Mainstay Medical has suffered a setback in its efforts to get its ReActiv8 implant approved for therapeutic use in Australia, with regulators requesting additional clinical data.
ReActiv8 is an implantable neurostimulation system intended to treat disabling chronic low back pain.
The medical device firm said it would use the data submitted through its ongoing ReActiv8-B clinical study to satisfy the request from the Therapeutic Goods Administration (TGA). However, the clinical study is only expected to be fully enrolled by the end of the second quarter of the year, and a full read-out is not anticipated until closer to the end of the year.
“Upon availability of the ReActiv8-B data, we plan to submit a new application to the TGA seeking admission of ReActiv8,” the company said. The TGA may seek further information during the review process, but it must complete assessment of applications within about one year.
Mainstay, which is listed both in Paris and Dublin, said when it first submitted the application in January 2017 that the Australian authorities might require further information, Davy analyst Andrew Young said in a note to clients.
Shares in Mainstay were trading up nearly 3 per cent at 17 cent in Paris following the news.