new mass market for c-pulse

Rosa mentioned a new 1,000,000 patient plus potential market for C_Pulse.
Is this management trying to shore up their position re FDA trial going slow?
Clutching at straws?
I'm interpreting it as management informing the market they are not going to sell SSH cheap, lots of value in it and
they are very confident in the safety profile and patient friendliness of the fully implantable C-Pulse, (assuming the patients in the new application are roughly equivalent to a class 2)