Breakthrough Device designation has much more liberal guidelines. A company only has to prove the device "Offers Significant Advantages over Existing Approved or Cleared Alternatives" or that "Device Availability is in the Best Interest of Patients", so it's not uncommon for companies to receive the designation. As a result, it wouldn't allow us to start selling the DurAVR commercially. It just speeds up our interactions with the FDA. It also wouldn't allow us to bypass trials or reduce the number of patients that need to be enrolled.
The Humanitarian Device designation would allow us to sell up to 8,000 DurAVR's per year but that designation does require that there be no comparable device approved and available, although there may be a bit of wiggle room with that depending on how the guidelines are interpreted by the FDA (and they do make the decisions). We'd still need a separate ViV trial to go for that designation to try to prove the DurAVR is a highly significant improvement on current ViV options, and even then it might not be enough as there are approved options. So Wayne and the team likely are weighing whether committing resources to a separate ViV trial is a prudent decision near-term.
AVR Price at posting:
$20.00 Sentiment: Hold Disclosure: Held
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