Medovex Corporation's DenerveX(TM) Device Passes Significant Development Milestone
ATLANTA, GA -- (Marketwired) -- 04/02/15 -- Medovex Corporation (NASDAQ: MDVX), a developer of medical technology products, announced today that its DenerveX™ device has successfully completed its Phase III design and development device testing.
Jarrett Gorlin, CEO of Medovex, stated, "This is a significant milestone for the design and development of the DenerveX device as what we believe to be a promising solution for treatment of patients who are suffering from Facet Joint Pain. The significance of this milestone is that the DenerveX device can now confidently proceed to the final verification and validation phases with confidence that it will meet customer expectations for delivering a longer lasting pain relief therapy for patients with Facet Joint Pain."
Facet Joint Syndrome (FJS), a condition in which the joints in the back of the spine degenerate or are injured and subsequently cause pain. FJS is also called spinal osteoarthritis, facet joint osteoarthritis or spinal arthritis; it is a leading cause of back pain. Studies indicate that 10% of the U.S. adult population suffers from lower back pain and that 31% of lower back pain patients' pain is attributed to Facet Joint Pain.
"The testing of the first build of devices using our production manufacturer met the established goals set at the beginning of the project and the design is now frozen. This is a significant milestone in our overall five phase development process," commented Patrick Kullmann, President and COO of Medovex.
The development is led by Devicix, a medical device design and development firm based in Minneapolis, MN.
According to Andreas Pfahnl Sc.D., CTO and General Manager at Devicix, a five phase development approach is used to design and develop the DenerveX device that is part of the Devicix ISO 13485 certified quality management system. The phases include: Concept Development, Planning and Architecture, Detail Design, Verification and Optimization, and finally Validation and Launch. "The DenerveX device has now reached the successful completion of Phase III and will next move into Phase IV for its final design testing and verification which includes biocompatibility, sterilization, distribution, shelf life, and functional testing. The project has already started the transition to the contract manufacturer."
