Mainstay Medical has applied for ReActiv8 to be admitted to the Australian Register of Therapeutic Goods (ARTG) which would allow for commercialisation in Australia.
Mainstay’s ARTG application includes the results of the ReActiv8-A Clinical Trial, which showed clinically important, statistically significant, and lasting improvement in pain, disability, and quality of life for people with chronic low back pain and limited treatment options.
Peter Crosby, chief executive officer of Mainstay, says, “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 commercialisation 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.”
The Therapeutic Goods Agency will review the application and may request additional data during the review process. Subject to successful ATRG registration and reimbursement, Mainstay plans to establish its own direct sales force to market ReActiv8 in Australia.