The DenerveX Device Kit and Pro-40 generator was tested as a working system under rigorous conditions using all the required federal and international standards. The GLP evaluation is an accepted standard in the medical technology field for commercialization under Title 21 of the Federal code. Good Laboratory Practice for Non-Clinical Laboratory Studies contain the highest federal standards that medical technology company’s must meet prior in submitting for regulatory approval in the U.S. and the European Union.
Patrick Kullmann, President and COO of Medovex, states, “This is yet another major milestone achievement for the development and future commercialization of the DenerveX System. We continue to work aggressively towards a future CE mark process and successful launch in the European Union and other countries that accept the CE mark globally. The DenerveX kit and generator successfully worked together in an excellent manner, as designed and developed at this stage of development. This successful test paves the way towards the completion of the final set of testing and verification. The system used in this laboratory testing consisted of the latest pre-production model of the system that is the identical model to the device for human use. It represents a continued confirmation of the future utility of the DenerveX System in treating patients with Facet Joint Syndrome.”
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 very well together in this widely expanded 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 in the future as a new standard.”
The Company’s patented DenerveX System, currently in the final development stages 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 kit, 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. The combined procedure is expected to provide a longer lasting solution and potential savings to the health care system.
DenerveX system 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., visitwww.medovex.com
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