Welcome to our dedicated page for Sanuwave Health SEC filings (Ticker: SNWV), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
SANUWAVE Health, Inc. filings document a Nevada medical-device company focused on directed-energy systems for advanced wound care and regenerative medicine. Form 8-K reports record results of operations, preliminary financial information, investor presentation materials and material-event disclosures related to the company’s wound care business.
Regulatory filings also cover governance and capital-market disclosure subjects, including annual meeting proxy proposals, director elections, auditor ratification, stockholder advisory votes on executive compensation, officer appointments, compensatory arrangements and separation agreements. Additional filings document accounting matters such as non-reliance on previously issued financial statements connected to historical sales and use tax liabilities.
Sanuwave Health updated its outlook for the quarter ending June 30, 2026, now expecting second-quarter revenue between $8.5 million and $9.5 million, which is below the guidance discussed on its prior quarterly call.
The company cites worsening conditions in the capital equipment market for its Ultramist system, driven by widespread clawbacks of CMS reimbursement for skin substitutes and allografts. These clawbacks are pressuring wound care practices, leading to closures and a growing secondary market for used Ultramist systems that is weighing on new system sales.
Despite weaker capital equipment demand, Sanuwave reports that applicator and other consumable volumes remain strong and that it is on pace for a record quarterly unit volume of consumables in the second quarter. Management emphasizes a focus on supporting new users, especially those acquiring systems via the secondary market, and remains optimistic about its product pipeline and longer-term potential while acknowledging near-term challenges for capital sales.
Sanuwave Health, Inc. reported results from its 2026 annual stockholder meeting held on June 11, 2026. Stockholders elected five directors—Morgan Frank, Gregory Bazar, Jeffrey Blizard, Ian Miller and James Tyler—to serve until the 2027 annual meeting, with each nominee receiving more votes for than withheld.
Stockholders also ratified Baker Tilly US, LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2026, with 6,057,957 votes for and limited opposition. In an advisory, non-binding vote, investors approved the compensation paid to the company’s named executive officers, with 4,666,444 votes for and 385,238 against.
Sanuwave Health reported Q1 2026 results showing modest growth but weaker profitability. Revenue for the quarter ended March 31, 2026 was $9.6 million, up 3.1% from $9.3 million a year earlier and the highest first-quarter revenue in the company’s history. Ultramist® products generated 100% of revenue, with consumables revenue rising 15.0% to $6.7 million.
Gross margin remained strong at 77.3%, slightly below 79.0% last year, mainly due to lower wholesale pricing to resellers. Operating results deteriorated, with a GAAP operating loss of $1.1 million compared to operating income of $0.6 million in Q1 2025, driven by higher selling, marketing, and R&D expenses. Net loss was $1.4 million versus $6.1 million, largely because the prior-year period included a $4.9 million non-cash loss on derivative liabilities.
On a non-GAAP basis, Adjusted EBITDA was $1.1 million, down from $2.3 million in the prior-year quarter. The company ended the quarter with $10.8 million in cash and cash equivalents and stockholders’ equity of $1.8 million. Management forecasts Q2 2026 revenue of $11.1–$11.6 million, a 10–15% increase from Q2 2025, and reiterates full-year 2026 revenue guidance of $51.0–$55.0 million, implying 16–25% growth over 2025.
Sanuwave Health, Inc. reports Q1 2026 results with revenue of $9.6 million, up 3% from Q1 2025, driven mainly by higher UltraMIST consumable volumes despite lower pricing. Gross margin was 77%, but higher operating expenses led to an operating loss of $1.1 million versus prior-year operating income.
Net loss narrowed to $1.4 million from $6.1 million, largely because a prior-year $4.9 million non‑cash loss on derivative liabilities did not recur and interest expense declined. EBITDA was a loss of $0.6 million, while Adjusted EBITDA was positive $1.1 million.
The company ended the quarter with $10.8 million in cash and cash equivalents, $20.1 million outstanding on its Term Loan and $0.7 million drawn on its Revolver, and believes current resources and credit availability can fund operations and debt service for at least twelve months. Management restated Q1 2025 results for sales tax and warranty accounting and continues to report material weaknesses in internal control over financial reporting, with a remediation plan in progress.
Opaleye Management Inc., a more than ten percent holder of SANUWAVE Health, Inc., reported open-market sales of a total of 35,581 shares of common stock. The sales occurred on April 30 and May 1 at weighted average prices of $16.1510 and $16.1105 per share, respectively, across multiple trades within disclosed price ranges. After these transactions, the filing reports 853,569 shares held through Opaleye, L.P. and 5,000 shares in a separately managed account, all owned indirectly, with Opaleye Management disclaiming beneficial ownership beyond its pecuniary interest.
SANUWAVE Health, Inc. (Common Stock) is the subject of an amended Schedule 13G/A filed by Opaleye Management Inc., Opaleye, L.P., and James Silverman. The Fund directly holds 853,569 shares and the Reporting Persons collectively report beneficial ownership of 858,569 shares, representing 9.99% of the class. The percent is calculated using 8,594,209 Common Shares outstanding as of 03/24/2026, as reported in SANUWAVE's Form 10-K.
Opaleye Management Inc., a more than 10% owner of SANUWAVE Health, Inc., reported open-market sales of the company’s common stock over two days. On April 28, 2026, accounts it manages sold 46,288 shares at a weighted average price of $18.4674 per share, in multiple trades between $18.41 and $18.6615.
On April 29, 2026, these accounts sold an additional 24,360 shares at a weighted average price of $17.2476, in trades between $16.58 and $17.51. After the transactions, Opaleye-related vehicles held 887,650 shares through Opaleye, L.P. and 6,500 shares in a separately managed account, and Opaleye Management disclaims beneficial ownership beyond its pecuniary interest.
SANUWAVE Health, Inc. has called a virtual annual stockholder meeting for June 11, 2026, asking investors to vote on board elections, auditor ratification, and executive pay. Stockholders will elect five directors, including CEO and chairman Morgan Frank, to serve until the 2027 meeting.
Investors are also asked to ratify Baker Tilly US, LLP as independent auditor for 2026 and to approve, on a non-binding basis, compensation for named executive officers. The board highlights that four of five directors are independent and that it uses a lead independent director and fully independent audit, compensation, and nominating committees.
The proxy describes a Nasdaq-compliant clawback policy adopted in March 2025 and explains that, although prior periods were restated, no incentive-based compensation was received in the affected years, so no recovery was required. It also outlines equity incentive plans, option grants, related-party financings previously converted into equity, and current ownership levels of major shareholders and insiders.
Opaleye-related entities reported open-market sales of SANUWAVE Health, Inc. common stock. On April 17, Opaleye, L.P. sold 11,267 shares at a weighted average price of $20.4611 per share, and a separately managed account sold 5,000 shares at the same price.
On April 21, Opaleye, L.P. sold an additional 202 shares at a weighted average price of $20.5025. Following these transactions, Opaleye, L.P. held 954,798 shares, and the managed account held 10,000 shares. Opaleye Management Inc. disclaims beneficial ownership beyond its pecuniary interest.