Mainstay Medical has announced that the first subject in the ReActiv8-B clinical trial has been implanted with ReActiv8, which is an implantable neurostimulation system used to treat disabling chronic low back pain (CLBP).
The implantation was carried out at the Monash House Private Hospital in Melbourne, Australia by Dr. Bruce Mitchell, a sports and interventional pain physician.
Dr Mitchell noted: “Following our positive experience in the ReActiv8-A trial, we are very excited to be part of this pivotal trial to support a PMA in the US.
"Many of our patients have been suffering from chronic low back pain for years and have exhausted all available treatment options.
"ReActiv8 allows us to offer them a new, unique approach which addresses the cause of pain rather than just the symptoms.”
The study is an international, multi-centre, prospective randomised sham controlled blinded trial with one-way crossover conducted under an Investigational Device Exemption (IDE).
The trial’s statistical design requires data from 128 randomised subjects at the 120-day primary outcome assessment visit.
ReActiv8-B clinical trial is intended to collect data in support of an application for pre-market approval (PMA) from the US Food and Drug Administration (FDA).
This is essential towards commercialisation of ReActiv8 in the US.
The clinical trial will be considered successful if there is a statistically significant difference in responder rates between the treatment and control arms.
ReActiv8 is intended to electrically stimulate the nerves meant for contracting muscles that stabilise the lumbar spine.
Activation of these muscles to restore functional stability has been indicated to facilitate recovery from CLBP.
The firm secured CE Marking for ReActiv8 in May 2016 based on positive results from the ReActiv8-A clinical trial, which indicated a lasting improvement in pain, disability and quality of life in people with disabling CLBP.
Mainstay chief executive officer Peter Crosby said: “The implant of the first subject in the ReActiv8-B Clinical Trial represents further significant progress for Mainstay.
“During a year in which we have obtained CE Mark for ReActiv8, triggering the start of European commercialization activities, and raised €30m of new capital in June, the ReActiv8-B Clinical Trial provides further traction for our route to market in the US.”