ATLANTA, GA--(Marketwired - Jan 14, 2016) - Medovex Corp. (
The DenerveX Device Kit and Pro-40 generator was tested as a working system under rigorous conditions using many of the standards required under GLP evaluation models (Good Laboratory Practice) which is an accepted standard in the medical technology field for commercialization.
According to Scott Haufe M.D., Medical Director, inventor and co-developer of the DenerveX Device and the physician performing this latest test and evaluation, "The DenerveX device and Pro-40 generator worked excellently together in this living tissue model as expected. We believe the DenerveX procedure as designed, has the potential to fit very well into the way these patients should be treated as a future new standard."
Patrick Kullmann, President and COO, stated, "This is a major milestone for the development of the DenerveX System as we continue to work towards a successful CE mark process and launch in the European Union and other countries that accept the CE mark globally. The DenerveX kit worked together as designed and developed, paving the way towards the final offering. Importantly, this first use in living tissue with the final pre-production model of the system is the closest model to human use. It represents a continued confirmation of the utility of the device in treating patients with Facet Joint Syndrome."
The Company's patented DenerveX System, currently in final development and not yet commercially available, 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.
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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