Irish-listed firm Mainstay Medical has received approval from the Food and Drug Administration (FDA) in the US to begin a clinical trial of its implantable neurostimulation system aimed at treating chronic low back pain.
The system, Reactiv8, helps restore control to the muscles that stabilise the lumbar spine.
“The FDA approval to start a US clinical trial of ReActiv8 is a major step towards our goal of bringing ReActiv8 to the US market,” said Peter Crosby, chief executive of Mainstay Medical. “We are impressed with the FDA’s responsiveness during the development and review of this trial. It helped us to develop a clinical trial to meet the needs of the company, the FDA, and the millions of people who could potentially benefit from ReActiv8.”
The trial will evaluate the safety and efficacy of ReActiv8 in treating adults suffering with chronic low back pain who have had no previous back surgery. It will be conducted at up to 40 clinical trial sites, with 128 randomised subjects implanted with ReActiv8
Once the trial has been completed, Mainstay can begin the process to commercialise the product in the US.
