0001654954-17-006608.txt : 20170721 0001654954-17-006608.hdr.sgml : 20170721 20170721170755 ACCESSION NUMBER: 0001654954-17-006608 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20170719 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20170721 DATE AS OF CHANGE: 20170721 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Medovex Corp. CENTRAL INDEX KEY: 0001591165 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 000000000 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36763 FILM NUMBER: 17977142 BUSINESS ADDRESS: STREET 1: 3729 HARDEE AVENUE CITY: ATLANTA STATE: GA ZIP: 30341 BUSINESS PHONE: (404) 393-6989 MAIL ADDRESS: STREET 1: 3729 HARDEE AVENUE CITY: ATLANTA STATE: GA ZIP: 30341 FORMER COMPANY: FORMER CONFORMED NAME: SpineZ DATE OF NAME CHANGE: 20131105 8-K 1 mdvx_8k.htm FORM 8-K Blueprint
 
 

 
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): July 19, 2017
 
MEDOVEX CORP.
 
(Exact Name of Registrant as Specified in Charter)
 
Nevada
 
001-36763
 
46-3312262
(State or other jurisdiction
of incorporation)
 
(Commission File Number)
 
(IRS Employer Identification No.)
 
 
 
 
 
1950 Airport Road, Suite A
Atlanta, Georgia
 
 
 
30341
(Address of principal executive offices)
 
 
 
(Zip Code)
 
Registrant’s telephone number, including area code: (844) 633-6839
 
____________________________________________________________
 
Copies to:
Harvey Kesner, Esq.
Arthur S. Marcus, Esq.
Sichenzia Ross Friedman Kesner LLP
61 Broadway, 32nd Floor
New York, New York 10006
(212) 930-9700
(212) 930-9725 (fax)
 
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:
 
□       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))
 

 
 
 
 
Item 7.01    Regulation FD Disclosure
 
On July 19, 2017, Medovex Corp. (the “Company”) issued a press release relating to the first human cases being performed using its DenerveX Device, a copy of which is attached hereto as Exhibit 99.1.
 
The information contained in this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”) or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.  The furnishing of the information in this Current Report on Form 8-K is not intended to, and does not, constitute a representation that such furnishing is required by Regulation FD or that the information contained in this Current Report on Form 8-K constitutes material investor information that is not otherwise publicly available.
 
The Securities and Exchange Commission encourages registrants to disclose forward-looking information so that investors can better understand the future prospects of a registrant and make informed investment decisions. This Current Report on Form 8-K and exhibits may contain these types of statements, which are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, and which involve risks, uncertainties and reflect the Registrant’s judgment as of the date of this Current Report on Form 8-K. Forward-looking statements may relate to, among other things, operating results and are indicated by words or phrases such as “expects,” “should,” “will,” and similar words or phrases. These statements are subject to inherent uncertainties and risks that could cause actual results to differ materially from those anticipated at the date of this Current Report on Form 8-K. Investors are cautioned not to rely unduly on forward-looking statements when evaluating the information presented within.
 
Item 9.01    Financial Statements and Exhibits
 
(d)          Exhibits.
 
Exhibit No.
 
Description
99.1
 
MedoveX Corp. press release dated July 19, 2017
 
 
 
 
 
 
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.
 
 
 
 
 Date: July 21, 2017
MEDOVEX CORPORATION
 
By: /s/ Jarrett Gorlin
        Jarrett Gorlin
        Chief Executive Officer
 
 
                                                                 
 
 
 
 
EX-99.1 2 ex99-1.htm PRESS RELEASE Exhibit 99.1
 
 Exhibit 99.1
 
Medovex Corporation Announces First Human Cases Using Its DenerveX Device and First Revenue Events
 
Highly Disruptive and Patented Less Invasive Device with Faster Recovery Time than Current Surgical Treatment Options for Facet Joint Syndrome
 
ATLANTA, GA--(Marketwired – July 19, 2017) - Medovex Corp. (NASDAQ: MDVX), (“Medovex” or the “Company”), a developer of medical technology products, today announced the first human cases performed using its recently launched DenerveX™ System and first revenue events.
 
The DenerveX System which has recently received CE Mark approval and clearance for commercialization in the European countries, is a new and novel device designed for enduring relief of Facet Joint Syndrome related to lower back pain.
 
Jarrett Gorlin, Medovex CEO stated, “Our first human use cases for the DenerveX System which took place in Manchester, England recently with very encouraging initial procedural success. We anticipate performing up to as many as 30 plus additional procedures by the end of August. This is the beginning of delivering on our goal of “proof of principle” in the adoption of the technology in this very sizable market.” Gorlin concluded, “We are also pleased to have also reached our first revenue events in the EU with others soon to expected to follow.”
 
The DenerveX System offers a fast and simple way to perform a safe Facet Joint Syndrome treatment.
 
Patrick Kullmann, Medovex President and COO., added, "With the DenerveX™ System, we can offer surgeons and pain management specialists the ability to attain precise treatment of the Facet Joint pain. The DenerveX treatment uses “Rotacapsulation™, a combination of high heat and rotational capsular tissue shaving, in a minimally invasive posterior procedure for the treatment of Facet Joint Syndrome. The DenerveX System offers an alternative to existing treatments only providing temporary relief.”
 
Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem in the United States and other countries in the EU and Rest of World affecting millions each year. Current treatment options are generally temporary and there is no proven long-lasting option for FJS.
 
The DenerveX System is a highly differentiated technology. It denervates and removes capsular tissue from the Facet Joint in one single procedure. Treatment results from the combined effect of a deburring or polishing action and RF ablation treatment on the Facet Joint. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint.
 
The DenerveX System consists of the DenerveX Kit which contains the DenerveX Device, a single use medical device and the DenerveX Pro-40 Power Generator. DenerveX system is not yet FDA cleared.
 
About Medovex
Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company's first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com
 
Safe Harbor Statement
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company's filings with the Securities and Exchange Commission (the "SEC"), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
 
CONTACT INFORMATION
Medovex Corp.
 
Jason Assad
 
470-505-9905
 
jassad@medovex.com