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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
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Date of
Report (Date of earliest event reported)
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December 28, 2017
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SANUWAVE HEALTH, INC.
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(Exact
name of registrant as specified in its charter)
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Nevada
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000-52985
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20-1176000
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(State
or other jurisdiction
of
incorporation)
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(Commission
File Number)
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(IRS
Employer
Identification
No.)
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3360 Martin Farm Road, Suite 100, Suwanee, Georgia
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30024
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code
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(770) 419-7525
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N/A
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(Former
name or former address, if changed since last report)
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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))
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. ☐
Cautionary Statement Regarding Forward-Looking
Information
This
Current Report on Form 8-K contains certain statements that
constitute “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended
(the “Securities Act”), and Section 21E of the
Securities Exchange Act of 1934, as amended (the “Exchange
Act”), and are covered by the safe harbor provisions of the
United States Private Securities Litigation Reform Act of 1995.
Words such as “anticipate,” “believes,”
“budget,” “continue,” “could,”
“estimate,” “expect,”
“forecast,” “intend,” “may,”
“plan,” “potential,”
“predicts,” “project,”
“should,” “will” and similar expressions
are intended to identify such forward-looking statements.
Forward-looking statements in this Form 8-K may include, without
limitation, statements regarding projected growth, future revenue,
benefits of entering into the investment agreements, anticipated
improvements in earnings and other financial performance measures,
future expectations concerning available cash and cash equivalents,
assumptions underlying or relating to any of the foregoing, and
other matters. Forward-looking statements involve known and unknown
risks, uncertainties and other important factors that may cause
actual results, performance or achievements to differ materially
from results expressed in or implied by this Form 8-K. Any
expectations based on these forward-looking statements are subject
to risks and uncertainties and other important factors, including
those discussed in SANUWAVE Health, Inc.’s Annual Report on
Form 10-K filed with the Securities and Exchange Commission,
including the section titled “Risk Factors” therein,
and all other filings made by the Company under the Exchange Act.
You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the filing date
of this Form 8-K. All forward-looking statements are qualified in
their entirety by this cautionary statement. We assume no
obligation to update the forward-looking statements, or to update
the reasons why actual results could differ from those projected in
the forward-looking statements.
Item 7.01
Regulation FD Disclosure.
On
December 28, 2017, SANUWAVE Health, Inc., a Nevada Corporation
(the “Company”), received notice from the United States
Food and Drug Administration permitting marketing of the
dermaPACE® System. The letter from the FDA is
furnished on this Current Report on Form 8-K (this
“Current
Report”) as Exhibit 99.1 and incorporated
by reference herein.
The
Company also issued on December 29, 2017, a press release regarding
the FDA’s notice and a conference call to be held by the
Company on January 2, 2018, at 11:00 am eastern to discuss the FDA
letter and its implications for the Company. The press release is
furnished on this Current Report as Exhibit 99.2 and incorporated
by reference herein.
Item 9.01
Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit
No.
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Description
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Letter
from the U.S. Food and Drug Administration to the
Company
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Press
Release dated December 29, 2017 issued by the Company
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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.
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SANUWAVE HEALTH, INC. |
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Dated: December 29,
2017
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By:
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/s/ Kevin A. Richardson,
II
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Name: |
Kevin
A. Richardson, II |
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Title: |
Acting Chief
Executive Officer |
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EXHIBIT INDEX
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Exhibit
No.
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Description
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Letter
from the U.S. Food and Drug Administration to the
Company
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Press
Release dated December 29, 2017 issued by the Company
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