We had a second status meeting with the FDA on Wednesday, July 20, 2016. Senior Management from the Neurology and Physical Medicine Group, 4 examiners, the Head of the Physical Medicine, and the project statistician were present. The meeting went well and the tenor was very good.
They have accepted our knee and plantar fasciitis studies as indicative of musculoskeletal pain relief and our explanation of our unique mechanism of action. However, they would like a third study to substantiate our broader indication of use. To accommodate our request for market clearance for the relief of musculoskeletal pain, the examiners have agreed to exclusively review the back pain data from our UK Registry studies. Some of this data is peer reviewed and published. We have approximately 4,500 subject’s responses, who used the trial device for musculoskeletal back pain, as well as data on over 100 subjects demonstrating the durability of therapy over a 6 month study period for back pain.