On February 15th, 2017, the Company announced that it had successfully completed its final CE Mark audit meeting. The review of the Company’s DenerveX™ System was conducted February 7-9, 2017 by LNE/GMED, a French-based Notified Body firm. This audit is required to demonstrate compliance with the regulatory requirements to achieve CE Mark approval.
Patrick Kullmann, Medovex President and COO, stated, “Upon successfully completing this audit, the CE certificate would generally be expected to be issued paving the way to the future launch of the DenerveX System in the EU and other countries which accept the CE Mark.”
On February 9, 2017, Medovex Corporation announced it had entered into a unit purchase agreement with selected accredited investors. Pursuant to the terms of the agreement, the Company sold an aggregate of 2,905,770 shares and 1,452,885 warrants for gross proceeds of $3,022,000. Each warrant has an initial exercise price of $1.50 per share, subject to adjustment, and is initially exercisable for a period of five years from the date of issuance. Certain officers and directors of Medovex participated in the financing.
In conjunction with the closing of the transaction, the Company’s previously issued $1,150,000 of senior secured promissory notes has been converted to 165,864 shares of Common Stock and 9399 shares of Series A Preferred Stock and warrants on the same terms as the other investors. Each share of Series A Preferred Stock is convertible into 100 shares of common stock and effectively has the same price of $1.04 per share of Common Stock.
In addition to the recent financing transaction, in a transaction filed with the SEC on a Form 8k on December 6, 2016, insiders Jesse Crowne, Steve Gorlin and a third party, completed the purchase of 571,429 shares of the Company’s common stock at above then market pricing of $1.75 per share, such that the Company received an aggregate of $1,000,000.
On January 3, 2017, the Company announced it had successfully received certification of compliance for its DenerveX System from SGS S.A. a Swiss based multinational testing and certification firm. Compliance testing included electrical safety testing for US, Canada and the European Union.
Prior to that on November 3, 2016, the Company announced that it held a successful cadaver lab during NASS 2016. Medical advisory board members Martin Deeg, MD from Stuttgart, Germany, Vik Kapoor, MD from Manchester, England, as well as Gabriel Davila, MD from Colombia, Latin America, highlighted the DenerveX System. Thirty spine surgeons from Europe and Latin America attended the lab, both experiencing and using the device.
Jarrett Gorlin, Medovex CEO, commented, “Design, development and commercialization of our flagship patented DenerveX System has been years in the making. It was designed by surgeons for surgeons to be less invasive with faster recovery time than current surgical treatment options, and is designed to provide for a longer lasting treatment solution while offering potential savings to the health care system. We are pleased with the recent completion of the final CE Mark audit meeting conducted February 7-9, 2017 by LNE/GMED, a French-based Notified Body firm.”
Gorlin concluded, “My personal commitment is no better evidenced than by my recent insider purchases as filed in recent Form 4 filings made with the SEC. In addition, both our Co-founder and VP of Business Development have too made recent insider purchases. I believe it important that we lead by example putting our own money where our mouth is. Recent filings memorializing our own actions affirm our collective commitment and belief in both our team and the opportunity.”
The DenerveX System consists of the DenerveX device, a single use medical device and the DenerveX Pro-40 Power Generator. DenerveX system is not yet CE marked or FDA cleared and is not yet commercially available.
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