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 26, 2018
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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
(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 1.01
Entry Into a Material Definitive Agreement.
On
January 26, 2018, SANUWAVE Health, Inc., a Nevada Corporation (the
“Company”
),
entered into a Master Equipment Lease with NFS Leasing Inc.
(
“NFS”
) to
provide financing for equipment purchases to enable the Company to
begin placing the dermaPACE System in the marketplace (the
“Agreement
”).
The Agreement provides for a lease line of up to $1,000,000 with a
lease term of 36 months, and grants NFS a security interest in the
Company’s accounts receivable, personal property and money
and deposit accounts of the Company. A copy of the Agreement is
attached to this Current Report on Form 8-K (this
“Current Report”
) Exhibit
10.1 and is incorporated by reference herein.
Item
7.01 Regulation FD Disclosure.
On
February 12, 2018, the Company issued a press release regarding
entry into the Agreement. The press release is furnished on this
Current Report as Exhibit 99.1 and incorporated by reference
herein.
Item 2.03
Creation of a Direct Financial Obligation or an Obligation under an
Off-Balance Sheet Arrangement of a Registrant.
The
information contained or incorporated in Item 1.01 of this Form 8-K
is incorporated by reference in this Item 2.03.
Item 9.01
Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit
No.
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Description
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Master
Equipment Lease, dated January 26, 2018, by and among the Company
and NFS Leasing, Inc.
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Press release, dated February 12,
2018, 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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Date:
February 16,
2018
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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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Master Equipment
Lease, dated January 26, 2018, by and among the Company and NFS
Leasing, Inc.
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Press release, dated February 12,
2018, issued by the Company.
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Exhibit 99.1
FOR IMMEDIATE RELEASE
SANUWAVE SIGNS $1 MILLION EQUIPMENT FINANCING LINE WITH NFS
LEASING
SUWANEE, GA, FEBRUARY 12, 2018 - SANUWAVE Health, Inc. (OTCQB:
SNWV)
is
pleased to announce that the Company has signed a one million
dollar equipment financing lease agreement with NFS Leasing, Inc.
This agreement will enable SANUWAVE to begin placing the
dermaPACE
®
System in the
hands of clinicians and wound care centers in the United States to
utilize in the treatment of diabetic foot ulcers, a billion dollar
market.
NFS
Leasing, Inc. has an extensive background in medical equipment
financing and will be a valuable partner to SANUWAVE in our initial
commercialization of dermaPACE in the United States after receiving
FDA clearance in December 2017. The line will be called as we order
equipment, which will allow us to distribute the dermaPACE System
domestically without dilution to the current
shareholders.
“The
agreement with NFS is a crucial announcement for the Company as we
execute our plan for a successful rollout in the massive US
diabetic foot ulcer (DFU) market. This allows us to access capital
to place devices which in turn will drive procedures and ultimately
revenue,” stated Kevin A. Richardson II, Chief Executive
Officer of SANUWAVE. “We have a well developed plan in place
to roll out dermaPACE methodically throughout 2018. We are very
excited to have this line in place which allows us to launch our
rapid revenue growth,” concluded Mr. Richardson.
The
Company has had overwhelming inbound information calls and support
from the wound care community since the announcement of our FDA
clearance. We anticipate the first draw on this line later in
February with our initial delivery shortly thereafter.
“We
have been following SANUWAVE’s progress for a while and began
discussions about doing business together prior to their good news
from the FDA. We are glad to be providing capital for a business
model that will help heal a massive medical problem involving
diabetic foot ulcers. The Company has developed a great go to
market strategy and we are looking forward to a successful
strategic relationship,” stated David DePamphilis, Chief
Operating Officer of NFS Leasing, Inc.
About SANUWAVE Health, Inc.
SANUWAVE
Health, Inc. (OTCQB:SNWV) (
www.sanuwave.com
)
is a shock wave technology company initially focused on the
development and commercialization of patented noninvasive,
biological response activating devices for the repair and
regeneration of skin, musculoskeletal tissue and vascular
structures. SANUWAVE’s portfolio of regenerative medicine
products and product candidates activate biologic signaling and
angiogenic responses, producing new vascularization and
microcirculatory improvement, which helps restore the body’s
normal healing processes and regeneration. SANUWAVE applies its
patented PACE technology in wound healing, orthopedic/spine,
plastic/cosmetic and cardiac conditions. Its lead product candidate
for the global wound care market, dermaPACE
®
, is US FDA
cleared for the treatment of Diabetic Foot Ulcers. The device is
also CE Marked throughout Europe and has device license approval
for the treatment of the skin and subcutaneous soft tissue in
Canada, South Korea, Australia and New Zealand. SANUWAVE
researches, designs, manufactures, markets and services its
products worldwide, and believes it has demonstrated that its
technology is safe and effective in stimulating healing in chronic
conditions of the foot (plantar fasciitis) and the elbow (lateral
epicondylitis) through its U.S. Class III PMA approved
OssaTron
®
device, as well
as stimulating bone and chronic tendonitis regeneration in the
musculoskeletal environment through the utilization of its
OssaTron, Evotron
®
and
orthoPACE
®
devices in
Europe, Asia and Asia/Pacific. In addition, there are
license/partnership opportunities for SANUWAVE’s shock wave
technology for non-medical uses, including energy, water, food and
industrial markets.
About NFS Leasing, Inc.
NFS
Leasing Inc. (www.nfsleasing.com) is an independent equipment
leasing company, serving growth-oriented companies in a variety of
fields. NFS specializes in leasing technology equipment, scientific
and medical equipment, as well as robotic, manufacturing and
construction equipment. Having helped a wide array of businesses
grow for more than a decade, NFS is approaching a billion dollars
in lease originations. NFS’ management team averages over 25
years of technology and finance experience. NFS has developed a
broad base of extensive affiliations throughout the IT, medical,
scientific, construction and manufacturing marketplace that can be
leveraged to bring their customers unique incremental
value.
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, 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.
For additional information about the Company, visit
www.sanuwave.com
.
Contact:
Millennium Park Capital
LLC
Christopher
Wynne
312-724-7845
cwynne@mparkcm.com
SANUWAVE
Health, Inc.
Kevin
Richardson II
Chairman
of the Board
978-922-2447
investorrelations@sanuwave.com
