As far as getting approval by the FDA, the best info I've been able to find is from a study done in 2010. Above is the breakdown by stages of the Premarket Approval process, both monthly cost and total cost.
What it shows is that the bulk of the cash needed for these approvals is, on average, still ahead of us. Around $50 million needed for the pivotal trial and the process of obtaining the PMA, out of the total of around $90 million spent on average from the inception of the specific medtech program. These numbers are all USD and are from 2010, obviously things are going to be more expensive now.
But this is an average, I have no idea how we fit into that. The good part is that the FDA has lessened the average time PMA takes since then so that could save money, but the trials are still a big cost. Wayne has said that he may be able to offload some of those costs to participating sites so that may mitigate what we pay.
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