Mainstay Medical announces regulatory approval from Australian Therapeutic Goods Administration (TGA) for ReActiv8

- 06/12/2019
  • Next step is applying for inclusion on Australian Prostheses List for private reimbursement; decision expected in the third quarter of 2020.

Dublin, Ireland: 6 December 2019 – Mainstay Medical International plc (Euronext Paris: MSTY.PA and Euronext Growth operated by Euronext Dublin: MSTY.IE), today announced that it has received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for ReActiv8, its implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain. This approval confirms inclusion of ReActiv8 in the Australian Register of Therapeutic Goods (ARTG), enabling commercialization throughout Australia.

More information on Mainstay’s website.