SANUWAVE Health, Inc. reported a significant financial turnaround in its 2025 fiscal year, with total revenues reaching $44.1 million, a 35% increase from $32.6 million in 2024. The growth was primarily driven by a 24% increase in sales volumes of UltraMIST® consumables and a 67% rise in UltraMIST® systems sold. The company also improved its gross margin to 77%, up from 75% in the previous year, reflecting better pricing strategies and cost management. Notably, SANUWAVE achieved a net income of $11.8 million, or $1.38 per basic share, compared to a net loss of $33.1 million, or $7.41 per share, in 2024.
The company underwent a restatement of its financial statements for 2024 and the first three quarters of 2025 due to misstatements related to sales tax liabilities and revenue recognition for extended warranties. This restatement resulted in an increase in accrued expenses and a corresponding adjustment to the accumulated deficit. Despite these challenges, SANUWAVE's operational performance improved, with operating income rising by 29% to $4.9 million in 2025.
Strategically, SANUWAVE has focused on expanding its market presence and enhancing its product offerings. The UltraMIST system, which utilizes non-invasive ultrasound technology for wound care, remains the company's flagship product, accounting for approximately 99% of total revenues. As of December 31, 2025, there were 1,292 active UltraMIST systems in use, indicating strong product adoption. The company is also building a direct sales force and distribution network to facilitate growth in the U.S. and explore international markets.
Operationally, SANUWAVE has made significant investments in its workforce, increasing its employee count to 55, with a focus on research and development, which saw a 101% increase in expenses to $1.4 million. The company is also addressing material weaknesses in its internal controls over financial reporting, which were identified during the preparation of its financial statements. Management is implementing measures to strengthen its control environment, including enhancing technical accounting resources and improving oversight of key control activities.
Looking ahead, SANUWAVE is optimistic about its growth trajectory, bolstered by its recent refinancing of debt, which has alleviated previous concerns about its ability to continue as a going concern. The company plans to leverage its improved financial position to support ongoing operations and execute its strategic objectives, including potential geographic expansion and further product development.
About SANUWAVE Health, Inc.
Sanuwave Health, Inc. develops noninvasive medical devices using ultrasound and shockwave technologies for wound healing and regenerative medicine. Its flagship products, UltraMIST and PACE systems, promote tissue repair, reduce healing times, and improve patient outcomes across acute and chronic wounds. Serving healthcare providers in the U.S. and abroad, the company leverages proprietary technology, FDA clearances, and a patent portfolio to deliver user-friendly, cost-effective solutions in the wound care market.
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