Saturday June 6, 2020

Mainstay hopes US regulator will approve back pain device in 2020

Company says it will need to raise €45 million if it gets FDA green light

Ian Guider

Markets Editor

22nd September, 2019

Mainstay Medical has said it will need to raise about $50 million (€45 million) if it secures approval from drug regulators to launch its chronic back pain treatment in America

Dublin stock market-listed Mainstay has submitted its treatment for pre-market approval by the US Food & Drug Administration (FDA) and is hopeful of securing the green light late next year.

Jason Hannon, Mainstay’s chief executive, said data submitted to the FDA based on patients using its...

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