Thanks for the reply and the only thing I'll add is that CardioCel has an FDA Class 2 approval but we will need a Class 3 approval for DurAVR. Class 3 is for devices that sustain human life, carry the highest risk and Class 3 devices take a separate, more stringent path to approval: the Premarket Approval application, which requires extra proof of safety and efficacy.
AVR Price at posting:
$16.50 Sentiment: Buy Disclosure: Held
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