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Medovex Corporation Converts IDE Submission to a Pre-Submission with Food and Drug Administration for its DenerveX System
Medovex Corporation Converts IDE Submission to a Pre-Submission with Food and Drug Administration for its DenerveX System.
About this update from Innoveren Scientific Inc.
[{"type":"text","content":"\n\n ATLANTA, Dec. 29, 2017 (GLOBE NEWSWIRE) -- Medovex Corp. (OTCQB: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 it has elected to voluntarily convert its previously submitted Investigational Device Exemption (IDE), to a Pre-Submission  with the U.S. Food and Drug Administration (“FDA”), for its DenerveX System targeting pain associated with the Facet Joint.\n Jill Schweiger, Sr. Vice President Regulatory and Clinical Affairs for Medovex commented, \"Early dialogue with the FDA has been both encouraging and productive. The feedback gained from recent interactions convinced us that converting the IDE submission to a pre-submission beneficially allows us to engage in a more interactive and collaborative review of the planned clinical investigation. The standard IDE review timeframe is 30 days, while our submission exceeded nearly 2500 pages of technical data. We are confident that early collaboration with FDA regarding its planned clinical evaluation will help ensure that the study design will ultimately yield the results that will support the safety and effectiveness of the DenerveX System.” Schweiger concluded, “Significant time, effort and resources have been invested in what we continue to believe will ultimately be a successful submission and review by the FDA, followed by a US clinical trial in the future.” The DenerveX System is already CE Marked in Europe and it is commercially available in Europe and certain other international markets. In addition, the Company recently added six new independent spine surgery sales agents for additional distribution throughout Germany. The Company is also working as planned with several early adopting physicians on the collection of the initial clinical results in the UK and Germany for post procedural outcomes of patients treated with the DenerveX System. This data is expected to support a scientific abstract being planned for submission late in 2018.  To maintain the best chance of abstract acceptance, the scientific abstract will include data collection from various sites, c...