Medovex Corporation Releases Letter to Shareholders
Medovex Corp. ( NASDAQ : MDVX ), a developer of medical technology products, today released the following open letter to shareholders:
Dear Fellow Shareholder,
I want to personally thank you for your continuing investment in Medovex.
Since my last letter, we have achieved great strides in the development of our flagship product, the DenerveX™ System. The DenerveX System is designed to provide relief from debilitating pain associated with Facet Joint Syndrome (FJS). Lower back pain remains the second most common cause of disability in the U.S., and affects approximately 10% of adults. Studies indicate that that 31% of lower back pain cases are attributed to FJS.
The DenerveX system combines two actions into one minimally invasive device, which will potentially improve patient outcomes. The combined procedure is designed to and is expected to provide longer lasting pain relief than competitive offerings, while potentially lowering costs to the health care system.
In October 15, 2015, we conducted a very successful DenerveX System cadaver lab study at the North American Spine Society (NASS) meeting in Chicago, IL with 17 spine surgeons from several European countries as part of our pre-launch strategy. One of the most recognized expert spine surgeon attendees made the following comment after observing the use of the DenerveX device.
Dr. Ritter-Lang, advisor and leading spine surgeon from Germany stated, “The DenerveX is a safe treatment to address facet joint disease in an easy and fast approach with a new and innovative technology. A missing link to successfully treat pain related to the facet joint.”
In January, we followed up by attending Forum Spine Surgery of the German Spine Society where more than 150 leading spine surgeons from Germany, the European Union and the United States were in attendance where we provided demonstrations and introductory training for the DenerveX System.
More recent accomplishments include:
On January 14, 2016, 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.”
On February 4, 2016, we announced that the reimbursement authority in Germany had released new reimbursement payment coding for the DenerveX System technology for the treatment of the Facet Joint Syndrome. The new reimbursement coding was released in the Diagnosis-Related Group (DRG) system in 2016 in Germany. This new coding allows for hospitals and outpatient centers to receive reimbursement for the use of the DenerveX System.
On April 5, 2016, we announced that we had entered into an international distribution agreement with Innosurge, a supplier of innovative orthopedic surgery equipment. The agreement covers the distribution of its DenerveX System throughout Scandinavia, including Denmark, Sweden, Norway and Finland.
On May 7, 2016, we announced that we had placed our first commercial order for the DenerveX Pro-40 Power Generator in preparation for its anticipated European launch later this year.
On June 2, 2016, we announced that we had completed our first live tissue test via receipt of positive test results from January’s non-human living tissue test of the DenerveX System.
On June 6, 2016, we announced that its DenerveX System had successfully been used in its most extensive live tissue test to date completing an extensive twelve subject live tissue laboratory using the most stringent standards for Good Laboratory Practice standards (GLP) using the final pre-production model device and generator.
On August 8, 2016, we filed a form 8k with the SEC disclosing that we entered into a Unit Purchase Agreement with selected accredited investors for proceeds of $1,150,000, led by a $750,000 investment by Sorrento Therapeutics Inc., in a private placement of common stock and warrants at a fixed purchase price. The proceeds allow the Company to finalize testing of the DenerveX System while providing additional working capital.