You are looking at the glass half full. But broken down to the absolute bone, the FDA must approve the procedure as a non-drug, minimally-manipulated, primary doctor out-patient treatment for a host of afflictions. For the FDA that is a tall order near-term. Is there any date set with the FDA on this issue?
The most obvious and immediate reversal of fortune lies with the international patent. The process is already approved in Europe and Asia.
The most common error many make is getting in too early. FDA could take a year or two. Who knows? It's all guesswork presently.
Unless someone can add to this question.