DAVY VIEW

Incremental news flow in the H1 results states that Mainstay has filed a pre-market approval (PMA) application with the US FDA for ReActiv8. The company has compiled a compelling data package that should resonate with regulators – an approval decision is expected end-2020. At the end of July, Mainstay secured funding that will take it through to 2021, past the key FDA decision in 2020 that could unlock the US commercial opportunity. Commercial efforts continue to advance in Germany where strategy will continue to be refined, with the experience gained used to propel commercial activities in future markets.