Mainstay Medical announced in a company release that it has secured approval from Ethics Committees in Australia to start a clinical trial of ReActiv8, its innovative implantable neurostimulation device for the treatment of people with chronic low-back pain. Recruitment of subjects for the trial has commenced at three clinical sites in Australia.
The purpose of the clinical trial is to investigate ReActiv8 as a treatment for adults with debilitating chronic low-back pain for whom surgery is not indicated. One of the root causes of chronic low-back pain is impaired control by the nervous system of the muscles that stabilise the spine in the lower back, and an unstable spine can lead to back pain. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve spine stability, allowing the body to recover from chronic low-back pain.
“Our novel approach of electrical stimulation to help restore the muscle control system is based on published scientific research, and the performance of the therapy was demonstrated in the recently completed European Feasibility Study.” says Peter Crosby, the chief executive officer of Mainstay Medical. “The energy and experience of the Mainstay Medical team has enabled us to complete the development of our innovative, therapy-specific device and obtain approval to start the ReActiv8 clinical trial within a year after the Feasibility Study results.”
Results from Mainstay Medical’s European Feasibility Study were presented at the meeting of the International Neuromodulation Society in Berlin in June 2013. Results showed a statistically significant and clinically important improvement in key outcome measures, including reduction in pain and disability from chronic low-back pain and an improved quality of life.