Follica Pivotal Study And Fda Filing In 2020

[Rho Gain]

The available protocols do not operate via this mechanism.

The resilience of remaining hair is also totally irrelevant here.



Your analogy is completely off.

Because this therapy is akin to regrowing a whole finger.



That is relevant to therapies which seek to revitalize or maintain existing hair.

There is no hard evidence that neogenesis is less likely in slick bald areas



No, again you're comparing apples to coconuts and once again missing the fact that this isn't innately a one-and-done treatment. The patent on the device includes an attachment that allows you to bypass existing hair.

There is, however — due to the body's healing response — reason to assume that the treatment may not be as effective on many older patients.

You're also operating under the assumption that a lower cm2 amount of hair is somehow more acceptable on lower norwoods; it's not, as it would leave you diffuse regardless of whether you're NW7 or 1. If this thing only produced diffuse amounts of hair, then it is not a viable option for those with receding hairlines — it's target demographic.

Goal post: Follica will only be good for gaining a couple of norwoods or lower-tier norwoods

- Since the concept of the treatment is to grow new follicles wherever it is applied (the process is repeatable) and we have no evidence suggesting that this treatment is less effective in particular areas or after a certain passage of time (in young patients), and a diffuse amount is unfavorable at any hairloss stage, it is therefore unreasonable to assume that the treatment's utility is limited by the amount of hair one already has instead of other biological factors.

Well, we'll have to wait (about two years or so) and see. But the facts we know - the data we actually have - says 25 terminal hairs per cm^2, and their optimization study is focusing on mid NWs, not high ones. There must be a reason they gave that number and chose that cohort profile, and if it was the case that results could be compounded to a more natural 140-200 hairs per cm^2 on high NWs, they would have said - or alluded to - as much. I hope you're right, but all research to date says you're not. That's not to say it could change; this is Follica V.01 - they will be fine-tuning it for the next ten to twenty years, adding new compounds as they are cleared, applying new techniques developed from data gathered from commercial patients, applying AI deep learning to greater data sets, etc. I would be surprised if it couldn't some day grow significantly more hair than it can now, just not on its first day of commercialization.

Follica definitely sounds appealing. My concern however is: will the population that cant use minoxidil and finasteride be at a loss once again with this product? Seems like their future compounds wont he released for many many years as there compounds are in pre clinical stage.

They have said in the past that this will be an adjunct therapy to those already available, and that it would work in conjuncture with minoxidil/finasteride (https://www.hairlosstalk.com/news/new-research/follica-presents-at-the-aad-2017-annual-meeting/ : "Treatment modality not the same as minoxidil/finasteride, so they would most likely not discourage people from stopping their current treatments"). Given that, I believe that the new hair will be as dht-sensitive as the patient's miniaturized hair.

My only caution to this...... while everything you’ve said maybe correct, our own experiences as it relates to dermarolling on our own have shown that it is the higher norwoods with more substantial loss and diffuse thinners that are far advanced, that respond most favorably. At least as it relates to the most drastic of meddling recoveries. The guys that have mild recession, or are just starting to thin, they seem to be the guys for which it doesn’t work. That one makes me shake my head.

I don't give much credence to anything claimed on the forums, and the modality - simple rolling with or without minoxidil - is very different than what Follica has developed. The key to Follica's value isn't in the wound response, it's the precision with which they've harnessed it. They have spent 15 years studying this phenomena, and are finally coming to market after feeling satisfied that they have perfected every aspect of it - depth, frequencies, windows, etc. There are just so many factors to the wound response that have to be accounted for and manipulated that no home roller could possibly stumble upon all of them. This is why I haven't tried it myself - I am too afraid that I would end up doing more harm than good, since the protocols developed by the handful of available studies are very unsophisticated in comparison to what Follica has achieved.

 

[MrV88]

Well, we'll have to wait (about two years or so) and see. But the facts we know - the data we actually have - says 25 terminal hairs per cm^2, and their optimization study is focusing on mid NWs, not high ones. There must be a reason they gave that number and chose that cohort profile, and if it was the case that results could be compounded to a more natural 140-200 hairs per cm^2 on high NWs, they would have said - or alluded to - as much. I hope you're right, but all research to date says you're not. That's not to say it could change; this is Follica V.01 - they will be fine-tuning it for the next ten to twenty years, adding new compounds as they are cleared, applying new techniques developed from data gathered from commercial patients, applying AI deep learning to greater data sets, etc. I would be surprised if it couldn't some day grow significantly more hair than it can now, just not on its first day of commercialization.



They have said in the past that this will be an adjunct therapy to those already available, and that it would work in conjuncture with minoxidil/finasteride (https://www.hairlosstalk.com/news/new-research/follica-presents-at-the-aad-2017-annual-meeting/ : "Treatment modality not the same as minoxidil/finasteride, so they would most likely not discourage people from stopping their current treatments"). Given that, I believe that the new hair will be as dht-sensitive as the patient's miniaturized hair.



I don't give much credence to anything claimed on the forums, and the modality - simple rolling with or without minoxidil - is very different than what Follica has developed. The key to Follica's value isn't in the wound response, it's the precision with which they've harnessed it. They have spent 15 years studying this phenomena, and are finally coming to market after feeling satisfied that they have perfected every aspect of it - depth, frequencies, windows, etc. There are just so many factors to the wound response that have to be accounted for and manipulated that no home roller could possibly stumble upon all of them. This is why I haven't tried it myself - I am too afraid that I would end up doing more harm than good, since the protocols developed by the handful of available studies are very unsophisticated in comparison to what Follica has achieved.

Let's say you want to sell a product and this product will be perfected later or the results will be better over time, but you want to sell now...what do you do?

Show the 25 hairs on a slick bald head that would look like sh*t or a chose a lower Norwood and close the temples or get thicker hair like a NW1 in a "relative"short amount of time?

IF this works and neogenesis is the real deal with this it should give you much more than those 25 hairs over time, because it's repeatable and there is no reason why forming new hair should stop at a specific number (25). If it works it will give you more, if not it's already garbage

As far as I remember they are developing several new compounds or will use a combination of new ones from other companies that aren't available at the moment, so hope for the best and get ready for the worst..

 

[OneDay_NW0]

Smart words

 

[Xander94]

Can some1 explain how follica will work ? will u need to go to a clinic to get treated ? Will u buy a device and a topical ? I am confused

 

[Seuxin]

Maybe a silly question but....Does anyone have an idea when we could be able to know the topical coumpound used ?
What about Follicas patent?

 

[Tom4362]

Will it be available in Europe?

 

[Rho Gain]

Let's say you want to sell a product and this product will be perfected later or the results will be better over time, but you want to sell now...what do you do?

Show the 25 hairs on a slick bald head that would look like sh*t or a chose a lower Norwood and close the temples or get thicker hair like a NW1 in a "relative"short amount of time?

IF this works and neogenesis is the real deal with this it should give you much more than those 25 hairs over time, because it's repeatable and there is no reason why forming new hair should stop at a specific number (25). If it works it will give you more, if not it's already garbage

As far as I remember they are developing several new compounds or will use a combination of new ones from other companies that aren't available at the moment, so hope for the best and get ready for the worst..

It's not "garbage" and there's a great reason to release a protocol that produces those results: There isn't a single solitary balding man on the planet who would, after being asked if he'd like two Norwood's worth of har back via a minimally invasive, relatively affordable procedure, say, "Nah - no thanks." There has yet to be - in all of human history - anything that can reliably regrow two NWs. By you logic, Apple should have waited a decade (two? three?) to release the first iPhone, because it would be able to produce a much better version later. For me, two NWs makes me - at least cosmetically - a Norwood 0; two NWs is literally life-changing for tens of millions of men (customers). And as the product evolves and efficacy improves, more and more of the market is unlocked. They are the only company to have pursued this technique commercially, they are the only company to have invested in 15 years-worth of R&D - they will quite literally own the market until their patent expires. Why on earth would they wait and risk FIFTEEN YEARS of capex when they can make billions right now?

And where has Follica claimed results are compoundable? I've seen it repeated many times, but please link the actual source for the claim? I'm not saying it isn't so, but I've never seen it mentioned in the Follica-generated documents I've read.

 

[That Guy]

And where has Follica claimed results are compoundable? I've seen it repeated many times, but please link the actual source for the claim? I'm not saying it isn't so, but I've never seen it mentioned in the Follica-generated documents I've read.

Cotsarelis had said so years ago. There's an article somewhere on this site about it.

But you don't even need that: Just common sense. I don't mean to sound so patronizing here, but like, you really aren't considering the most obvious questions.

Can you dermaroll more than once?

How many successful dermarollers only ever did it once?

Why would they include an attachment to bypass hair if it would only worked on slick bald areas? If you grow some hair back, but not all of it, why couldn't they just do it again and use that attachment?

I'd also linked some years back now an article about how the body can only delegate so much of its resources to healing at any one time. So given that, why would it even be reasonable to expect that it would be one-and-done?

What do you theorize — and what scientific data do you have to support — would prevent the results from being compoundable?

 

[Kagaho]

As an almost 2 year dermaroller user, i can assure you, results are compoundable.

 

[Rho Gain]

Cotsarelis had said so years ago. There's an article somewhere on this site about it.

But you don't even need that: Just common sense. I don't mean to sound so patronizing here, but like, you really aren't considering the most obvious questions.

Can you dermaroll more than once?

How many successful dermarollers only ever did it once?

Why would they include an attachment to bypass hair if it would only worked on slick bald areas? If you grow some hair back, but not all of it, why couldn't they just do it again and use that attachment?

I'd also linked some years back now an article about how the body can only delegate so much of its resources to healing at any one time. So given that, why would it even be reasonable to expect that it would be one-and-done?

What do you theorize — and what scientific data do you have to support — would prevent the results from being compoundable?

I appreciate you aren't being condescending, and I understand that dermarolling is a repetitive effort. That being said, there is also likely a point of diminishing returns, just as there is for just about all cosmetic treatments. I say, "likely" because no one knows for sure, but again, if it was possible to repeat the process enough times to grow a full head of hair, I think they would be hinting at that by now. So I don't have any data (and neither is there any to support the opposing theory), only the fact that Follica hasn't said that's the case. Further, if it were possible to grow a full head as the protocol is currently configured, why would they be investigating other compounds? There'd be no (or at least, no compelling) need.

And I think there's some confusion as to what I believe; I don't believe that it "only works on slick bald areas," I believe the opposite - that it probably works better where there is still some hair left. To that, the device is designed to pass around existing hair because it's intended to be used on thinning areas, not slick bald ones (though it will work in that case, just not as well). This is why they've chosen mid NWs as subjects for their final, pivotal trial; if they thought they could rescue NW7s, wouldn't they include them in the cohort? That would be something to really crow about, and would make headlines around the world. Instead, they went with mid NWs, which I believe is because they feel it is in those where they will see both the strongest and most obvious results (no NW2's, because the transformation wouldn't be as visually dramatic). There has been some hypotheses postulated that rolling has a synergistic effect on locally miniaturizing hair - that the de novo growth "wakes up" nearby recently miniaturized hair. I think there's probably a good chance of that, and that at least some of the yield generated by rolling protocols are previously slumbering follicles; this has been true of legacy therapies, so I don't think it's unreasonable to assume the same of this one.

 

[OneDay_NW0]

It's not "garbage" and there's a great reason to release a protocol that produces those results: There isn't a single solitary balding man on the planet who would, after being asked if he'd like two Norwood's worth of har back via a minimally invasive, relatively affordable procedure, say, "Nah - no thanks." There has yet to be - in all of human history - anything that can reliably regrow two NWs. By you logic, Apple should have waited a decade (two? three?) to release the first iPhone, because it would be able to produce a much better version later. For me, two NWs makes me - at least cosmetically - a Norwood 0; two NWs is literally life-changing for tens of millions of men (customers). And as the product evolves and efficacy improves, more and more of the market is unlocked. They are the only company to have pursued this technique commercially, they are the only company to have invested in 15 years-worth of R&D - they will quite literally own the market until their patent expires. Why on earth would they wait and risk FIFTEEN YEARS of capex when they can make billions right now?

And where has Follica claimed results are compoundable? I've seen it repeated many times, but please link the actual source for the claim? I'm not saying it isn't so, but I've never seen it mentioned in the Follica-generated documents I've read.

You can't read. He never said they should wait. He just explained why it's better marketing to close a bit of NW1 temples than making NW6 to a slightly better NW6 or NW5.

 

[NewUser]

And don't forget, Follica has *not said that we'll be able to play the piano after one procedure, either. That's an asterisk as far as some of us are concerned.

Our technology is based on a proprietary approach intended to create an "embryonic window" in adult skin, allowing new follicles and new hair to form from epithelial stem cells.

 

[coolio]

The compoundability of Follica's deal is not easy for them to study in controlled conditions. Clinical trials are mostly dealing in windows like 6 months, not 6 years. It costs them a lot more money & trouble to keep a trial going for several years than it costs us. And without the confirmation of a longer-term trial result, Follica would be out of line making any claims about it.

All that said, I agree there may be a point of diminishing returns. If was possible for this to work as THE CURE then you'd think we would know about it already. Dermarollers & needling are getting more attention lately but they are not really new techniques. Guys on hair loss forums were messing around with the principle 10-15 years ago.

 

[BalderBaldyBald]

Can some1 explain how follica will work ? will u need to go to a clinic to get treated ? Will u buy a device and a topical ? I am confused

There's no in-home abrasive device, that's for sure, only clinics or derms as they stated in their 'news'
As for the rest, @NewUser posted their website presentation, a compounds of existing treatments maybe, but their 'novel' drug is not planned anytime soon.

No new molecule was patented by Follica, they just tried existing ones, you can find almost all their patents and trials online.
They've tried Valporic Acid VPA, some PGD2 (now we know it's a dead end, cf Seti and Fevi), minoxidil, topical finasteride, topical dutasteride and list goes on...all available to read online.

So yeah, they'll maybe sell their own formula that may better suits Androgenetic Alopecia with their 10yrs trials behind, nobody knows, but as for new developed drug, nothing...not even an ID, Ref, temporary name of any kind of novel drug in any of their patent...

There's just nothing more to say
I don't know where people find their magical sources, but that's obviously still R&D, even their main website mentioned Existing Treatments + Their Device

CB and some visits to derms to get our scalps burns seems the only way, or stick to finasteride, minoxidil and those disruptive scalp burning sessions

 

[That Guy]

Personally, I'm glad they've seemingly abandoned the at-home device.

I don't think we actually need a device that would probably cost a lot just so that we can make sure we're following the routine and then have to presumably order more products. Products that, at least right now, we should be able to buy where we are.

It not only cuts down the cost for the consumer, but also increases availability and a faster launch.

Because now, they'll only have to manufacture a handful of the devices.

 

[Xander94]

aka bullshit cope...

 

[Xander94]

Unless they are gonna give the tech to derms worldwide and not only US

 

[BigOl'BaldingHead]

Does anyone have any idea when the results of the optimization study of follica should come out?

 

[HairOnFire]

And where has Follica claimed results are compoundable? I've seen it repeated many times, but please link the actual source for the claim? I'm not saying it isn't so, but I've never seen it mentioned in the Follica-generated documents I've read.

From Follica's recent press release:

https://www.biospace.com/article/re...e-interim-data-in-male-androgenetic-alopecia/

"The safety and optimization study is an endpoint-blinded, randomized, controlled study designed to evaluate Follica’s proprietary skin disruption device in men with androgenetic alopecia and to establish therapeutic parameters, including the optimal duration and frequency of treatment. The study will continue to enroll up to 60 men, ages 18-40, with moderate grades of androgenetic alopecia (Hamilton Norwood III-IV)."

This is in line with the paradigm shift in recent years with respect to facial rejuvenation. Years ago, you'd get a single, severe treatment - like a phenol peel, or an ablative laser - which did major damage to the face, which would ultimately heel and rejuvenate the skin. However, the downtime associated with these procedures was measured in weeks to months. Side-effects were also a concern - pain, scarring, hypopigmentation, etc. Nowadays, multiple less-invasive treatments are performed, usually 3-6 treatments spaced about a month or two apart. The downtime is far less, and side-effects are relatively minimal.

The only concern I have with multiple treatments for alopecia is shock loss or transection (physical damage) of existing hair follicles, which can happen with hair transplants, for example. I am not sure if Follica accounts for this or not, but they do say their procedure thickens existing hair, so maybe there's not much to worry about.

 

[tomJ]

From Follica's recent press release:

https://www.biospace.com/article/re...e-interim-data-in-male-androgenetic-alopecia/

"The safety and optimization study is an endpoint-blinded, randomized, controlled study designed to evaluate Follica’s proprietary skin disruption device in men with androgenetic alopecia and to establish therapeutic parameters, including the optimal duration and frequency of treatment. The study will continue to enroll up to 60 men, ages 18-40, with moderate grades of androgenetic alopecia (Hamilton Norwood III-IV)."

This is in line with the paradigm shift in recent years with respect to facial rejuvenation. Years ago, you'd get a single, severe treatment - like a phenol peel, or an ablative laser - which did major damage to the face, which would ultimately heel and rejuvenate the skin. However, the downtime associated with these procedures was measured in weeks to months. Side-effects were also a concern - pain, scarring, hypopigmentation, etc. Nowadays, multiple less-invasive treatments are performed, usually 3-6 treatments spaced about a month or two apart. The downtime is far less, and side-effects are relatively minimal.

The only concern I have with multiple treatments for alopecia is shock loss or transection (physical damage) of existing hair follicles, which can happen with hair transplants, for example. I am not sure if Follica accounts for this or not, but they do say their procedure thickens existing hair, so maybe there's not much to worry about.

My concern is that one will have to couple it with minoxidil.