September 14, 2017
ATLANTA, GA–(Marketwired – Sep 14, 2017) – Medovex Corp. (NASDAQ: MDVX) (“Medovex” or the “Company”), the developer of the DenerveX® System, a new and novel device designed for enduring relief of Facet Joint Syndrome related to back pain, today announced that it has formed a direct Medovex sales operation in Germany with a direct sales force. This new sales structure which will allow it to go direct in Germany, a large key market opportunity that has seen strong initial sales interest, and offers great dedicated reimbursement.
Dennis Moon, Medovex Executive Vice President, stated, “Initial sales of the DenerveX System in Germany, our most important market outside of the U.S., have been encouraging. While we continue to go narrow and deep, in a very controlled manner, early rollout procedure results have exceeded expectations. Being able to take control of our distribution through our new direct presence is expected to gain us numerous strategic advantages, not limited to better product control, increased selling focus and greater sales force accountability.”
The Company previously recently announced it had received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for its DenerveX System allowing the Company to market the device in Australia, the first country in the Asia Pacific region. Ahead of schedule, this paves the way for entry into an important area globally, Asia Pacific. Australia is a highly regarded market by many in the global medical community for the quality of care and delivery of the latest technology for the treatment of chronic disease such as Facet Joint Pain.
The Company also announced it had received its first order for the DenerveX System from Australia. On September 17, 2017, the Company expects to conduct sales and product training with its Australia distributor with anticipated initial procedures to be conducted shortly thereafter, following receipt of first shipments of the product.
Recently, the Company also provided a 30 day post procedure update on one of the first cases using its DenerveX System. It has also now received a five week post procedure update from Dr. Chris Dare on his first patient in the UK.
The first case was conducted on July 15, 2017 and results were assessed via visual analog scale (VAS) at 30 days post procedure. According to the VAS score, the patient reported a 70% reduction in pain. The second patient was recently assessed five weeks post procedure, reporting an 80% reduction in pain. The Company continues to secure additional patient testimonials which it intends to make available to shareholders upon completion.
Videos of leading spine surgeon Dr. Vik Kapoor talking about FJS and the DenerveX Device may be viewed at the following links:
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.
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.