Ann: 30-day Haemodynamic Results from the DurAVR US EFS Trial, page-71

Yeah I don't think there's any way we could get all patients implanted within a year. I think anything less than 2 years would be a win.

Just looking at Edwards, they have completed or started ViV trials for all three of the iterations of their Sapien device with around 200 patients in each trial. The XT trial was completed in 2020 and they are about to begin a ViV trial for their new version while they are currently running its pivotal trial. I agree that if money were no issue, doing the same and running a ViV concurrent with the pivotal would be great but money is obviously an issue. A partner paying some costs may be an option if we are willing to forgo a cut of revenue. That way after approval we would be guaranteed to immediately be able to sell valves for patients getting their first valves and ViV.

The gamble would be running a ViV trial with the aim of getting a Humanitarian Device Exemption, which would let us sell up to 8,000 valves per year for a profit before a full approval. The problem with that, as we've discussed a few times, is the FDA's guidelines state that to get an HDE no comparable device can be approved and commercially available, and there are other valves approved for ViV. So getting an HDE would be in no way guaranteed. Wayne and management have to be very strategic with their moves.