I consider any pre-revenue company to be very speculative and being clinical-stage does add risk. Devices are much, much more likely in general to be approved when compared to drugs so I agree with Wayne that the chance of a DurAVR approval is high but there is always the possibility that something unfortunate could happen to a patient during the trial, causing the trial to be halted. I don't expect that to happen given the DurAVR's safety record in a relatively small number of patients but the risk is there.
I assume that anybody invested in AVR is willing to take on the fundamental risks of being pre-revenue and clinical stage. This is not an investment for anybody not willing to assume those risks. And of course there is the specific risk of the DurAVR not showing superiority over the other valve systems its matched against in the pivotal trial, which could make it extremely difficult to capture even a small market share from the big boys.
My point was that the reward is still there if the next 3-4 years follows the expected path but yeah, this isn't Google or Apple, it's a speculative bet.
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