The Company previously announced that it had received its first three commercial orders for its DenerveX System on the heels of receiving CE Mark approval for the system allowing it to be marketed in Europe. The first commercial orders of the DenerveX System included both the DenerveX Kit containing the DenerveX Device and the DenerveX Pro-40 Generators for Germany, UK and Italy.
Manny Sablowski, Sr. Vice President of Sales and Marketing, stated, “We are pleased to be building atop recent momentum having established near term dates for the first human cases in the EU. The first human cases follow the recent receipt of stocking orders from our distributors EDGE Medical of Manchester England, TCB Ortho Division of Germany, and AlfaMed of Porto San Giorgio, Italy.”
Sablowski continued, “In recent weeks, we also received additional positive feedback holding a successful DenerveX training session with our Italian distributor. I have high hopes that all our other distributors are equally excited like the AlfaMed team. Their twelve sales representatives are all specialists in the Spinal field and clearly understand Facet Joint Syndrome.”
Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem affecting millions each year in the United States, the EU, and rest of the world. Current treatment options are generally temporary and there is no proven long-lasting option for FJS.
The DenerveX System is differentiated from radiofrequency ablation technologies by denervating and removing 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.
Published studies indicate that lower back pain is the fifth most common reason for U.S. doctor office visits, the most common cause for activity limitations in persons under the age of 45, and a driver of physician opioid prescribing patterns. Additionally, research indicates that total health care expenditure for LBP in the U.S. exceeds $100 billion dollars annually. The DenerveX System was specifically designed to address long term lower back pain management seeking to alleviate, and/or mitigate pain, in addition to potentially reducing dependence on pharmaceutical based remedies.
The DenerveX System consists of the DenerveX Device Kit, containing a single use medical device and the DenerveX Pro-40 Power Generator. The 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.