Medovex Corporation Submits IDE with the Food and Drug Administration for its DenerveX System
ATLANTA, Nov. 27, 2017 (GLOBE NEWSWIRE) -- Medovex Corporation (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 chronic back pain, a non-addictive, non-opioid drug alternative capable of restoring a patient to a more normal and active lifestyle, today announced that has submitted an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (“FDA”) for its DenerveX System targeting pain associated with the Facet Joint.
The DenerveX System is CE Marked in Europe and it is commercially available in Europe and certain other international markets.
Jill Schweiger, Sr. Vice President Regulatory and Clinical Affairs for Medovex commented, "The submission of the IDE marks a major milestone for Medovex. The Company has been preparing for this moment for the past four years in the development and testing of the DenerveX System.Significant time, effort and resources have been invested in what we believe will be a successful submission and review by the FDA, followed by a US clinical trial in the future.
An investigational device exemption (IDE) allows the investigational device to be used in an FDA clinical study in order to collect safety and effectiveness data. Many clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated. Once the IDE is approved by the FDA Medovex may then proceed with initiating the clinical study.
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.
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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 System, 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 Corp.