enVVeno Medical Corp 10-K

ITEM 9A. Controls and Procedures Evaluation of Controls and Procedures Our management carried out an evaluation, under the supervision and with the participation of our Chief Executive Officer (who is our Principal Executive Officer) and our Chief Financial Officer (who is our Principal Financial Officer and Principal Accounting Officer), of the effectiveness of the design of our disclosure controls and procedures (as defined by Exchange Act Rules 13a-15(e) or 15d-15(e)) as of December 31, 2024, pursuant to Exchange Act Rule 13a-15(b). Based upon that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, 2024 to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to management, including our Chief Executive Officer and our Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure and are effective to provide reasonable assurance that such information is recorded, processed, summarized and reported within the time periods specified by the Securities and Exchange Commission’s rules and forms. Inherent Limitations on Effectiveness of Controls It should be noted that any system of controls, however well designed and operated, can provide only reasonable, and not absolute assurance, that the objectives of the system will be met. In addition, the design of any control system is based in part upon certain assumptions about the likelihood of future events. Because of these and other inherent limitations of control systems, there is only reasonable assurance that our controls will succeed in achieving their goals under all potential future conditions. Management’s Report on Internal Control Over Financial Reporting There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Exchange Act Rule 13a-15(d) during the quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Management, including the principal executive officer and principal financial officer, does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all error and all fraud. Controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or deterioration in the degree of compliance with the policies or procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles. Under the supervision and with the participation of our management, including the principal executive officer and principal financial officer, we conducted an evaluation as to the effectiveness of our internal control over financial reporting as of December 31, 2024. In making this assessment, our management used the criteria for effective internal control set forth by the Committee of Sponsoring Organizations of the Treadway Commission in the 2013 Internal Control – Integrated Framework. Based on this assessment, our management concluded that our internal control over financial reporting was effective as of December 31, 2024. This Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s independent registered public accounting firm pursuant to an exemption from Section 404(b) of the Sarbanes-Oxley Act of 2002 that permits the Company to provide only management’s report in this Annual Report on Form 10-K. Accordingly, our management’s assessment of the effectiveness of our internal control over financial reporting as of December 31, 2024 has not been audited by our auditors, Marcum LLP. Item 9B. Other Information None . Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections Not Applicable. 31 PART III ITEM 10. Directors, Executive Officers and Corporate Governance Listed below are the names of the directors and executive officers of the Company, their ages as of the date of this Annual Report, their positions held and the year they commenced service with the Company. Name Age Position(s) Held Year of Service Commencement Robert A. Berman 62 Director, Chief Executive Officer 2018 Craig Glynn 63 Chief Financial Officer and Treasurer 2020 Dr. Francis Duhay 64 Director 2018 Dr. Sanjay Shrivastava 57 Director 2018 Matthew M. Jenusaitis 63 Director 2019 Robert C. Gray 77 Director 2019 Marc H. Glickman, M.D. 75 Senior Vice President and Chief Medical Officer 2016 Hamed Alavi 41 Senior Vice President & Chief Technology Officer 2020 Robert A. Berman Robert Berman has served as our Chief Executive Officer and a member of our Board of Directors since April of 2018. Mr. Berman has over 25 years of experience in a broad variety of areas including healthcare, finance, acquisitions, marketing, compliance, turnarounds, and the development and licensing of emerging technologies. From September 2012 until July 2017, he served as the President, Chief Executive Officer, and a member of the Board of Directors of ITUS Corporation (now called Anixa Biosciences), which at the time he joined the company was a developer of flat panel display technologies, and under his leadership became a Nasdaq listed cancer therapeutics company. From 2000 to March 2007, Mr. Berman was the Chief Operating Officer and General Counsel of Acacia Research Corporation, where he successfully transitioned the company from being an incubator of internet startups into a preeminent, publicly traded company for licensing and enforcing patented technologies with a market cap exceeding $2 billion. Mr. Berman started his career at the law firm of Blank Rome. Mr. Berman has a B.S. in Entrepreneurial Management from the Wharton School of the University of Pennsylvania and holds a J.D. from the Northwestern University School of Law, where he is an adjunct faculty member. We believe that Mr. Berman is qualified to serve as a member of our board of directors because of his experience in a broad variety of areas including healthcare, finance, acquisitions, marketing, compliance, turnarounds, and the development and licensing of emerging technologies. Dr. Francis Duhay has served as member of our board of directors since October 2018. He is an accomplished heart surgeon, entrepreneur, and corporate executive. Board certified in general (UCSF) and cardiothoracic surgery (Duke), his seminal work in minimally invasive cardiac surgery led to 32 patents for surgical devices used in thousands of heart operations. Dr Duhay left clinical practice for industry in 2008, where he served as Vice President and General Manager of the nascent transcatheter heart valve therapy program (Ascendra) at Edwards Lifesciences (“Edwards”), the world’s leading manufacturer of bioprosthetic heart valves. With European CE Mark, he oversaw growth in sales of transcatheter heart valves from $3M to over $250M within the first four years of commercial launch. Promoted to Vice President of Global Medical & Clinical Affairs, he led planning and execution of four US FDA pivotal clinical trials. He was eventually promoted to Chief Medical Officer, where, in addition to overseeing Global Medical & Clinical Affairs, he supported other areas within Edwards including Health Economics & Reimbursement in its successful application for a procedure code, payment, and coverage of transcatheter aortic valve replacement (TAVR), and Regulatory Affairs, as an industry representative and clinical expert on the ISO 5840:2014 and 5910:2018 cardiac valve working groups. After departing Edwards, he co-founded and led Koa Accel, a major medical device accelerator in the Orange County, CA, ecosystem. This bore three medical device startups – Makani Science (selected into the 2021 cohort of the prestigious Y-Combinator), Kino Discovery (selected into the 2021 cohort of MedTech Innovator), and Kahala Biosciences. Most recently, Dr Duhay served as Senior Vice President of Global Medical & Clinical Affairs for Olympus Corporation, the world’s leading manufacturer of colonoscopes, duodenoscopes, bronchoscopes, and cystoscopes. We believe that Dr. Duhay is qualified to serve as a member of our board of directors because he is a trained cardiac and thoracic surgeon and former Chief Medical Officer at Edwards Life Sciences. 32 Dr. Sanjay Shrivastava has served as a member of our board of directors since October 2018. He has been involved in developing, commercializing, evaluating, and acquiring medical devices for more than 24 years, including serving in leadership positions in research and development, business development, and marketing at J&J, BTG, plc, Medtronic, Abbott Vascular, and Edwards Life Sciences. He is presently serving as the chief executive officer at Innova Vascular, Inc., an early commercial stage medical device company engaged in peripheral venous thrombectomy space. Prior to this, he co-founded BlackSwan Vascular, Inc., where he served on its board of directors and led a strategic alliance including the acquisition deal with Sirtex Medical. Sirtex Medical’s parent company acquired BlackSwan Vascular, Inc. in 2023. Dr. Shrivastava worked on several acquisition and investment deals during his roles as a senior director, business development at J&J and a vice president, upstream marketing and strategy at BTG, plc, which had an annual revenue of about $800 million and is now part of Boston Scientific Corporation through an acquisition. At Medtronic, Dr. Shrivastava was the Director of Global Marketing for the Cardiac and Vascular Group where he helped build the embolization business, from its initiation to a substantial revenue with a very high CAGR over a period of six years. Dr. Shrivastava was part of the peripheral vascular business at Abbott Vascular and worked on trans-catheter heart valve repair and replacement products at Edwards Life Sciences. Dr. Shrivastava received his Bachelor of Engineering degree at the Indian Institute of Technology and a doctorate degree in materials science and engineering from the University of Florida. We believe that Dr. Shrivastava is qualified to serve as a member of our board of directors because of having served in Chief Executive Officer and board of director positions at several medical device start-ups, and leadership positions in research and development, business development, and marketing at Innova Vascular, Inc., BTG, Medtronic, Abbott Vascular, and Edwards Life Sciences. Matthew M. Jenusaitis has served as a member of our board of directors since September 2019. He has over 30 years of health care experience with an emphasis on building and selling companies that develop medical devices to treat vascular diseases. Since March 2015, Mr. Jenusaitis has been a senior administrative executive at the UC San Diego Health System. He currently serves as the Chief Administrative Officer for UCSD’s Moore’s Cancer Center and UCSD Oncology. From June 2009 to March 2015, Mr. Jenusaitis was President and CEO of OCTANe Foundation for Innovation, a non-profit focused on the development of innovation in Orange County, CA. Over the course of his career, Mr. Jenusaitis has been on the board of directors of Pulsar Vascular (2008-2017), which was sold to Johnson and Johnson, Creagh Medical (2008-2015), which was sold to SurModics, and Precision Wire Components (2009-2014), which was sold to Creganna Medical. Mr. Jenusaitis was also a Senior Vice President at ev3 (April 2006 to July 2008), which was sold to Covidian and later purchased by Medtronics. In addition, Mr. Jenusaitis was the President of the Peripheral Division at Boston Scientific (July 2003 to August 2005) and was an Executive in Residence at Warburg Pincus (September 2005 to March 2006). Mr. Jenusaitis has an MBA from the University of California, Irvine, a Masters Degree in Biomedical Engineering from Arizona State University, and a Bachelors Degree in Chemical Engineering from Cornell University. We believe that Mr. Jenusaitis is qualified to serve as a member of our board of directors because of over 30 years of health care experience with an emphasis on building and selling companies that develop medical devices to treat vascular diseases and his prior board experiences. Robert C. Gray has served as a member of our board of directors since September 2019. He had a 20-year career at Highmark, Inc., one of America’s largest health insurance organizations, which serves over 20 million subscribers, and includes Highmark Blue Cross Blue Shield Pennsylvania, Highmark Blue Cross Blue Shield Delaware, and Highmark Blue Cross Blue Shield West Virginia, which he retired from in 2008. While at Highmark, Mr. Gray helped increase revenues to $12.3 billion from $6.9 billion, and helped generate an operating gain of $375 million from an operating loss of $91 million. In addition to being the board chairman, Chief Executive Officer, and President of several of Highmark’s subsidiaries and affiliated companies, Mr. Gray was the Chief Financial Officer of Highmark’s parent company and was the primary contact to Highmark’s board of directors for Highmark’s audit, investment and compensation (incentive plans) committees. His many responsibilities at Highmark included rate setting and reimbursement negotiations. Following Highmark, Mr. Gray co-founded U.S. Holdings LLC (U.S. Implants LLC.), a national distributor of orthopedic implants, and has served as Vice President since 2009. Since 2011, Mr. Gray has also been self-employed as a strategy and financial consultant. Mr. Gray also currently serves as Chairman and President of Metropolitan Woodworks, Inc., a manufacturer of custom kitchen cabinetry based in North Carolina. Mr. Gray engaged in Postgraduate Studies at the University of North Carolina–Chapel Hill and has an undergraduate degree from Bucknell University. We believe that Mr. Gray is qualified to serve as a member of our board of directors because of his financial and medical reimbursement expertise having served as the Chief Financial Officer at Highmark, Inc., one of America’s largest health insurance organization. Marc H. Glickman, M.D. has served as our Senior Vice President and Chief Medical Officer since May 2016 and served as member of our board of directors from July 2016 to August 2017. In 1981, Dr. Glickman started a vascular practice in Norfolk, Virginia. He established the first Vein Center in Virginia and also created a dialysis access center. He was employed by Sentara Health Care as director of Vascular Services until he retired in 2014. Dr. Glickman is a board certified vascular surgeon. Dr. Glickman received his Doctor of Medicine from Case Western Reserve, in Cleveland, Ohio and completed his residency at the University of Washington, Seattle. He is board certified in Vascular Surgery and was the past president of the Vascular Society of the Americas. He has served on the advisory boards of Possis Medical, Cohesion Technologies, Thoratec, GraftCath, Inc., TVA medical, Austin, Texas. Craig Glynn was hired as our interim Chief Financial Officer in April 2020 and has subsequently been elevated to our fulltime Chief Financial Officer effective January 2021. Mr. Glynn has more than thirty-nine years of experience providing financial services to a variety of public and private companies, including in the role as Chief Financial Officer. In 2012, Mr. Glynn founded Edward Thomas Associates, a firm that provides public and private companies with accounting and finance services, including chief financial officer services. Mr. Glynn has been a Managing Director of Edward Thomas Associates since 2012. Mr. Glynn has a proven record of success managing the financial aspects of dynamic organizations either as a member of the management team or in a consulting capacity. He started his career as an auditor with Deloitte and went on to be the CFO and Controller of several technology, manufacturing, and distribution companies. Mr. Glynn earned his BS and MS degrees in Accounting from California State University Northridge. He is a member of the American Institute of CPAs. Dr. Hamed Alavi joined enVVeno Medical as Director, Research, Development and Quality in July 2020 and was promoted to Vice President of Research, Development and Quality in January 2021. Prior to joining enVVeno Medical, Dr. Alavi was the head of engineering at NaviGate Cardiac Structures Inc., a company which developed tricuspid heart valve replacement and delivery system devices, and held roles at Medtronic Cardiac and Vascular Group (CVG) and Edwards Lifesciences Center for Advanced Cardiovascular Technology where he used his technical and leadership skills to drive early-stage medical device technologies from conception to commercialization. Dr. Alavi received his doctorate in biomedical engineering from the University of California, Irvine where he was trained in one of the most prominent cardiovascular engineering doctoral programs in the US. His pioneering work in hybrid tissue and implantable medical devices was broadly recognized and given accolades by a number of institutions – such as the American Heart Association. He also holds an M.S. degree in biomedical engineering and a B.S. degree in mechanical engineering. 33 Family Relationships There are no arrangements between our directors and any other person pursuant to which our directors were nominated or elected for their positions. There are no family relationships between any of our directors or executive officers. Section 16(a) Beneficial Ownership Reporting Compliance Section 16(a) of the Exchange Act requires our directors, executive officers and ten percent stockholders to file initial reports of ownership and reports of changes in ownership of our common stock with the Commission. Directors, executive officers and ten percent stockholders are also required to furnish us with copies of all Section 16(a) forms that they file. Based upon a review of these filings, we believe that all required Section 16(a) reports were made on a timely basis during fiscal year 2024. Board Composition Our business and affairs are organized under the direction of our board of directors, which currently consists of five members. Our directors hold office until the earlier of their death, incapacity, removal or resignation, or until their successors have been elected and qualified. Our board of directors does not have a formal policy on whether the roles of a Chief Executive Officer and Chairman of our board of directors should be separate. The primary responsibilities of our board of directors are to provide oversight, strategic guidance, counseling, and direction to our management. Our board of directors meets on a regular basis. Our bylaws provide that the authorized number of directors may be changed only by resolution of the board of directors. We have no formal policy regarding board diversity. Our priority in selection of board members is identification of members who will further the interests of our stockholders through his or her established record of professional accomplishment, the ability to contribute positively to the collaborative culture among board members, knowledge of our business and understanding of the competitive landscape. Our amended and restated certificate of incorporation divides our board of directors into three classes, with staggered three-year terms, as follows: Class I Directors (serving until the 2027 Annual Meeting of Stockholders, or until their earlier death, disability, resignation or removal): Dr. Francis Duhay* and Dr. Sanjay Shrivastava* Class II Directors (serving until the 2025 Annual Meeting of Stockholders, or until their earlier death, disability, resignation or removal) : Matthew M. Jenusaitis*, Robert A. Berman Class III Director (serving until the 2026 Annual Meeting of Stockholders, or until his earlier death, disability, resignation or removal) : Robert C. Gray* (*) Independent Director. At each annual meeting of stockholders to be held after the initial classification, the successors to directors whose terms then expire will serve until the third annual meeting following their election and until their successors are duly elected and qualified. The authorized size of our board of directors is currently five members. The authorized number of directors may be changed only by resolution of the board of directors. Any additional directorships resulting from an increase in the number of directors will be distributed between the three classes so that, as nearly as possible, each class will consist of one-third of the directors. This classification of the board of directors may have the effect of delaying or preventing changes in our control or management. Our directors may be removed for cause by the affirmative vote of the holders of at least 66 2/3% of our voting stock. 34 Director Independence The Nasdaq Marketplace Rules require a majority of a listed company’s board of directors to be comprised of independent directors within one year of listing. In addition, the Nasdaq Marketplace Rules require that, subject to specified exceptions, each member of a listed company’s audit, compensation and nominating and corporate governance committees be independent and that audit committee members also satisfy independence criteria set forth in Rule 10A-3 under the Exchange Act. Under Rule 5605(a)(2) of the Nasdaq Marketplace Rules, a director will only qualify as an “independent director” if, in the opinion of our board of directors, that person does not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. In order to be considered independent for purposes of Rule 10A-3 of the Exchange Act, a member of an audit committee of a listed company may not, other than in his or her capacity as a member of the audit committee, the board of directors, or any other board committee, accept, directly or indirectly, any consulting, advisory, or other compensatory fee from the listed company or any of its subsidiaries or otherwise be an affiliated person of the listed company or any of its subsidiaries. Our board of directors has reviewed the composition of our board of directors and its committees and the independence of each director. Based upon information requested from and provided by each director concerning his background, employment and affiliations, including family relationships, our board of directors has determined that each of Dr. Duhay, Mr. Gray, Mr. Jenusaitis and Dr. Shrivastava is an “independent director” as defined under Rule 5605(a)(2) of the Nasdaq Marketplace Rules. Our board of directors also determined that Mr. Gray, Mr. Jenusaitis and Dr. Shrivastava will serve on our audit committee, Mr. Gray and Mr. Jenusaitis and Dr. Shrivastava will serve on our compensation committee, and Dr. Duhay, Mr. Jenusaitis and Dr. Shrivastava will serve on our nominating and corporate governance committee, and that each of the committees satisfy the independence standards for such committees established by the SEC and the Nasdaq Marketplace Rules, as applicable. In making such determinations, our board of directors considered the relationships that each such non-employee director has with our company and all other facts and circumstances our board of directors deemed relevant in determining independence, including the beneficial ownership of our capital stock by each non-employee director. Meetings of the Board and Stockholders Our board of directors met in person and telephonically five times during 2024 and also acted by unanimous written consent. There were four Audit Committee meetings and three Compensation Committee meetings held in 2024. All of the members of our board of directors were present during at least 75% of the board of director meetings and all of the members of the respective committees of the board of directors were present during at least 75% of such committee meetings held other than Matthew Jenusaitis who was present for 67% of the Compensation Committee meetings. Our board of directors had 100% attendance for the Annual Meeting that was held on December 18, 2024. It is our policy that all directors must attend all stockholder meetings, barring extenuating circumstances. 35 Board Committees Our board of directors has established three standing committees—audit, compensation, and nominating and corporate governance—each of which operates under a charter that has been approved by our board of directors. Copies of each committee’s charter are posted on the Investors section of our website, which is located at www.envveno.com. Each committee has the composition and responsibilities described below. Our board of directors may from time to time establish other committees. Audit Committee Our audit committee consists of Mr. Gray, who is the chair of the audit committee, Mr. Jenusaitis and Dr. Shrivastava. Our board of directors has determined that each of the members of our audit committee satisfies the Nasdaq Marketplace Rules and SEC independence requirements. The functions of this committee include, among other things: ● evaluating the performance, independence and qualifications of our independent auditors and determining whether to retain our existing independent auditors or engage new independent auditors; ● reviewing and approving the engagement of our independent auditors to perform audit services and any permissible non-audit services; ● reviewing our annual and quarterly consolidated financial statements and reports, including the disclosures contained under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and discussing the statements and reports with our independent auditors and management; ● reviewing with our independent auditors and management significant issues that arise regarding accounting principles and financial statement presentation and matters concerning the scope, adequacy and effectiveness of our financial controls; ● reviewing our major financial risk exposures, including the guidelines and policies to govern the process by which risk assessment and risk management is implemented; and ● reviewing our cybersecurity data breach risk and impact, cyber prevention and detection controls, privacy matters, incident response, third-party cyber risk, cyber trends and events, and other cyber topics; and ● reviewing and evaluating on an annual basis the performance of the audit committee, including compliance of the audit committee with its charter. Our board of directors has determined that Mr. Gray qualifies as an “audit committee financial expert” within the meaning of applicable SEC regulations and meets the financial sophistication requirements of the Nasdaq Marketplace Rules. Both our independent registered public accounting firm and management periodically meet privately with our audit committee. 36 Compensation Committee Our compensation committee consists of Dr. Shrivastava, who is the chair of the committee, Mr. Gray and Mr. Jenusaitis. Our board of directors has determined that each of the members of our compensation committee is an outside director, as defined pursuant to Section 162(m) of the Internal Revenue Code of 1986, as amended, or the Code, and satisfies the Nasdaq Marketplace Rules independence requirements. The functions of this committee include, among other things: ● reviewing, modifying and approving (or if it deems appropriate, making recommendations to the full board of directors regarding) our overall compensation strategy and policies; ● reviewing and approving the compensation, the performance goals and objectives relevant to the compensation, and other terms of employment of our Chief Executive Officers and our other executive officers; ● reviewing and approving (or if it deems appropriate, making recommendations to the full board of directors regarding) the equity incentive plans, compensation plans and similar programs advisable for us, as well as modifying, amending or terminating existing plans and programs; ● reviewing and approving the terms of any employment agreements, severance arrangements, change in control protections and any other compensatory arrangements for our executive officers; ● reviewing with management and approving our disclosures under the caption “Compensation Discussion and Analysis” in our periodic reports or proxy statements to be filed with the SEC; and ● preparing the report that the SEC requires in our annual proxy statement; ● advising the board and any other board committees if the clawback provisions of Rule 10D-1 under the Exchange Act (the “Rule”) are triggered based upon a financial statement restatement or other financial statement change, with the assistance of management and the audit committee and to the extent that our securities continue to be listed on an exchange and subject to the Rule. Nominating and Corporate Governance Committee Our nominating and corporate governance committee consists of Dr. Duhay, who is the chair of the committee, Mr. Jenusaitis and Dr. Shrivastava. Our board of directors has determined that each of the members of this committee satisfies the Nasdaq Marketplace Rules independence requirements. The functions of this committee include, among other things: ● identifying, reviewing and evaluating candidates to serve on our board of directors consistent with criteria approved by our board of directors; ● evaluating director performance on our board of directors and applicable committees of our board of directors and determining whether continued service on our board of directors is appropriate; ● evaluating, nominating and recommending individuals for membership on our board of directors; and ● evaluating nominations by stockholders of candidates for election to our board of directors. 37 Code of Conduct Our board of directors has adopted a written code of conduct that applies to our directors, officers and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. We have posted on our website a current copy of the code and all disclosures that are required by law or Nasdaq Marketplace Rules concerning any amendments to, or waivers from, any provision of the code. Insider Trading Policy The Company has adopted an insider trading policy governing the purchase, sale, and/or other dispositions of the Company’s securities by directors, officers and employees. The policy is designed to promote compliance with insider trading laws, rules and regulations, and any listing standards applicable to the Company. A copy of the Company’s insider trading policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K for the fiscal year ended December 31, 2024. Board Leadership Structure Our board of directors is free to select the Chairman of the board of directors and a Chief Executive Officer in a manner that it considers to be in the best interests of our company at the time of selection. Currently, Robert A. Berman serves as our Chief Executive Officer. The office of the Chairman of the board of directors has been vacant since May 2019. We currently believe that this leadership structure is in our best interests and strikes an appropriate balance between our Chief Executive Officer’s responsibility for the day-to-day management of our company and the Chairman of the board of directors’ responsibility to provide oversight, including setting the board of directors’ meeting agendas and presiding at executive sessions of the independent directors. Additionally, four of our five members of our board of directors have been deemed to be “independent” by the board of directors, which we believe provides sufficient independent oversight of our management. Our board of directors has not designated a lead independent director. Our board of directors, as a whole and also at the committee level, plays an active role overseeing the overall management of our risks. Our Audit Committee reviews risks related to financial and operational items with our management and our independent registered public accounting firm. Our board of directors is in regular contact with our Chief Executive Officer, who reports directly to our board of directors and who supervises day-to-day risk management. Role of Board in Risk Oversight Process Our board of directors believes that risk management is an important part of establishing, updating and executing on our business strategy. Our board of directors has oversight responsibility relating to risks that could affect the corporate strategy, business objectives, compliance, operations, and the financial condition and performance of our company. Our board of directors focuses its oversight on the most significant risks facing us and on our processes to identify, prioritize, assess, manage and mitigate those risks. Our board of directors receives regular reports from members of our senior management on areas of material risk to us, including strategic, operational, financial, legal and regulatory risks. While our board of directors has an oversight role, management is principally tasked with direct responsibility for management and assessment of risks and the implementation of processes and controls to mitigate their effects on us. Certain Legal Proceedings None of the Company’s directors or executive officers have been involved, in the past ten years and in a manner material to an evaluation of such director’s or officer’s ability or integrity to serve as a director or executive officer, in any of those “Certain Legal Proceedings” more fully detailed in Item 401(f) of Regulation S-K, which include but are not limited to, bankruptcies, criminal convictions and an adjudication finding that an individual violated federal or state securities laws. 38 ITEM 11. Executive Compensation The following table sets forth total compensation paid to our named executive officers for the years ended December 31, 2024 and 2023. Individuals we refer to as our “named executive officers” include our current Chief Executive Officer, our current Chief Financial Officer and our other most highly compensated executive officer whose salary and bonus for services rendered in all capacities exceeded $100,000 during the fiscal year ended December 31, 2024. Name and Principal Position Year Salary ($) Bonus ($) Option Awards ($) Other Equity Incentive Plan Compensation ($) Nonqualified Deferred Compensation Earnings ($) All Other Compensation ($) Total ($) Robert A. Berman 2024 500,000 232,500 400,513 (1) - 28,119 (8) 1,161,132 Chief Executive Officer 2023 500,000 500,000 854,393 (2) - 16,491 (9) 1,870,884 Craig Glynn 2024 250,000 38,750 - - 13,476 (10) 302,226 Chief Financial Officer 2023 250,000 50,000 213,598 (3) - 13,693 (11) 527,291 Marc H. Glickman, M.D. 2024 367,500 56,963 150,192 (4) - 51,918 (12) 626,573 Chief Medical Officer and Senior Vice President 2023 367,500 73,500 284,798 (5) - 50,586 (13) 776,384 Dr. Hamed Alavi 2024 300,000 46,500 150,192 (6) - 25,203 (14) 521,895 Senior Vice President & Chief Technology Officer 2023 300,000 60,000 284,798 (7) - 24,390 (15) 669,188 (1) Represents the grant date fair value of 200,000 stock options granted on December 18, 2024, computed in accordance with FASB ASC Topic 718. The options vest quarterly over a three-year period (2) Represents the grant date fair value of 300,000 stock options granted on December 5, 2023, computed in accordance with FASB ASC Topic 718. The options vest quarterly over a three-year period. (3) Represents the grant date fair value of 75,000 stock options granted on December 5, 2023, computed in accordance with FASB ASC Topic 718. The options vest quarterly over a three-year period. (4) Represents the grant date fair value of 75,000 stock options granted on December 18, 2024, computed in accordance with FASB ASC Topic 718. The options vest quarterly over a three-year period. (5) Represents the grant date fair value of 100,000 stock options granted on December 5, 2023, computed in accordance with FASB ASC Topic 718. The options vest quarterly over a three-year period. (6) Represents the grant date fair value of 75,000 stock options granted on December 18, 2024, computed in accordance with FASB ASC Topic 718. The options vest quarterly over a three-year period. (7) Represents the grant date fair value of 100,000 stock options granted on December 5, 2023, computed in accordance with FASB ASC Topic 718. The options vest quarterly over a three-year period. (8) Includes company paid healthcare of $9,679 and 401(k) match of $18,441. (9) Includes company paid healthcare of $1,241 and 401(k) match of $15,250. (10) Includes company paid healthcare of $1,360 and 401(k) match of $12,115. (11) Includes company paid healthcare of $1,241 and 401(k) match of $12,452. (12) Includes company paid healthcare of $34,406 and 401(k) match of $17,512. (13) Includes company paid healthcare of $35,336 and 401(k) match of $15,250. (14) Includes company paid healthcare of $10,665 and 401(k) match of $14,538. (15) Includes company paid healthcare of $9,505 and 401(k) match of $14,885. 39 Employment Agreements We have entered into various employment agreements with certain of our executive officers. Set forth below is a summary of many of the material provisions of such agreements, which summaries do not purport to contain all of the material terms and conditions of each such agreement. For purposes of the following employment agreements: ● “Cause” generally means the executive’s (i) willful misconduct or gross negligence in the performance of his or her duties to us; (ii) willful failure to perform his or her duties to us or to follow the lawful directives of the Chief Executive Officer (other than as a result of death or disability); (iii) indictment for, conviction of or pleading of guilty or nolo contendere to, a felony or any crime involving moral turpitude: (iv) repeated failure to cooperate in any audit or investigation of our business or financial practices; (v) performance of any material act of theft, embezzlement, fraud, malfeasance, dishonesty or misappropriation of our property; or (vi) material breach of his or her employment agreement or any other material agreement with us or a material violation of our code of conduct or other written policy. ● “Good reason” generally means, subject to certain notice requirements and cure rights, without the executive’s consent, (i) material diminution in his or her base salary or annual bonus opportunity; (ii) material diminution in his or her authority or duties (although a change in title will not constitute “good reason”), other than temporarily while physically or mentally incapacitated, as required by applicable law; (iii) relocation of his or her primary work location by more than 25 miles from its then current location; or (iv) a material breach by us of a material term of the employment agreement. ● “Change of control” generally means (i) the acquisition, other than from us, by any individual, entity or group (within the meaning of Section 13(d)(3) or Section 14(d)(2) of the Exchange Act), other than us or any subsidiary, affiliate (within the meaning of Rule 144 promulgated under the Securities Act) or employee benefit plan of ours, of beneficial ownership (within the meaning of Rule 13d-3 promulgated under the Exchange Act) of more than 50% of the combined voting power of our then outstanding voting securities entitled to vote generally in the election of directors; (ii) a reorganization, merger, consolidation or recapitalization of us, other than a transaction in which more than 50% of the combined voting power of the outstanding voting securities of the surviving or resulting entity immediately following such transaction is held by the persons who, immediately prior to the transaction, were the holders of our voting securities; or (iii) a complete liquidation or dissolution of us, or a sale of all or substantially all of our assets. Robert A. Berman On March 30, 2018, we entered into an employment agreement with Robert A. Berman, our current Chief Executive Officer and director. Pursuant to the terms of his employment agreement, Mr. Berman’s base salary was initially $400,000, subject to annual review and adjustment at the discretion of our compensation committee. In November 2021 the board of directors increased Mr. Berman’s base salary to $450,000 for 2022 and $500,000 commencing in 2023. In December 2024 the board of directors increased Mr. Berman’s base salary to $525,000. Mr. Berman also participates in an annual discretionary bonus pool where he is eligible for a bonus of up to 60% of his base salary. The bonus amount actually paid, if any, is subject to the achievement of key performance indicators established each year by our compensation committee. Mr. Berman may also receive additional discretionary bonuses as determined by our compensation committee. Mr. Berman’s employment agreement may be terminated at any time with or without cause and with or without notice or for good reason thereunder. Mr. Berman is entitled to participate in our employee benefit, pension and/or profit sharing plans, and we will pay certain health and dental premiums on his behalf. Mr. Berman’s employment agreement prohibits him from inducing, soliciting or entertaining any of our employees to leave our employ during the term of the agreement and for 12 months thereafter. Pursuant to the terms of his employment agreement, Mr. Berman is entitled to severance in the event of certain terminations of employment. In the event Mr. Berman’s employment is terminated by us without cause and other than by reason of disability or he resigns for good reason, subject to his timely executing a release of claims in our favor and in addition to certain other accrued benefits, he is entitled to receive 12 months of continued base salary (or 24 months if such termination occurs within 24 months following a change of control). In connection with his employment, Mr. Berman received an initial equity grant of an option to purchase 43,209 shares for $10.00 per share, with 8,642 vesting on the date of his Employment Agreement, March 30, 2018, and the remaining 80% vested ratably on a monthly basis over the following 24 months. In February 2021, the board of directors approved an option grant to Mr. Berman to purchase 838,000 shares of common stock at an exercise price of $8.20 per share (the closing price of the Company’s common stock on February 18, 2021). The stock option vested in equal quarterly installments over a two-year period. In November 2021, the board of directors approved an option grant to Mr. Berman to purchase 349,781 shares of common stock at an exercise price of $6.70 per share (the closing price of the Company’s common stock on November 30, 2021). The stock option vested in equal quarterly installments over a three-year period. Also in November 2021, the board of directors granted Mr. Berman 200,000 restricted stock units. The restricted stock units were initially subject to milestone-based vesting as follows: (i) 50% upon SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) endpoints being achieved, and (ii) 50% upon the Pre-Market Approval of the VenoValve. On December 5, 2023, the Board removed the first vesting condition and conditioned vesting of all 200,000 of the restricted stock units on the Pre-Market Approval of the VenoValve. In December 2023, the board of directors approved an option grant to Mr. Berman to purchase 300,000 shares of common stock at an exercise price of $3.59 per share (the closing price of the Company’s common stock on December 4, 2023). The stock option vests in equal quarterly installments over a three-year period. In December 2024, the board of directors approved an option grant to Mr. Berman to purchase 200,000 shares of common stock at an exercise price of $2.57 per share (the closing price of the Company’s common stock on December 18, 2024). The stock option vests in equal quarterly installments over a three-year period. Additionally, the board of directors paid Mr. Berman a cash bonus of $232,500 and $500,000 for 2024 and 2023, respectively. 40 Craig Glynn On February 19, 2021, the Company entered into an employment agreement with Mr. Glynn, in connection with Mr. Glynn’s elevation to full time Chief Financial Officer, treasurer and secretary of the Company. Pursuant to the employment agreement, Mr. Glynn provided for an initial salary of $225,000 per year, subject to annual review and adjustment at the discretion of the Board. In November 2024 the board of directors increased Mr. Glynn’s base salary to $262,500. Mr. Glynn also participates in an annual discretionary bonus pool where he is eligible for a bonus of up to 20% of his base salary. The bonus amount actually paid, if any, is subject to the achievement of key performance indicators established each year by our compensation committee. Mr. Glynn may also receive additional discretionary bonuses as determined by our compensation committee. The board of directors paid Mr. Glynn a cash bonus of $38,750 for 2024. The employment agreement further provides that Mr. Glynn is entitled to participate in any employee benefit plans that the Company has adopted or may adopt. Pursuant to the terms of the employment agreement, Mr. Glynn’s employment is terminable due to Mr. Glynn’s disability or death, for “Cause” (as defined in the employment agreement) or without “Cause” by the Company, and for “Good Reason” (as defined in the employment agreement) or voluntarily by Mr. Glynn. In the event of Mr. Glynn’s death or disability, or termination for “Cause” by the Company or without “Good Reason” by Mr. Glynn, Mr. Glynn (or his estate) is entitled to receive any unpaid base salary through the termination date, reimbursement for unreimbursed business expenses, accrued but unused vacation time in accordance with the Company’s policy and any other payments or benefits that Mr. Glynn is entitled to in accordance with any Company benefit plans (collectively, the “Accrued Benefits”). Upon termination without “Cause” (other than by reason of death or disability) or resignation for “Good Reason,” Mr. Glynn will be entitled to three months of severance for each year Mr. Glynn is employed up to one year of severance, in addition to all Accrued Benefits. Any outstanding unvested securities owned by Mr. Glynn on the termination date will vest (or terminate) in accordance with the terms of such grant. In February 2021, the board of directors approved an option grant to Mr. Glynn to purchase 324,000 shares of common stock of the Company at an exercise price of $8.20 per share (the closing price of the Company’s common stock on February 18, 2021). The stock options vest in equal quarterly installments over a three-year period with a six-month cliff. In November 2021, the board of directors approved an option grant to Mr. Glynn to purchase 125,925 shares of common stock at an exercise price of $6.70 per share (the closing price of the Company’s common stock on November 30, 2021). The stock option vests in equal quarterly installments over a three-year period. In November 2021, the board of directors granted Mr. Glynn 50,000 restricted stock units. The restricted stock units were initially subject to milestone-based vesting as follows: (i) 50% upon SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) endpoints being achieved, and (ii) 50% upon the Pre-Market Approval of the VenoValve. On December 5, 2023, the Board removed the first vesting condition and conditioned vesting of all 50,000 of the restricted stock units on the Pre-Market Approval of the VenoValve. In December 2023, the board of directors approved an option grant to Mr. Glynn to purchase 75,000 shares of common stock at an exercise price of $3.59 per share (the closing price of the Company’s common stock on December 4, 2023). The stock option vests in equal quarterly installments over a three-year period. 41 Marc H. Glickman, M.D. On July 22, 2016, we entered into an employment agreement with Marc H. Glickman, M.D., our Senior Vice President and Chief Medical Officer (the “Pre-existing Employment Agreement”). Pursuant to the terms of his Pre-existing Employment Agreement, Dr. Glickman’s base salary was $300,000, subject to annual review and adjustment at the discretion of our board of directors. In connection with his Pre-existing Employment Agreement, Dr. Glickman received an initial equity grant of an option to purchase up to 7,380 shares of our common stock with 20% of the shares vesting immediately and 80% vesting on a monthly basis over 24 months thereafter. The initial term of Dr. Glickman’s Pre-existing Employment Agreement ended on December 31, 2018 and was automatically extended for an additional three-year term. On July 26, 2019, we entered into an employment agreement with Dr. Glickman (the “New Employment Agreement”) that supersedes the terms of the Pre-existing Employment Agreement. Pursuant to the terms of the New Employment Agreement, Dr. Glickman’s base salary is $350,000 per year, subject to annual review and adjustment at the discretion of the Board. In December 2022, the board of directors increased Dr. Glickman’s base salary to $367,500. Dr. Glickman also participates in an annual year-end discretionary bonus pool where he is eligible for a bonus of up to 20% of his base salary. The bonus amount actually paid, if any, is subject to the achievement of key performance indicators established each year by our compensation committee. Dr. Glickman may also receive additional discretionary bonuses as determined by our compensation committee. In connection with entering into the New Employment Agreement, Dr. Glickman’s existing seven thousand three hundred and eighty (7,380) options (“Existing Options”) to purchase Company common stock at two hundred and fifty dollars ($250.00) per share until October 1, 2026, were repriced to fifty dollars ($50.00) per share. Additionally, Dr. Glickman, in connection with the New Employment Agreement, was granted stock options for the right to purchase seven thousand two hundred (7,200) common stock at a price equal to fifty dollars ($50.00) per share exercisable until July 26, 2029, which vested quarterly over a three (3) year period. Pursuant to the terms of the New Employment Agreement, Dr. Glickman is an at-will employee and is entitled to severance in the event of certain terminations of his employment. In the event that Dr. Glickman’s employment is terminated by the Company without Cause (as defined in the New Employment Agreement), other than by reason of Disability (as defined in the New Employment Agreement), or he resigns for Good Reason (as defined in the New Employment Agreement), subject to his timely executing a release of claims in favor of the Company and in addition to certain other accrued benefits, Dr. Glickman is entitled to receive three months of his base salary for each year that he has been employed by the Company at the time of termination, up to a total of one year of his base salary. In February 2021, the board of directors approved an option grant to Dr. Glickman to purchase 406,000 shares of common stock at an exercise price of $8.20 per shares (the closing price of the Company’s common stock on February 18, 2021). The stock option vested in equal quarterly installments over a two-year period. In November 2021, the board of directors approved an option grant to Mr. Glickman to purchase 265,700 shares of common stock at an exercise price of $6.70 per share (the closing price of the Company’s common stock on November 30, 2021). The stock option vests in equal quarterly installments over a three-year period. Also in November 2021, the board of directors granted Mr. Glickman 100,000 restricted stock units. The restricted stock units were initially subject to milestone-based vesting as follows: (i) 50% upon SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) endpoints being achieved, and (ii) 50% upon the Pre-Market Approval of the VenoValve. On December 5, 2023, the Board removed the first vesting condition and conditioned vesting of all 100,000 of the restricted stock units on the Pre-Market Approval of the VenoValve. In December 2023, the board of directors approved an option grant to Mr. Glickman to purchase 100,000 shares of common stock at an exercise price of $3.59 per share (the closing price of the Company’s common stock on December 4, 2023). The stock option vests in equal quarterly installments over a three-year period. In December 2024, the board of directors approved an option grant to Mr. Glickman to purchase 75,000 shares of common stock at an exercise price of $2.57 per share (the closing price of the Company’s common stock on December 18, 2024). The stock option vests in equal quarterly installments over a three-year period. Additionally, the board of directors paid Mr. Glickman a cash bonus of $56,963 and $73,500 for 2024 and 2023, respectively. Hamed Alavi On July 29, 2020, we entered into an employment agreement with Dr. Hamed Alavi, our Senior Vice President and Chief Technology Officer (the “Employment Agreement”). Pursuant to the terms of the Employment Agreement, Mr. Alavi’s base salary was $190,000, subject to annual review and adjustment at the discretion of our board of directors. Mr. Alavi also participates in an annual year-end discretionary bonus pool where he is eligible for a bonus of up to 25% of his base salary. The bonus amount actually paid, if any, is subject to the achievement of key performance indicators established each year by our compensation committee. Mr. Alavi may also receive additional discretionary bonuses as determined by our compensation committee. In November 2021 the board of directors increased Mr. Alavi’s base salary to $240,000 and, in November 2022, the board of directors increased Mr. Alavi’s annual base salary to $300,000. Additionally, the board of directors paid Mr. Alavi a cash bonus of $46,500 and $60,000 for 2024 and 2023, respectively. Pursuant to the terms of the employment agreement, Mr. Alavi’s employment is terminable due to Mr. Alavi’s disability or death, for “Cause” (as defined in the employment agreement) or without “Cause” by the Company, and for “Good Reason” (as defined in the employment agreement) or voluntarily by Mr. Alavi. In the event of Mr. Alavi’s death or disability, or termination for “Cause” by the Company or without “Good Reason” by Mr. Alavi, Mr. Alavi (or his estate) is entitled to receive any unpaid base salary through the termination date, reimbursement for unreimbursed business expenses, accrued but unused vacation time in accordance with the Company’s policy and any other payments or benefits that Mr. Alavi is entitled to in accordance with any Company benefit plans (collectively, the “Accrued Benefits”). Upon termination without “Cause” (other than by reason of death or disability) or resignation for “Good Reason,” Mr. Alavi will be entitled to three months of severance for each year Mr. Alavi is employed up to one year of severance, in addition to all Accrued Benefits. Any outstanding unvested securities owned by Mr. Alavi on the termination date will vest (or terminate) in accordance with the terms of such grant. The employment agreement further provides that Mr. Alavi is entitled to participate in any employee benefit plans that the Company has adopted or may adopt. In February 2021, the board of directors approved an option grant to Mr. Alavi to purchase 320,000 shares of common stock of the Company at an exercise price of $8.20 per shares (the closing price of the Company’s common stock on February 18, 2021). The stock options vested in equal quarterly installments over a three year period with a six month cliff. In November 2021, the board of directors approved an option grant to Mr. Alavi to purchase 125,925 shares of common stock at an exercise price of $6.70 per shares (the closing price of the Company’s common stock on November 30, 2021). The stock option vested in equal quarterly installments over a three year period. Also in November 2021, the board of directors granted Mr. Alavi 50,000 restricted stock units. The restricted stock units were initially subject to milestone-based vesting as follows: (i) 50% upon SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) endpoints being achieved, and (ii) 50% upon the Pre-Market Approval of the VenoValve. On December 5, 2023, the Board removed the first vesting condition and conditioned vesting of all 50,000 of the restricted stock units on the Pre-Market Approval of the VenoValve. In December 2023, the board of directors approved an option grant to Mr. Alavi to purchase 100,000 shares of common stock at an exercise price of $3.59 per shares (the closing price of the Company’s common stock on December 4, 2023). The stock option vests in equal quarterly installments over a three-year period. In December 2024, the board of directors approved an option grant to Mr. Alavi to purchase 75,000 shares of common stock at an exercise price of $2.57 per shares (the closing price of the Company’s common stock on December 18, 2024). The stock option vests in equal quarterly installments over a three-year period. Potential Payments Upon Termination or Change-in-Control Pursuant to the terms of the employment agreements discussed above, we will pay severance in the event of certain terminations of employment. In the event employment is terminated by us without cause and other than by reason of disability or if the executive resigns for good reason, subject to his or her timely executing a release of claims in our favor and in addition to certain other accrued benefits, he or she is entitled to receive severance pursuant to the terms of his or her employment agreements discussed above. 42 Outstanding Equity Awards at Fiscal Year-End The following table sets forth information regarding equity awards held by our named executive officers as of December 31, 2024. Name Number of securities underlying unexercised options (#) exercisable Number of securities underlying unexercised options (#) unexercisable Equity incentive plan awards: Number of securities underlying unexercised unearned options (#) Option exercise price ($) Option expiration date Robert A. Berman , 43,209 (1) - N/A $ 10.00 September 23, 2028 Chief Executive Officer 40,000 (2) - $ 10.00 July 18, 2030 838,000 (3) - $ 8.20 February 18, 2031 349,781 (4) - (4) $ 6.70 November 30, 2031 107,222 (10) 192,778 (10) $ 3.59 December 2, 2033 - 200,000 (11) $ 2.57 February 16, 2034 Marc H. Glickman, M.D. 7,200 (5) - N/A $ 50.00 July 25, 2029 Chief Medical Officer and 7,380 (5) - N/A $ 50.00 October 1, 2026 Senior Vice President 40,000 (2) - - $ 10.00 July 18, 2030 406,000 (3) - $ 8.20 February 18, 2031 265,700 (4) - (4) $ 6.70 November 30, 2031 35,741 (10) 64,259 (10) $ 3.59 December 2, 2033 - 75,000 (11) $ 2.57 February 16, 2034 Craig Glynn, 4,000 (7) - N/A $ 10.00 July 18, 2030 Chief Financial Officer (6) 324,000 (8) - (8) $ 8.20 February 18, 2031 125,925 (4) - (4) $ 6.70 November 30, 2031 26,806 (10) 48,194 (10) $ 3.59 December 2, 2033 Dr. Hamed Alavi 8,000 (7) - (7) N/A $ 10.00 July 18, 2030 Senior Vice President and 320,000 (8) - (8) $ 8.20 February 18, 2031 Chief Technology Officer 125,925 (4) - (4) $ 6.70 November 30, 2031 66,664 (9) 24,999 (9) $ 6.70 November 30, 2032 27,407 (10) 72,593 (10) $ 3.59 December 2, 2033 - 75,000 (11) $ 2.57 February 16, 2034 (1) Options were granted on September 24, 2018, and vested 20% on the date of his Employment Agreement, March 30, 2018, and the remaining 80% vests ratably on a monthly basis over the 24 months following the date of his Employment Agreement. (2) Options were granted on July 18, 2020 and vest ratably on a monthly basis over 36 months. (3) Options were granted on February 18, 2021 and vest ratably on a quarterly basis over two years. (4) Options were granted on November 30, 2021 and vest ratably on a quarterly basis over three years. (5) On July 26, 2019, the Company entered a new employment agreement with Dr. Glickman that superseded the terms of his existing employment agreement. In connection with entering into the new employment agreement, Dr. Glickman’s existing 7,380 options that were granted on October 1, 2016 were repriced from $250.00 to $50.00 per share. Additionally, on July 26, 2019, Dr. Glickman was granted 7,200 options at $50.00 per share vesting quarterly over a three-year period. (6) Mr. Glynn was elevated to permanent Chief Financial Officer in January 2021. (7) Options were granted on July 18, 2020 and vest ratably on a quarterly basis over three years. (8) Options were granted on February 18, 2021 and vest ratably on a quarterly basis over three years. (9) Options were granted on November 30, 2022 and vest ratably on a quarterly basis over three years. (10) Options were granted on December 5, 2023 and vest ratably on a quarterly basis over three years. (11) Options were granted on December 18, 2024 and vest ratably on a quarterly basis over three years. Name Grant Date Number of unearned restricted stock units that have not vested Market value of unearned restricted stock units that have not vested (a) Robert A. Berman, Chief Executive Officer 11/30/2021 200,000 (1) $ 604,000 Marc H. Glickman, M.D., Chief Medical Officer and Senior Vice President 11/30/2021 100,000 (1) $ 302,000 Craig Glynn, Chief Financial Officer 11/30/2021 50,000 (1) $ 151,000 Dr. Hamed Alavi, Senior Vice President and Chief Technology Officer 11/30/2021 50,000 (1) $ 151,000 (a) Determined by multiplying the number of restricted stock units that have not vested by $3.02, the closing price of NVNO’s common stock on December 31, 2024, the last trading day of 2024. (1) On November 30, 2021, Mr. Berman was granted 200,000 restricted stock units, Dr. Glickman was granted 100,000 restricted stock units, Mr. Glynn was granted 50,000 restricted stock units and Mr. Alavi was granted 50,000 restricted stock units. The restricted stock units were initially subject to milestone-based vesting as follows: (i) 50% upon SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) endpoints being achieved, and (ii) 50% upon the Pre-Market Approval of the VenoValve. On December 5, 2023, the Board removed the first vesting condition and conditioned vesting of all of the restricted stock units on the Pre-Market Approval of the VenoValve. 43 Employee Benefit Plans Amended and Restated 2016 Omnibus Incentive Plan On October 1, 2016, our board of directors and our stockholders adopted and approved the enVVeno Medical Corporation 2016 Omnibus Incentive Plan, and, subsequently, on April 26, 2018, our board of directors and our stockholders adopted and approved the Amended and Restated 2016 Omnibus Incentive Plan which was subsequently amended by Amendment No. 1 to the Amended and Restated 2016 Omnibus Incentive Plan following receipt of stockholder approval on December 17, 2020 and by Amendment No. 2 to the Amended and Restated 2016 Omnibus Incentive Plan following receipt of stockholder approval on November 30, 2021 (as amended, the “2016 Plan”). The principal features of the 2016 Plan are summarized below. This summary is qualified in its entirety by reference to the text of the 2016 Plan, which is filed as an exhibit to this Annual Report on Form 10-K. Equity Award Grant Timing We generally grant equity awards to our employees and directors in the fourth quarter each calendar year, except in the case of equity awards for new hires which are granted at the board meeting following the acceptance of the employment offer. We do not have a written policy regarding the timing of equity awards, but we do not grant equity awards in anticipation of the release of material nonpublic information, nor do we time the release of material nonpublic information based on equity award grant dates. Share Reserve We currently have reserved 7,150,497 shares of our common stock for issuance under the 2016 Plan, provided, however, if at any time the Company issues additional shares of Common Stock or securities that are convertible or exercisable into shares of Common Stock (other than pursuant to the Plan) then the number of shares authorized to be awarded under the Plan shall increase to an amount equal to no less than 20% of the issued and outstanding shares of common stock of the Company on a fully diluted basis. Such increase, if any, shall occur automatically upon each applicable issuance of securities by the Company. All shares available for issuance under the Plan may be granted as incentive stock options under Code Section 422. The shares of common stock issuable under the 2016 Plan will consist of authorized and unissued shares, treasury shares or shares purchased on the open market or otherwise, all as determined by our company from time to time. If any award is cancelled, terminates, expires or lapses for any reason prior to the issuance of shares or if shares are issued under the 2016 Plan and thereafter are forfeited to us, the shares subject to such awards and the forfeited shares will not count against the aggregate number of shares of common stock available for grant under the 2016 Plan. In addition, the following items will not count against the aggregate number of shares of common stock available for grant under the 2016 Plan: (1) shares issued under the 2016 Plan repurchased or surrendered at no more than cost or pursuant to an option exchange program, (2) any award that is settled in cash rather than by issuance of shares of common stock, (3) shares surrendered or tendered in payment of the option price or purchase price of an award or any taxes required to be withheld in respect of an award or (4) awards granted in assumption of or in substitution for awards previously granted by an acquired company. Administration The 2016 Plan may be administered by our board of directors or our compensation committee. Our compensation committee, in its discretion, selects the individuals to whom awards may be granted, the time or times at which such awards are granted and the terms and conditions of such awards. Our board of directors also has the authority, subject to the terms of the 2016 Plan, to amend existing options (including to reduce the option’s exercise price), to institute an exchange program by which outstanding options may be surrendered in exchange for options that may have different exercise prices and terms, restricted stock, and/or cash or other property. Eligibility Awards may be granted under the 2016 Plan to officers, employees, directors, consultants and advisors of us and our affiliates. Incentive stock options may be granted only to employees of us or our subsidiaries. 44 Awards The 2016 Plan permits the granting of any or all of the following types of awards: ● Stock Options . Stock options entitle the holder to purchase a specified number of shares of common stock at a specified price (the exercise price), subject to the terms and conditions of the stock option grant. Our compensation committee may grant either incentive stock options, which must comply with Code Section 422, or nonqualified stock options. Our compensation committee sets exercise prices and terms and conditions, except that stock options must be granted with an exercise price not less than 100% of the fair market value of our common stock on the date of grant (excluding stock options granted in connection with assuming or substituting stock options in acquisition transactions). Unless our compensation committee determines otherwise, fair market value means, as of a given date, the closing price of our common stock. At the time of grant, our compensation committee determines the terms and conditions of stock options, including the quantity, exercise price, vesting periods, term (which cannot exceed 10 years) and other conditions on exercise. ● Stock Appreciation Rights . Our compensation committee may grant SARs, as a right in tandem with the number of shares underlying stock options granted under the 2016 Plan or as a freestanding award. Upon exercise, SARs entitle the holder to receive payment per share in stock or cash, or in a combination of stock and cash, equal to the excess of the share’s fair market value on the date of exercise over the grant price of the SAR. The grant price of a tandem SAR is equal to the exercise price of the related stock option and the grant price for a freestanding SAR is determined by our compensation committee in accordance with the procedures described above for stock options. Exercise of a SAR issued in tandem with a stock option will reduce the number of shares underlying the related stock option to the extent of the SAR exercised. The term of a freestanding SAR cannot exceed 10 years, and the term of a tandem SAR cannot exceed the term of the related stock option. ● Restricted Stock, Restricted Stock Units and Other Stock-Based Awards . Our compensation committee may grant awards of restricted stock, which are shares of common stock subject to specified restrictions, and restricted stock units, or RSUs, which represent the right to receive shares of our common stock in the future. These awards may be made subject to repurchase, forfeiture or vesting restrictions at our compensation committee’s discretion. The restrictions may be based on continuous service with us or the attainment of specified performance goals, as determined by our compensation committee. Stock units may be paid in stock or cash or a combination of stock and cash, as determined by our compensation committee. Our compensation committee may also grant other types of equity or equity-based awards subject to the terms and conditions of the 2016 Plan and any other terms and conditions determined by our compensation committee. ● Performance Awards . Our compensation committee may grant performance awards, which entitle participants to receive a payment from us, the amount of which is based on the attainment of performance goals established by our compensation committee over a specified award period. Performance awards may be denominated in shares of common stock or in cash, and may be paid in stock or cash or a combination of stock and cash, as determined by our compensation committee. Cash-based performance awards include annual incentive awards. 45 Clawback All cash and equity awards granted under the 2016 plan will be subject to all applicable laws regarding the recovery of erroneously awarded compensation pursuant to Rule 10D-1 of the Exchange Act, any implementing rules and regulations under such laws, any policies we adopted to implement such requirements and any other compensation recovery policies as we may adopt from time to time, including our recently adopted clawback policy that was adopted in accordance with Nasdaq rules. Change in Control Under the 2016 Plan, in the event of a change in control (as defined in the 2016 Plan), outstanding awards will be treated in accordance with the applicable transaction agreement. If no treatment is provided for in the transaction agreement, each award holder will be entitled to receive the same consideration that stockholders receive in the change in control for each share of stock subject to the award holder’s awards, upon the exercise, payment or transfer of the awards, but the awards will remain subject to the same terms, conditions and performance criteria applicable to the awards before the change in control, unless otherwise determined by our compensation committee. In connection with a change in control, outstanding stock options and SARs can be cancelled in exchange for the excess of the per share consideration paid to stockholders in the transaction, minus the option or SARs exercise price. Subject to the terms and conditions of the applicable award agreements, awards granted to non-employee directors will fully vest on an accelerated basis, and any performance goals will be deemed to be satisfied at target. For awards granted to all other service providers, vesting of awards will depend on whether the awards are assumed, converted or replaced by the resulting entity. ● For awards that are not assumed, converted or replaced, the awards will vest upon the change in control. For performance awards, the amount vesting will be based on the greater of (1) achievement of all performance goals at the “target” level or (2) the actual level of achievement of performance goals as of our fiscal quarter end preceding the change in control, and will be prorated based on the portion of the performance period that had been completed through the date of the change in control. ● For awards that are assumed, converted or replaced by the resulting entity, no automatic vesting will occur upon the change in control. Instead, the awards, as adjusted in connection with the transaction, will continue to vest in accordance with their terms and conditions. In addition, the awards will vest if the award recipient has a separation from service within two years after a change in control by us other than for “cause” or by the award recipient for “good reason” (each as defined in the applicable award agreement). For performance awards, the amount vesting will be based on the greater of (1) achievement of all performance goals at the “target” level or (2) the actual level of achievement of performance goals as of our fiscal quarter end preceding the change in control, and will be prorated based on the portion of the performance period that had been completed through the date of the separation from service. Amendment and Termination of the 2016 Plan Unless earlier terminated by our board of directors, the 2016 Plan will terminate, and no further awards may be granted, 10 years after October 1, 2016, the date on which it was approved by our stockholders. Our board of directors may amend, suspend or terminate the 2016 Plan at any time, except that, if required by applicable law, regulation or stock exchange rule, stockholder approval will be required for any amendment. The amendment, suspension or termination of the 2016 Plan or the amendment of an outstanding award generally may not, without a participant’s consent, materially impair the participant’s rights under an outstanding award. 46 Limitation of Liability and Indemnification Matters Our amended and restated certificate of incorporation limits the liability of our directors for monetary damages for breach of their fiduciary duties, except for liability that cannot be eliminated under the DGCL. Consequently, our directors will not be personally liable for monetary damages for breach of their fiduciary duties as directors, except liability for any of the following: ● any breach of their duty of loyalty to us or our stockholders; ● acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law; ● unlawful payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 of the DGCL; or ● any transaction from which the director derived an improper personal benefit. Our amended and restated bylaws also provide that we will indemnify our directors and executive officers and may indemnify our other officers and employees and other agents to the fullest extent permitted by law. Our amended and restated bylaws also permit us to secure insurance on behalf of any officer, director, employee or other agent for any liability arising out of his or her actions in this capacity, regardless of whether our amended and restated bylaws would permit indemnification. We have obtained directors’ and officers’ liability insurance. We have entered into separate indemnification agreements with our directors and executive officers, in addition to indemnification provided for in our amended and restated bylaws. These agreements, among other things, provide for indemnification of our directors and executive officers for expenses, judgments, fines and settlement amounts incurred by this person in any action or proceeding arising out of this person’s services as a director or executive officer or at our request. We believe that these provisions and agreements are necessary to attract and retain qualified persons as directors and executive officers. The above description of the indemnification provisions of our amended and restated bylaws and our indemnification agreements is not complete and is qualified in its entirety by reference to these documents, each of which is incorporated by reference as an exhibit to this Annual Report on Form 10-K. The limitation of liability and indemnification provisions in our amended and restated certificate of incorporation and amended and restated bylaws may discourage stockholders from bringing a lawsuit against directors for breach of their fiduciary duties. They may also reduce the likelihood of derivative litigation against directors and officers, even though an action, if successful, might benefit us and our stockholders. A stockholder’s investment may be harmed to the extent we pay the costs of settlement and damage awards against directors and officers pursuant to these indemnification provisions. Insofar as indemnification for liabilities under the Securities Act may be permitted to directors, officers or persons controlling us pursuant to the foregoing provisions, we have been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and may be unenforceable. There is no pending litigation or proceeding naming any of our directors or officers as to which indemnification is being sought, nor are we aware of any pending or threatened litigation that may result in claims for indemnification by any director or officer. Director Compensation The Board determines the form and amount of director compensation after its review of recommendations made by the Compensation Committee. A substantial portion of each director’s annual retainer is in the form of equity. Under the Company’s nonemployee director compensation program members of the Board who are not also Company employees (“Non-Employee Directors”) are granted options worth up to thirty-seven thousand five hundred dollars ($37,500) per annum (the “Annual Award”). A Non-Employee Director who is newly appointed to the Board other than in connection with an annual meeting of stockholders will generally receive a grant of two thousand four hundred (2,400) options and RSUs worth up to seventy-five thousand dollars ($75,000) upon appointment (an “Initial Award”), which covers their compensation for their first three years of service. The Initial Award and Annual Award to Non-Employee Directors will vest as long as they remain directors in equal annual portions over three years following the date on which the award is granted. 47 The table below shows the compensation paid to our non-employee directors during 2024 and 2023. Name Fees earned or paid in cash Stock awards ($) Option awards ($)(3) Non-equity incentive plan compensation ($) Nonqualified deferred compensation earnings ($) All other compensation ($) Total ($) Francis Duhay, M.D. 2024 $ 32,500 - $ 37,500 (1) - - - $ 70,000 2023 $ 32,500 - $ 37,500 (2) - - - $ 70,000 Dr. Sanjay Shrivastava 2024 $ 37,500 - $ 37,500 (1) - - - $ 75,000 2023 $ 37,500 - $ 37,500 (2) - - - $ 75,000 Robert Gray 2024 $ 40,000 - $ 37,500 (1) - - - $ 77,500 2023 $ 40,000 - $ 37,500 (2) - - - $ 77,500 Matthew Jenusaitis 2024 $ 37,500 - $ 37,500 (1) - - - $ 75,000 2023 $ 37,500 - $ 37,500 (2) - - - $ 75,000 (1) Under the Company’s nonemployee director compensation program, Dr. Duhay, Dr. Shrivastava, Mr. Gray and Mr. Jenusaitis were each granted 13,856 options to purchase shares of our common stock on December 5, 2023, as part of their compensation for the year ending December 31, 2024, at an exercise price of $3.59 per share. The options were valued at $2.71 per share as of the date of the grant and will vest in equal quarterly portions starting on March 31, 2024 and through December 31, 2024, such that they were fully vested at December 31, 2024. The grant date value of each grant determined in accordance with FASB ASC Topic 718 was $37,500. (2) Under the Company’s nonemployee director compensation program, Dr. Duhay, Dr. Shrivastava, Mr. Gray and Mr. Jenusaitis were each granted 8,403 options to purchase shares of our common stock on November 30, 2022, as part of their compensation for the year ending December 31, 2023, at an exercise price of $6.70 per share. The options were valued at $4.46 per share as of the date of the grant and vested in equal quarterly portions starting on March 31, 2023 and through December 31, 2023, such that they were fully vested at December 31, 2023. The grant date value of each grant determined in accordance with FASB ASC Topic 718 was $37,500. (3) Under the Company’s nonemployee director compensation program, Dr. Duhay, Dr. Shrivastava, Mr. Gray and Mr. Jenusaitis were each granted 19,752 options to purchase shares of our common stock on December 18, 2024, as part of their compensation for the year ending December 31, 2025, at an exercise price of $2.57 per share. The options were valued at $1.90 per share as of the date of the grant and will vest in equal quarterly portions starting on March 31, 2025 and through December 31, 2025, such that they will fully vest by December 31, 2025. The grant date value of each grant determined in accordance with FASB ASC Topic 718 was $37,500. 48 ITEM 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters The following table lists, as of February 26, 2025, the number of shares of common stock of our Company that are beneficially owned by (i) each person or entity known to our Company to be the beneficial owner of more than 5% of the outstanding common stock; (ii) each officer and director of our Company; and (iii) all officers and directors as a group. Applicable percentage ownership is based on 17,536,000 shares of common stock outstanding as the date of this Form 10-K. We have determined beneficial ownership in accordance with the rules of the SEC. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting or dispositive power with respect to such securities. In addition, pursuant to such rules, we deemed outstanding shares of common stock subject to options or warrants held by that person that are currently exercisable or exercisable within 60 days of February 26, 2025. We did not deem such shares outstanding, however, for the purpose of computing the percentage ownership of any other person. Except as indicated by the footnotes below, we believe, based on the information furnished to us, that the beneficial owners named in the table below have sole voting and dispositive power with respect to all shares of our common stock that they beneficially own, subject to applicable community property laws. Beneficial Ownership Name and Address of Beneficial Owner (1) Number of Shares Percentage 5% Stockholders Perceptive Life Sciences Master Fund Ltd. (2) 1,869,219 9.9 % Nantahala Capital Management, LLC(3) 1,285,857 7.1 % Named Executive Officers and Directors Robert A. Berman (4) 1,442,114 7.6 % Marc Glickman, M.D. (5) 770,824 4.2 % Hamed Alavi (6) 545,912 3.0 % Craig Glynn (7) 486,981 2.7 % Francis Duhay, M.D. (8) 148,825 * Dr. Sanjay Shrivastava (9) 55,769 * Robert Gray (10) 56,836 * Matthew Jenusaitis (11) 62,226 * All directors and executive officers as a group (7 persons) 3,569,486 17.0 % * Represents beneficial ownership of less than 1%. (1) Except as otherwise noted below, the address for each person or entity listed in the table is c/o enVVeno Medical Corporation, 70 Doppler, Irvine, California 92618. (2) Based on a Schedule 13G/A filed with the SEC on November 14, 2024 by (i) Perceptive Advisors LLC(“Perceptive Advisors”), (ii) Joseph Edelman, and (iii) the Perceptive Life Sciences Master Fund Ltd. (the “Master Fund”), the Master Fund directly holds 694,315 shares of common stock and 1,759,035 pre-funded warrants to purchase shares of common stock at an exercise price of $0.001 per share, (c) 861,192 pre-funded warrants to purchase shares of common stock at an exercise price of $0.0001 per share, (d) 861,192 warrants to purchase shares of common stock at $8.334 per share, and (e) 861,192 warrants to purchase shares of common stock at $6.945 per share. The pre-funded warrants and warrants may not be exercised if the Master Fund would beneficially own more than 9.9% of the Company’s outstanding shares of common stock after giving effect to such exercise. Perceptive Advisors serves as the investment manager to the Master Fund and may be deemed to beneficially own such shares. Mr. Edelman is the managing member of Perceptive Advisors and may be deemed to beneficially own such shares. (3) Based on a Schedule 13G/A filed with the SEC on November 14, 2024 by (i) Nantahala Capital Management, LLC (“Nantahala”) (ii) Wilmot B. Harkey and (iii) Daniel Mack , Nantahala directly holds 596,917 shares of common stock and 688,940 warrants. The warrants may not be exercised if Nantahala would exceed certain beneficial ownership limitations included therein. Nantahala may be deemed to beneficially own such shares. Messrs. William B. Harkey and Daniel Mack are the managing members of Nantahala, and as the managing members of Nantahala, each of Messrs. Harkey and Mack is a control person in respect of shares beneficially owned by Nantahala and may be deemed to beneficially own such shares. (4) Includes 1,419,878 shares of common stock issuable upon exercise of options that are currently exercisable or exercisable within 60 days of February 26, 2025. (5) Includes 769,224 shares of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60 days of February 26, 2025. (6) Includes 545,912 shares of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60 days of February 26, 2025. (7) Includes 486,981 shares of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60 days of February 26, 2025. (8) Includes 46,481 shares of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60 days of February 26, 2025. (9) Includes 46,481 shares of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60 days of February 26, 2025. (10) Includes 46,481 shares of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60 days of February 26, 2025. (11) Includes 46,481 shares of common stock that are issuable upon exercise of options that are currently exercisable or exercisable within 60 days of February 26, 2025. 49 ITEM 13. Certain Relationships and Related Transactions, and Director Independence The following is a description of transactions since January 1, 2024 to which we were a party in which (i) the amount involved exceeded or will exceed the lesser of (A) $120,000 or (B) one percent of our average total assets at year end for the last two completed fiscal years and (ii) any of our directors, executive officers or holders of more than 5% of our capital stock, or any member of the immediate family of, or person sharing the household with, any of the foregoing persons, who had or will have a direct or indirect material interest, other than equity and other compensation, termination, change in control and other similar arrangements, which are described under “Executive Compensation.” Perceptive Life Sciences Master Fund, Ltd. Perceptive Life Sciences Master Fund, Ltd. (“Perceptive”), a holder of greater than 5% of our Common Stock based on the Schedule 13G/A filed by Perceptive on November 14, 2024, participated as an investor in a financing with the Company pursuant to a purchase agreement that was executed on October 6, 2023. Pursuant to the purchase agreement, Perceptive purchased pre-funded warrants (the “Pre-Funded Warrants”) to purchase 861,192 shares of Common Stock, Tranche A Warrants (the “Tranche A Warrants”) to purchase 861,192 shares of Common Stock, and Tranche B Warrants (the “Tranche B Warrants”) to purchase 861,192 shares of Common Stock for a combined purchase price per Pre-Funded Warrant and accompanying Tranche A Warrant and Tranche B Warrant of $5.8059. The warrants are immediately exercisable at an exercise price of $6.945 per share for the Tranche A Warrants, $8.334 per share for the Tranche B Warrants, and a nominal exercise price of $0.0001 per share for the Pre-Funded Warrants. The Tranche A Warrants expired on April 5, 2024, the thirtieth (30th) calendar day following the release by the Company of initial top line efficacy data including rVCSS data constituting a 3 or more point improvement for the SAVVE clinical trial. The Tranche B Warrants will expire on the date that is the earlier of (i) 5:00 p.m. Eastern time on the thirtieth (30th) calendar day following the PMA Approval by the U.S. FDA for the VenoValve or (ii) October 12, 2026. The Pre-Funded Warrants will terminate when they are exercised in full. The offering closed on October 11, 2023. Indemnification of Officers and Directors Our amended and restated certificate of incorporation and amended and restated bylaws provide that we will indemnify each of our directors and officers to the fullest extent permitted by the DGCL. Further, we intend to enter into indemnification agreements with each of our directors and officers, and we intend to purchase a policy of directors’ and officers’ liability insurance that insures our directors and officers against the cost of defense, settlement or payment of a judgment under certain circumstances. For further information, see “Executive Compensation—Limitations of Liability and Indemnification Matters.” To the best of our knowledge, during the past two fiscal years, other than as set forth above, there were no material transactions, or series of similar transactions, or any currently proposed transactions, or series of similar transactions, to which we were or are to be a party, in which the amount involved exceeds the lesser of (A) $120,000 or (B) one percent of our average total assets at year end for the last two completed fiscal years, and in which any director or executive officer, or any security holder who is known by us to own of record or beneficially more than 5% of any class of our common stock, or any member of the immediate family of any of the foregoing persons, has an interest (other than compensation to our officers and directors in the ordinary course of business). Policies and Procedures for Related Party Transactions All future transactions between us and our officers, directors or five percent stockholders, and respective affiliates will be on terms no less favorable than could be obtained from unaffiliated third parties and will be approved by a majority of our independent directors who do not have an interest in the transactions and who had access, at our expense, to our legal counsel or independent legal counsel. Director Independence The information provided in Item 10, under the subheading “Director Independence” is incorporated herein. 50 ITEM 14. Principal Accounting Fees and Services Audit Fees. The aggregate fees billed by Marcum LLP (“ Marcum ”) for professional services rendered for the audit of our annual consolidated financial statements, review of the financial information included in our Forms 10-Q for the respective periods and other required filings with the SEC for the years ended December 31, 2024 and 2023 totaled $255,000 and $177,000, respectively. The above amounts are for services rendered in connection with audits and reviews of consolidated financial statements and the issuance of consents in connection with registration statements. All Other Fees. None. Procedures For Board of Directors Pre-Approval of Audit and Permissible Non-Audit Services of Independent Auditor Our audit committee is ultimately responsible for reviewing and approving, in advance, any audit and any permissible non-audit engagement or relationship between us and our independent registered public accounting firm. Our engagement of Marcum to conduct all audit and permissible non-audit related activities incurred during fiscal years 2024 and 2023 were approved by our audit committee in accordance with these procedures. PART IV ITEM 15. Exhibits and Consolidated Financial Statement Schedules 1. Consolidated Financial Statements Our consolidated financial statements and the notes thereto, together with the report of our independent registered public accounting firm on those consolidated financial statements, are hereby filed as part of this report beginning on page F-1. 2. Consolidated Financial Statement Schedules All consolidated financial statement schedules have been omitted since the required information is not applicable or is not present in amounts sufficient to require submission of the schedule, or because the information required is included in the consolidated financial statements and notes thereto. 51 3. Exhibits The following is a complete list of exhibits filed as part of this Form 10-K. Exhibit numbers correspond to the numbers in the Exhibit Table of Item 601 of Regulation S-K. Exhibit Number Description 3.1 Fifth Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed on September 16, 2020). 3.2 Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K filed on June 6, 2018). 3.3 Certificate of Amendment to the Fifth Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on December 2, 2020). 3.4 Certificate of Amendment to the Fifth Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on October 1, 2021). 4.1 Specimen common stock certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-1 (No. 333-220372) filed on September 7, 2017). 4.2 Form of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on March 2, 2020). 4.3 Form of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on April 28, 2020). 4.4 Form of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on June 3, 2020). 4.5 Form of Warrant Agent Agreement, inclusive of Form of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on July 21, 2020). 4.6 Form of Private Placement Warrant (incorporated by reference to Exhibit 4.18 to the Registrant’s Registration Statement on Form S-1/A (No. 333-239658) filed on July 16, 2020). 4.7 Form of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on October 8, 2020). 4.8 Form of Warrant Agent Agreement (including Form of Warrant Certificate) (incorporated by reference to Exhibit 4.20 to the Registrant’s Registration Statement on Form S-1/A (No. 333 -251528) filed on February 5, 2021). 4.9 Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on September 8, 2021). 4.10 Form of Warrant (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed on September 8, 2021). 4.11 Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K filed on October 12, 2023). 4.12 Form of Tranche A Warrant (incorporated by reference to Exhibit 4.2 of the Registrant’s Current Report on Form 8-K filed on October 12, 2023). 4.13 Form of Tranche B Warrant (incorporated by reference to Exhibit 4.3 of the Registrant’s Current Report on Form 8-K filed on October 12, 2023). 4.14 Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.4 of the Registrant’s Current Report on Form 8-K filed on October 12, 2023). 4.15 Description of the Company’s Securities Registered under Section 12 of the Exchange Act (incorporated by reference to Exhibit 4.21 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2020) 4.16 Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on September 30, 2024). 4.17 Form of Underwriter Warrant (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed on September 30, 2024). 10.1 Form of Indemnification Agreement (incorporated by reference to Exhibit 10.30 to the Registrant’s Registration Statement on Form S-1/A (No. 333-220372) filed on December 14, 2017). 52 10.2 Employment Agreement, dated as of March 30, 2018, by and between the Registrant and Robert A. Berman. (incorporated by reference to Exhibit 10.47 to the Registrant’s Registration Statement on Form S-1/A (No. 333-220372) filed on April 16, 2018). 10.3 Amended and Restated 2016 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.50 to the Registrant’s Registration Statement on Form S-1/A (No. 333-220372) filed on May 14, 2018). 10.4 Amendment No. 1 to Amended and Restated 2016 Omnibus Incentive Plan. (incorporated by reference to Exhibit 10.4 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2020). 10.5 Amendment No. 2 to Amended and Restated 2016 Omnibus Incentive Plan. (incorporated by reference to Exhibit 10.5 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2021). 10.6 Form of Stock Option Grant under Amended and Restated 2016 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.44 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2018). 10.7 Form of Restricted Stock Unit under Amended and Restated 2016 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.45 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2018). 10.8 Employment Agreement, dated as of July 26, 2019, by and between enVVeno Medical Corporation and Marc Glickman, M.D. (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on August 1, 2019). 10.9 Employment Agreement, dated as of February 19, 2021, by and between enVVeno Medical Corporation and Craig Glynn (incorporated by reference to Exhibit 10.18 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2020). 10.10 Employment Agreement, dated as of July 29, 2020, by and between enVVeno Medical Corporation and Hamed Alavi. (incorporated by reference to Exhibit 10.21 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2022).* 10.11 Form of Securities Purchase Agreement, dated October 6, 2023 (incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on October 12, 2023). 10.12 Form of Placement Agency Agreement, dated October 6, 2023 (incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed on October 12, 2023). 10.13 Form of Registration Rights Agreement, dated October 6, 2023 (incorporated by reference to Exhibit 10.3 of the Registrant’s Current Report on Form 8-K filed on October 12, 2023) . 14.1 Code of Conduct (incorporated by reference to Exhibit 14.1 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2020). 19.1 Insider Trading Policy (incorporated by reference to Exhibit 19.1 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2023). 21.1 Subsidiaries of the registrant incorporated by reference to Exhibit 21.1 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2020). 23.1 Consent of Marcum LLP, independent registered public accounting firm* 31.1 Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act. * 31.2 Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Sarbanes-Oxley Act. * 32 Certification of Chief Executive Officer and Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act** 99.1 Compensation Clawback Policy (incorporated by reference to Exhibit 99.1 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2023). 101.INS Inline XBRL Instance Document* 101.SCH Inline XBRL Taxonomy Extension Schema Document* 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document* 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document* 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document* 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document* * Filed herewith. ** Furnished and not filed herewith. ITEM 16. Form 10-K Summary Not applicable 53 SIGNATURES Pursuant to the requirements of Section 12 of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Date: February 27, 2025 ENVVENO MEDICAL CORPORATION By: /s/ Robert Berman Robert Berman Chief Executive Officer (Principal Executive Officer) By: /s/ Craig Glynn Craig Glynn Chief Financial Officer (Principal Financial and Accounting Officer) 54 ENVVENO MEDICAL CORPORATION ANNUAL REPORT ON FORM 10-K INDEX TO AUDITED CONSOLIDATED FINANCIAL STATEMENTS Report of Independent Registered Public Accounting Firm (PCAOB: 688 ) F-2 Consolidated Balance Sheets as of December 31, 2024 and 2023 F-3 Consolidated Statements of Operations for the Years Ended December 31, 2024 and 2023 F-4 Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2024 and 2023 F-5 Consolidated Statements of Cash Flows for the Years Ended December 31, 2024 and 2023 F-6 Notes to Consolidated Financial Statements F-7 F- 1 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Shareholders and Board of Directors of enVVeno Medical Corporation Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of enVVeno Medical Corporation (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of operations, changes in stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”). In our opinion, based on our audits, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America. Basis for Opinion These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. Critical Audit Matters Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters. /s/ Marcum llp Marcum LLP We have served as the Company’s auditor since 2015. New York, NY February 27, 2025 F- 2 ENVVENO MEDICAL CORPORATION CONSOLIDATED BALANCE SHEETS 2024 2023 December 31, 2024 2023 (In thousands except par values, unless otherwise indicated) Assets Current Assets: Cash and cash equivalents $ 1,754 $ 3,620 Short-term investments 41,399 42,792 Prepaid expenses and other current assets 581 511 Total Current Assets 43,734 46,923 Property and equipment, net 182 334 Operating lease right-of-use assets, net 1,007 1,347 Security deposits and other assets 31 31 Total Assets $ 44,954 $ 48,635 Liabilities and Stockholders’ Equity Current Liabilities: Accounts payable, accrued expenses and other current liabilities $ 1,731 $ 1,033 Current portion of operating lease liabilities 364 338 Total Current Liabilities 2,095 1,371 Long-term operating lease liabilities 700 1,064 Total Liabilities 2,795 2,435 Commitments and Contingencies - - Stockholders’ Equity: Preferred stock, par value $ 0.00001 , 10,000 shares authorized: no shares issued or outstanding - - Common stock, par value $ 0.00001 , 250,000 shares authorized, 17,536 and 13,317 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively - - Additional paid-in capital 194,014 176,236 Accumulated deficit ( 151,855 ) ( 130,036 ) Total Stockholders’ Equity 42,159 46,200 Total Liabilities and Stockholders’ Equity $ 44,954 $ 48,635 The accompanying notes are an integral part of these consolidated financial statements. F- 3 ENVVENO MEDICAL CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS 2024 2023 For the Years Ended December 31, 2024 2023 (In thousands except per share data) Operating Expenses: Research and development expenses $ 12,249 $ 13,583 Selling, general and administrative expenses 11,577 11,655 Loss from Operations ( 23,826 ) ( 25,238 ) Other Income: Realized gain from sales of trading securities 1,640 1,074 Unrealized (loss) gain from trading securities ( 22 ) 468 Interest income 389 180 Total Other Income 2,007 1,722 Net Loss $ ( 21,819 ) $ ( 23,516 ) Net Loss Per Basic and Diluted Common Share: $ ( 1.27 ) $ ( 1.91 ) Weighted Average Number of Common Shares Outstanding: Basic and diluted 17,142 12,301 The accompanying notes are an integral part of these consolidated financial statements. F- 4 ENVVENO MEDICAL CORPORATION CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (In thousands, unless otherwise indicated) Shares Amount Capital Deficit Equity Common Stock Additional Paid-in Accumulated Total Stockholders’ Shares Amount Capital Deficit Equity Balance at January 1, 2024 13,317 $ - $ 176,236 $ ( 130,036 ) $ 46,200 Common stock and warrants issued in private placement offering 4,206 - 13,591 - 13,591 Shared-Based Compensation - - 4,141 - 4,141 Stock Options exercised 13 - 46 - 46 Net loss - - - ( 21,819 ) ( 21,819 ) Balance at December 31, 2024 17,536 $ - $ 194,014 $ ( 151,855 ) $ 42,159 Common Stock Additional Paid-in Accumulated Total Stockholders’ Shares Amount Capital Deficit Equity Balance at January 1, 2023 9,472 $ - $ 145,249 $ ( 106,520 ) $ 38,729 Balance 9,472 $ - $ 145,249 $ ( 106,520 ) $ 38,729 Common stock and warrants issued in private placement offering 3,845 - 25,791 25,791 Shared-Based Compensation - - 5,196 - 5,196 Net loss - - - ( 23,516 ) ( 23,516 ) Balance at December 31, 2023 13,317 $ - $ 176,236 $ ( 130,036 ) $ 46,200 Balance 13,317 $ - $ 176,236 $ ( 130,036 ) $ 46,200 The accompanying notes are an integral part of these consolidated financial statements. F- 5 ENVVENO MEDICAL CORPORATION CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands, unless otherwise indicated) 2024 2023 For the Years Ended December 31, (In thousands, unless otherwise indicated) 2024 2023 Cash Flows from Operating Activities Net loss $ ( 21,819 ) $ ( 23,516 ) Adjustments to reconcile net loss to net cash used in operating activities: Share-based compensation 4,141 5,196 Depreciation and amortization 189 220 Amortization of right-of-use assets 339 326 Unrealized loss (gain) from investments 22 ( 468 ) Changes in operating assets and liabilities: Prepaid expenses and other current assets ( 70 ) ( 119 ) Accounts payable, accrued expenses and other current liabilities 698 ( 183 ) Operating lease liabilities ( 338 ) ( 314 ) Net Cash Used in Operating Activities ( 16,838 ) ( 18,858 ) Cash Flows from Investing Activities Maturities of investments 56,939 48,685 Purchase of investments ( 55,567 ) ( 56,520 ) Purchases of property and equipment ( 37 ) ( 33 ) Net Cash Provided by (Used in) Investing Activities 1,335 ( 7,868 ) Cash Flows from Financing Activities Proceeds from private placement offering 13,591 25,791 Proceeds from stock option exercises 46 - Net Cash Provided by Financing Activities 13,637 25,791 Net Decrease in Cash and Cash Equivalents ( 1,866 ) ( 935 ) Cash and cash equivalents - Beginning of year 3,620 4,555 Cash and cash equivalents - End of year $ 1,754 $ 3,620 The accompanying notes are an integral part of these consolidated financial statements. F- 6 ENVVENO MEDICAL CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 1 – Business Organization and Nature of Operations enVVeno Medical Corporation (the “Company”) is a late clinical-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. The Company is developing surgical and non-surgical replacement venous valves for patients suffering from severe Chronic Venous Insufficiency (“CVI”) of the deep venous system of the leg. The Company’s lead product is the VenoValve®, which is a potential first-in-class surgical replacement venous valve that is currently being evaluated in a U.S. pivotal study. The Company is also developing a second product called enVVe®, which is a potential first-in-class, non-surgical, transcatheter based replacement venous valve system consisting of the enVVe valve, the enVVe delivery system, and the delivery system accessories. The Company is currently conducting pre-clinical testing on enVVe. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the veins of the leg, and back to the heart and lungs. The VenoValve and enVVe are being developed first for approval by the U.S. Food and Drug Administration (FDA). We expect the VenoValve to be eligible for FDA approval first, followed two to three years later by enVVe. If approved, we expect the VenoValve and enVVe to co-exist, with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option. Note 2 – Management’s Liquidity Plan As of December 31, 2024, the Company had a cash balance of $ 1.8 million, investments of $ 41.4 million and working capital of $ 41.7 million. Although the Company expects to continue incurring losses for the foreseeable future and may need to raise additional capital to sustain its operations, pursue its product development initiatives and penetrate markets for the sale of its products, Management believes that our capital resources are sufficient to meet our obligations as they become due within one year after the date of this Annual Report. Note 3 – Significant Accounting Policies Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from these estimates. Investments We consider all highly liquid interest-earning investments with a maturity of three months or less at the date of purchase to be cash equivalents. The fair values of these investments approximate their carrying values. Investments with original maturities of greater than three months and remaining maturities of less than one year are classified as short-term investments. Investments with maturities beyond one year are classified as long-term investments. Debt investments are classified as trading securities and realized gains and losses are recorded using the specific identification method. Changes in fair value, excluding credit losses and impairments, are recorded in unrealized gains (losses) from investments. Fair value is calculated based on publicly available market information. If the cost of an investment exceeds its fair value, we evaluate, among other factors, general market conditions, credit quality of debt instrument issuers, and the extent to which the fair value is less than cost. We recognize interest income based on the stated coupon rate of the investments purchased. Property and Equipment, Net Property and equipment are stated at cost, net of accumulated depreciation using the straight-line method over their estimated useful lives, which range from 5 to 7 years. Leasehold improvements are amortized over the lesser of (a) the useful life of the asset; or (b) the remaining lease term. Expenditures for maintenance and repairs, which do not extend the economic useful life of the related assets, are charged to operations as incurred, and expenditures, which extend the economic life are capitalized. When assets are retired, or otherwise disposed of, the costs and related accumulated depreciation or amortization are removed from the accounts and any gain or loss on disposal is recognized. Impairment of Long-lived Assets The Company reviews for the impairment of long-lived assets whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. F- 7 ENVVENO MEDICAL CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Income Taxes The Company follows the asset and liability method of accounting for income taxes under ASC 740, “Income Taxes.” Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that included the enactment date. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected to be realized. ASC 740 prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. The Company recognizes accrued interest and penalties related to unrecognized tax benefits as income tax expense. There were no unrecognized tax benefits and no amounts accrued for interest and penalties as of December 31, 2024 or December 31, 2023. The Company is currently not aware of any issues under review that could result in significant payments, accruals or material deviation from its position. Fair Value of Financial Instruments The Company measures the fair value of financial assets and liabilities based on the guidance of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) ASC 820 “Fair Value Measurements and Disclosures” (“ASC 820”) which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. FASB ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value: Level 1 Quoted prices available in active markets for identical assets or liabilities trading in active markets. Level 2 Observable inputs other than quoted prices included in Level 1, such as quotable prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant unobservable inputs. Financial instruments, including accounts payable are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments. Net Loss per Share The Company computes basic and diluted loss per share by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period including warrants exercisable for little or no cash consideration. Basic and diluted net loss per common share are the same since the inclusion of common stock issuable pursuant to the exercise of warrants and options, would have been anti-dilutive. F- 8 ENVVENO MEDICAL CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Stock-Based Compensation The Company has an Equity Incentive Plan under which the Board of Directors may grant restricted stock or stock options to employees and nonemployees. The accounting treatment for share-based payments to employees and non-employees is substantially equivalent. Share-based compensation cost is recorded for all option grants and awards of non-vested stock based on the grant date fair value of the award, and is recognized over the service period required for the award. The fair value of the Company’s stock options is estimated at the date of grant using the Black-Scholes based option valuation model. For the expected term, the Company uses SEC Staff Accounting Bulletin No. 107 simplified method for “plain vanilla” options with following characteristics: (i) the share options are granted at the market price on the grant date; (ii) exercisability is conditional on performing service through the vesting date on most options; (iii) if an employee terminates service prior to vesting, the employee would forfeit the share options; (iv) if an employee terminates service after vesting, the employee would have 30 to 90 days to exercise the share options; and (v) the share options are nontransferable and nonhedgeable. The Company uses its stock’s historical market information to calculate volatility used in estimating fair value of options granted. The volatility assumption is based on the historical volatility of the Company’s common stock with an equivalent remaining expected term. The risk-free interest rate is based on the implied yield available on U.S. treasury zero-coupon issues with an equivalent remaining expected term. The dividend yield assumption is based on the Company’s history and expectation of future dividend payouts on the common stock. For option grants without performance conditions, the Company recognizes compensation expense over the requisite service period ratably, recognizing expense for each tranche of each grant starting on the grant date. For grants that have both service and performance conditions, the Company recognizes compensation expense using the graded attribution method. Compensation expense for grants with performance conditions is recognized only for those awards expected to vest. Forfeitures of unvested stock options are recorded when they occur. Loss Contingencies The Company will accrue an estimated loss if information available before the consolidated financial statements are issued or are available to be issued indicates that it is probable that an asset had been impaired or a liability had been incurred at the date of the consolidated financial statements and the amount of loss can be reasonably estimated. Recently Adopted Accounting Standards In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280)—Improvements to Reportable Segment Disclosures (ASU 2023-07). ASU 2023-07 requires that a public entity that has a single reportable segment, such as the Company, provide all the disclosures required by the existing segment disclosure requirements in Topic 280, as amended. These segment disclosures include significant segment expenses regularly provided to the chief operating decision maker (CODM) and included within each reported measure of segment loss, disclosure of other segment items by reportable segment and a description of the segment’s composition, disclosures about our reportable segment’s profit or loss and assets currently required, disclose the title and position of the CODM and an explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. We adopted ASU 2023-07 effective on January 1, 2024, and have retrospectively applied it to all periods presented. There was no impact on our financial statements from its adoption. Recent Accounting Standards In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740 – Improvements to Income Tax Disclosures (ASU 2023-09). ASU 2023-09 is effective for annual periods beginning after December 15, 2024, and requires enhanced disclosures related to the income tax rate reconciliation and income taxes paid to improve the transparency of income tax disclosures by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. We are currently evaluating the impact that this guidance will have on our consolidated financial statements. In December 2024, the FASB issued ASU No. 2024-03, Income Statement - Reporting Comprehensive Income- Expense Disaggregation Disclosures (ASU 2024-03). ASU 2024-03 requires disclosure of specific information about certain costs and expenses in the notes to its financial statements for interim and annual reporting periods. The objective of the disclosure requirements is to provide disaggregated information to help financial statement users (a) better understand the Company’s performance, (b) better assess the Company’s prospects for future cash flows, and (c) compare the Company’s performance over time and with that of other entities. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027. We are currently evaluating the impact that this guidance will have on our consolidated financial statements. F- 9 ENVVENO MEDICAL CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 4 – Concentrations The Company maintains cash with major financial institutions. Cash held in United States bank institutions is currently insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $ 250,000 at each institution. There were aggregate uninsured cash balances of $ 0.9 million as of December 31, 2024. Note 5 – Investments The components of investments were as follows at December 31, 2024 and December 31, 2023: Schedule of Components of Investments (In thousands) December 31, 2024 December 31, 2023 Cash Equivalents Short-Term Investment Cash Equivalents Short-Term Investments Fair Value Level 1 U.S. Government securities $ 1,352 $ 41,399 $ 3,187 $ 42,792 Total debt investments $ 1,352 $ 41,399 $ 3,187 $ 42,792 Unrealized losses of $ 0.1 million and unrealized gains of $ 0.5 million for the year ended December 31, 2024 and 2023, respectively, from fixed-income securities are primarily attributable to changes in interest rates. Note 6 – Property and Equipment As of December 31, 2024, and 2023, property and equipment consist of the following: Schedule of Property and Equipment (In thousands) 2024 2023 December 31, (In thousands) 2024 2023 Laboratory equipment $ 566 $ 548 Computer equipment and software 500 482 Furniture and fixtures and leasehold improvements 373 373 Total property and equipment 1,439 1,403 Less: accumulated depreciation ( 1,257 ) ( 1,069 ) Property and equipment, net $ 182 $ 334 Depreciation expense was $ 0.2 million and $ 0.2 million for both the years ended December 31, 2024 and 2023 and is reflected in general and administrative expenses in the accompanying statements of operations. F- 10 ENVVENO MEDICAL CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 7 – Right-of-Use Assets and Liabilities The Company leases its facility in Irvine, California under an operating lease which it amended in November 2021 to extend the lease term an additional 60 months through September 30, 2027. The lease rate at the date of the amendment was $ 30,206 per month with escalating payments adjusting annually. In connection with the lease, the Company is obligated to pay $ 7,254 monthly for operating expenses for building repairs and maintenance. The Company has no other operating or financing leases with terms greater than 12 months. Lease liabilities were determined using the Company’s estimated incremental borrowing rate of 3.95 % to estimate the present value of the remaining monthly lease payments. Our operating lease cost is as follows (in thousands) : Schedule of Operating Lease Cost For the Year Ended December 31, 2024 Operating lease cost $ 389 Supplemental cash flow information related to our operating lease is as follows: Schedule of Supplemental Cash Flow Information Related to Operating Lease (Dollars in thousands) For the Year Ended December 31, 2024 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ 387 Remaining lease term and discount rate for our operating lease is as follows: Schedule of Operating Remaining Lease Term and Discount Rate December 31, 2024 Remaining lease term 2.7 years Discount rate 3.95 % Maturity of our lease liabilities by fiscal year for our operating lease is as follows: Schedule of Maturity of Lease Liabilities (In thousands) Year ended December 31, 2025 399 Year ended December 31, 2026 411 Year ended December 31, 2027 315 Total $ 1,125 Less: Imputed interest ( 61 ) Present value of our lease liability $ 1,064 F- 11 ENVVENO MEDICAL CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 8 – Accounts payable, accrued expenses and other current liabilities As of December 31, 2024 and 2023, accounts payable, accrued expenses and other current liabilities consist of the following: Schedule of Accounts Payable, Accrued Expenses and Other Current Liabilities (In thousands) 2024 2023 December 31, (In thousands) 2024 2023 Accounts Payable $ 1,006 $ 427 Accrued compensation costs 604 478 Other 121 128 Accrued expenses $ 1,731 $ 1,033 Note 9 – Income Taxes The following summarizes the Company’s income tax provision (benefit): Schedule of Income Tax Provision (Benefit) (Dollars in thousands) 2024 2023 For the Years Ended December 31, (Dollars in thousands) 2024 2023 Federal: Current $ - $ - Federal Current $ - $ - Deferred ( 4,030 ) ( 4,165 ) Federal Deferred ( 4,030 ) ( 4,165 ) State and local: Current - - State and local: Current - - Deferred ( 1,393 ) ( 1,388 ) State and local: Deferred ( 1,393 ) ( 1,388 ) Federal, State and Local, Tax Expense ( 5,423 ) ( 5,553 ) Change in valuation allowance 5,423 5,553 Income tax provision (benefit) $ - $ - The reconciliation between the U.S. statutory federal income tax rate and the Company’s effective tax rate for the year’s ended December 31, 2024 and 2023 is as follows: Schedule of Effective Income Tax Rate Reconciliation 2024 2023 For the Years Ended December 31, 2024 2023 Tax benefit at federal statutory rate ( 21.0 )% ( 21.0 )% State taxes, net of federal benefit ( 7.0 )% ( 7.0 )% Nondeductible compensation 3.8 % 4.7 % Permanent differences ( 0.1 )% 0.2 % True up adjustments ( 0.5 )% ( 0.5 )% Change in valuation allowance 24.8 % 23.6 % Effective income tax rate 0.0 % 0.0 % F- 12 ENVVENO MEDICAL CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Significant components of the Company’s deferred tax assets at December 31, 2024 and 2023 are as follows: Schedule of Deferred Tax Assets and Liabilities (In thousands) 2024 2023 December 31, (In thousands) 2024 2023 Deferred tax assets: Net operating loss carryforwards $ 22,163 $ 17,229 Research and development credit carryforwards 186 186 Research and development expense 5,347 5,367 Intangible assets 190 218 Operating lease liability 298 393 Stock-based compensation 2,245 1,889 Impairment loss 137 137 Property and equipment 25 - Unrealized loss on short-term investments 6 - Total gross deferred tax assets 30,597 25,419 Deferred tax liabilities Operating lease asset ( 282 ) ( 377 ) Unrealized gain on short-term investments - ( 131 ) Property and equipment - ( 19 ) Total net deferred tax assets 30,315 24,892 Less: valuation allowance ( 30,315 ) ( 24,892 ) Total $ - $ - ASC 740 requires that the tax benefit of net operating losses, temporary differences and credit carryforwards be recorded as an asset to the extent that management assesses that realization is “more likely than not.” Realization of any future tax benefit is dependent on the Company’s ability to generate sufficient taxable income within the carryforward period. Because of the Company’s history of operating losses, management believes that recognition of the deferred tax assets arising from the above listed future tax benefits is currently not more likely than not to be realized and, accordingly, has provided a full valuation allowance. The valuation allowance increased by $ 5.4 million and $ 5.6 million during the years ended December 31, 2024 and 2023, respectively. Under Section 382 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period), the corporation’s ability to use net operating loss (NOL) carryforwards and other pre-change tax attributes to offset its post-change income taxes may be limited. Due to various equity transactions, the Company’s ownership changes crossed the 50 % threshold in 2018, 2020, 2021 and 2024, creating NOL annual use limitations based on the Company’s value at each of the change dates. Further, the federal annual limit of NOL use is 80 % of taxable income. As a result, the maximum amount of NOL the Company may use in any year is currently 80 % of taxable income for that year, or $ 2.0 million, whichever is less. At December 31, 2024 and 2023, the Company net operating loss carryforwards for federal income tax purposes of approximately $ 72.2 million and $ 61.7 million, respectively. Of this, pre-2018 federal NOLs of approximately $ 12.0 million may be carried forward for twenty years and begin to expire in 2029. Post 2018 federal NOLs of approximately $ 60.2 million can be carried forward indefinitely. Based on the 2020, 2021, and 2024 ownership changes, the Company expects substantially all of its pre-2018 federal NOLs to expire unused. To the extent the Company utilizes its NOL carryforwards in the future, the tax years in which the attribute was generated may still be adjusted upon examination by the Internal Revenue Service or state tax authorities of the future period tax return in which the attribute is utilized. The Company also has federal research and development tax credit carryforwards of approximately $ 0.2 million which begin to expire in 2027. As of December 31, 2024 and 2023, the Company had net operating loss carryforwards for state income tax purposes of approximately $ 97.7 million and $ 61.1 million, respectively, which can be carried forward for twenty years and begin to expire in 2029. The Company files income tax returns in the U.S. federal jurisdiction as well as California and local jurisdictions and is subject to examination by those taxing authorities. The Company’s federal income taxes for the years beginning in 2020 remain subject to examination. The Company’s state and local income tax returns for the years beginning in 2021 remain subject to examination. No tax audits were initiated during 2024 or 2023. Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financial statements as of December 31, 2024 and 2023. The Company does not expect any significant changes in its unrecognized tax benefits within twelve months of the reporting date. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrative expenses in the statements of operations. F- 13 ENVVENO MEDICAL CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 10 – Commitments and Contingencies Litigation Claims and Assessments In the normal course of business, the Company may be involved in legal proceedings, claims and assessments. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements. F- 14 ENVVENO MEDICAL CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 11 – Stockholders’ Equity Equity Issuances The Company completed equity transactions in each of 2024 and 2023. The following table provides an overview of those transactions. Schedule of Equity Transactions (In thousands) Date Description Type Number of shares Transaction Fees Net Proceeds 2023 October 6, 2023 Private Investment in Public Equity (PIPE) Common Stock 3,845 $ 2,208 $ 25,791 2024 September 30, 2024 Confidentially Marketed Public Offering (CMPO) Common Stock 4,206 $ 1,409 $ 13,591 The 2023 transaction included 9.6 million warrants subject to performance conditions, 1.0 million prefunded warrants and 0.2 million warrants to the placement agent. The weighted average exercise price of the warrants was $ 6.94 . The performance condition for 50% of the warrants was met on March 6, 2024, and the warrants expired. The performance condition for the remaining 50% of the warrants has not yet been met. If the performance conditions for the remaining 50% of these warrants is not met, they will expire in October 2026. If the performance conditions are achieved the holders have 30 days to exercise. The 2024 transaction included 0.1 million prefunded warrants and 0.3 million warrants to the underwriter. The weighted average exercise price of the warrants is $ 4.03 . The warrants issued in 2024 and 2023 have a fair value of $ 1.0 million and $ 19.7 million, respectively, based on the Black Scholes method and the following weighted average input assumptions: Schedule of Estimated Fair Values and Assumptions 2024 2023 Contractual life 5.0 years 2.07 years Volatility 90 % 76 % Risk free interest rate 4 % 5 % Dividend yield 0.00 % 0.00 % Warrants A summary of warrant activity during the years ended December 31, 2024 and 2023 is presented below: Schedule of Stock Warrant Activity Common Stock Number of Warrants Weighted Average Exercise Price Weighted Average Remaining Life in Years Intrinsic Value (In thousands) Outstanding, January 1, 2023 6,351,658 $ 8.21 Issued 10,889,238 6.93 Exercised - - Expired ( 111,481 ) 146.94 Outstanding, January 1, 2024 17,129,415 $ 6.49 3.03 $ 14,096 Issued 379,610 3.18 Exercised - - Expired ( 4,846,072 ) 7.23 Outstanding and exercisable, December 31, 2024 12,662,953 $ 6.11 2.80 $ 8,505 F- 15 ENVVENO MEDICAL CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 12 – Share Based Compensation Omnibus Incentive Plan The Company issues share-based awards under its Company’s 2016 Omnibus Incentive Plan, as amended, which enables the Company to grant stock options, stock appreciation rights, restricted stock, restricted stock units, unrestricted stock, other share based awards and cash awards to associates, directors, consultants, and advisors of the Company and its affiliates, and to improve the ability of the Company to attract, retain, and motivate individuals upon whom the Company’s sustained growth and financial success depend, by providing such persons with an opportunity to acquire or increase their proprietary interest in the Company. Stock options granted under the 2016 Plan may be non-qualified stock options or incentive stock options, within the meaning of Section 422(b) of the Internal Revenue Code of 1986, except that stock options granted to outside directors and any consultants or advisers providing services to the Company or an affiliate shall in all cases be non-qualified stock options. The option price must be at least 100% of the fair market value on the date of grant and if issued to a 10% or greater shareholder must be 110% of the fair market value on the date of the grant. The 2016 Plan is to be administered by the Board, which has discretion over the awards and grants thereunder. No awards may be issued after November 21, 2026. The number of shares authorized to be issued under the Plan is automatically adjusted from time to time when the Company issues additional shares of common stock or securities that are convertible or exercisable into shares of common stock (other than pursuant to the Plan) such that shares authorized under the plan after such issuance shall be equal to at least 20 % of the issued and outstanding shares of the Company on a fully diluted basis. As of December 31, 2024 there are approximately 7.2 million shares authorized to be issued under the Plan. Stock Options The fair value of each option grant is estimated at the grant date using the Black Scholes method. The following assumptions were used in estimating fair value: Schedule of Stock Options Assumptions in Estimated Fair Value 2024 2023 Expected term 5.5 – 6.5 years 5.5 – 6.5 years Volatility 89 – 91 % 92 – 94 % Risk free interest rate 3 – 4 % 3 – 4 % Dividend yield 0.00 % 0.00 % A summary of the option activity during the years ended December 31, 2024 and 2023 is presented below: Schedule of Stock Option Activity Weighted Weighted Average Average Remaining Aggregate Number of Exercise Life Intrinsic Options Price In Years Value Outstanding, January 1, 2023 3,794,452 $ 8.91 Granted 1,026,424 3.88 Forfeited ( 35,600 ) 6.72 Outstanding, December 31, 2023 4,785,276 7.85 8.0 $ 1,444 Granted 1,213,008 4.38 Exercised ( 12,710 ) 3.59 Forfeited ( 63,875 ) 5.38 Outstanding, December 31, 2024 5,921,699 $ 7.17 7.5 $ 306 Exercisable, December 31, 2024 4,036,569 $ 8.51 6.7 $ - The Company includes share-based compensation expense in selling, general and administrative expenses, and recognized $ 4.1 million and $ 5.2 million during the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, there was $ 4.9 million of unrecognized share-based compensation expense related to outstanding stock options and restricted stock units that will be recognized over the weighted average remaining vesting period of 1.7 years. Restricted Stock Units The Company also issues restricted shares and restricted stock units under the 2016 Plan. A summary of the restricted share and restricted stock units activity during the years ended December 31, 2023 and 2022 is presented below: Schedule of Restricted Stock Units Number of Restricted Shares Outstanding, January 1, 2023 400,000 Granted - Shares vested - Outstanding, December 31, 2023 400,000 Granted - Shares Vested - Outstanding, December 31, 2024 400,000 F- 16 Note 13 – Net Loss Per Share The following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted net loss per common share as of December, 2024 and 2023: Schedule of Dilutive Net Loss Per Common Share (In thousands) 2024 2023 December 31, (In thousands) 2024 2023 Shares of common stock issuable upon exercise of warrants 9,846 14,392 Shares of common stock issuable upon exercise of options 6,322 5,185 Potentially dilutive common stock equivalents excluded from diluted net loss per share 16,168 19,577 Note 14 – Segment Reporting The Company has determined that it currently operates in a single segment, Medical Device development, located in a single geographic location, the United States. The accounting policies of the segment are the same as those described in the summary of significant accounting policies. Since the Company operates in a single segment, the measure of segment total assets and loss from operations is the same as that reported on the accompanying balance sheets as total assets, and the accompanying statement of operations as loss from operations, respectively. The Company’s chief operating decision maker (“CODM”) is the chief executive officer. The CODM uses operating expenses to measure performance against progress in its clinical trials and its product development. The following table sets forth segment expenses. Schedule of Segment Expenses (In thousands) 2024 2023 December 31, (In thousands) 2024 2023 Research and Development: Employee expense $ 4,984 $ 4,004 Clinical 5,345 7,567 Product 1,147 1,443 Other 773 569 Total research and development 12,249 13,583 Selling, general and administrative expense Employee expense $ 6,285 7,436 Professional fees 2,451 1,729 Occupancy 626 631 Insurance 655 724 Other 1,560 1,135 Total selling, general and administrative expense 11,577 11,655 Loss from Operations 23,826 25,238 Adjustments and reconciling Items ( 2,007 ) ( 1,722 ) Net Loss $ 21,819 $ 23,516 Adjustments and reconciling items in the above table consist of interest income and realized and unrealized gains and losses related to our investments in US Treasury securities. F- 17