ENvue Medical, Inc.

We also maintain an office in Tyler, Texas, for which we pay approximately $1,200 per month. 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.

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.

• 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.
• Our operations and financial performance depend on global and regional economic conditions. Inflation, fluctuations in currency exchange rates, changes in consumer confidence and demand, and weakness in general economic conditions and threats, or actual recessions, could materially affect our business, results of operations, and financial condition.
• 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.
• The 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.
• We face the risk of product liability claims and may not be able to obtain insurance.
• Our products may not be developed or commercialized successfully.
• 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.
• 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.
• We face risks associated with litigation and claims.
• 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.
• Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security.
• We may acquire businesses or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions.
• 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.
• Our 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
• Complying with regulations enforced by FDA and other regulatory authorities is expensive and time consuming, and failure to comply could result in substantial penalties.
• 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.
• Certain modifications to our products may require new 510(k) clearance or other marketing authorizations.
• 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.
• We may be subject to certain federal, state, and foreign fraud and abuse laws, health information privacy and security laws, and transparency laws, which, if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business.
• Our products may cause or contribute to adverse medical events that we are required to report to the FDA and other governmental authorities, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, results of operations, and financial condition. 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.
• Disruptions at the FDA, other agencies or notified bodies caused by funding shortages or global health concerns could hinder their ability to hire, retain, or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, cleared or approved, or commercialized in a timely manner, or at all, which could negatively impact our business.
• Changes in internet regulations could adversely affect our business.
• Increased focus on current and anticipated environmental, social and governance (“ESG”) laws and increased scrutiny of our ESG policies and practices may materially increase our costs, expose us to potential liability, adversely impact our reputation, employee retention, willingness of potential customers and suppliers to do business with us and willingness of investors to invest in us.
• We are subject to consumer protection laws that regulate our marketing practices and prohibit unfair or deceptive acts or practices. Our actual or perceived failure to comply with such obligations could harm our business, and changes in such regulations or laws could require us to modify our products, marketing or advertising efforts.
• Risks 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.
• The impact of planned changes in the Israeli Judicial System on capital raising in the high-tech sector is difficult to predict.
• Our “Israeli identity” may have negative impact on our sales.
• 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.
• It 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
• Our 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.
• If 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.
• Our failure to secure trademark registrations could adversely affect our ability to market our products and operate our business.
• We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
• Obtaining 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.
• Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.
• We may be subject to claims challenging the inventorship of our patents and other intellectual property.
• We 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
• 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.
• 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.
• 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.
• 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.
• 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.
• Mandatory conversion of Series G Preferred Stock on Mandatory Conversion Date can result in substantial dilution to our existing shareholders.
• Future issuances of preferred stock may adversely affect the market price for our common stock.
• We 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.
• 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.
• Anti-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.
• If 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.
• Because 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.
• Our ability to use our net operating loss carry forwards and certain other tax attributes may be limited.
• If we fail to maintain effective internal control over financial reporting, our business, financial condition or results of operations may be adversely affected.
• 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.
• 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.
• If we are unable to successfully scale our marketing, training and quality control systems our business, financial condition and results of operations would be harmed.
• We may be unable to compete successfully with competitive technologies, which could harm our sales, business, financial condition and results of operations.
• The misuse or off-label use of our ENvue System may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies, particularly if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
• Use 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.
• Our 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.
• We 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.
• Future sales of our ENvue System may depend on providers’ and patients’ ability to obtain reimbursement from third-party payors, such as insurance carriers.