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)
October 10, 2023

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 October 10, 2023, SANUWAVE Health, Inc., a Nevada corporation (the “Company”), issued a press release announcing certain preliminary financial results for the quarter ended September 30, 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 October 10, 2023
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: October 10, 2023
By:
/s/ Toni Rinow
  
 
Name:
Toni Rinow
  
 
Title:
Chief Financial Officer
  


Exhibit 99.1


SANUWAVE Health Announces Preliminary Revenue Results for the Third Quarter Ended September 30, 2023
 
SANUWAVE is pleased to announce preliminary revenues of $4.7 million to $4.9 million for the third quarter ended September 30, 2023
 
Results indicate 13-18% growth rate over Q3 2022
 
UltraMist revenues (systems and consumables) increased in excess of 25% year on year and by greater than 10% vs Q2 2023
 
EDEN PRAIRIE, MN, October 10, 2023 (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 third quarter of 2023 (ending September 30) are expected to be in the range of $4.7 to $4.9 million.
 
“As the Company continues to make progress alleviating the production constraints discussed on the last earnings call, we are pleased to have been able to achieve ongoing revenue growth,” said Morgan Frank, Chairman and CEO. “Overall revenues in the quarter were positively impacted by significant growth in the core UltraMIST product lines which constituted greater than 90% of SANUWAVE’s overall revenues in the quarter.  The Company plans to release its full quarterly numbers for Q3 in mid-November, and we look forward to speaking with you then to give you a more complete update on our quarterly performance and our future plans.”
 
The preliminary revenue results described herein are based on management’s initial analysis of the third quarter ended September 30, 2023 and may be subject to adjustments based on the Company’s completion of its quarter-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 financial results and plans for future business development activities and are thus prospective. 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 product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, the consummation of the transaction 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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Oct. 10, 2023
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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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