SOURCE: Medovex Corporation

August 07, 2017 10:50 ET

Medovex Corporation DenerveX System Completes First Human Case in Italy

Professor Dr. Pier Vittorio Nardi, Neurosurgeon at the University La Sapienza in Rome, Italy Performs 2 Level Facet Joint Syndrome Case

ATLANTA, GA--(Marketwired - Aug 7, 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 reported it has successfully completed its first case in Italy.

Professor Dr. Pier Vittorio Nardi, a neurosurgeon at the University La Sapienza in Rome, Italy, Sapienza, one of the top Italian universities, ranking competitively amongst the best universities around the world according to the international rankings published in 2017, performed a 2 level Facet Joint syndrome case. The procedure targeted the L4/5 and resulted in Dr. Nardi commenting that he was very satisfied with the performance of the DenerveX Device and liked it.

Over his career, he has performed over 2,000 spinal and cranial surgeries and has spent the past decade at the specialization of some minimally invasive spinal techniques.

Currently, fourteen cases using the DenerveX System have been completed and there are an additional approximately 30 additional cases scheduled for coming weeks. Dr. Vik Kapoor completed two additional cases last week which marks the first return doctor to complete additional procedures.

As previously announced, on July 26, 2017, Dr. Martin Deeg performed two cases in Stuttgart. Dr. Deeg and Dr. Vik Kapoor are members of the Company's European Medical Advisory Board.

Case summary from Dr. Deeg's cases:

  • Case One: Female, 40 years old, L4, two joints treated. Patient had injection local only at the facet joint. At the end of the procedure the patient moved herself from the table and walked under her own power out of the procedure room and was discharged shortly after with no pain prescription provided other than over the counter pain relief medicines.

  • Case Two: Male, 42 year old, L5, two joints treated. Patient had an injected local only at the facet joint. At the end of the procedure the patient moved from the table and walked out of the procedure room on their own power and was discharged shortly after, again no pain relief prescriptions provided only over the counter medicines recommended. A picture of Dr. Deeg and patient may be found here on the Company's Facebook page: https://www.facebook.com/medovex/

Dr. Martin Deeg stated, "Both of the first two DenerveX™ System cases met with what I consider excellent initial success. Both patients experienced initial pain reduction of the Facet Joint during the actual running of the device. Additionally, both patients walked out of the procedure room on their own power and were discharged shortly following the procedure."

Deeg concluded, "I am pleased to see the very positive initial results of the procedures, the DenerveX System has great potential in the treatment of Facet Joint Pain and could become the new standard of care."

The Company previously announced it had completed first human use cases for the DenerveX System in Manchester, England with very encouraging initial procedural success. The Company intends to update patient longer term progress, including first hand patient testimonials at approximately 90 day post procedure.

The DenerveX System recently received CE Mark approval and clearance for commercialization in the European countries and offers a unique way to perform a Facet Joint Syndrome treatment.

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.

About Medovex

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.

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