SECURITIES & EXCHANGE COMMISSION EDGAR...

SECURITIES & EXCHANGE COMMISSION EDGAR FILING

SANUWAVE Health, Inc.

Form: 8-K

Date Filed: 2018-02-16

Corporate Issuer CIK: 1417663

© Copyright 2018, Issuer Direct Corporation. All Right Reserved. Distribution of this document is strictly prohibited, subject to the terms of use.

UNITED STATESSECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

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

Date of Report (Date of earliest event reported) January 26, 2018

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.)

3360 Martin Farm Road, Suite 100,Suwanee, Georgia

30024

(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 followingprovisions (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 theSecurities 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 orrevised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

EDGAR Stream is a copyright of Issuer Direct Corporation, all rights reserved.

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 theSecurities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and arecovered 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 toidentify 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, futureexpectations concerning available cash and cash equivalents, assumptions underlying or relating to any of the foregoing, and other matters. Forward-lookingstatements involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to differmaterially from results expressed in or implied by this Form 8-K. Any expectations based on these forward-looking statements are subject to risks anduncertainties and other important factors, including those discussed in SANUWAVE Health, Inc.’s Annual Report on Form 10-K filed with the Securities andExchange Commission, including the section titled “Risk Factors” therein, and all other filings made by the Company under the Exchange Act. You are cautionednot 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 arequalified in their entirety by this cautionary statement. We assume no obligation to update the forward-looking statements, or to update the reasons why actualresults 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 accountsreceivable, 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 asExhibit 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. Exhibit No. Description 10.1 Master Equipment Lease, dated January 26, 2018, by and among the Company and NFS Leasing, Inc. 99.1 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 theundersigned hereunto duly authorized. SANUWAVE HEALTH, INC. Date: February 16, 2018 By: /s/ Kevin A. Richardson, II

Name: Kevin A. Richardson, II Title: Acting Chief Executive Officer

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EXHIBIT INDEX Exhibit No. Description 10.1 Master Equipment Lease, dated January 26, 2018, by and among the Company and NFS Leasing, Inc. 99.1 Press release, dated February 12, 2018, issued by the Company.

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Exhibit 10.1


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 dollarequipment financing lease agreement with NFS Leasing, Inc. This agreement will enable SANUWAVE to begin placing the dermaPACE® System in the hands ofclinicians 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 ofdermaPACE in the United States after receiving FDA clearance in December 2017. The line will be called as we order equipment, which will allow us todistribute 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, ChiefExecutive Officer of SANUWAVE. “We have a well developed plan in place to roll out dermaPACE methodically throughout 2018. We are very excited to havethis 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. Weanticipate 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. Weare 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 agreat 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 andcommercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascularstructures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producingnew vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies itspatented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound caremarket, dermaPACE®, is US FDA cleared for the treatment of Diabetic Foot Ulcers. The device is also CE Marked throughout Europe and has device licenseapproval 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 inchronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well asstimulating 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.

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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. NFSspecializes in leasing technology equipment, scientific and medical equipment, as well as robotic, manufacturing and construction equipment. Having helped awide array of businesses grow for more than a decade, NFS is approaching a billion dollars in lease originations. NFS’ management team averages over 25years of technology and finance experience. NFS has developed a broad base of extensive affiliations throughout the IT, medical, scientific, construction andmanufacturing 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 statementsrelating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements thatare not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that anysuch forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s abilityto control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that mayaffect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s productcandidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resourceissues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Companyundertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com. Contact:

Millennium Park Capital LLCChristopher [email protected]

SANUWAVE Health, Inc.

Kevin Richardson IIChairman of the [email protected]

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