Medovex Corporation Receives Positive Final Laboratory Test Results Report
ATLANTA, GA -- (Marketwired) -- 06/02/16 -- Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that it has completed its first live tissue test via receipt of test positive results from January 11, 2016 non-human living tissue test of the DenerveX™ System.
According to Patrick Kullmann, President and COO of Medovex, "This latest test report is yet another example of the DenerveX System's potential in the intended use concept of the DenerveX System." The laboratory report conclusion stated that "The observed gross and histopathological changes at 30 and 60 days post treatment of the animal subjects were consistent with the findings expected for a radio frequency heating device combined with mechanical abrasion of the facet bone surface."
Kullmann concluded, "The test results further build confidence in the DenerveX system for our second and final GLP (Good Laboratory Practice) test in the near future. The development of our DenerveX System continues to advance as planned and on schedule. Currently being addressed are certain final testing of the design and development elements of the product, which we believe will ultimately lead to gaining regulatory approval in the European Union (EU) counties that require the CE mark. The initial findings are also consistent with our recently obtained German reimbursement codes."
Ms. Deborah Schmalz, Executive Director of Regulatory Affairs at Medpace Medical Device, a global leader in such matters, commented, "The results obtained in this non-human tissue test of the DenerveX System as reflected in the lab reports makes evident that the DenerveX System performed as designed and expected in intended destruction of the tissue on the Facet Joint while preserving the non-targeted healthy tissue."
The Company's patented DenerveX System, currently in final development is designed to provide longer lasting relief of pain associated with the facet joint. Lower back pain is the second most common cause of disability in the U.S. for adults. Studies indicate that 10% of the U.S. adult population suffers from lower back pain and that 31% of lower back pain is attributed to facet joint pain.
The DenerveX System consists of the DenerveX device, a single use device, and the DenerveX Pro-40 Power Generator. The DenerveX system is designed to provide a minimally invasive treatment option which combines two actions into one device.
DenerveX is not yet CE marked or FDA cleared and is not yet commercially available.
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 June 2, 2016