TCT 2023 PHYSICIAN PANEL INTERVIEW, page-16

THE FOLLOWING IS ANSWERING LEX's QUESTION ABOUT ANOTHER COMPANY, NVNO. IT'S NOT ABOUT ANTERIS:

It's just preliminary safety results through 30 days, the company won't file their application for approval until a year from now when all patients have had their valves implanted for a year, but the adverse event percentage was below the endpoint, although just below at 8% having events vs the cutoff at 9%. And all 6 of the adverse events are expected to be moderate with the patients that had problems and have had the device implanted long enough still showing improvement in their function vs before they received the implants.

So I think it's good although I would have liked to have seen a lower percentage and we'll see what the data looks like a year from now. The very good is that there were no severe adverse events and even the patients that had moderate problems had their function improve.

I think the biggest risk is the FDA eventually deciding that the 74 patient trial (after one dropped out) is not enough to prove safety and requiring a another trial, which would not be good for the company. If we do get an approval and start selling devices in 2025, the upside could be massive very quickly but there is the chance that the FDA could need more years of data. I'm without question holding my position.