Hi John,
Just to clarify we are “seeking” approval for continuation of use after the trial use. Hopefully this comes through. We have also added extra sites with small patient numbers to expand the number of centres that may be able to use DurAVR after they have committed their trial commitment.
The other good news was having Dr Marty Leon and Dr Mike Reardon as Co Chairs of our pivotal study.
We also don’t have to pay for the competitors valves as part of the trial as they are covered by insurance.
Ann: AGM Chairman and CEO Presentation, page-12
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