Mainstay back pain treatment clinical trial passes mid-way point
Dublin-listed Mainstay Medial has announced that over half the required number of implants in the ReActiv8-B Clinical Trial have been performed.
ReActiv8 is designed to electrically stimulate the nerves responsible for contracting muscles which stabilize the lumbar spine.
Activation of these muscles to restore functional stability has been shown to facilitate recovery from chronic lower back pain.
The company said that the trial is intended to gather data in support of an application for pre-market approval from the US Food and Drug Administration (FDA).
Read more: Back treatment boost for Mainstay Medical
Approval from the FDA would be a key step towards commercialization of ReActiv8 in the US.
Mainstay has begun commercialization in Europe, focusing initially on Germany, where the company aims to drive adoption of ReActiv8 in a select number of high volume multi-disciplinary spine care centres.
More recently, commercialization has begun in Ireland.
"Our initial commercialization of ReActiv8 in Europe is well underway. Our strategy is to work with key reference centres in Germany, and then build on that experience and data from the ReActiv8-B trial to expand commercialization to additional centres and other countries," Peter Crosby, CEO of Mainstay, said.
In the US almost 70 subjects have been implanted with ReActiv8 in the clinical trial.
The trial 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.
"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," Mr Crosby, said.