Mainstay Medical has secured approval from the US Food and Drug Administration (FDA) for its flagship ReActiv8 device, which is used to treat chronic back pain.
ReActiv8, which won European approval in 2016, is implanted in a surgical procedure and works by electrically stimulating nerves in muscles supporting the lower spine.
FDA approval is primarily based on results from a clinical study involving more than 200 patients.
"This milestone is the culmination of a development process over many years," said Mainstay chief executive Jason Hannon.
FDA approval grants Mainstay the right to market ReActiv8 in the US as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction in adults who have failed therapy and are not candidates for spine surgery.
Mainstay, which is based in Dublin, with subsidiaries in Australia, the US and Germany, said it is currently refining its commercial launch plans for the US, including building out its commercial team in the region.
The company currently estimates that there are approximately 2 million people in the EU and the US who could be candidates for ReActiv8. It estimates the market for disabling chronic lower back pain in patients not suitable for surgery is worth approximately $30 billion (€26.7 billion).
Mainstay made its first commercial sale for ReActive8 in 2017 shortly after it won a CE mark, which authorises the product’s sale across the EU. The product was this month approved for inclusion in a list which means it is eligible for reimbursement from all private health insurers in Australia.
Mainstay recently announced plans to take the listed company private due to a lack of liquidity in its shares and the costs associated with being publicly listed.
