SANUWAVE Health, Inc. 10-K

Item 9A. CONTROLS AND PROCEDURES Evaluation of Disclosure Controls and Procedures We maintain disclosure controls and procedures, as defined in Rule 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are designed 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 recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. We carried out an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer and accounting officer), of the effectiveness of the design and operation of our disclosure controls and procedures as of December 31, 2024. Based on this evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not operating effectively as of December 31, 2024. Management’s Annual Report on Internal Control over Financial Reporting Management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) for the Company. The Company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance of achieving their control objectives. Management, with the participation of the Chief Executive Officer (principal executive officer) and the Chief Financial Officer (principal financial and accounting officer), evaluated the effectiveness of the Company’s internal control over financial reporting as of December 31, 2024. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control — Integrated Framework (2013). As of December 31, 2024, the Company identified the following material weaknesses: 1. The Company lacked expertise and resources to analyze and properly apply U.S. GAAP to complex and non-routine transactions such as complex financial instruments and derivatives and complex sales distributing agreements with select vendors. 2. The Company lacked of internal resources to analyze and properly apply U.S. GAAP to account for financial instruments included in service agreements with select vendors. 3. The Company has failed to implement controls around the following accounting processes: Equity, Financial Reporting, Accounts Payable, Expenses, Revenue, Accounts Receivable, Tax, Cash, Debt, Fixed Assets, Inventory, Commissions, Entity-Level, Human Resources/Payroll, and IT processes: change management, operations, access security. As such, we believe that accounting and IT processes and procedures need to be tested for operating effectiveness. As a result, management concluded that its internal control over financial reporting was not effective as of December 31, 2024. 46 Table of Contents Remediation Plan Management is fully committed to addressing the material weaknesses in our internal controls and has implemented several key initiatives to strengthen them. To that end, the Company has continued to implement and enhance appropriate internal controls and contracted with CliftonLarsonAllen LLP starting in the third quarter 2023 to conduct a valuation engagement. This engagement aims to provide an estimated conclusion of value and a summary, restricted appraisal report to assist management in determining the fair value of warrants to purchase the Company’s stock, embedded derivatives, and other interests. We plan to remediate and implement these controls for high-risk processes throughout 2025. We hired a highly experienced Director of Internal Audit to review, adjust, as needed, and test our internal controls and ensure they function as intended. We recently deployed Governance, Risk, and Compliance software from Workiva to support these efforts. Furthermore, we plan to hire additional personnel and segregate certain duties to enhance our control activities and effectively mitigate risks. Until we fully remediate the material weaknesses, we will perform additional analyses and procedures to ensure our consolidated financial statements comply with U.S. GAAP. We remain vigilant in identifying any additional material weaknesses that may arise and are prepared to adjust our remediation strategies as needed. We are collaborating with an external vendor to enhance our IT general controls over our enterprise resource planning system. This initiative aims to establish a robust framework for executing IT general controls, addressing weaknesses in our internal controls, and providing a solid framework for future testing. The existence of any material weakness or significant deficiency requires management to devote significant time and incur significant expense to remediate any such material weaknesses or significant deficiencies, and management may not be able to remediate any such material weaknesses or significant deficiencies in a timely manner. The existence of any material weakness in our internal control over financial reporting could also result in errors in our financial statements that could require us to restate our financial statements, cause us to fail to meet our reporting obligations, and cause shareholders to lose confidence in our reported financial information, all of which could materially and adversely affect our business and stock price. Changes in Internal Control over Financial Reporting There have been no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2024, that materially affect, or are reasonably likely to materially affect, our internal control over financial reporting, except as disclosed in “Remediation Plan” above. Item 9B. OTHER INFORMATION During the three months ended December 31, 2024, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted or terminated any contract, instruction, or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act or any non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K). Item 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS Not applicable. 47 Table of Contents PART III Item 10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE MANAGEMENT The following section sets forth the name, age, and business experience of the Company’s executive officers and directors. Name Age Position Held Morgan Frank 53 Chief Executive Officer, Chairman of the Board Peter Sorensen 32 Chief Financial Officer Peter Stegagno 65 Chief Operating Officer Iulian Cioanta, PhD 62 Chief Science and Technology Officer Andrew Walko 41 President Tim Wern 57 Executive Vice President of Sales Nanci Gilmore 53 Chief Commercial Officer A. Michael Stolarski 54 Director Jeff Blizard 56 Director Ian Miller 49 Director James Tyler 67 Director Morgan Frank joined the board as Chairman in August 2022 and was appointed Chief Executive Officer in May 2023. Mr. Frank is a founder and principal at Manchester Explorer Fund (19 years) and at Manchester Explorer Ltd (Cayman), two life science focused public equity hedge funds specializing in hands-on microcap growth and development companies. He has over 30 years of experience in investing, capital markets, corporate strategy, corporate finance, corporate restarts, and intellectual property. Mr. Frank was formerly a principal at First Principles Group, a firm focused on corporate restarts and a portfolio manager for technology and venture capital at Hollis Capital, a San Francisco hedge fund. He also sits on the board of Modular Medical, Inc. (MODD), a development stage company focused on next generation insulin delivery. Mr. Frank has degrees in economics and political science from Brown University. Peter Sorensen joined the Company as Chief Financial Officer in April 2024 and brings over a decade of finance experience including in the medical device industry since 2017. Peter was most recently the Vice President of Finance and Human Resources at Endogenex, Inc., a venture-backed medical device company focused on the treatment of type-2 diabetes. Prior to Endogenex, he spent time at LivaNova PLC in the new ventures group with the Transcatheter Mitral Valve Replacement and Vagus Nerve Stimulation for Heart Failure divisions. He also spent time in consulting at eCapital Advisors implementing FP&A solutions for large public and private companies. Mr. Sorensen brings strong finance, forecasting, analysis, and capital markets experience as well as abilities in software, process automation, and human resources to Sanuwave. Mr. Sorensen earned his bachelor’s degree from Bethel University and his Master of Business Administration from St. Cloud State University. Peter Stegagno joined the Company as Vice President, Operations in March 2006 and was named Chief Operating Officer in 2018. Mr. Stegagno brings to the Company significant experience in the medical device market encompassing manufacturing, design and development, quality assurance and international and domestic regulatory affairs. He most recently served as Vice President of Quality and Regulatory Affairs for Elekta, and other medical device companies including Genzyme Biosurgery. Before focusing on the medical field, Mr. Stegagno enjoyed a successful career encompassing production roles in the space industry, including avionics guidance systems for military applications and control computers for the space shuttle. Mr. Stegagno graduated from Tufts University with a Bachelor of Science degree in Chemical Engineering. Iulian Cioanta, PhD joined the Company in June 2007 as Research and Development Director. In 2009, he was promoted to Vice President of Research and Development and in 2018 to Chief Science and Technology Officer. Before joining the Company, Dr. Cioanta served as Business Unit Manager with Cordis Endovascular, a Johnson & Johnson company. Prior to that, Dr. Cioanta worked as Director of Development Engineering with Kensey Nash Corporation, Research Manager at ArgoMed Inc. and Project Manager and Scientist with the Institute for the Design of Research Apparatus. Dr. Cioanta also worked in academia at Polytechnic University of Bucharest in Romania, Leicester University in the United Kingdom and 48 Table of Contents Duke University in the United States. Dr. Cioanta received a Master of Science degree in Mechanical Engineering and Technology from the Polytechnic University of Bucharest and he earned his PhD degree in Biomedical Engineering from Duke University in the field of extracorporeal shockwave lithotripsy. Andrew Walko joined the Company as President in July 2023. Mr. Walko brings deep experience in contract manufacturing, supply chain management, medical device production, and logistics from his previous roles as President at Biomerics, LLC (medical device contract manufacturing) from August 2021 to April 2023; at Minnetronix, Inc. (medical device design and manufacturing), including as Director of Manufacturing (Operations) from March 2020 to July 2021 and Senior Manager, Manufacturing (Operations) from June 2018 to February 2020; and at Integer Holdings Corporation. Prior to this, he served as Operations and Logistics Manager for the U.S. Army both at home and overseas. He earned his MBA from the University of Minnesota and Bachelor of Science from West Virginia University. Tim Wern joined the Company as Executive Vice President of Sales for the U.S. Wound business in January 2025. He brings over 20 years of experience in sales leadership within the medical device industry.Tim has held progressive leadership roles at pioneering companies in healthcare, including HeartWare (acquired by Medtronic), Abiomed (acquired by Johnson & Johnson), and Ceevra Inc. His extensive background includes leading high-performing sales teams and successfully launching cutting-edge medical devices in the U.S. and Canadian markets.Tim is known for his passion for building strong, results-driven teams and his dedication to delivering impactful results. He takes pride in fostering a collaborative environment where individuals can thrive, which has led to consistent growth and innovative strategies that connect sales efforts to company goals. His expertise spans sales management, strategic planning, and launching transformative technologies that improve patient outcomes. Tim earned a Bachelor of Science in Economics from Cornell University. Nanci Gilmore joined the Company as Vice President of Commercial Operations in February 2023 and was named Chief Commercial Officer in June 2024. Ms. Gilmore has over 25 years of progressive experience in the medical device industry, specifically focusing on start-up, rapid-growth enterprises. Ms. Gilmore’s passion and commitment to bringing innovative technologies to clinicians, with a patient-centric mindset, results in high-yield, consumer program development and implementation. Ms. Gilmore’s diverse experience spans multiple medical specialties, representing organizations including Entellus Medical, SenoRx, Echosens, and most recently, THINK Surgical. Ms. Gilmore’s unique skill set will vitalize Sanuwave’s customer relations and strategic growth. Ms. Gilmore earned her bachelor’s degree from Clark University and her master’s from the University of North Carolina at Chapel Hill. Michael Stolarski joined the Company as a member of the Board of Directors in April 2016. Mr. Stolarski founded Premier Shockwave, Inc. in October 2008 and has since served as its President & CEO. From 2005 to 2008, Mr. Stolarski was the Vice President of Business Development and, previously, Acting CFO of Sanuwave, Inc. From 2001 to 2005, he was the President – Orthopedic Division and Vice President of Finance for HealthTronics Surgical Services, Inc. From 1994 to 2001, he was the CFO and Controller of the Lithotripsy Division, Internal Auditor, and Paralegal of Integrated Health Services, Inc. Mr. Stolarski brings to our board an in-depth understanding of the orthopedic and podiatric shock wave market. In addition to being a Certified Public Accountant in the state of Maryland (inactive), he holds a M.S. in Finance from Loyola College, Baltimore and a B.S. in Accounting and a B.S. in Finance from the University of Maryland, College Park. Jeff Blizard joined the Board as a Director in April 2022. Mr. Blizard is the Senior Director of Sales at Abiomed, where he led sales of Impella in the surgical market bringing it from $16 million to $150 million in 6 years. Mr. Blizard brings a strong knowledge of capital equipment and sales leadership specific to the medical industry. Throughout his career, Mr. Blizard has shown strength in business and market development. Ian Miller joined the Board as a Director in April 2022. Mr. Miller is the Commercial Vice President of Hoogwegt US where he manages a team of traders generating more than $500 million in annual revenue by purchasing and selling in excess of 250,000 metric tons of commodities which are distributed around the globe. Mr. Miller has a Master of Business Administration from Drake University and brings over 20 years of sales leadership knowledge that will help SANUWAVE develop its non-medical verticals and growth strategies. Throughout his career, Mr. Miller has built a successful track record for business development and strategic implementation that have helped companies grow both their top and bottom lines. James Tyler joined the Board as a Director in April 2021. Mr. Tyler is an advisory partner to Morgan Stanley Expansion Capital. Mr. Tyler has over 40 years of operations and financial leadership in various healthcare delivery models. Mr. Tyler 49 Table of Contents built a successful track record for operational excellence, specifically in the wound care industry, as COO with National Healing which later became Healogics, the nation’s leading provider of advanced wound care. CORPORATE GOVERNANCE AND BOARD MATTERS The Board of Directors The Company’s current board of directors consists of five members, four of whom have been determined by the board to be “independent” as defined under the Nasdaq rules. The board of directors has determined that Mr. Frank is not independent under the applicable Nasdaq rules. During 2024, the Board held five meetings. Each incumbent director attended at least 75% of the aggregate of the total number of meetings of the Board held during the period for which he has been a director and the total number of meetings held by all committees of the Board on which he served during the periods that he served. Board’s Leadership Structure The Company’s board of directors elects the Company’s chief executive officer and its chairman, and each of these positions may be held by the same person or may be held by two persons. The chairman’s primary responsibilities are to manage the board and serve as the primary liaison between the board of directors and the chief executive officer, while the primary responsibility of the chief executive officer is to manage the day-to-day affairs of the Company, considering the policies and directions of the board of directors. Such an arrangement promotes more open and robust communication among the board and provides an efficient decision-making process with proper independent oversight. The Company’s board of directors, as of May 2023, with the appointment of Morgan Frank as Chief Executive Officer,, determined that it is currently in the best interest of the Company and its stockholders to combine the roles of chairman of the board and chief executive officer. Because Mr. Frank is not independent, the board of directors has designated Ian Miller to serve as our Lead Director. The Lead Director’s responsibilities include, but are not limited to: presiding over all meetings of the board of directors at which the chairman of the board of directors is not present, including any executive sessions of the independent directors; approving board of directors' meeting schedules and agendas; and acting as the liaison between the independent directors and the chief executive officer. The Company believes, however, that there is no single leadership structure that is always the best and most effective in all circumstances. Accordingly, the board of directors retains the authority to later separate these roles if doing so would be in the best interests of the Company and its stockholders. The Company’s board of directors is authorized to have an audit committee, a compensation committee, a nominating and corporate governance committee, and a strategy and finance committee, to assist the Company’s board of directors in discharging its responsibilities. Board’s Role in Risk Oversight While the Company’s management is responsible for the day-to-day management of risk to the Company, the board of directors has broad oversight responsibility for the Company’s risk management programs. The various committees of the board of directors assist the board of directors in fulfilling its oversight responsibilities in certain areas of risk. In particular, the audit committee focuses on financial and enterprise risk exposures, including internal controls, and discusses with management and the Company’s independent registered public accountants the Company’s policies with respect to risk assessment and risk management. The compensation committee is responsible for considering those risks that may be implicated by the Company’s compensation programs and reviews those risks with the Company’s board of directors and chief executive officer. Audit Committee The audit committee operates under a written charter adopted by the board of directors which is available on the Company’s website at www.sanuwave.com . The primary responsibility of the audit committee is to oversee the Company’s financial reporting process on behalf of the board of directors. The Audit Committee reviews and discusses with management and the independent registered public accounting firm the annual audited and quarterly financial statements (including the related disclosures under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the annual report on Form 10-K and the quarterly reports on Form 10-Q), reviews the integrity of the financial reporting processes, both internal and external, and reviews the qualifications, performance, and independence of the registered public accounting firm. Among other things, the audit committee is also responsible for reviewing with 50 Table of Contents management the effectiveness of the Company’s internal controls and disclosure controls and procedures. The audit committee is directly responsible for the appointment, compensation, retention, and oversight of the work of the Company’s independent auditors, currently Marcum LLP, including the resolution of disagreements, if any, between management and the auditors regarding financial reporting. In addition, the audit committee is responsible for reviewing and approving any related party transaction that is required to be disclosed pursuant to Item 404 of Regulation S-K promulgated under the Exchange Act. The current members of the Company’s audit committee are Ian Miller (Chairperson), Jeffrey Blizard, and James Tyler. Mr. Miller, Mr. Blizard, and Mr. Tyler are determined to be independent directors, pursuant to Nasdaq rules and Rule 10A-3 of the Exchange Act. Mr. Miller, who is the chair of the committee, has been determined by the board of directors to be an audit committee financial expert as defined pursuant to the rules of the SEC. Compensation Committee The current chair of the Company’s compensation committee is Jeffrey Blizard, who is an independent director, pursuant to the Nasdaq rules. The other current member of the compensation committee is Jim Tyler, who is also an independent director pursuant to the Nasdaq rules. Each of Messrs. Blizard and Tyler is also independent pursuant to Rule 10C-1(b)(1) promulgated under the Exchange Act and is a “Non-Employee Director” as defined in Rule 16b-3 under the Exchange Act. The primary purpose of the compensation committee is to discharge the responsibilities of the board of directors relating to compensation of the Company’s executive officers. Pursuant to the Company’s Compensation Committee Charter, the compensation committee is required to consist of at least two independent directors. The compensation committee operates under a written charter adopted by the board of directors which is available on the Company’s website at www.sanuwave.com . Specific responsibilities of the compensation committee include reviewing and recommending approval of compensation of the Company’s named executive officers, administering the Company’s stock incentive plan, and reviewing and making recommendations to the Company’s board of directors with respect to incentive compensation and equity plans. Nominating and Corporate Governance Committee The current chair of the Company’s nominating and corporate governance committee is James Tyler, who is an independent director, pursuant to the Nasdaq rules. The other current members of the committee are Ian Miller, A. Michael Stolarski, and Jeffrey Blizard, who are also independent directors pursuant to the Nasdaq rules. Pursuant to the Company’s Nominating and Corporate Governance Committee Charter, the nominating and corporate governance committee is required to consist of at least two independent directors. The nominating and corporate governance committee operates under a written charter adopted by the board of directors which is available on the Company’s website at www.sanuwave.com . Specific responsibilities of the nominating and corporate governance committee include identifying and recommending nominees for election to the Company’s board of directors; developing and recommending to the board of directors the Company’s corporate governance principles; overseeing the evaluation of the board of directors; and reviewing and approving compensation for non-employee members of the board of directors. Strategy and Finance Committee The current chair of the Company’s strategy and finance committee is A. Michael Stolarski. The other current members of the committee are James Tyler and Ian Miller. The strategy and finance committee operates under a written charter adopted by the board of directors which is available on the Company’s website at www.sanuwave.com . Specific responsibilities of the strategy and finance committee include identifying financial strategies to improve the Company’s balance sheet position and stockholder value. Stockholder Communications with the Board of Directors The board of directors has implemented a process for stockholders to send communications to the board of directors. Stockholders who wish to communicate directly with the board of directors or any director should deliver any such communications in writing to the Secretary of the Company. The Secretary will compile any communications they receive from stockholders and deliver them periodically to the board of directors or the specific directors requested. The Secretary of the Company will not screen or edit such communications but will deliver them in the form received from the stockholder. 51 Table of Contents Code of Conduct and Ethics It is the Company’s policy to conduct its affairs in accordance with all applicable laws, rules and regulations of the jurisdictions in which it does business. The Company has adopted a code of business conduct and ethics with policies and procedures that apply to all associates (all employees are encompassed by this term, including associates who are officers) and directors, including the chief executive officer, chief financial officer, controller, and persons performing similar functions. The Company has made the code of business conduct and ethics available on its website at www.sanuwave.com . If any substantive amendments to the code of business conduct and ethics are made or any waivers are granted, including any implicit waiver, the Company intends to disclose the nature of such amendment or waiver on its website or in a Current Report on Form 8-K. Insider Trading Policy We have adopted an insider trading policy governing the purchase, sale, and other disposition of our securities by directors, officers, employees and certain other covered persons, a copy of which is filed as an exhibit to this Annual Report on Form 10-K. The policy is designed to promote compliance with insider trading laws, rules, and regulations, as well as applicable listing standards. In addition, with regard to the Company’s trading in its own securities, it is the Company's policy to comply with the federal securities laws. No Family Relationships Among Directors and Officers There are no family relationships between any director or executive officer of the Company and any other director or executive officer of the Company. Limitation of Directors Liability and Indemnification The Nevada Revised Statutes authorize corporations to limit or eliminate, subject to certain conditions, the personal liability of directors to corporations and their stockholders for monetary damages for breach of their fiduciary duties. Our articles of incorporation limit the liability of our directors to the fullest extent permitted by Nevada law. We have director and officer liability insurance to cover liabilities our directors and officers may incur in connection with their services to us, including matters arising under the Securities Act of 1933, as amended. Our articles of incorporation and bylaws also provide that we will indemnify our directors and officers who, by reason of the fact that he or she is one of our directors or officers, is involved in a legal proceeding of any nature. There is no pending litigation or proceeding involving any of our directors, officers, employees, or agents in which indemnification will be required or permitted. We are not aware of any threatened litigation or proceeding that may result in a claim for such indemnification. DELINQUENT SECTION 16(a) REPORTS Section 16(a) of the Exchange Act requires our directors and executive officers, and persons who own more than 10% of our equity securities which are registered pursuant to Section 12 of the Exchange Act, to file with the SEC initial reports of ownership and reports of changes in ownership of our equity securities. Based solely upon a review of the Forms 3, 4 and 5 (and amendments thereto) furnished to us for our fiscal year ended December 31, 2024, written representations by our directors and executive officers , and the issuances of securities in the Company’s records, we have determined that the following reports and transactions were not timely reported during our fiscal year ending December 31, 2025 to date, our fiscal year ended December 31, 2024, and prior fiscal years: five reports and eight transactions for Mr. Tyler; four reports and three transactions for Mr. Cioanta; three reports and two transactions for Mr. Blizard; three reports and four transactions for Mr. Frank; two reports and one transaction each for Ms. Gilmore, Mr. Sorensen and Mr. Wern; one report and one transaction for Mr. Hendricks; and eight reports and 63 transactions for Manchester Management PR, LLC, Manchester Management Company, LLC, Manchester Explorer, L.P., James E. Besser and Mr. Frank. The Company has also determined that the following reports and transactions have not been reported during our fiscal year ended December 31, 2024 or prior fiscal years: six reports and 13 transactions for Kevin A. Richardson, II; 11 reports and 13 transactions for Mr. Stegagno; eight reports and 15 transactions for Mr. Miller, seven 52 Table of Contents reports and 22 transactions for Mr. Stolarski and one report and zero transactions for Toni Rinow. The Company is working with all of its current executive officers and directors to disclose all remaining undisclosed transactions pursuant to Section 16(a) of the Exchange Act as soon as practicable. Item 11. EXECUTIVE COMPENSATION This section discusses the material components of the executive compensation program offered to our executives, and in particular to our named executive officers for 2024, who were: • Morgan Frank, Chief Executive Officer • Nanci Gilmore, Chief Commercial Officer • Andrew Walko, President Summary Compensation Table The following table provides certain information concerning compensation earned for services rendered in all capacities by our named executive officers during the fiscal years ended December 31, 2024, and 2023. Name and Position Year Salary Bonus (1) Option Awards (2) All other compensation (3) Total Morgan Frank, Chief Executive Officer 2024 $ 4 $ - 1,383,842 $ - $ 1,383,846 2023 1 - - 100,000 100,001 Andrew Walko, President 2024 230,000 - 909,230 - 1,139,230 2023 95,833 - - - 95,833 Nanci Gilmore, Chief Commercial Officer 2024 225,000 65,000 636,462 7,200 933,662 2023 212,308 - - 6,900 219,208 (1) The bonus paid to Ms. Gilmore in 2024 was a discretionary bonus. (2) The amounts reported in the "Option Awards" column represent the grant-date fair value of stock options granted to the named executive officers in 2024, calculated in accordance with FASB ASC 718. These stock options vest over a three-year period, except for $20,000 paid to Mr. Frank for 2024 board fees which vested immediately upon grant, subject to continued service with the Company. The reported values reflect the total grant-date fair value and do not correspond to the amounts the executives may ultimately realize upon vesting or exercise. (3) All other compensation paid to Mr. Frank in 2023 includes board fees earned. 2024 board fees were changed to option awards in lieu of cash fees earned. All other compensation paid to Ms. Gilmore includes a car allowance. 2024 Named Executive Officer Compensation Plan Base Salary Our salaries reflect the responsibilities of each Named Executive Officer (NEO) and the competitive market for comparable professionals in our industry. Base salaries and benefits packages are fixed components of our NEO’s compensation and do not vary with Company performance. Short-term Cash Incentives The performance-based compensation plan reflects our pay-for-performance philosophy and directly ties short-term incentives to short-term business performance. These awards are linked to specific annual financial goals and key business initiatives for the overall Company. Annual employee bonus incentives are paid to reward the achievement of critical short-term operating, financial, and strategic goals. The annual employee bonus is calculated based on a percentage of each NEO’s salary: 50% is paid on individual performance goals, as assigned by leadership and the Board of Directors, and the remainder is paid based on Company performance measures. 53 Table of Contents 2006 Stock Incentive Plan On October 24, 2006, Sanuwave, Inc.’s board of directors adopted the 2006 Stock Incentive Plan of Sanuwave, Inc. On November 1, 2010, the Company approved the Amended and Restated 2006 Stock Incentive Plan of SANUWAVE Health, Inc. effective as of January 1, 2010 (the “2006 Plan”). The 2006 Plan permitted grants of awards to selected employees, directors, and advisors of the Company in the form of restricted stock or options to purchase shares of common stock. The 2006 Plan was administered by the board of directors of the Company. The 2006 Plan gave broad powers to the board of directors of the Company to administer and interpret the form and conditions of each option. The stock options granted under the 2006 Plan are generally non-statutory options which vested over a period of up to three years and have a maximum ten-year term. The options were granted at an exercise price equal to the fair market value of the common stock on the date of the grant. The terms of the options granted under the 2006 Plan expire as determined by individual option agreements (or on the tenth anniversary of the grant date), unless terminated earlier, on the first to occur of the following: (1) the date on which the participant’s service with the Company is terminated by the Company for cause; (2) 60 days after the participant’s death; or (3) 60 days after the termination of the participant’s service with the Company for any reason other than cause or the participant’s death; provided that, if during any part of such 60 day period the option is not exercisable solely because of specified securities law restrictions, the option will not expire until the earlier of the expiration date or until it has been exercisable for an aggregate period of 60 days after the termination of the participant’s service with the Company. The options vested as provided for in each option agreement and the exercise prices for the options were determined by the board of directors at the time the option was granted, provided that the exercise price could in no event be less than the fair market value per share of the Company’s common stock on the grant date. In the event of any change in the common stock underlying the options, by reason of any merger or exchange of shares of common stock, the board of directors shall make such substitution or adjustment as it deems to be equitable to (1) the class and number of shares underlying such option, (2) the exercise price applicable to such option, or (3) any other affected terms of such option. In the event of a change of control, unless specifically modified by an individual option agreement: (1) all options outstanding as of the date of such change of control will become fully vested; and (2) notwithstanding (1) above, in the event of a merger or share exchange, the board of directors may, in its sole discretion, determine that any or all options granted pursuant to the 2006 Plan will not vest on an accelerated basis if the board of directors, the surviving corporation or the acquiring corporation, as the case may be, has taken such action that in the opinion of the board of directors is equitable or appropriate to protect the rights and interests of the participants under the 2006 Plan. 2024 Equity Incentive Plan The stockholders of the Company approved the Company’s 2024 Equity Incentive Plan (the “2024 Plan”) on August 7, 2024 (the “Effective Date”). The following shares of the Company’s common stock, are available for issuance under the 2024 Plan: (a) 1,376,556 shares of common stock (the “New Shares”), and (b) up to 42,605 shares of common stock which were subject to outstanding awards under the 2006 Plan as of the Effective Date (the “Outstanding Shares”). The Outstanding Shares will be available for future grants under the 2024 Plan to the extent that, on or after the Effective Date, such awards are forfeited, cancelled, settled, paid in cash, or expire before being exercised or settled in full. Upon stockholder approval of the 2024 Plan on the Effective Date, no new awards may be granted under the 2006 Plan. Awards under the 2024 Plan may be granted to employees, non-employee directors and consultants of the Company and its subsidiaries in the form of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock, restricted stock units, and other equity-based or equity-related awards. The 2024 Plan is administered by the Compensation Committee of the Board. The stock options granted under the 2024 Plan typically vest over a period of up to three years and have a maximum ten-year term. The options are granted at an exercise price equal to the fair market value of the common stock on the date of the grant. Employment Agreement with Mr. Frank Effective May 23, 2023, the Sanuwave board appointed Morgan Frank, as Sanuwave’s interim Chief Executive Officer. In connection with this appointment, Sanuwave and Mr. Frank entered into an Executive Employment Agreement, effective May 23, 2023 (the “Frank Employment Agreement”). Pursuant to the Frank Employment Agreement, Mr. Frank was paid a de minimis base salary of $1.00 per year, which was increased to $3,704 per year as of August 2024, may be eligible to 54 Table of Contents receive an incentive bonus opportunity in accordance with certain performance criteria determined by the Sanuwave board, and is entitled to participate in Sanuwave’s employee benefit plans and programs. Mr. Frank’s employment will be terminated upon (i) written notice of termination or resignation by either Sanuwave or Mr. Frank, respectively, for any reason, provided that Mr. Frank must provide at least 60 days’ prior notice of his resignation, or (ii) Mr. Frank’s death or disability. Moreover, during the term of his employment and for a period of one year thereafter, Mr. Frank agreed (i) not to perform services for or have any interest in any competitive business and (ii) not to solicit (a) Sanuwave’s current or former employees or independent contractors or (b) actual or prospective customers, clients, vendors, service providers, suppliers or contractors. Finally, the Frank Employment Agreement also includes customary confidentiality and non-disparagement provisions. Offer Letter with Mr. Walko Effective July 31, 2023, the Board of Directors of Sanuwave appointed Andrew Walko as the Company’s President. In connection with his appointment as President, the Company and Mr. Walko entered into an offer letter, dated July 20, 2023 (the “Walko Offer Letter”). Pursuant to the Walko Offer Letter, Mr. Walko (i) receives an annual base salary of $230,000, (ii) is eligible to earn an annual bonus of 25% of his base salary, based on the achievement of performance goals established by the Company, and (iii) received an option grant. Offer Letter with Ms. Gilmore Effective January 23, 2023, Nanci Gilmore joined the Company as Vice President Commercial Strategy. The Company and Ms. Gilmore entered into an offer letter, dated January 11, 2023 (the “Gilmore Offer Letter”). Pursuant to the Gilmore Offer Letter, Ms. Gilmore (i) receives an annual base salary of $225,000, (ii) is eligible to earn an annual bonus of 50% of her base salary, based on the achievement of performance goals established by the Company, (iii) received an option grant, and (iv) is eligible for cash severance in the amount equal to five months of base salary at the rate in effect on the termination date. Outstanding Equity Awards at 2024 Fiscal Year End The following table provides certain information concerning the outstanding equity awards for each named executive officer as of December 31, 2024: Name Number of securities underlying unexercised options exercisable Number of securities underlying options unexercisable Equity incentive plan awards number of securities underlying unexercised unearned options Exercise price ($) Expiration Date Morgan Frank, Chief Executive Officer - 160,000 - $ 14.20 10/22/2034 1,559 - - $ 22.76 12/31/2029 Andrew Walko, President - 106,667 - $ 14.20 10/22/2034 Nancy Gilmore, Chief Commercial Officer - 74,667 - $ 14.20 10/22/2034 Director Compensation Table for Fiscal Year 2024 Beginning October 2024, the director compensation plan changed from a base retainer of cash to option awards. The Company provides an additional option award for committee leadership of the Audit Committee. The Compensation Committee believes the structure aligns compensation according to the level of service contributions by each director. Mr. 55 Table of Contents Frank's compensation is described above in the Summary Compensation Table which includes his director compensation earned for 2024. Director Fee Earned or paid in cash (in thousands) Option Awards Earned (in thousands) (1) A. Michael Stolarski $ – $ 20 Jeff Blizard $ – $ 20 Ian Miller $ – $ 23 James Tyler $ – $ 20 (1) The amounts reported in the "Option Awards Earned" column represent the grant-date fair value of stock options granted to the directors in 2024, calculated in accordance with FASB ASC 718. These stock options vest immediately upon grant and are subject to continued service with the Company. The reported values reflect the total grant-date fair value and do not correspond to the amounts the directors may ultimately realize upon exercise. Policies and Practices Related to the Grant of Certain Equity Awards We have established processes to ensure that the timing of any stock option grants to executives is not influenced by material nonpublic information (“MNPI”), and that all grant decisions are made based on a predetermined schedule , taking into account factors like employee performance and market conditions, regardless of any upcoming announcements or events that could impact our stock price. The compensation committee carefully reviews any potential MNPI before granting options and will delay a grant if necessary to avoid any appearance of impropriety related to the timing of the award. Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS The following table sets forth certain information, as of March 18, 2025, with respect to the beneficial ownership of the Company’s outstanding common stock by (i) any holder of more than five percent, (ii) each of the Company’s named executive officers and directors, and (iii) the Company’s directors and executive officers as a group. Name of Beneficial Owner (1) Number of Share Beneficially Owned Percent of Shares Outstanding (2) Morgan Frank (3) 1,087,668 12.7 % Andrew Walko 17,777 * Nanci Gilmore 14,015 * A. Michael Stolarski 363,087 4.2 % James Tyler 17,147 * Ian Miller 57,068 * Jeff Blizard 8,447 * All Directors and Executives as a group (11 persons) 1,610,342 18.5% Greater than 5% Holders: Opaleye, L.P. (4) 944,132 11.0 % Manchester Management PR, LLC Manchester Management Company, LLC Manchester Explorer, L.P. James E. Besser 1,094,789 12.8 % Solas Capital Management, LLC (5) 713,752 8.3 % AWM Investment Company, Inc (6) 606,061 7.1 % 56 Table of Contents * Denotes less than 1% beneficial ownership. (1) Unless otherwise noted, each beneficial owner has the same address as the Company. (2) Applicable percentage ownership is based on 8,548,473 shares of common stock outstanding as of March 18, 2025. “Beneficial ownership” includes shares for which an individual, directly or indirectly, has or shares voting or investment power, or both, and includes options, warrants and convertible promissory notes, that are exercisable within 60 days of March 18, 2025. Unless otherwise indicated, all the listed persons have sole voting and investment power over the shares listed opposite their names. Beneficial ownership as reported in the above table has been determined in accordance with Rule 13d-3 of the Exchange Act. (3) Manchester Management PR, LLC (“Manchester”) and Manchester Management Company, LLC (“GP”) may be deemed to be the owner of 1,090,789 shares of common stock. Manchester and GP have the sole power to vote or direct the vote of 0 shares of common stock, and have the shared power to vote or direct the vote of 1,090,789 shares of common stock. Manchester Explorer, L.P. (“ Explorer ”) may be deemed to be the beneficial owner of 1,006,790 shares of common stock. Explorer has the sole power to vote or direct the vote of 0 shares of common stock, and has the shared power to vote or direct the vote of 1,006,790 shares of common stock. Mr. Besser has the sole power to vote or direct the vote of 4,000 shares of common stock, and has the shared power to vote or direct the vote of 1,090,789 shares of common stock. Mr. Frank has the sole power to vote or direct the vote of 52,653 shares of common stock, and has the shared power to vote or direct the vote of 1,059,443 shares of common stock. Mr. Besser is the managing member of Manchester and GP and Mr. Frank serves as a portfolio manager and as a consultant for Explorer. Manchester is the investment manager of Explorer and GP is the general partner of Explorer. The principal business address for each of Manchester, GP, Explorer and Messrs. Besser and Frank is 2 Calle Candina, #1701, San Juan, Puerto Rico, 00907. (4) Opaleye Management Inc. (“Opaleye”) serves as investment manager to Opaleye, L.P. and as a portfolio manager for a separate managed account (the “Managed Account”) and may be deemed to indirectly beneficially own securities owned by the Managed Account. Opaleye disclaims beneficial ownership of the shares held by the Managed Account. Mr. James Silverman is the President of Opaleye. The address of Opaleye is One Boston Place, 26 th Floor, Boston, MA 02108. (5) Solas Capital Management, LLC is an investment adviser that is registered under the Investment Advisers Act of 1940. Solas Capital Management, LLC, which serves as the investment manager to two private funds ("Funds") and as sub-adviser to another private fund ("Other Fund"), which hold securities for the benefit of their investors, and Mr. Frederick Tucker Golden, as Portfolio Manager of Solas Capital Management, LLC, with the power to exercise investment and voting discretion, may be deemed to be the beneficial owner of all shares of common stock held by the Funds and by the Other Fund. Pursuant to Rule 13d-4 under the Exchange Act, each of the Funds expressly disclaims beneficial ownership over any of the securities held by the Funds and the Other Fund. (6) AWM Investment Company, Inc., a Delaware corporation ("AWM"), is the investment adviser to Special Situations Cayman Fund, L.P., a Cayman Islands Limited Partnership ("CAYMAN"), Special Situations Fund III QP, L.P., a Delaware limited partnership ("SSFQP"), Special Situations Private Equity Fund, L.P., a Delaware limited partnership ("SSPE") and Special Situations Life Sciences Fund, L.P., a Delaware limited partnership ("SSLS"). The principal business of each fund is to invest in equity and equity-related securities and other securities of any kind or nature. David M. Greenhouse ("Greenhouse") and Adam C. Stettner ("Stettner") are members of: SSCayman, L.L.C., a Delaware limited liability company ("SSCAY"), the general partner of CAYMAN; MGP Advisers Limited Partnership, a Delaware limited partnership ("MGP"), the general partner of SSFQP; MG Advisers, L.L.C., a New York limited liability company ("MG"), the general partner of SSPE; and LS Advisers, L.L.C., a New York limited liability company ("LS"). Greenhouse and Stettner are also controlling principals of AWM. 57 Table of Contents AWM is the investment adviser to each of the funds. As the investment adviser to the funds, AWM holds sole voting over 91,948 shares of common stock of the Company held by CAYMAN, 330,835 shares held by SSFQP, 109,091 shares held by SSPE and 74,187 shares held by SSLS. Greenhouse and Stettner are members of: SSCAY, the general partner of CAYMAN; MGP, the general partner of SSFQP; MG, the general partner of SSPE; and LS, the general partner of SSLS. Greenhouse and Stettner are also controlling principals of AWM. Securities Authorized for Issuance Under Equity Compensation Plans Plan category Number of securities to be issued upon exercise of outstanding options, warrants, and rights (a) Weighted- average exercise price of outstanding options, warrants and rights (b) Number of securities remaining available for future issuance under equity compensation plans (c) Equity compensation plans approved by security holders 1,118,658 $ 14.55 257,898 Equity compensation plans not approved by security holders 42,605 51.55 - Total 1,161,263 $ 15.97 257,898 Stock Incentive Plans The stockholders of the Company approved the 2024 Plan on the Effective Date. The following shares of the Company’s common stock are available for issuance under the 2024 Plan: (a) 1,376,556 shares of common stock, and (b) up to 42,605 Outstanding Shares. The Outstanding Shares will be available for future grants under the 2024 Plan to the extent that, on or after the Effective Date, such awards are forfeited, cancelled, settled, paid in cash, or expire before being exercised or settled in full. Upon stockholder approval of the 2024 Plan on the Effective Date, no new awards may be granted under the 2006 Plan. Awards under the 2024 Plan may be granted to employees, non-employee directors and consultants of the Company and its subsidiaries in the form of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock, restricted stock units, and other equity-based or equity-related awards. The 2024 Plan is administered by the Compensation Committee of the Board. The stock options granted under the 2024 Plan typically vest over a period of up to three years and have a maximum ten-year term. The options are granted at an exercise price equal to the fair market value of the common stock on the date of the grant. On November 1, 2010, the Company approved the 2006 Plan. The 2006 Plan permitted grants of awards to selected employees, directors, and advisors of the Company in the form of restricted stock or options to purchase shares of common stock. The 2006 Plan was administered by the board of directors of the Company. The 2006 Plan gave broad powers to the board of directors of the Company to administer and interpret the form and conditions of each option. The stock options granted under the 2006 Plan are generally non-statutory options which vested over a period of up to three years and have a ten-year term. The options were granted at an exercise price equal to the fair market value of the common stock on the date of the grant which was approved by the board of directors of the Company. No further awards may be made under the 2006 Plan after the effective date of the 2024 Plan. Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE Director Independence Our board of directors has determined that Jeffrey Blizard, Ian Miller, James Tyler and A. Michael Stolarski qualify as independent directors based on Nasdaq's definition of “independent director.” Our board of directors has determined that our other director, Morgan Frank, does not qualify as an independent director based on Nasdaq's definition of “independent director.” There are no family relationships among any of the directors or executive officers of the Company. 58 Table of Contents Related Party Transactions In August 2022 and November 2022, the Company entered into Purchase Agreements for the sale of Notes and Common Stock Purchase Warrants in an aggregate principal amount of $16.2 million in August and $4.0 million in November. In these transactions, James Besser, Morgan C. Frank, Chief Executive Officer and Chairman of the Board; Kevin A. Richardson, II, former Chairman of the Board and former Chief Executive Officer and Chief Strategy Officer of the Company; A. Michael Stolarski; Manchester Explorer, L.P., and Opaleye, L.P., beneficial owners of more than five percent of the Company’s common stock, purchased Notes, which were accompanied by Common Stock Purchase Warrants, with an aggregate principal amount of $400,000, $250,000, $261,780, $1,434,966, $2,500,000 and $2,900,000, respectively. Messrs. Besser and Frank share voting and dispositive power with respect to the securities acquired by Manchester Explorer, L.P. The Notes issued to each of Messrs. Richardson and Stolarski included $90,000 in principal amount for which the consideration was accrued and unpaid director fees. Certain other directors received Notes with an aggregate principal amount of $527,000 for which the consideration was accrued and unpaid director fees. These Notes along with interest were converted into shares of common stock during 2023. Additional information regarding the Notes and accompanying Common Stock Purchase Warrants issued in August 2022 and November 2022 is disclosed in Note 11 to the consolidated financial statements in Part II, Item 8. “Financial Statements and Supplementary Data” in this Annual Report on Form 10-K. In May 2023 and December 2023, the Company entered into Purchase Agreements for the sale of Notes and Common Stock Purchase Warrants in an aggregate principal amount of $1.2 million and $1.8 million, respectively. In these transactions, Manchester Explorer, L.P. purchased Notes, which were accompanied by Common Stock Purchase Warrants, with an aggregate principal amount of $300,000 in May 2023 and $100,000 in December 2023. Additional information regarding the Notes and accompanying Common Stock Purchase Warrants issued in May 2023 and December 2023 is disclosed in Note 11 to the consolidated financial statements in Part II, Item 8. “Financial Statements and Supplementary Data” in this Annual Report on Form 10-K. In July 2023, the Company issued Asset-Backed Secured Promissory Notes ("ABS Promissory Notes") in the aggregate principal amount of $4.6 million at an original issue discount of 33.33%. The Company and the parties to the ABS Promissory Notes entered into a side letter pursuant to which the parties agreed that upon the maturity date, the Company would issue each lender a convertible promissory note and warrants consistent with the form of the above-described Purchase Agreements for the sale of Notes and Common Stock Purchase Warrants. A. Michael Stolarski, Manchester Explorer and Opaleye, L.P, purchased ABS Promissory Notes in an aggregate principal amount of $149,993, $862,457, and $299,985, respectively. In January 2024, these ABS Promissory Notes were converted to convertible notes consistent with the Notes described above. Additional information regarding the ABS Promissory Notes is disclosed in Note 12 to the consolidated financial statements in Part II, Item 8. “Financial Statements and Supplementary Data” in this Annual Report on Form 10-K. In June 2024, the Company issued a promissory note to Manchester Explorer, L.P. (“Manchester”) in an aggregate principal amount of $0.5 million (the “Promissory Note”). The Promissory Note bore interest at a rate of fifteen percent (15%) per annum and matured on December 18, 2024 (the “Maturity Date”). Prepayment of the Promissory Note by the Company was permitted in whole or in part, at any time or from time to time, without penalty, upon seven calendar days’ prior written notice. The Promissory Note was paid in full in October 2024. In October 2024, the Company entered into a securities purchase agreement with the purchasers named therein (the “Purchasers”), for the private placement (the “Private Placement”) of approximately 1.3 million shares (the “Shares”) of common stock at a purchase price of $8.25 per Share. The Private Placement closed in October 2024, and aggregate gross proceeds were approximately $10.3 million, before deducting offering expenses. In this transaction, Manchester Explorer, L.P. purchased $1,500,000 of common stock. Additional information regarding the Private Placement is disclosed in Note 15 to the consolidated financial statements in Part II, Item 8. “Financial Statements and Supplementary Data” in this Annual Report on Form 10-K. In October 2024, the Company issued an aggregate of 3,989,456 shares of common stock in exchange for all outstanding Notes and Common Stock Purchase Warrants issued by the Company in private placements in August 2022, November 2022, May 2023, December 2023, January 2024 and June 2024 (the “Exchange”). Pursuant to the Exchange, (i) each outstanding Note was fully accelerated to maturity (with 15% interest paid on the outstanding principal) and then converted (per the terms of the Note) into shares of common stock at $15.00 per share, (ii) each Common Stock Purchase Warrant with an exercise price of $15.00 per share was exchanged for 0.0024 shares of common stock per share subject to such Common Stock Purchase Warrant, and (iii) each common Stock Purchase Warrant with an exercise price of $25.13 per 59 Table of Contents share was exchanged for approximately 0.0023 shares of common stock per share subject to such Common Stock Purchase Warrant. Additional information regarding the Exchange is disclosed in Note 16 to the consolidated financial statements in Part II, Item 8. “Financial Statements and Supplementary Data” in this Annual Report on Form 10-K. Item 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES The following table summarizes the fees that we have paid or accrued for audit and other services provided by our principal independent registered public accounting firm, Marcum LLP: (In thousands) For the Year Ended December 31, Fee Category 2024 2023 Audit fees $ 471 $ 545 Total Fees $ 471 $ 545 For purposes of the preceding table: • Audit fees consist of fees for the annual audit of our consolidated financial statements, the review of the interim financial statements included in our quarterly reports on Form 10-Q, and other professional services provided in connection with statutory and regulatory filings and consents related to capital markets transactions and engagements for those fiscal years. The audit committee must pre-approve all audits and permitted non-audit services to be provided by our principal independent registered public accounting firm unless an exception to such pre-approval exists under the Exchange Act or the rules of the SEC. Each year, the board of directors approves the retention of the independent auditor to audit our consolidated financial statements, including the associated fee. At this time, the audit committee evaluates and approves other known potential engagements of the independent auditor, including the scope of audit-related services, tax services and other services proposed to be performed and the proposed fees, and approves or rejects each service, taking into account whether the services are permissible under applicable law and the possible impact of each non-audit service on the independent auditor’s independence from management. 60 Table of Contents PART IV Item 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 1. All financial statements The following financial statements are included in this Annual Report on Form 10-K in Item 8 of Part II: Page Consolidated financial statements Report of Independent Registered Public Accounting Firm (PCAOB ID: 688) F- 1 Consolidated Balance Sheets as of December 31, 202 4 and 202 3 F- 3 Consolidated Statements of Comprehensive Loss for the years ended December 31, 2024 and 2023 F- 4 Consolidated Statements of Stockholders’ Deficit 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 2. Financial statement schedules No schedules are required because either the required information is not present 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 or the notes thereto. The exhibits below are furnished or filed and, as applicable, are incorporated by reference herein as part of this Annual Report on Form 10-K. Exhibit No. Description 2.1 Agreement and Plan of Merger, dated as of August 23, 2023, by and among SEP Acquisition Corp., SEP Acquisition Holdings Inc., and SANUWAVE Health, Inc. (Incorporated by reference to Exhibit 2.1 to the Form 8-K filed with the SEC on August 23, 2023). 2.2 Amendment Number One to Agreement and Plan of Merger, dated as of February 27, 2024, by and between SEP Acquisition Corp. and SANUWAVE Health, Inc. (Incorporated by reference to Exhibit 2.1 to the Form 8-K filed with the SEC on February 28, 2024). 2.3 Amendment Number Two to Agreement and Plan of Merger, dated as of April 25, 2024, by and between SEP Acquisition Corp. and SANUWAVE Health, Inc. (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on April 26, 2024). 2.4 Amended Number Three to Agreement and Plan of Merger, dated as of May 28, 2024, by and between SEP Acquisition Corp. and SANUWAVE Health, Inc. (Incorporated by reference to Exhibit 2.1 to the Form 8-K filed with the SEC on June 3, 2024). 3.1 Articles of Incorporation (Incorporated by reference to Exhibit 3.1 to the Form 10-SB filed with the SEC on December 18, 2007). 3.2 Certificate of Amendment to the Articles of Incorporation (Incorporated by reference to Appendix A to the Definitive Schedule 14C filed with the SEC on October 16, 2009). 3.3 Certificate of Amendment to the Articles of Incorporation (Incorporated by reference to Exhibit A to the Definitive Schedule 14C filed with the SEC on April 16, 2012). 3.4 Amended and Restated Bylaws (Incorporated by reference to Exhibit 3.0 1 to the Form 8-K filed with the SEC on March 7 , 20 25 ). 61 Table of Contents 3.5 Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock of the Company dated March 14, 2014 (Incorporated by reference to Exhibit 3.1 to the Form 8-K filed with the SEC on March 18, 2014). 3.6 Certificate of Amendment to the Articles of Incorporation, dated September 8, 2015 (Incorporated by reference to Exhibit 3.6 to the Form 10-K filed with the SEC on March 30, 2016). 3.7 Preferred Stock of the Company dated January 12, 2016 (Incorporated by reference to Exhibit 3.1 to the Form 8-K filed with the SEC on January 19, 2016). 3.8 Preferred Stock of the Company dated January 31, 2020 (Incorporated by reference to Exhibit 3.1 to the Form 8-K filed with the SEC on February 6, 2020). 3.9 Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock of the Company dated January 12, 2016 (Incorporated by reference to Exhibit 3.1 to the Form 8-K filed with the SEC on January 19, 2016). 3.10 Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock of the Company dated January 31, 2020 (Incorporated by reference to Exhibit 3.1 to the Form 8-K filed with the SEC on February 6, 2020). 3.11 Certificate of Designation of Series D Convertible Preferred Stock (Incorporated by reference to Exhibit 3.1 to the Form 8-K filed with the SEC on May 20, 2020). 3.12 Certificate of Amendment of the Articles of Incorporation (Incorporated by reference to Exhibit 3.1 to the Form 8-K filed with the SEC on January 5, 2021). 3.13 Certificate of Amendment of the Articles of Incorporation, dated January 31, 2023 (Incorporated by reference to Exhibit 3.12 to the Form S-1/A filed with the SEC on January 31, 2023). 3.14 Certificate of Amendment of the Articles of Incorporation, effective as of October 18, 2024 (Incorporated by reference to Exhibit 3.1 to the Form 8-K filed with the SEC on October 18, 2024). 10.1∞ Amended and Restated 2006 Stock Option Incentive Plan of SANUWAVE Health, Inc. (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on November 3, 2010). 10.2 Master Equipment Lease, dated January 26, 2018, by and among the Company and NFS Leasing, Inc. (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on February 15, 2018). 10.3 Note and Warrant Purchase and Security Agreement by and among the Company, the noteholder party thereto and NH Expansion Credit Fund Holdings LP, as agent, dated August 6, 2020 (Incorporated by reference to Exhibit 10.5 to the Form 8-K filed with the SEC on August 12, 2020). 10.4 Second Amendment to the Note and Warrant Purchase and Security Agreement by and between the Company and NH Expansion Credit Fund Holdings L.P., dated February 25, 2022 (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on March 2, 2022). 10.5 Form of Registration Rights Agreement, dated August 5, 2022, by and among the Company and certain lenders (Incorporated by reference to Exhibit 10.4 to the Form 8-K filed with the SEC on August 8, 2022). 10.6 Third Amendment to the Note and Warrant Purchase and Security Agreement by and between the Company and NH Expansion Credit Fund Holdings L.P., dated June 30, 2022 (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on July 7, 2022). 10.7 Registration Rights Agreement, dated November 14, 2022, by and among the Company and certain lenders (Incorporated by reference to Exhibit 10.70 to the Form S-1/A filed with the SEC on January 31, 2023). 10.8 Registration Rights Agreement, dated May 9, 2023, by and among the Company and certain lenders. 10.9∞ Executive Employment Agreement, effective May 23, 2023, by and between the Company and Morgan Frank (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on May 30, 2023). 10.10 Fourth Amendment to Note and Warrant Purchase and Security Agreement, dated June 23, 2023, by and among the Company, the noteholder party thereto and NH Expansion Credit Fund Holdings LP, as agent (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on June 29, 2023). 10.11∞ Offer Letter, dated July 20, 2023, by and between the Company and Andrew Walko (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on July 31, 2023). 10.12∞ Non-Compete and Confidentiality Agreement, dated July 31, 2023, by and between the Company and Andrew Walko (Incorporated by reference to Exhibit 10.2 to the Form 8-K filed with the SEC on July 31, 2023). 62 Table of Contents 10.13 Registration Rights Agreement, dated December 30, 2023, by and among the Company and certain lenders (Incorporated by reference to Exhibit 10.4 to the Form 8-K filed with the SEC on January 3, 2024). 10.14 Registration Rights Agreement, dated January 21, 2024, by and among the Company and certain lenders (Incorporated by reference to Exhibit 10.4 to the Form 8-K filed with the SEC on January 21, 2024). 10.15 Consent, Limited Waiver and Fifth Amendment to Note and Warrant Purchase and Security Agreement, dated as of March 6, 2024, by and among NH Expansion Credit Fund Holdings LP, as agent, the noteholders party thereto, and the Company (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on March 7, 2024). 10.16 Amendment to Agreement for Purchase and Sale, Limited Exclusive Distribution and Royalties, and Servicing and Repairs of dermaPACE System ® and Equipment, effective as of November 1, 2023, by and between the Company and Premier Shockwave Wound Care, Inc. (Incorporated by reference to Exhibit 10.4 to the Form 10-K filed with the SEC on March 21, 2024). 10.17∞ Offer Letter of Peter Sorensen, dated March 26, 2024 (Incorporated by reference to Exhibit 10.2 to the Form 8-K filed with the SEC on April 1, 2024). 10.18 Registration Rights Agreement, dated June 18, 2024, by and among the Company and certain lenders (Incorporated by reference to Exhibit 10.4 to the Form 8-K filed with the SEC on June 21, 2024). 10.19 Sixth Amendment to Note and Warrant Purchase and Security Agreement, dated as of July 15, 2024, by and among NH Expansion Credit Fund Holdings LP, as agent, the noteholders party thereto, and the Company (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on July 17, 2024). 10.20∞ SANUWAVE Health, Inc. 2024 Equity Incentive Plan (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on August 9, 2024). 10.21 Consent and Limited Waiver to Note and Warrant Purchase and Security Agreement, dated as of October 1 7 , 2024, by and among NH Expansion Credit Fund Holdings LP, as agent, the noteholders party thereto, and the Company (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on October 1 8 , 2024). 10.22 Securities Purchase Agreement, dated October 16, 2024, by and among the Company and the purchasers identified on the signature pages thereto (Incorporated by reference to Exhibit 10.2 to the Form 8-K filed with the SEC on October 18, 2024). 10.23 Registration Rights Agreement, dated October 16, 2024, by and among the Company and the purchasers identified on the signature pages thereto (Incorporated by reference to Exhibit 10.3 to the Form 8-K filed with the SEC on October 18, 2024). 10.24∞ Form of Stock Option Award Agreement under the SANUWAVE Health, Inc. 2024 Equity Incentive Plan (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on October 25, 2024). 10.25∞ Acknowledgment and Mutual Agreement, effective as of November 12, 2024, by and between the Company and Kevin A. Richardson, II (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on November 13, 2024). 10.26∞ Amendment to Stock Option Agreement, dated as of November 12, 2024, by and between the Company and Kevin A. Richardson, II (Incorporated by reference to Exhibit 10.2 to the Form 8-K filed with the SEC on November 13, 2024). 10.27∞ Separation and Release Agreement, dated January 13, 2025, between Timothy Hendricks and the Company (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on January 15, 2025). 19.1* SANUWAVE Health, Inc. Insider Trading Policy. 23.1* Consent of Marcum LLP, independent registered public accountants. 24.1* Power of Attorney (included on signatures page) . 31.1* Rule 13a-14(a)/15d-14(a) Certification of the Chief Executive Officer. 31.2* Rule 13a-14(a)/15d-14(a) Certification of the Chief Financial Officer. 32.1* Section 1350 Certification of the Chief Executive Officer. 32.2* Section 1350 Certification of the Chief Financial Officer. 63 Table of Contents 97.1* SANUWAVE Health, Inc. Compensation Recovery Policy. 101.INS XBRL Instance 101.SCH XBRL Taxonomy Extension Schema 101.CAL XBRL Taxonomy Extension Calculation 101.DEF XBRL Taxonomy Extension Definition 101.LAB XBRL Taxonomy Extension Labels 101.PRE XBRL Taxonomy Extension Presentation 104 Cover Page with Interactive Data File ________________________________________________________________ ∞ Indicates management contract or compensatory plan or arrangement. * Filed herewith # Confidential treatment has been requested as to certain portions of this exhibit, which portions have been omitted and submitted separately to the Securities and Exchange Commission. β Confidential portions of this exhibit have been omitted as permitted by applicable regulations. Item 16. Form 10-K Summary The Company has elected not to include summary information. 64 Table of Contents SIGNATURES Pursuant to the requirements of Section 13 of 15(d) 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. SANUWAVE HEALTH, INC. Dated: March 20, 2025 By:_ /s/ Morgan Frank Name: Morgan Frank Title: Chief Executive Officer POWER OF ATTORNEY Know all persons by these presents, that each person whose signature appears below constitutes and appoints Morgan Frank and Peter Sorensen, and each of them, as such person’s true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for such person and in such person’s name, place and stead, in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto, and all other documents in connection therewith, with the Securities and Exchange Commission, granting unto each said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as such person might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them or their or such person’s substitute or substitutes, may lawfully do or cause to be done by virtue thereof. Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated: Signatures Capacity Date By: /s/ Morgan Frank Name: Morgan Frank Chief Executive Officer and Chairman of the Board of Directors (principal executive officer) March 20, 2025 By: /s/ Peter Sorensen Name: Peter Sorensen Chief Financial Officer (principal financial and accounting officer) March 20, 2025 By: /s/ A. Michael Stolarski Name: A. Michael Stolarski Director March 20, 2025 By: /s/ Jeffrey Blizard Name: Jeffrey Blizard Director March 20, 2025 By: /s/ Ian Miller Name: Ian Miller Director March 20, 2025 By: /s/ James Tyler Name: James Tyler Director March 20, 2025 65