibronix’s common stock after the Merger may be subject to significant fluctuations and volatility, and the stockholders of the company may be unable to resell their shares at a profit and may incur losses
Post-merger stock price fluctuations might prevent stockholders from reselling shares at a profit.
- Dropped
Changes in the business operations, strategies and focus of the combined company following the Merger may not result in an improvement in the value of NanoVibronix common stock
Combined company operational changes and focus on ENvue business plans might not improve common stock value.
- Dropped
The concentration of the capital stock ownership with insiders of NanoVibronix after the Merger will likely limit the ability of the stockholders of NanoVibronix to influence corporate matters
Insiders owning approximately 65% of post-merger stock will limit other stockholders' ability to influence corporate matters.
- Dropped
Pursuant to the terms of the Merger Agreement, we are required to obtain stockholder approval for conversion of all outstanding shares of our Series X Preferred Stock into shares of our common stock. We cannot guarantee that our stockholders will approve this matter
- DroppedRisks 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
Stockholders might fail to approve the conversion of Series X Preferred Stock issued in the Merger.
- DroppedRisks Related to NanoVibronix’s Business
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. Management has substantial doubt about the Company’s ability to continue as a going concern
The company has a history of net losses and accumulated deficits, expecting future losses.
- DroppedRisks Related to NanoVibronix’s Business
Increasing inflation could adversely affect our business, financial condition, results of operations or cash flows
Management has substantial doubt about the company's ability to continue as a going concern given low cash balances.
- DroppedRisks Related to NanoVibronix’s Business
If we fail to retain our key management, or to attract and keep additional key personnel, we may be unable to successfully execute our business plan
- DroppedRisks Related to NanoVibronix’s Business
Our failure to protect our intellectual property rights could diminish the value of our solutions, weaken our competitive position and reduce our revenue
Increasing inflation could adversely affect business, financial condition, results of operations, or cash flows.
- DroppedRisks Related to NanoVibronix’s Business
We could incur substantial costs and disruption to our business as a result of any dispute related to, or claim of infringement of another party’s intellectual property rights, which could harm our business and operating results
- DroppedRisks Related to NanoVibronix’s Regulatory and Compliance Matters
We are subject to extensive governmental regulation, including the requirement of U.S. 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
- DroppedRisks Related to NanoVibronix’s Regulatory and Compliance Matters
If we fail to comply with the U.S. federal and state fraud and abuse and other health care laws and regulations, we could be subject to criminal and civil penalties and exclusion from the Medicare and Medicaid programs, which would have a material adverse effect on our business and results of operations
- DroppedRisks Related to NanoVibronix’s Organization and Securities
There can be no assurance that we will ultimately regain compliance with all applicable requirements for continued listing on Nasdaq
- DroppedRisks Related to NanoVibronix’s Organization and Securities
We may be subject to ongoing restrictions related to grants from the Israeli Office of the Chief Scientist
Failure to retain or attract key management and personnel could impede execution of the business plan.
- DroppedRisks Related to ENvue’s Financial Condition, Business and Operations
The financial statement footnotes of the Company include disclosure regarding the substantial doubt about the ability of the Company to continue as a going concern
- DroppedRisks Related to ENvue’s Financial Condition, Business and Operations
ENvue’s financial statement footnotes include disclosure regarding the substantial doubt about our ability to continue as a going concern and indicated that, as of December 31, 2024, they had recurring losses with minimal revenue from operations
Failure to protect intellectual property rights could diminish solution values and reduce revenue.
- DroppedRisks Related to ENvue’s Financial Condition, Business and Operations
We are subject to operating risks, including excess or constrained capacity and operational inefficiencies, which could adversely affect our results of operations
- DroppedRisks Related to ENvue’s Financial Condition, Business and Operations
Political events, trade and other international disputes, war, and terrorism could harm or disrupt international commerce and the global economy and could have a material effect on our business as well as our potential customers, suppliers, contract manufacturers, distributors, and other business partners
- DroppedRisks Related to ENvue’s Financial Condition, Business and Operations
We conduct certain of our operations in Israel. Conditions in Israel, including the October 2023 attack by Hamas and other terrorist organizations from the Gaza Strip and Israel’s war against them, may affect our operations
- DroppedRisks Related to the ENvue System
We expect to increase the size of our organization in the future, and we may experience difficulties in managing the operational elements or timing of this growth. If we are unable to manage or appropriately time the anticipated growth of our business, our future revenue and operating results may be harmed
- DroppedRisks Related to ENvue Legal, Regulatory and Compliance Matters
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
- DroppedRisks Related to ENvue Legal, Regulatory and Compliance Matters
Our ENvue System is a Class II medical device and received FDA clearance under the 510(k) pathway for marketing to adults (ages 22 and above) only
- DroppedRisks Related to ENvue Legal, Regulatory and Compliance Matters
Ongoing changes in healthcare regulation could negatively affect our revenues, business and financial condition
- DroppedRisks Related to ENvue Legal, Regulatory and Compliance Matters
Security breaches, data breaches, cyber attacks, other cybersecurity incidents or the failure to comply with privacy, security and data protection laws could materially impact our operations, patient care could suffer, we could be liable for damages, and our business, operations and reputation could be harmed
- DroppedRisks Related to the 2025 Reverse Stock Split
There can be no assurance that we will satisfy the conditions required by the Panel regarding the market price or ultimately regain compliance with all applicable requirements for continued listing on Nasdaq and maintain listing of our common stock
- DroppedRisks Related to the 2025 Reverse Stock Split
The 2025 Reverse Stock Split may lead to a decrease in our overall market capitalization
Reworded
- 100% rewrittenRisks Related to Our Regulatory and Compliance Matters
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
The risk text shifted focus from UroShield's FDA enforcement discretion status during the COVID-19 pandemic to general pre-market 510(k) clearance requirements.
- 97% rewrittenRisks Related to Our Regulatory and Compliance Matters
Changes in internet regulations could adversely affect our business
Internet regulation and e-commerce risk text remained identical to the prior year.
- 92% rewrittenRisks Related to Our Business
Global economic and political instability and conflicts, such as the conflicts in Venezuela, between Russia and Ukraine or in the Middle East, could adversely affect our business, financial condition or results of operations
Geopolitical conflict risks expanded to explicitly include conflicts in Venezuela and the Middle East alongside Russia and Ukraine.
Was: Global economic and political instability and conflicts, such as the conflict between Russia and Ukraine, could adversely affect our business, financial condition or results of operations
- 78% rewrittenRisks Related to Our Regulatory and Compliance Matters
These modifications may have an effect on the way we conduct our business in the EEA
Discussions on EEA modifications added specific warnings regarding U.S. federal, state, and foreign fraud, abuse, and health information privacy laws.
- 70% rewrittenRisks Related to the ENvue System
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
Commercial success risk regarding ENvue System adoption and hospital procurement budgets remained identical to the prior year.
- 69% rewrittenRisks Related to Our Regulatory and Compliance Matters
Failure to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our products abroad
Foreign regulatory approval risk text updated references from product candidates to products.
- 68% rewrittenRisks Related to Our 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
FDA regulatory compliance risk expanded to explicitly detail length, expense, and uncertainty of obtaining approvals for NanoVibronix product candidates.
- 66% rewrittenRisks Related to Our Operations in Israel
We conduct our operations in Israel. Conditions in Israel, including the recent attack by Hamas and other terrorist organizations from the Gaza Strip, and the region, and Israel’s war against them, may affect our operations
Israel operations risk updated references from specific Hamas attacks in October 2023 to broader regional acts of terrorism and hostilities.
- 62% rewrittenRisks Related to the ENvue System
If we are not successful in enhancing awareness of our ENvue System, driving adoption across our current target population and expanding the population of eligible patients, our sales, business, financial condition and results of operations will be negatively affected
- 61% rewrittenRisks Related to the ENvue System
We may be unable to compete successfully with competitive technologies, which could harm our sales, business, financial condition and results of operations
- 59% rewrittenRisks Related to Our Business
We may acquire businesses or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions
- 58% rewrittenRisks Related to Our Business
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
- 40% rewrittenRisks Related to Our Business
We may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative effect on our financial condition, results of operations and stock price
Was: NanoVibronix may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative effect on its financial condition, results of operations and stock price, which could cause you to lose some or all of your investment
- 35% rewrittenRisks Related to Our Regulatory and Compliance Matters
We are uncertain regarding the success of our clinical trials for our products in development
- 33% rewrittenRisks Related to Our Business
We are highly dependent on our senior management team and key personnel, and our business could be harmed if we are unable to attract and retain personnel necessary for our success
- 29% rewrittenRisks Related to Our Business
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
Was: 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
- 28% rewrittenRisks Related to Our Business
On October 3, 2022, the court issued a decision granting Protrade its petition to confirm the award and denying the cross-motion
- 28% rewrittenRisks Related to Our Business
Our need to increase the size of our organization in order to successfully manage our growth may adversely affect our business, financial condition and results of operations
Was: Our need to increase the size of our organization in order to successfully manage our growth
- 26% rewrittenRisks Related to Our Regulatory and Compliance Matters
Healthcare reform measures could adversely affect our business and financial results
All 68 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Business
- 01The intended benefits of the Merger may not be realizedNew
- 02We may be required to take write-downs or write-offs, restructuring and impairment or other charges that could have a significant negative effect on our financial condition, results of operations and stock price40% rewritten
- 03Global economic and political instability and conflicts, such as the conflicts in Venezuela, between Russia and Ukraine or in the Middle East, could adversely affect our business, financial condition or results of operations92% rewritten
- 04If 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
- 05The medical device and therapeutic product industries are highly competitive and subject to rapid technological change. If our competitors are able to develop and market products that are safer and more effective than any products we may develop, our commercial opportunities will be reduced or eliminated
- 06We face the risk of product liability claims and may not be able to obtain insurance
- 07Our products may not be developed or commercialized successfully
- 08We are highly dependent on our senior management team and key personnel, and our business could be harmed if we are unable to attract and retain personnel necessary for our success33% rewritten
- 09Our need to increase the size of our organization in order to successfully manage our growth may adversely affect our business, financial condition and results of operations28% rewritten
- 10We 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
- 11On October 3, 2022, the court issued a decision granting Protrade its petition to confirm the award and denying the cross-motion28% rewritten
- 12As 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”New
- 13Our 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 results58% rewritten
- 14Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security
- 15We may acquire businesses or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions59% rewritten
- 16Certain stockholders could attempt to influence changes within the Company, which could adversely affect our operations, financial condition and the value of our common stock29% rewritten
- 17Our operations may be impacted by natural disasters, which may become more frequent or severe as a result of climate change and may adversely impact our business and operating results as well as those of our potential customers and suppliers
Risks Related to Our Regulatory and Compliance Matters
- 18Complying with regulations enforced by FDA and other regulatory authorities is expensive and time consuming, and failure to comply could result in substantial penalties68% rewritten
- 19UroShield has not been cleared or approved by the FDA, nor has it undergone the same type of review as an FDA-approved or cleared device100% rewritten
- 20the applicable regulatory authority may identify deficiencies in our submissions or in the facilities or processes of our third party contract manufacturersNew
- 21Certain modifications to our products may require new 510(k) clearance or other marketing authorizations
- 22Failure to obtain regulatory approval in foreign jurisdictions will prevent us from marketing our products abroad69% rewritten
- 23We are uncertain regarding the success of our clinical trials for our products in development35% rewritten
- 24Healthcare reform measures could adversely affect our business and financial results26% rewritten
- 25These modifications may have an effect on the way we conduct our business in the EEA78% rewritten
- 26Changes in internet regulations could adversely affect our business97% rewritten
Risks Related to Our Operations in Israel
- 27We conduct our operations in Israel. Conditions in Israel, including the recent attack by Hamas and other terrorist organizations from the Gaza Strip, and the region, and Israel’s war against them, may affect our operations66% rewritten
- 28The impact of planned changes in the Israeli Judicial System on capital raising in the high-tech sector is difficult to predict
- 29Our “Israeli identity” may have negative impact on our sales
- 30Because 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
- 31It may be difficult for investors in the United States to enforce any judgments obtained against us or any of our directors or officers
Risks Related to Our Intellectual Property
- 32Our success depends in part on our proprietary technology, and if we are unable to successfully enforce our intellectual property rights, our competitive position may be harmed
- 33If we infringe or violate the patents or proprietary rights of other parties or are subject to an intellectual property infringement or misappropriation claim, our ability to grow our business may be severely limited
- 34Our failure to secure trademark registrations could adversely affect our ability to market our products and operate our business
- 35We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
- 36Obtaining and maintaining patent protection depends on compliance with various procedures and other requirements, and our patent protection could be reduced or eliminated in case of non-compliance with these requirements
- 37Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time
- 38We may be subject to claims challenging the inventorship of our patents and other intellectual property
- 39We use AI in our business, and challenges with properly managing its use could result in reputational harm, competitive harm, and legal liability, and adversely affect our results of operations
Risks Related to Our Organization and Securities
- 40The price of our securities may be volatile, and the market price of our securities may drop below the price you pay
- 41We 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
- 42If 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
- 43On 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 LetterNew
- 44The Certificate of Designations of the Series H Convertible Preferred Stock (“Series H Certificate of Designations”) provides for the payment of cumulative dividends in shares of our common stock which will require us to have shares of common stock available to pay the dividendsNew
- 45The Series G Certificate of Designations and the Series H Certificate of Designations both contain certain anti-dilution provisions, which may dilute the interests of our stockholders, depress the price of our common stock, and make it difficult for us to raise additional capitalNew
- 46Under the Series H Purchase Agreement and the September 2025 Purchase Agreement, we are subject to certain restrictive covenants that may make it difficult to procure additional financingNew
- 47Mandatory conversion of Series G Preferred Stock on Mandatory Conversion Date can result in substantial dilution to our existing shareholdersNew
- 48Future issuances of preferred stock may adversely affect the market price for our common stockNew
- 49We are a smaller reporting company, and we cannot be certain if the reduced disclosure requirements applicable to our filing status will make our common stock less attractive to investors
- 50Although 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
- 51Anti-takeover provisions of our certificate of incorporation, our bylaws and Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove the current members of our board and management
- 52If securities or industry analysts do not publish research or reports or publish unfavorable research about our business, the price of our securities and their trading volume could decline
- 53Because we do not expect to pay cash dividends for the foreseeable future, you must rely on appreciation of our common stock price for any return on your investment. Even if we change that policy, we may be restricted from paying dividends on our common stock
- 54Our ability to use our net operating loss carry forwards and certain other tax attributes may be limited
- 55If 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 the ENvue System
- 56If we are not successful in enhancing awareness of our ENvue System, driving adoption across our current target population and expanding the population of eligible patients, our sales, business, financial condition and results of operations will be negatively affected62% rewritten
- 57Our 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 harmed70% rewritten
- 58If we are unable to successfully scale our marketing, training and quality control systems our business, financial condition and results of operations would be harmed
- 59We may be unable to compete successfully with competitive technologies, which could harm our sales, business, financial condition and results of operations61% rewritten
- 60Use of our ENvue System requires appropriate training and inadequate training may lead to negative clinician experiences, which could harm our business, financial condition, and results of operations
- 61Our business could be adversely affected by professional and legal challenges to our business model or by new state actions restricting our ability to provide our products and services in certain states
- 62We may not be able to achieve or maintain satisfactory pricing and margins for our ENvue System, which could harm our business and results of operations
- 63Future sales of our ENvue System may depend on providers’ and patients ’ ability to obtain reimbursement from third-party payors, such as insurance carriers
- 64Our results of operations may be harmed if we are unable to accurately forecast clinician demand for our ENvue System or any future products
- 65Adoption of our ENvue System depends on positive clinical data as well as medical providers’ acceptance of the data and our products, and negative clinical data, publicly reported adverse events, or perceptions among these medical providers would harm our sales, business, financial condition, and results of operations
Risks Related to the 2025 Reverse Stock Split
- 66The 2025 Reverse Stock Split may not increase the price of our common stock over the long-term and our common stock may be delisted
- 67The 2025 Reverse Stock Split may decrease the liquidity of our common stock
- 68The 2025 Reverse Stock Split may result in some stockholders owning “odd lots” that may be more difficult to sell or require greater transaction costs per share to sell
Other ENvue Medical 10-Ks
- FY2024 10-K risk factors88 risks
This company has no prior year risk factors on file. The risk section is dominated by merger-related risks, going concern doubts, regulatory dependencies for medical devices, and operational exposure in Israel.
Filed Mar 31, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.