Mainstay Medical eyeing late 2020 US commercialisation approval

Mainstay Medical eyeing late 2020 US commercialisation approval

Irish medical device firm Mainstay Medical is expecting, by the end of next year, a decision on whether its treatment for chronic back pain will be commercially approved for sale in the US.

Mainstay's sole product - already commercially available in Ireland, the UK and most notably Germany - is an implantable device called ReActiv8, which can be activated twice a day to treat the condition.

"We continue to make significant progress on our key corporate objectives of pursuing regulatory approval in the US and advancing the commercial validation effort in Germany and other select European markets," said chief executive Jason Hannon.

Mainstay submitted its pre-market approval application for ReActiv8 to the US regulator, the Food and Drug Administration - or FDA - last month. It expects FDA acceptance of the application for review next month and expects a final decision regarding approval "around the end of 2020".

"We also continue to make progress working with key physician partners in Germany who are incorporating ReActiv8 into their practices in order to validate commercial adoption, refine patient selection strategies and follow ongoing patient progress," said Mr Hannon.

Coinciding with its agm, Mainstay published interim figures showing a near 67% year-on-year increase in first half revenues to $600,000 (€544,200). Cash on hand, as of the end of June, stood at $5.8m, down from $29.7m at the end of 2018 and $23.5m last June.

The company is hopeful that further success in its core European market of Germany will pave the way for further expansion into the UK, Australia and the US.

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