Hi - to all AVRers.............. I need help-- having read/seen...

Hi - to all AVRers.............. I need help-- having read/seen most announcements/videos, I am at a bit of a loss. Help !.

I highlighted below:-
-'...........single piece of bioengineered tissue.
-'...........patented anti-calcification tissue technology...
-'...........has been used clinically for over 10 years and distributed for use in over 50,000patients worldwide.
-'......... how do ' they ' place the 50,000+ tissue in patients? -
-'......... has there been any reported problems with the 'tissue' ?

We are to do some work with the FDA.
My questions are;-
- what are we now to prove to the FDA. ?
- our valve is 'ADAPT® tissue has been used clinically for over 10 years and
distributed for use in over 50,000patients worldwide.'

- Is it ' our valve'
-Is it how we place the DurAVRTM Surely it cannot be the 'tissue'

Thanks all - my mind has gone off on this and I cannot fathom ?

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The Company’s lead product, DurAVRTM, is a transcatheter heart valve (THV) for the treatment of
aortic stenosis. DurAVRTM THV has been designed in partnership with the world’s leading
interventional cardiologists and cardiac surgeons and is the first transcatheter aortic valve
replacement (TAVR) to use a single piece of bioengineered tissue. This biomimetic valve is
uniquely shaped to mimic the performance of a healthy human aortic valve.
DurAVRTM is made using ADAPT® tissue,Anteris’ patented anti-calcification tissue technology.
ADAPT® tissue has been used clinically for over 10 years and distributed for use in over 50,000
patients worldwide.
Controlled deployment and accurate placement of DurAVRTM THV is via Anteris’ proprietary
ComASURTM Delivery System. This system allows precision alignment with the heart’s native
commissures to achieve optimal valve positioning.
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