DAVY VIEW

Mainstay has announced regulatory approval of ReActiv8 in Australia, a major milestone that will enable the device to be commercialised. Pending the securing of reimbursement status, we think that launch could occur in 2021. This approval decision is indicative of the strong clinical data built up to date for the device and follows approval in Europe in 2016. The next and main target market is the US, for which an approval decision is expected at the end of 2020. We envisage no change to our current forecasts.