SANUWAVE Health, Inc.

Special Note Regarding Forward-Looking Statements

This Annual Report on Form 10-K of SANUWAVE Health, Inc. and its subsidiaries (“Sanuwave” or the “Company”) contains forward-looking statements. All statements in this Annual Report on Form 10-K, including those made by the management of the Company, other than statements of historical fact, are forward-looking statements. Examples of forward-looking statements include, but are not limited to, statements regarding: results of operations, liquidity, and operations, restrictions and new regulations on our operations and processes, including the execution of clinical trials; the Company’s future financial results, operating results, and projected costs; market acceptance of and demand for UltraMIST®; the estimated size of the wound care market; success of future business development and acquisition activities; management’s plans and objectives for future operations; industry trends; regulatory actions that could adversely affect the price of or demand for our approved products; our intellectual property portfolio; our business, marketing and manufacturing capacity and strategy; estimates regarding our capital requirements, the anticipated timing of the need for additional funds, and our expectations regarding future capital-raising transactions, including through investments by strategic partners for market opportunities, which may include strategic partnerships or licensing agreements, or raising capital through the conversion of outstanding warrants or issuances of securities; product liability claims; economic conditions that could adversely affect the level of demand for or the cost of our products; timing of clinical studies and any eventual United States ("U.S.") Food and Drug Administration ("FDA") approval of new products and new uses of our current products; financial markets; the competitive environment; supplier and customer disputes; and our plans to remediate our material weaknesses in our disclosure controls and procedures and our internal control over financial reporting. These forward-looking statements are based on management’s estimates, projections and assumptions as of the date hereof and include the assumptions that underlie such statements. Forward-looking statements may contain words such as “may,” “will,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential” and “continue,” the negative of these terms, or other comparable terminology. Any expectations based on these forward-looking statements are subject to risks and uncertainties and other important factors, including those discussed in this report, including the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Other risks and uncertainties are and will be disclosed in the Company’s subsequent filings with the U.S. Securities and Exchange Commission (the “SEC”).

These and many other factors could affect the Company’s future financial condition and operating results and cause actual results to differ materially from expectations based on forward-looking statements made in this document or elsewhere by the Company or on its behalf. Except to the extent required by law, the Company does not undertake, and expressly disclaims, any duty, or obligation to revise or update any forward-looking statements whether as a result of new information, future events, changes in assumptions or otherwise.

Except as otherwise indicated by the context, references in this Annual Report on Form 10-K to “we," “us,” and “our” are to the consolidated business of the Company.

EXPLANATORY NOTE REGARDING RESTATEMENT

This Annual Report on Form 10-K for the year ended December 31, 2025, includes the restatement of previously issued consolidated financial statements, data, and related disclosures for the following periods:

•The audited consolidated financial statements and related disclosures as of and for the year ended December 31, 2024, as included in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 (see Part II, Item 8);

•Unaudited quarterly financial information as of and for the three months ended March 31, 2024, the three and six months ended June 30, 2024, and the three and nine months ended September 30, 2024 (see Part II, Item 8);

•Unaudited quarterly financial information as of and for the three months ended March 31, 2025, the three and six months ended June 30, 2025, and the three and nine months ended September 30, 2025 (see Part II, Item 8).

During the preparation of this Annual Report on Form 10-K, the Company determined that it had not appropriately accounted for certain transactions under US GAAP. For the years ended December 31, 2024 and 2025, presented, the transactions related to sales tax, which led to an understatement of accrued expenses and a corresponding, non-recurring increase in expense due to the recognition of previously unrecorded taxes, associated interest, and penalties. For the quarters ended March 31, June 30, and September 30, 2025, the Company also determined that revenue was overstated and current portion of contract liabilities and contract liabilities, less current portion were understated related to extended warranties.

In accordance with Staff Accounting Bulletin (“SAB”) 99, Materiality, and SAB 108, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements, the Company evaluated the materiality of the errors from qualitative and quantitative perspectives, individually and in the aggregate, and concluded that the errors in aggregate were material to the consolidated financial statements for the affected periods.

Accordingly, previously issued financial information for the periods indicated above, as included in the Company’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, earnings releases, and similar communications, should no longer be relied upon and is superseded by the information contained in this Annual Report.