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)
January 10, 2024

SANUWAVE Health, Inc.
(Exact name of registrant as specified in its charter)

Nevada
000-52985
20-1176000
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)

11495 Valley View Road, Eden Prairie, Minnesota
 
55344
(Address of principal executive offices)
 
(Zip Code)

Registrant’s telephone number, including area code
(770) 419-7525

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
N/A
N/A
N/A

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

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. ☐



Item 2.02
Results of Operations and Financial Condition.

On January 10, 2024, SANUWAVE Health, Inc., a Nevada corporation (the “Company”), issued a press release announcing certain preliminary financial results for the quarter and fiscal year ended December 31, 2023. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, 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
     
 
Press release dated January 10, 2024
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: January 10, 2024
By:
/s/ Toni Rinow
 
Name:
Toni Rinow
 
Title:
Chief Financial Officer




Exhibit 99.1


SANUWAVE Health Announces Preliminary Revenue Results for the Fourth Quarter and Fiscal Year 2023, Ended December 31, 2023

SANUWAVE is pleased to announce preliminary revenues of $6.6 million to $6.8 million for the fourth quarter ended December 31, 2023.  This represents a new quarterly revenue record for the Company.
 
Q4 2023 revenue increased 20% to 24% over Q4 2022 and in excess of 30% versus the third quarter of 2023.
 
Preliminary FY 2023 revenue range was $20.0 million to $20.2 million, an increase of 19% to 20% year over year. This represents record annual revenues for the Company.
 
UltraMist revenues for Q4 2023 increased by more than 30% versus Q3 2023 and accounted for approximately 95% of the Company’s total revenues.
 
EDEN PRAIRIE, MN, January 10, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- SANUWAVE Health, Inc. (the "Company" or "SANUWAVE”) (OTCQB: SNWV), a leading provider of next-generation FDA-approved wound care products, today announced that revenues for the fourth quarter of 2023 are expected to be in the range of $6.6 to $6.8 million, an increase of 20% to 24% over Q4 2022. Fiscal year 2023 revenues are expected to be in the range of $20.0 million to $20.2 million, an increase of 19% to 20% over the fiscal year ended 2022.
 
“Q4 2023 was a record quarter of revenue for SANUWAVE driven by strength in the UltraMist product line.  Consumables and in particular system sales saw accelerating growth as production constraints were overcome,” said CEO Morgan Frank.  “We’re extremely pleased to have shown this level of growth year on year up against what had previously been the best quarter in SANUWAVE history in Q4 2022 and look forward to carrying this success on into 2024.  The Company plans to release its full Q4 and annual results in late March and we look forward to speaking with you then to give you a more complete update on our quarterly and yearly performance and our future plans and guidance.”
 
The preliminary revenue results described herein are based on management’s initial analysis of the fourth quarter ended December 31, 2023, and may be subject to adjustments based on the Company’s completion of its year-end financial close process.
 
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 help 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.
 

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 constraints, plans for future business development activities and the Company’s proposed business combination with SEP Acquisition Corp. 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 the regulatory approval and marketing of the Company’s  products, supply chain and production constraints, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, the Company’s ability to consummate the proposed business combination with SEP Acquisition Corp. 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
 


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Jan. 10, 2024
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Entity File Number 000-52985
Entity Registrant Name SANUWAVE Health, Inc.
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Entity Incorporation, State or Country Code NV
Entity Tax Identification Number 20-1176000
Entity Address, Address Line One 11495 Valley View Road
Entity Address, City or Town Eden Prairie
Entity Address, State or Province MN
Entity Address, Postal Zip Code 55344
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