Medical device firm Mainstay Medical has sought approval to market in Australia its implantable device for chronic low back pain.
The Dublin-listed company has applied to have ReActiv8, a neurostimulation system, added to the Australian Register of Therapeutic Goods. If approved, it would clear the way for commercialisation in Australia.
"This application for approval to sell ReActiv8 in Australia is another step on our path to commercialising ReActiv8 in major world markets, adding to our initial commercialisation activities in Germany and plans for other European markets," said chief executive Peter Crosby. "We are also making good progress with the ReActiv8-B Trial to gather data for an application for US marketing approval."
If the application is successful, Mainstay will create a sales force in Australia to market ReActiv8. The company won European approval for the device in May.
The move follows a fundraising round in June last year that yielded €30 million.
Mainstay is headquartered in Ireland, relocating from the US in 2012 following a $20 million funding round led by Fountain Healthcare Partners.
