Over half the required number of implants in Mainstay Medical’s ReActiv8-B clinical trial have been performed. The clinical trial is investigating the company’s novel multifidus stimulation device (ReActiv8), which is intended to help strengthen the muscle as a means to reduce back pain and disability.
The trial is intended to gather data in support of an application for pre-market approval (PMA) from the US Food and Drug Administration (FDA).
Sixty-nine subjects have been implanted with ReActiv8 in the trial. The study design requires 128 subjects in the pivotal cohort to reach the 120-day endpoint before data are made available. An “interim look” for sample size re-estimation is planned when half the implanted subjects have data from the 120-day visit. The enrolment rate has been accelerating as the number of active sites has increased during 2017.
ReActiv8 is designed to electrically stimulate the nerves responsible for contracting muscles which stabilise the lumbar spine. Activation of these muscles to restore functional stability has been shown to facilitate recovery from chronic low back pain. Mainstay received CE mark for ReActiv8 in May 2016 based on positive results from the ReActiv8-A clinical trial, which demonstrated a clinically important, statistically significant and lasting improvement in pain, disability and quality of life in people with disabling chronic low back pain and few other treatment options.
Mainstay has begun commercialisation in Europe, focusing initially on high volume multi-disciplinary spine care centres in Germany. More recently, commercialisation has begun in Ireland, Mainstay’s home market.
Peter Crosby, chief executive officer of Mainstay, comments, “The ReActiv8-B clinical trial is advancing well, and, based on our experience to date, we anticipate completing enrolment around the end of this year, with results available in 2018.”