07.01.14
Mainstay Medical International plc has been give the go-ahead by the Belgian Federal Agency for Medicines and Health Products to expand the clinical trial of ReActiv8 (ReActiv8-A), its implantable neurostimulation device for the treatment of people with chronic low back pain, to include clinical trial sites in Belgium. The added sites also participated in the European Feasibility Study, results of which were presented in mid-2013.
“We continue to make progress, in line with our plan, on the path to regulatory approval and commercialization of ReActiv8,” said CEO Peter Crosby. “We are pleased to now add Belgium to our clinical trial which follows the commencement of our trial in Australia in March. When available, ReActiv8 has the potential to change the lives of the millions of people who suffer from chronic low back pain.”
The ReActiv8-A clinical trial started in Australia, and several sites have been actively enrolling subjects since March 2014. The purpose of the trial is to investigate ReActiv8 as a treatment for adults with debilitating chronic low back pain who have few other treatment options.
Mainstay is headquartered in Dublin, Ireland, and the company in primarily focused on its neurostimulation devices for low back pain.
“We continue to make progress, in line with our plan, on the path to regulatory approval and commercialization of ReActiv8,” said CEO Peter Crosby. “We are pleased to now add Belgium to our clinical trial which follows the commencement of our trial in Australia in March. When available, ReActiv8 has the potential to change the lives of the millions of people who suffer from chronic low back pain.”
The ReActiv8-A clinical trial started in Australia, and several sites have been actively enrolling subjects since March 2014. The purpose of the trial is to investigate ReActiv8 as a treatment for adults with debilitating chronic low back pain who have few other treatment options.
Mainstay is headquartered in Dublin, Ireland, and the company in primarily focused on its neurostimulation devices for low back pain.