Dublin listed medical device company Mainstay Medical has received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for its ReActiv8 device.
ReActiv8 is a device Mainstay has developed to treat chronic lower back pain.
The approval confirms inclusion of the device in the Australian Register of Therapeutic Goods (ARTG), which will enable its commercialisation in Australia.
Mainstay Medical estimates that there are about two million people in the EU and the US alone who could be candidates for ReActiv8 today.
Jason Hannon, CEO of Mainstay, said the company was excited to receive TGA approval and take the next step toward making ReActiv8 available to patients in Australia.
"Australian physicians who have been part of our clinical studies to date are among the most experienced globally in selecting and treating patients with ReActiv8 therapy," Mr Hannon said.
