There’s a liklihood that the clinical trials he is referring to aren’t necessarily relates to Follica. (-: he’s in NY no? Maybe someone could ask him in a consult
Nice. I too think he is referring to Follica, its consistent with the timeline and it was known they will pursue FDA Clearance for the device rather than FDA Approval.
Thats why Bhanusali is going to trial the device in his clinic.
@hanginginthewire That is a possible explanation, but neither of us know for sure what’s on his mind. He could be a sneaky dude trying to get people into his clinic, or he could be genuinely wanting this Follica thing to work out (if that’s even what he is talking about). Or it could be a bit of both.
You’re comment seems a tad slanderous unless you have information we don’t know about this particular person? Were you his patient? Has he been convicted of fraud?
FDA cleared devices are ones that is “determined to be substantially equivalent to an already marketed device”
This isn’t really good news in my opinion. You’d want FDA approval over Clearance. Where did you hear about this? It’s rather difficult to discern official information from hearsay
So the clearance might be for their “similar” version of microneedling, which does seems to work quite well as an adjunct therapy.