Mainstay Medical International PLC believes it has enough data to move forward with a PMA application to US FDA for its ReActiv8 implantable spinal neuromodulator device to treat chronic back pain, even after its ReActiv8-B trial did not reach the primary endpoint in a key clinical trial.
In ReActiv8 B, a total of 204 patients were surgically implanted with the device at centers in the US, Europe, and Australia and randomized to either "subject appropriate stimulation" or low stimulation two-weeks after implantation