Yes and no - it's an HCT/P, meaning it uses human cells, tissues, or tissue-based products. Hence the FDA 'registration' process is different than the long-winded approval process for drugs. It's good to go though. It can be used, yes. But PolarityTE, the company that makes it has stated they are doing a controlled, limited release to select medical institutions this year. So some of the aforementioned institutions might already be putting it in action... Then they plan to rev up commercialization of the product in Q1 next year, which is when I assume others will be able to get their on hands on it as well.
I say we will know very soon if this works because it is already out in clinical settings being used. And in the coming few months (Q1 2018) even more places will be able to use it. If it works as they say it does, we will hear about and we will see the results, and vice versa.
If Dr. Cole is a communicative, easy-to-reach Doctor, then yeah - I think that's an excellent idea! Definitely worth a shot to put this on his radar if it's not already. Might even be able to get some of his thoughts or insight into the product!