Medovex Enters Into Service Agreement With LNE/G-MED for Regulatory Services in Preparation for CE Marking
ATLANTA, GA -- (Marketwired) -- 04/07/16 -- Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that it has entered into a service agreement with a leading Notified Body regulatory firm, France based, LNE/G-Med, for its pathway for the DenerveX™ System to the CE Mark for the EU.
According to Patrick Kullmann, President and COO of Medovex, "The development of our DenerveX System continues to advance. Currently being addressed are certain final 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."
Kullmann concluded, "Before you can offer for sale your medical products in nations within the (EU) and the European Free Trade Association, you must first satisfy the requirements for CE Marking, a conformity mark that signifies a product has met all criteria of the relevant EU directives, especially in the areas of safety and performance. We are pleased to be working with LNE/G-MED toward this goal being a leading Notified Body in the EU with a strong history of assisting medical technologies in the CE Mark process."
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
LNE/G-MED is committed to providing Medical Device manufacturers with the knowledge and tools to create the Regulatory and Technical solutions they need to ensure Quality, Expertise, Speed and Innovation during their certification. The synergy between our American and European-based pool of Experts allow us to guide you to efficient solutions to your Domestic and International regulatory and Technical challenges. With over 11 local offices, LNE/G-MED offers its expertise and services to help you maintain control and compliance with the regulations affecting your products. For more information, please visit www.lne-america.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 April 7, 2016