Form 8-K

8-K — SANUWAVE Health, Inc.

Accession: 0001628280-26-034149

Filed: 2026-05-12

Period: 2026-05-12

CIK: 0001417663

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — snwv-20260512.htm (Primary)

EX-99.1 (ex-991snwvpressreleasex512.htm)

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8-K

8-K (Primary)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) May 12, 2026

SANUWAVE Health, Inc.

(Exact name of registrant as specified in its charter)

Nevada 000-42552 20-1176000

(State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.)

9600 W. 76th Street, Suite 118, Eden Prairie, Minnesota 55344

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code (952) 656-1029

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s)

Name of each exchange on which

registered

Common stock, par value $0.001 per share SNWV The Nasdaq Stock Market LLC

Indicate by check mark whether the registration is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

Emerging growth company o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 2.02 Results of Operations and Financial Condition.

On May 12, 2026, Sanuwave Health, Inc., a Nevada corporation (the “Company”), issued a press release announcing its financial results for the first quarter ended March 31, 2026. As previously announced, a business update via conference call will occur on May 13, 2026 at 8:30 am EST. Materials are provided on the Company’s website at www.sanuwave.com/investors.

The information in this Item 2.02 of this Current Report on Form 8-K and the exhibit attached hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d)Exhibits.

Exhibit

No.

Description

99.1

Press Release dated May 12, 2026

104 Cover Page Interactive Data File--the cover page XBRL tags are embedded within the Inline XBRL document.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

SANUWAVE HEALTH, INC.

Dated: May 12, 2026

By: /s/ Peter Sorensen

Name: Peter Sorensen

Title: Chief Financial Officer

EX-99.1

Filename: ex-991snwvpressreleasex512.htm · Sequence: 2

Document

Exhibit 99.1

Sanuwave Announces Revenues and Financial Results for Q1 FY2026

Q1 2026 revenues were $9.6 million, up 3.1% from $9.3 million in Q1 2025. This represents the highest Q1 quarterly revenues in Company history.

Q1 2026 gross margin was 77.3%, versus 79.0% in Q1 2025.

GAAP Operating Loss was $1.1 million for Q1 2026, a swing of $1.7 million from operating income of $0.6 million in Q1 2025.

Company provides guidance for revenue growth of 10-15% for Q2 2026 as compared to Q2 2025

EDEN PRAIRIE, MN, May 12, 2026 (GLOBE NEWSWIRE) -- Sanuwave Health, Inc. (the "Company" or "Sanuwave”) (NASDAQ: SNWV), a leading provider of next-generation FDA-approved wound care products, is pleased to provide its financial results for the three months ended March 31, 2026.

Q1 2026 ended March 31, 2026

•Revenue for the three months ended March 31, 2026, totaled $9.6 million, an increase of 3.1%, as compared to $9.3 million for the same period of 2025. This growth is consistent with guidance of 3-10% year on year for the quarter.

•97 Ultramist® systems were sold in Q1 2026 down from 98 in Q1 2025, and down from 255 in Q4 2025.

•Ultramist® consumables revenue increased by 15.0% to $6.7 million in Q1 2026, versus $5.8 million for the same quarter last year and increased 3% sequentially vs Q4 2025.

•Ultramist® revenue represented 100% of Sanuwave’s overall revenues in Q1 2026.

•Gross margin as a percentage of revenue amounted to 77.3% for the three months ended March 31, 2026, versus 79.0% for the same period last year. This decrease in gross margin as a percentage of revenue was largely driven by a decrease in pricing on our Ultramist® systems and applicators resulting from wholesale pricing for sales to resellers.

•For the three months ended March 31, 2026, operating loss totaled $1.1 million, a $1.7 million swing from operating income of $0.6 million in Q1 2025.

•Net loss for the first quarter of 2026 was $1.4 million compared to a net loss of $6.1 million in the first quarter of 2025, which was primarily driven by the $4.9 million non-cash loss on the change in fair value of derivative liabilities recognized in the prior year period.

•Adjusted EBITDA [1] for the three months ended March 31, 2026, was $1.1 million versus Adjusted EBITDA of $2.3 million for the same period last year.

“The seemingly ubiquitous question in advanced wound care during Q1 was ‘When is the turn coming and when will the recovery start?’” said CEO Morgan Frank. “Speaking for Sanuwave, the recovery appears to have begun in February and to have continued thereafter. Q1 started with a sort of “shock pause” as many seemed surprised that the changes in

reimbursement for skin subs had actually taken effect, and this seems to have contributed to a very slow first month of the year which, in turn, had a large effect on the overall quarter. The market appeared somewhat frozen. But, at least from our standpoint, we see the ice starting to break up and the quarter got better each month. Q1 applicator sales were up 3% sequentially from Q4 and 15% year over year (again, suppressed by a very slow January) and very nearly eclipsed the all-time applicator revenue figure from Q3 2025. Unit volumes on consumables for Q1 2026 set a new all-time record by a significant margin which we take to be a good sign with regard to utilization recovering. This was driven by both new placements of systems and by activity picking back up at existing users. Revenues lagged unit growth as a function of lower pricing resulting from more of our applicators sales running through resellers and therefore being priced at wholesale. We’re continuing to hire salespeople and to expand our reseller network. All in all, we exited the quarter with increasing optimism and a robust pipeline and we expect to see 2026 continue to get better from here.”

Financial Outlook

The Company forecasts Q2 2026 revenue of $11.1 to $11.6 million (10-15% increase from Q2 2025) and reiterates full year 2026 revenue guidance of $51.0-55.0 million (16-25% increase as compared to full year 2025 revenue).

As previously announced, a business update will occur via conference call on May 13, 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:1-833-316-1983

Toll/International: 1-785-838-9310

Conference ID: SANUWAVE

OR click the link below to access the live webcast.

https://viavid.webcasts.com/starthere.jsp?ei=1762392&tp_key=537d7338d6

A replay will be made available through May 27, 2026:

Toll-Free: 1-844-512-2921

Toll/International: 1-412-317-6671

Replay Access ID: 11161765

[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. Adjusted Gross Margin Percentage is gross margin percentage adjusted for inventory write-off. Adjusted Operating Income is operating income adjusted for inventory write-off, sales tax expense and release of historical accrual. EBITDA, Adjusted EBITDA, Adjusted Gross Margin Percentage and Adjusted Operating Income should not be considered as alternatives to net income (loss), gross margin percentage or operating income, as applicable, 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), gross margin percentage and operating income, as applicable.

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, plans for future business development activities and expectations regarding the impact of changes in reimbursement levels and tariff rates. Forward-looking statements include all statements that are not statements of historical fact regarding 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 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: investors@sanuwave.com

SELECTED FINANCIAL DATA

FOR THE THREE MONTHS ENDED MARCH 31, 2026 AND 2025

(in thousands) 2026 2025

Revenue $ 9,619 $ 9,333

Cost of Revenues 2,188 1,958

Gross Margin 7,431 7,375

Gross Margin % 77.3 % 79.0 %

Total Operating Expenses 8,555 6,774

Operating (Loss) Income $ (1,124) $ 601

Total Other Expense, net (315) (6,719)

Net Loss $ (1,439) $ (6,118)

NON-GAAP ADJUSTED EBITDA

Three Months Ended March 31,

(in thousands) 2026 2025

(As Restated)

Net Loss $ (1,439) $ (6,118)

Non-GAAP Adjustments:

Interest expense 546 1,909

Depreciation and amortization 1

294 209

EBITDA (599) (4,000)

Non-GAAP Adjustments for Adjusted EBITDA:

Change in fair value of derivative liabilities - 4,901

Other non-cash or infrequent charges:

Stock-based compensation 1,472 975

State & local sales tax 2

339 376

Sale of excess inventory (220) -

Shares issued for services 97 -

Adjusted EBITDA $ 1,089 $ 2,252

1 Depreciation and amortization excludes depreciation 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

(In thousands, except share data) March 31, 2026 December 31, 2025

ASSETS

Current Assets:

Cash and cash equivalents $ 10,779 $ 11,959

Accounts receivable, net of allowance of $1,305 and $1,265, respectively

6,000 5,422

Inventory 5,903 5,934

Prepaid expenses and other current assets 1,274 1,312

Total Current Assets 23,956 24,627

Non-Current Assets:

Property and equipment, net 1,913 1,972

Right of use assets, net 991 390

Intangible assets, net 2,919 3,026

Goodwill 7,260 7,260

Secured revolving credit facility debt issuance costs, net 58 68

Total Non-Current Assets 13,141 12,716

Total Assets $ 37,097 $ 37,343

LIABILITIES

Current Liabilities:

Current portion of secured term loan $ 5,585 $ 5,638

Accounts payable 3,320 3,251

Accrued expenses 8,584 8,382

Current portion of operating lease liabilities 300 157

Current portion of contract liabilities 487 388

Accrued interest 23 24

Other 5 7

Total Current Liabilities 18,304 17,847

Non-Current Liabilities:

Secured term loan, net of current portion and debt issuance costs 14,330 15,667

Secured revolving credit facility

655 655

Operating lease liabilities, less current portion 1,294 854

Contract liabilities, less current portion 676 701

Total Non-Current Liabilities 16,955 17,877

Total Liabilities $ 35,259 $ 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 March 31, 2026 and December 31, 2025

$ - $ -

Common stock, par value $0.001, 2,500,000,000 shares authorized; 8,594,209 and 8,588,876 issued and outstanding at March 31, 2026 and December 31, 2025, respectively

9 9

Additional paid-in capital 245,943 244,285

Accumulated deficit (244,124) (242,685)

Accumulated other comprehensive loss 10 10

Total Stockholders’ Equity 1,838 1,619

Total Liabilities and Stockholders’ Equity $ 37,097 $ 37,343

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In thousands, except share data) Three Months Ended March 31,

2026 2025

(As Restated)

Revenue $ 9,619 $ 9,333

Cost of Revenues 2,188 1,958

Gross Margin 7,431 7,375

Operating Expenses:

General and administrative 5,250 4,843

Selling and marketing 2,399 1,531

Research and development 660 208

Depreciation and amortization 246 192

Total Operating Expenses 8,555 6,774

Operating (Loss) Income (1,124) 601

Other (Expense) Income:

Interest expense (546) (1,909)

Change in fair value of derivative liabilities - (4,901)

Other expense (60) (1)

Other income

291 92

Total Other Expense, net (315) (6,719)

Net Loss (1,439) (6,118)

Other Comprehensive Loss

Foreign currency translation adjustments - -

Total Comprehensive Loss $ (1,439) $ (6,118)

Loss per Share:

Basic and Diluted $ (0.17) $ (0.72)

Weighted average shares outstanding

Basic and Diluted 8,591,098 8,547,675

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)

(In thousands, except share data)

Three Months Ended March 31, 2026

Common Stock

Number of Shares

Issued and Outstanding Par Value Additional Paid-

in Capital Accumulated

Deficit Accumulated

Other

Comprehensive

Loss Total

Balances as of December 31, 2025 8,588,876 $ 9 $ 244,285 $ (242,685) $ 10 $ 1,619

Stock-based compensation - - 1,439 - - 1,439

Stock options exercised 1,333 - 19 - - 19

Shares issued for services rendered 4,000 - 97 - - 97

Shares granted in lieu of board of director fees - - 103 - - 103

Net loss

- - - (1,439) - (1,439)

Balances as of March 31, 2026 8,594,209 $ 9 $ 245,943 $ (244,124) $ 10 $ 1,838

Three Months Ended March 31, 2025

Common Stock

Number of Shares

Issued and Outstanding Par Value Additional Paid-

in Capital Accumulated

Deficit Accumulated

Other

Comprehensive

Loss 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 - 1,101 - - 1,101

Net loss (As Restated) - - - (6,118) - (6,118)

Balances as of March 31, 2025 (As Restated) 8,548,473 $ 9 $ 239,786 $ (260,617) $ 10 $ (20,812)

CONSOLIDATED STATEMENTS OF CASH FLOWS

Three Months Ended March 31,

(in thousands) 2026 2025

(As Restated)

Operating Activities

Net loss $ (1,439) $ (6,118)

Adjustments to reconcile net loss to net cash provided by (used in) operating activities

Stock-based compensation 1,611 975

Depreciation and amortization 294 209

Amortization of right-of-use leases 18 65

Provision for credit losses 40 33

Shares issued for services 97 -

Change in fair value of derivative liabilities - 4,901

Amortization of debt issuance and debt discounts 57 530

Write-off of inventory 69 -

Loss on disposal of assets 6 -

Changes in operating assets and liabilities

Accounts receivable (617) (570)

Inventory (39) (1,308)

Prepaid expenses and other assets 78 (325)

Accounts payable 54 423

Accrued expenses and contract liabilities 205 (332)

Operating leases (37) -

Net Cash Provided by (Used in) Operating Activities 397 (1,517)

Investing Activities

Purchase of property and equipment

(23) (162)

Deposits on property and equipment (66) -

Investment in software development (69) -

Net Cash Used in Investing Activities (158) (162)

Financing Activities

Proceeds from exercises of stock options 19 -

Repayment of principal secured term loan (1,438) -

Payments of principal on finance leases - (57)

Net Cash Used in Financing Activities (1,419) (57)

Effect of Exchange Rates on Cash and Cash Equivalents - -

Net Change in Cash and Cash Equivalents During Period (1,180) (1,736)

Cash and Cash Equivalents at Beginning of Period

11,959 10,237

Cash and Cash Equivalents at End of Period

$ 10,779 $ 8,501

Supplemental Information:

Cash paid for interest $ 401 $ 1,118

Non-cash Investing and Financing Activities:

Right-of-use assets obtained in exchange for lease liabilities $ 619 $ 430

Shares granted in lieu of board of director fees 103 -

Stock options granted in lieu of cash bonus 69 117

Shares issued in exchange for services 97 -

Purchases of property and equipment in accounts payable 16 -

Capitalize interest into senior secured debt - 202

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

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dei_SolicitingMaterial

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dei_

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

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dei_WrittenCommunications

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dei_

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duration