Mainstay Medical International is seeking approval from the Australian Register of Therapeutic Goods (ARTG) for its ReActiv8 implantable neurostimulation system to treat disabling chronic low back pain (CLBP).
The company submitted an application to the ARTG for ReActiv8 neurostimulation system to commercialise in the country.
One of the reasons of CLBP is impaired control by the nervous system of the muscles, which stabilise the spine in the low back, while an unstable spine may cause back pain.
The firm has designed ReActiv8 to electrically stimulate the nerves responsible for contracting these muscles, helping to restore muscle control, improve spine stability, and recover from CLBP.
Mainstay has applied for the approval based on the results of the ReActiv8-A clinical trial.
According to the company, the trial demonstrated clinically important, statistically significant, and better improvement in pain, disability, and quality of life for people with CLBP) and limited treatment options
The ARTG will review the application and may call for additional data during the review process.
Mainstay CEO Peter Crosby said: “This application for approval to sell ReActiv8 in Australia is another step on our path to commercializing ReActiv8 in major world markets, adding to our initial commercialization activities in Germany and plans for other European markets.
“We are also making good progress with the ReActiv8-B Trial to gather data for an application for US marketing approval.”
Based in Dublin of Ireland, Mainstay operates subsidiaries in Ireland, the US, Australia and Germany.