Sanuwave Announces Q3 FY2026 Financial Results

Q3 2026 revenues were $8.6 million, down 24% from $11.3 million in Q3 2025.

Q3 2026 gross margin was 77.3%, versus 77.6% in Q3 2025.

GAAP operating loss was $1.1 million for Q3 2026 versus operating income of $0.9 million in Q3 2025.

EDEN PRAIRIE, Minn., Nov. 10, 2026 (GLOBE NEWSWIRE) -- Sanuwave Health, Inc. (the "Company" or "Sanuwave”) (NASDAQ: SNWV), a leading provider of next-generation FDA-cleared wound care products, is pleased to provide its financial results for the three months ended September 30, 2026.

• Revenue for the three months ended September 30, 2026, totaled $8.6 million, a decrease of 24%, as compared to $11.3 million for the same period of 2025.

• 40 Ultramist® systems were sold in Q3 2026, down from 155 in Q3 2025, and from 82 in Q2 2026.

• Ultramist® applicator revenue increased by 2% to $6.9 million in Q3 2026, as compared to $6.8 million for the same quarter last year.

• Gross margin as a percentage of revenue amounted to 77.3% for the three months ended September 30, 2026, versus 77.6% for the same period last year.

• For the three months ended September 30, 2026, operating loss totaled $1.1 million, compared to operating income of $0.9 million in Q3 2025.

• Net loss for the third quarter of 2026 was $1.4 million compared to net income of $9.7 million in the third quarter of 2025. The change was primarily attributable to a $6.1 million non-cash gain on the change in fair value of derivative liabilities and a one-time $5.0 million gain on the sale of patents, both recognized in the prior-year period and neither of which recurred, and an operating loss of $1.1 million in the current-year period, compared to operating income of $0.9 million in the prior-year period, partially offset by a $1.5 million decrease in interest expense.

• Adjusted EBITDA [1] for the three months ended September 30, 2026, was $0.7 million versus Adjusted EBITDA of $3.2 million for the same period last year.

• On September 30, 2026, the Company had $6.6 million in cash and cash equivalents. This number was affected by the approximately $2.3 million paid out under our sales tax voluntary disclosure agreements during the quarter.

“Q3 was very much the story of the CMS proposed rule,” said CEO Morgan Frank. “This affected Sanuwave in multiple ways. The proposal to maintain skin substitute pricing at 2026 levels for 2027 caused a number of mobile wound care practitioners, particularly those providing rural home care, to exit some or all of their operations. This affected a number of our customers. The proposed changes to the 97610 code caused our market to take a sort of ‘wait and see’ approach across the quarter which, in combination with an ongoing market for used Ultramist® units had a significant effect on system sales in the quarter. The silver linings in all this were a 14% increase in HOPD (hospital outpatient department) rates for 97610 and a removal of Q1 status from the code which will allow it to be billed at the same time as other procedures rather than being packaged to zero. CMS and the American Medical Association RUC (the group who makes recommendations to CMS on the value of medical procedures) have also both signaled interest in looking at the structure of the 97610 code around issues like the scaling factors for multiple, large, or difficult wounds that are common in other wound care codes. We will seek to encourage and engage with this. Meanwhile, the company continues to gain traction in hospitals and other users in which cost savings by halting wound progression is the primary concern and continues to see this as a core opportunity going forward.”

Certain percentages presented in this earnings release are calculated from the underlying whole-dollar amounts and therefore may not recalculate from the rounded numbers used for disclosure purposes.

As previously announced, a business update will occur via conference call on November 11, 2026 at 8:30 a.m. EST. Materials for the conference call are included on the Company’s website at http://www.sanuwave.com/investors.

Telephone access to the call will be available by dialing the following numbers:

Toll Free:1-800-420-1459 Toll/International: 1-203-518-9861 Conference ID: SANUWAVE

OR use the link for instant telephone access to the event.

A replay will be made available through November 25, 2026: Toll-Free: 1-844-512-2921 or 1-412-317-6671 Replay Access ID: 11162619

[1] This is a non-GAAP financial measure. Refer to “Non-GAAP Financial Measures” and the reconciliations in this release for further information.

About Sanuwave Sanuwave Health is focused on the research, development, and commercialization of its patented, non-invasive and biological response-activating medical systems for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures.

Sanuwave's end-to-end wound care portfolio of regenerative medicine products and product candidates helps restore the body’s normal healing processes. Sanuwave applies and researches its patented energy transfer technologies in wound healing, orthopedic/spine, aesthetic/cosmetic, and cardiac/endovascular conditions.

Non-GAAP Financial Measures This press release includes certain financial measures that are not presented in our financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). These financial measures are considered "non-GAAP financial measures" and are intended to supplement, and should not be considered as superior to, or a replacement for, financial measures presented in accordance with U.S. GAAP.

The Company uses Earnings Before Interest, Taxes, Depreciation and Amortization (“EBITDA”) and Adjusted EBITDA to assess its operating performance. Adjusted EBITDA is Earnings before Interest, Taxes, Depreciation and Amortization adjusted for the change in fair value of derivatives and any significant non-cash or infrequent charges. EBITDA and Adjusted EBITDA should not be considered as alternatives to net (loss) income, as a measure of financial performance or any other performance measure derived in accordance with U.S. GAAP, and they should not be construed as an inference that the Company’s future results will be unaffected by unusual or infrequent items. These non-GAAP financial measures are presented in a consistent manner for each period, unless otherwise disclosed. The Company uses these measures for the purpose of evaluating its historical and prospective financial performance, as well as its performance relative to competitors. These measures also help the Company to make operational and strategic decisions. The Company believes that providing this information to investors, in addition to U.S. GAAP measures, allows them to see the Company’s results through the eyes of management, and to better understand its historical and future financial performance. These non-GAAP financial measures are also frequently used by analysts, investors, and other interested parties to evaluate companies in our industry, when considered alongside other U.S. GAAP measures.

EBITDA and Adjusted EBITDA have their limitations as analytical tools, and you should not consider them in isolation or as a substitute for analysis of the Company’s results as reported under U.S. GAAP. For example, some of these limitations are that EBITDA and Adjusted EBITDA:

• Do not reflect every expenditure, future requirements for capital expenditures or contractual commitments.

• Do not reflect all changes in our working capital needs.

• Do not reflect interest expense, or the amount necessary to service our outstanding debt.

• Do not reflect stock-based compensation, which is a recurring expense and an important part of our compensation strategy, income tax expense, or the cost of replacing assets being depreciated and amortized.

As presented in the U.S. GAAP to Non-GAAP Reconciliations section below, the Company’s non-GAAP financial measures exclude the impact of certain charges that contribute to our net (loss) income.

Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to future financial results, market acceptance of and demand for Ultramist®, the estimated size of the wound care market, industry trends, regulatory actions that could adversely affect the price of or demand for the Company’s approved products, the Company's ability to comply with the financial and other covenants under its credit agreement with JPMorgan Chase Bank, N.A., production expectations, and plans for future business development activities. Forward-looking statements include all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company's ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are: anticipated reimbursement levels for skin substitutes, allografts, or other advanced wound care products, and their effect on customer behavior and capital budgets; the financial distress, closure, or liquidation of wound care practices and the resulting impact on demand for the Company's systems; the emergence and growth of a secondary market for used Ultramist systems and the cannibalizing effect of such resales on sales of new systems; the Company's ability to qualify, train, and support new users acquiring systems through the secondary market, and the related regulatory, quality, and product-liability considerations; the Company's ability to sustain applicator and consumable volumes and convert system placements into recurring consumable revenue; risks associated with regulatory oversight; the Company's ability to regain and maintain compliance with the Nasdaq listing requirements; the Company's ability to manage its capital resources; competition; and the other factors discussed in detail in the Company's periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

Contact: investors@sanuwave.com

1 Depreciation and amortization excludes amortization of right-of-use (ROU) leases. Prior period amounts have been retroactively revised to conform to this presentation. This change had no effect on previously reported U.S. GAAP results.

2 The charges represent a non-recurring state and local sales tax (benefit) expense related to the restatement of prior period financial statements.