Press Releases August 6, 2026 05:00 PM

Sanuwave Announces Q2 FY2026 Financial Results

Sanuwave Reports Slight Revenue Decline and Operating Loss in Q2 FY2026 Amid Market Challenges

By Leila Farooq
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Sanuwave Health, Inc. announced its Q2 FY2026 financial results with revenues of $9.7 million, a 3% decrease year-over-year. Gross margin declined slightly to 76.2%. The company reported a GAAP operating loss of $0.3 million compared to operating income of $1.4 million in the previous year, and a net loss of $0.7 million. Adjusted EBITDA also dropped to $1.2 million from $3.2 million. Sanuwave noted challenges from CMS reimbursement changes and the growth of a secondary market for used systems negatively impacting sales. Due to these uncertainties, Sanuwave withdrew its FY2026 financial guidance and plans to reassess after CMS issues its final rule in Q4 2026.

Sanuwave Announces Q2 FY2026 Financial Results
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Key Points

  • Q2 FY2026 revenues declined 3% to $9.7 million, impacted by CMS reimbursement changes and secondary market dynamics.
  • Ultramist applicator unit sales set a record with a 27% year-over-year increase, but system sales were below expectations.
  • Company withdrew FY2026 guidance pending CMS final reimbursement rule, highlighting regulatory impact on advanced wound care market.

Q2 2026 revenues were $9.7 million, down 3% from $10.1 million in Q2 2025. 

Q2 2026 gross margin was 76.2%, versus 78.1% in Q2 2025. 

GAAP Operating (Loss) Income was $(0.3) million for Q2 2026 versus $1.4 million in Q2 2025.

EDEN PRAIRIE, Minn., Aug. 06, 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 June 30, 2026.

Quarter ended June 30, 2026

  • Revenue for the three months ended June 30, 2026, totaled $9.7 million, an decrease of 3%, as compared to $10.1 million for the same period of 2025. Revenue for the three months ended June 30, 2026 was slightly above the high end of the revised guidance provided on June 16, 2026.
  • 82 Ultramist® systems were sold in Q2 2026 down from 116 in Q2 2025, and from 97 in Q1 2026.
  • Ultramist® applicator revenue increased by 13% to $7.3 million in Q2 2026, versus $6.4 million for the same quarter last year.
  • Gross margin as a percentage of revenue amounted to 76.2% for the three months ended June 30, 2026, versus 78.1% for the same period last year.
  • For the three months ended June 30, 2026, operating (loss) income totaled $(0.3) million, compared to $1.4 million in Q2 2025. 
  • Net loss for the second quarter of 2026 was $0.7 million. This compares to net income of $0.6 million in the second quarter of 2025.
  • Adjusted EBITDA [1] for the three months ended June 30, 2026, was $1.2 million versus Adjusted EBITDA of $3.2 million for the same period last year.

“2026 has been a challenging period for the advanced wound care market,” said Morgan Frank, CEO. “Despite this, Q2 was another all time record for Ultramist applicator unit volumes, which increased 13% sequentially from Q1 and 27% year on year. We take this to be a strong sign of ongoing demand for and confidence in the Ultramist system as a treatment modality for complex and non-healing wounds. As previously discussed, system sales were negatively impacted in the quarter both by ongoing stress in our customer base from CMS reimbursement changes and recoupments around allografts and by the emergence of a significant market for used Ultramist systems, which led to lower than expected sales by the Company. As a result, applicator sales accounted for approximately 75% of revenues in the quarter, a number above our target range of 60-65%. The silver lining on that seems to be that demand for systems during the quarter remained fairly robust if one includes our estimation of used sales on top of those sold by the Company. Moving on to the CMS proposed rule for 2027 97610 reimbursement announced this July, obviously, this is neither what we were hoping for nor what we expected, especially in light of having just had a 14% increase in our proposed reimbursement rate in the HOPD setting come out a couple of weeks prior. While Sanuwave wholeheartedly supports CMS’s goal of accurate, data driven payment, we have some material disagreements with the methodology, process, and assumptions utilized by CMS in their proposed rule for 2027 and, as one might expect, will be active in the comment period to seek reconsideration before a final rule is issued. Our goal in this comment period will be to ensure that the data that drives this decision is both accurate and complete and that it reflects the full practitioner costs (and the systemic benefits) of providing treatment under 97610, which is, of course, the intent of these rules. We believe that we have a strong case to make and, with the support of a great many customers and academic institutions and thought leaders who have reached out with gracious offers to help, we plan to make it vigorously.”

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.

Financial Outlook

Owing to market conditions including the Medicare reimbursement developments discussed above, Sanuwave is withdrawing its previously issued fiscal year 2026 guidance which should no longer be relied upon. The Company will not provide quarterly or annual guidance until there is greater clarity on these topics and expects to reassess after CMS publishes its final rule which is anticipated in the fourth quarter of 2026.

As previously announced, a business update will occur via conference call on August 7, 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:1-800-274-8461
Toll/International: 1-203-518-9814
Conference ID: SANUWAVE

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

https://viavid.webcasts.com/starthere.jsp?ei=1771327&tp_key=110b588de5

A replay will be made available through August 21, 2026:
Toll-Free: 1-844-512-2921
Toll/International: 1-412-317-6671
Replay Access ID: 11162356

[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 income (loss), 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, Adjusted EBITDA, Adjusted Gross Margin Percentage and Adjusted Operating Income 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.

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 income (loss).

Forward-Looking Statements
This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to future financial results, 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: reductions, clawbacks, or recoupments of CMS reimbursement 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 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: [email protected]



SELECTED FINANCIAL DATA
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2026 AND 2025     Three Months Ended June 30, Six Months Ended June 30,(in thousands) 2026   2025   2026   2025         Revenue$9,739  $10,054  $19,358  $19,387 Cost of Revenues 2,315   2,206   4,502   4,164         Gross Margin 7,424   7,848   14,856   15,223 Gross Margin % 76.2%  78.1%  76.7%  78.5%        Total operating expenses 7,704   6,410   16,260   13,184 Operating (Loss) Income$(280) $1,438  $(1,404) $2,039         Total other expense (396)  (887)  (711)  (7,606)        Net (Loss) Income$(682) $551  $(2,121) $(5,567)



NON-GAAP ADJUSTED EBITDA     Three Months Ended June 30, Six Months Ended June 30,(in thousands) 2026   2025   2026   2025         Net (Loss) Income$(682) $551  $(2,121) $(5,567)Non-GAAP Adjustments:       Interest expense 518   1,939   1,064   3,848 Depreciation and amortization1 313   226   607   493 EBITDA 149   2,716   (450)  (1,226)        Non-GAAP Adjustments for Adjusted EBITDA:       Change in fair value of derivative liabilities -   (990)  -   3,911 Other non-cash or infrequent charges:       Stock-based compensation 1,572   1,132   3,143   2,116 State & local sales tax2 (532)  329   (194)  705 Sale of excess inventory -   -   (220)  - Adjusted EBITDA$1,189  $3,188  $2,279  $5,506 

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 GAAP results.

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



CONDENSED CONSOLIDATED BALANCE SHEETS     June 30, 2026 December 31, 2025ASSETS   Current Assets:   Cash and cash equivalents$9,376  $11,959 Accounts receivable, net of allowance of $1,617 and $1,265, respectively 5,801   5,422 Inventory 7,070   5,934 Prepaid expenses and other current assets 954   1,312 Total Current Assets 23,201   24,627 Non-Current Assets:   Property and equipment, net 2,255   1,972 Right of use assets, net 953   390 Intangible assets, net 2,887   3,026 Goodwill 7,260   7,260 Secured revolving credit facility debt issuance costs, net 49   68 Total Non-current Assets 13,404   12,716     Total Assets$36,605  $37,343     LIABILITIES   Current Liabilities:   Current portion of secured term loan, net of debt issuance costs$5,599  $5,638 Accounts payable 3,308   3,251 Accrued expenses 8,605   8,382 Current portion of operating lease liabilities 5   157 Current portion of contract liabilities 632   388 Accrued interest 17   24 Other 7   7 Total Current Liabilities 18,173   17,847 Non-current Liabilities:   Secured term loan, net of current portion and debt issuance costs 12,922   15,667 Secured revolving credit facility 655   655 Operating lease liabilities, less current portion 1,525   854 Contract liabilities, less current portion 543   701 Total Non-current Liabilities 15,645   17,877 Total Liabilities$33,818  $35,724     STOCKHOLDERS’ EQUITY       Preferred Stock, par value $0.001, 5,000,000 shares authorized; 6,175 shares Series A, 293 shares Series B, 90 shares Series C and 8 shares Series D designated, respectively; no shares issued and outstanding at June 30, 2026 and December 31, 2025$-  $- Common stock, par value $0.001, 2,500,000,000 shares authorized; 8,602,309 and 8,588,876 issued and outstanding at June 30, 2026 and December 31, 2025, respectively 9   9 Additional paid-in capital 247,574   244,285 Accumulated deficit (244,806)  (242,685)Accumulated other comprehensive income 10   10 Total Stockholders’ Equity 2,787   1,619 Total Liabilities and Stockholders’ Equity$36,605  $37,343 



CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME     Three Months Ended June 30, Six Months Ended June 30,  2026  2025
(As Restated)  2026  2025
(As Restated)        Revenue$9,739  $10,054  $19,358  $19,387 Cost of Revenues 2,315   2,206   4,502   4,164 Gross Margin 7,424   7,848   14,856   15,223         Operating Expenses:       General and administrative 4,902   4,368   10,152   9,211 Selling and marketing 1,923   1,674   4,322   3,205 Research and development 628   194   1,289   402 Depreciation and amortization 251   174   497   366 Total Operating Expenses 7,704   6,410   16,260   13,184         Operating (Loss) Income (280)  1,438   (1,404)  2,039         Other (Expense) Income:       Interest expense (518)  (1,939)  (1,064)  (3,848)Change in fair value of derivative liabilities -   990   —   (3,911)Other expense (77)  (27)  (137)  (28)Other income 199   89   490   181 Total Other Expense, net (396)  (887)  (711)  (7,606)        Net (Loss) Income Before Income Taxes (676)  551   (2,115)  (5,567)        Income tax expense 6   -   6   -         Net (Loss) Income$(682) $551  $(2,121) $(5,567)        (Loss) Earnings per Share:       Basic$(0.08) $0.06  $(0.25) $(0.65)Diluted$(0.08) $(0.04) $(0.25) $(0.65)Weighted average shares outstanding       Basic 8,601,198   8,561,737   8,596,148   8,554,706 Diluted 8,601,198   9,167,846   8,596,148   8,554,706         



CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)
(In thousands, except share data) Three Months Ended June 30, 2026  Common Stock          Number of
Shares
Issued and
Outstanding Par Value Additional Paid-
in Capital Accumulated
Deficit Accumulated
Other
Comprehensive
Income Total             Balances as of March 31, 2026 8,594,209 $9 $245,943 $(244,124) $10 $1,838 Stock-based compensation -  -  1,403  -   -  1,403 Stock options exercised 4,100  -  58  -   -  58 Shares issued for services rendered 4,000  -  67  -   -  67 Shares granted in lieu of board of director fees -  -  102  -   -  102 Net loss -  -  -  (682)  -  (682)             Balances as of June 30, 2026 8,602,309 $9 $247,574 $(244,806) $10 $2,787              Three Months Ended June 30, 2025  Common Stock          Number of
Shares
Issued and
Outstanding Par Value Additional Paid-
in Capital Accumulated
Deficit Accumulated
Other
Comprehensive
Income Total             Balances as of March 31, 2025 (As Restated) 8,548,473 $9 $239,786 $(260,617) $10 $(20,812)Stock-based compensation -  -  1,132  -   -  1,132 Stock options exercised 17,008  -  253  -   -  253 Shares granted in lieu of board of director fees 2,524  -  77  -   -  77 Net income (As Restated) -  -  -  551   -  551              Balances as of June 30, 2025 (As Restated) 8,568,005 $9 $241,248 $(260,066) $10 $(18,799)



CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)
(In thousands, except share data) Six Months Ended June 30, 2026  Common Stock          Number of
Shares
Issued and
Outstanding Par Value Additional Paid-
in Capital Accumulated
Deficit Accumulated
Other
Comprehensive
Income Total             Balances as of December 31, 2025 8,588,876 $9 $244,285 $(242,685) $10 $1,619 Stock-based compensation    -  2,842  -   -  2,842 Stock options exercised 5,433  -  77  -   -  77 Shares issued for services rendered 8,000  -  164  -   -  164 Shares granted in lieu of board of director fees -  -  205  -   -  205 Net loss -  -  -  (2,121)  -  (2,121)             Balances as of June 30, 2026 8,602,309 $9 $247,574 $(244,806) $10 $2,787              Six Months Ended June 30, 2025  Common Stock          Number of
Shares
Issued and
Outstanding Par Value Additional Paid-
in Capital Accumulated
Deficit Accumulated
Other
Comprehensive
Income Total             Balance as of December 31, 2024 (As Restated) 8,543,686 $9 $238,685 $(254,499) $10 $(15,795)Stock-based compensation 4,787  -  2,233  -   -  2,233 Stock options exercised 17,008  -  253  -   -  253 Shares granted in lieu of board of director fees 2,524  -  77  -   -  77 Net loss (As Restated) -  -  -  (5,567)  -  (5,567)             Balances as of June 30, 2025 (As Restated) 8,568,005 $9 $241,248 $(260,066) $10 $(18,799)



CONSOLIDATED STATEMENTS OF CASH FLOWS   Six Months Ended June 30,(in thousands) 2026  2025
(As Restated)Operating Activities:   Net loss$(2,121) $(5,567)Adjustments to reconcile net loss to net cash provided by (used in) operating activities   Stock-based compensation 3,143   2,106 Depreciation and amortization 607   388 Amortization of right-of-use leases 56   185 Provision for credit losses 379   131 Change in fair value of derivative liabilities -   3,911 Amortization of debt issuance and debt discounts 111   1,062 Write-off of inventory 69   - Loss on disposal of assets 18   - Proceeds from tenant improvement funds -   429 Changes in operating assets and liabilities   Accounts receivable (757)  (650)Inventory (1,205)  (1,762)Prepaid expenses and other assets 385   (1,231)Accounts payable (133)  274 Accrued expenses and contract liabilities 370   200 Operating leases (100)  - Net Cash Provided by (Used in) Operating Activities 822   (524)    Investing Activities   Purchase of property and equipment (357)  (1,321)Deposits on property and equipment (35)  - Investment in software development (213)  - Net Cash Used in Investing Activities (606)  (1,321)    Financing Activities   Proceeds from exercises of stock options 77   253 Repayment of principal secured term loan (2,875)  - Payments of principal on finance leases -   (149)Net Cash (Used in) Provided by Financing Activities (2,798)  104     Net Change in Cash During Period (2,583)  (1,741)    Cash at Beginning of Period 11,959   10,237 Cash at End of Period$9,376  $8,496         Supplemental Information:   Cash paid for interest$828  $2,255 Cash paid for income taxes$51  $-     Non-cash Investing and Financing Activities:   Right-of-use assets obtained in exchange for lease liabilities 619   430 Stock options granted in lieu of cash bonus 69   117 Purchases of property and equipment in accounts payable 191   - Capitalize interest into senior secured debt -   407 RSUs granted in exchange for services -   10 



Risks

  • Uncertainty and negative impact from CMS reimbursement rule changes affecting revenue and customer purchasing behavior.
  • Growth of a secondary market for used Ultramist systems cannibalizing new system sales and complicating user support.
  • Financial risks including operating losses and dependence on regulatory decisions, impacting capital resources and growth prospects.

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