3D printed heart valves, page-26

I will just add my 2 cents worth. All of this is a little unclear so what I say may be incorrect. It’s just how I understand it.

I believe the Georgia study did mean something to the FDA and is perhaps the reason why we are only doing 15 patients as opposed to what I originally believed was going to be 30.

I have read somewhere, can’t bring to hand right now, that the primary end point for the EFS was 30 days.

I suspect the significant increase in the DurAVR population will likely come from commencement of EU CE Mark trials that I hope will start by the end of the year.

I agree on the BDD coming after some results for the EFS even though I would not be surprised if it was applied for after the 12 month data from Georgia is presented. The trial in Georgia was completed according to FDA protocols so the data is meaningful.