Article on piloscopy...

[tedwuji]

They will be delayed for whatever reasons. You can bet on it.

i think the small trials he just mentioned will start this month.

as far as completion in entirety, who knows.

[tedwuji]

bump.

[Banana Republic]

I sent an email to Wesley's assistant and received the same reply that others had received several months ago:

"The scarless surgery technique (piloscopy) that Dr. Wesley pioneered has received over one million Internet mentions since its inception in 2008. Thanks to a recent $2.2M research grant, piloscopy is now likely scheduled to be made available with FDA Clearance in a few months. Not only will new patients benefit from this technique, but even patients undergoing current techniques (FUT and FUE) will benefit from this novel approach in a subsequent session."

Misleading time frames are not cool. How hard is it to update these automated replies and include an accurate time frame?

[tedwuji]

I sent an email to Wesley's assistant and received the same reply that others had received several months ago:



Misleading time frames are not cool. How hard is it to update these automated replies and include an accurate time frame?

true.

[JayM]

But it is fda approved now? They technology has been approved? So it's just a case of rolling it out now and seeing how good it is.

[tedwuji]

But it is fda approved now? They technology has been approved? So it's just a case of rolling it out now and seeing how good it is.

Not FDA approved.

[tedwuji]

"The scarless surgery technique (piloscopy) that Dr. Wesley pioneered has received over one million Internet mentions since its inception in 2008.*Thanks to a recent $2.2M research grant, piloscopy is now likely scheduled to be made available with FDA Clearance in a few months.*Not only will new patients benefit from this technique, but even patients undergoing current techniques (FUT and FUE) will benefit from this novel approach in a subsequent session."

[tedwuji]

"The scarless surgery technique (piloscopy) that Dr. Wesley pioneered has received over one million Internet mentions since its inception in 2008.*Thanks to a recent $2.2M research grant, piloscopy is now likely scheduled to be made available with FDA Clearance in a few months.*Not only will new patients benefit from this technique, but even patients undergoing current techniques (FUT and FUE) will benefit from this novel approach in a subsequent session."

FDA clearance in a few months.

[lacazette]

But if it wasn't FDA approved, he couldn't clinicaly use it to test small sessions on some of his patients no?

He already done clinical trials with FDA conditions, and now it sounds more like a "real world" trial for me, without FDA supervision or whatever

[Banana Republic]

FDA clearance in a few months.

Well, this is what they said several months ago. The projection is completely off the mark. I'm not familiar with the process, but presumably they would need to complete the trials first, then report on their findings, and then apply for FDA approval. That could easily be another year. But perhaps I'm mistaken.

[JayM]

Hmmm I'm like almost fairly certain the whole reason there was a hold up was because he changed the design and had to present this change to the fda.

I read the quote mate haha. I really don't want to scroll back through the pages to find it but I'm certain it's all been approved. It's not the same as drugs.

[JayM]

He's already shown the fda that the technique works. The hope between all use is that you can do donor multiplying. But that doesn't need to be proved at all in terms of fda. The delay was a change in design to the tools used but now it's been cleared.

[barfacan]

2018.

[tedwuji]

But if it wasn't FDA approved, he couldn't clinicaly use it to test small sessions on some of his patients no?

He already done clinical trials with FDA conditions, and now it sounds more like a "real world" trial for me, without FDA supervision or whatever

these small sessions will most likely comprise part of the FDA clearance process. real world trials are part of that.

[tedwuji]

2018.

could be.