Medovex Corporation Updates European Union Launch Progress
Initial Orders for Company's CE Marked and Highly Disruptive DenerveX(TM) System Exceeding Internal Expectations
ATLANTA, GA -- (Marketwired) -- 07/05/17 -- Medovex Corp. (NASDAQ: MDVX) ("Medovex" or the "Company"), a developer of medical technology products, today announced that initial country distributor orders for the DenerveX™ System from Germany, UK and Italy have exceeded the Company's internal expectations. Additional orders from Switzerland and Chile are also currently ahead of schedule and expectations and at least one country distributor has increased its order size over their initial order.
Last week the Company announced that it had scheduled its first human cases for its DenerveX™ System in the EU to commence during mid-July, followed by other cases throughout the balance of the month and in July Dr. Vick Kapoor, an Orthopedic Surgeon from Manchester UK will be the first surgeon to utilize the new device.
Jarrett Gorlin, Medovex Chief Executive Officer, stated, "We're clearly pleased that current early orders for our DenerveX System are in excess of our internal models and expectations. This early indication of demand further strengthens our cautious optimism on acceptance by our customers for the DenerveX System in the EU for the treatment of Facet Joint Pain."
Gorlin concluded, "We are looking forward to the near term scheduled first human DenerveX procedures in both the UK and Germany in six hospital centers with leading surgeons who we expect to lead our already planned key opinion leader strategy."
Patrick Kullmann, Medovex President and COO, added, "Our launch plan is going very well, perhaps better than originally planned with countries ordering ahead of schedule and the list of initial cases is growing. Our approach remains to 'go narrow and deep in the market' in a controlled roll out launch strategy to confirm 'proof of principle.' We continue to believe that the DenerveX System has the potential to become the new standard of care for the treatment of Facet Joint Pain."
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 capsular joint.
Published studies indicate that lower back pain (LBP) 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 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.
Source: Medovex Corporation
Released July 5, 2017