Capital injection will help Mainstay Medical to complete a pivotal clinical study in the US and accelerate European commercialisation.
Dublin medtech player Mainstay Medical has raised €30m in financing to accelerate the development of its ReActiv8 product for chronic back pain.
Crucially, the funds will enable the medtech player to complete a pivotal US clinical study for ReActive8-B in order to get pre-market approval from the US Food and Drug Administration (FDA) ahead of a US launch.
‘Over the next year, we are targeting to have 10 or more physician partners who have performed multiple implants’
– JASON HANNON
It will also help to advance the initial commercialisation of ReActiv8 in Germany and other European markets.
New shares issued
The €30.1m financing was made possible through the issue of 2,151,332 new ordinary shares to new and existing shareholders.
The investors are primarily institutions in Europe and North America, at a price of €14 per new share. The Ireland Strategic Investment Fund (ISIF) is participating in the financing, subscribing for 714,285 new shares, representing approximately 33.2pc of the total number, for an amount of approximately €10m.
In addition to ISIF, Mainstay’s existing long-term investors, Sofinnova Partners, Fountain Healthcare Partners and KCK Limited, as well as several individual investors, are also participating in the financing.
“Our goals for the next two years are clear: complete the ReActiv8-B clinical study, file the PMA for ReActiv8 with the FDA and build our commercial presence in 2018 for more meaningful commercial expansion starting in 2019,” said Jason Hannon, CEO of Mainstay.
“A key focus in 2018 will be building market awareness in Germany and developing reference sites who care for chronic back pain patients and believe in ReActiv8.
“Over the next year, we are targeting to have 10 or more physician partners who have performed multiple implants, with whom we will work to expand market awareness and adoption, refine patient selection strategies, and follow ongoing patient progress. This financing provides the capital to drive forward on all these goals,” Hannon said.
Mainstay moved to Dublin in 2012 from its native Minneapolis base in Minnesota when it raised $20m in a Series B round led by Fountain Healthcare.