Medovex Corporation Launches Denervex System In Spain With Distributor PRIM, S.A.
Published: Sep 21, 2017
ATLANTA, GA--(Marketwired - September 19, 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 launched its DenerveX System Device in Spain with leading distributor Prim SA.
Spain is commonly referred to as one of the big five countries for Medtech in the EU with approximately 46 million people. Prim SA is a very large and well respected distributor that calls on the orthopedic and spine call point in hospitals. Training and first order is scheduled for the week of Sept 19th.
Manfred Sablowski, Medovex Sr. Vice President of Sales and Marketing, stated, "We are excited to continue to roll out the DenerveX System to large and opportunistic markets such as Spain with a high quality leading distributor like Prim SA."
Sablowski concluded, "We developed the DenerveX System to enhance a patient's quality of life. The agony of pain associated with the Facet Joint can be life-altering, robbing people of even the simplest joys of daily life like bending over to hug a grandchild, taking a walk or gardening. Powerful painkillers often prescribed for severe back pain are fanning the flames of the nation's opioid epidemic. The DenerveX System involves a simple, minimally invasive, "keyhole" procedure that is designed to bring faster, longer-lasting relief."
The Company recently announced that it is forming 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.
The Company also previously announced that it had recently 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 paved 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.
In addition, the Company recently provided post procedure updates on two of its early cases using its DenerveX System. 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.
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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
About Prim Group
Prim Group is a leader in hospital and orthopedic supplies and materials for physiotherapy, thalassotherapy, thermal therapy, rehabilitation, geriatrics, as well as daily living aids. Prim is structured to enhance its cultural and business values: commitment to providing customers with quality service, fair trading and transparency vis-à-vis suppliers, and corporate governance and social responsibility in relations with employees and society.
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.