Follica Pivotal Study And Fda Filing In 2020

[Kagaho]

Their micro-abrasion device has been tested with various compounds in three previous clinical trials, meaning human trials, all of which showed they are inducing neogenesis (new hair follicles).

Unlikely. The device was probably designed for the optimization study.

Not 100% sure but after reading the latest patents and following the job openings of the company all points to the design published last year.

 

[That Guy]

 

[Kev123]

Most of what I've heard about follica has been kind of vague info. Does anyone have an edjucated guess how much this will actually do? Could it half hair loss + maybe add some new stuff?

I wish there was more than just words and numbers. I wish there was pictures.

 

[Kev123]

Well it depends on "how slick is the targeted area".Many will see an improvement while others will not.
All in all in some cases that treatment will lower the cost in some cases of a hair transplant.
What is great is that many people will achieve a "functional" cure this way

I don’t think you guys should be going around throwing the word cure around for every little thing that comes out for hair loss. It’s depressing to read that word at this point for me. As much as I would like for something, anything, to be a cure, it just gets thrown around so much with no care in the world. Usually for things that don’t even have any solid proof like pictures.

 

[NewUser]

Unlikely. The device was probably designed for the optimization study.

Dosing, frequency and "other important parameters" have been optimized. Next is a pivotal trial.

“From years of clinical testing, we have optimised the dosing, frequency, and several other important parameters and translated these learnings into a unique and proprietary treatment. Based on this interim analysis and the results of three previously conducted studies, we are excited to move forward into a pivotal study at the end of 2019.”

 

[Rho Gain]

I don’t think you guys should be going around throwing the word cure around for every little thing that comes out for hair loss. It’s depressing to read that word at this point for me. As much as I would like for something, anything, to be a cure, it just gets thrown around so much with no care in the world. Usually for things that don’t even have any solid proof like pictures.

Well, this isn't going to be a "cure" - I would guess on average a 1-2 Norwood improvement, with better results for those who are lower NWs to begin with (which is why it's so important to do everything you can to keep as much hair as you can). The $65k question is: Is the new hair DHT resistant, or just as sensitive as their miniaturized friends? If it's still susceptible to DHT, a Big Three regimen will still be necessary. But this is it - it's happening. Follica is coming to market, and maybe sooner than I thought.

 

[That Guy]

Well, this isn't going to be a "cure" - I would guess on average a 1-2 Norwood improvement, with better results for those who are lower NWs to begin with (which is why it's so important to do everything you can to keep as much hair as you can).

Yeah, see...

People have thrown this around for at least the last couple of years, but the thing is: It's entirely baseless. The entire thing seems to stem from the fact that, many years ago, there was something about X amount of hair per cm2 and somehow people translated that into "only good for X norwoods", but haven't backed that up with anything and failed to consider that if it were only good for "low norwoods" then it's actually useless for everyone given the concept of the treatment.

So like, if you get this and you're NW7, it magically stops when you've recovered to say NW4? Why would it do something like that?

Are we saying that it's diffuse? Where are the pictures supporting that? If it's only diffuse, then it's sh*t even if you're NW3 because now you're NW1 will be diffuse. We know it's repeatable, so why can't it just be done again and fill in those areas?

In order for what you're saying to be true "an average of 1-2 norwood improvement" the treament would have to be ineffective at growing hair on certain areas of the scalp. Yet, not one person has provided a shred of proof that this the case, mainly because they don't know.

However, since there is no reason to assume this WOULD be the case, it is therefore more logical to assume that if the concept works as hypothesized reliably in most individuals to cause neogenesis upon application to an area, then it SHOULD be able to work for any stage of hairloss.

So it remains to be seen exactly how effective it is at growing hair, but this idea of "it's only going to be good for a couple norwoods" literally makes no sense at all.

 

[GrowPro]

It’s all in the press release, just not spelt out explicitly.

If you read the press release, they claim the following:

“Follica device has shown significant therapeutic advantages in scalp treatment versus commercially available skin disruption technology”

Let’s assume that the other commercially available products are dermapens and rollers. What they are claiming here is that follicas device is better than them, however they haven’t ruled out that the head to head comparison yielding a better result for follica is due to chance. This might be because their sample size was too small, poor research design or maybe the follica results weren’t substantially better. I suspect it’s the latter.

Based on this, I would guess the device would be similar, and maybe slightly better than Needling.

If you look on the needling thread, you’ll see some insane results for some people. Follica will probably be suited for those who aren’t comfortable needling at home due to Infections/lack of knowledge/queasiness and prefer the comfort of a doctors clinic. This probably applies to most consumers including myself.

Meanwhile, they are also working on compounds that will improve on their treatment, which I think will be released at a later stage. I’d be more excited by this..

I agree with your point on Follicas method/device being suited for those that aren’t comfortable with a diy approach and I think that’s fine, if they price it aggressively it could be a huge success for them. I don’t see why Follicas approach and DIY approach can’t co-exist being successful as a business and both producing successful results, I liken it to restaurants or coffee or beer, sure you can get all that at home for cheaper and diy-it but some people like eating in a nice restaurant or going to Starbucks or hitting up the local bar and don’t mind spending the money.

 

[GrowPro]

What's a realistic commercial launch window for this?

I would wager, at the earliest, last quarter of 2020, latest Summer of 2021.

 

[PeggyPeterson]

Does anyone know what the results of the 3 clinical trials were?

I recall someone mentioning a specific x/cm^2 number. I’ve also heard someone where they were testing a lithium based compound a while ago. Any sources to back these claims?

 

[MrV88]

Yeah, see...

People have thrown this around for at least the last couple of years, but the thing is: It's entirely baseless. The entire thing seems to stem from the fact that, many years ago, there was something about X amount of hair per cm2 and somehow people translated that into "only good for X norwoods", but haven't backed that up with anything and failed to consider that if it were only good for "low norwoods" then it's actually useless for everyone given the concept of the treatment.

So like, if you get this and you're NW7, it magically stops when you've recovered to say NW4? Why would it do something like that?

Are we saying that it's diffuse? Where are the pictures supporting that? If it's only diffuse, then it's sh*t even if you're NW3 because now you're NW1 will be diffuse. We know it's repeatable, so why can't it just be done again and fill in those areas?

In order for what you're saying to be true "an average of 1-2 norwood improvement" the treament would have to be ineffective at growing hair on certain areas of the scalp. Yet, not one person has provided a shred of proof that this the case, mainly because they don't know.

However, since there is no reason to assume this WOULD be the case, it is therefore more logical to assume that if the concept works as hypothesized reliably in most individuals to cause neogenesis upon application to an area, then it SHOULD be able to work for any stage of hairloss.

So it remains to be seen exactly how effective it is at growing hair, but this idea of "it's only going to be good for a couple norwoods" literally makes no sense at all.

I remember that (if it works) it could/should somehow repair scarred areas like FUE scars, what's your opionen about that?

 

[MrJolly16]

But this is Follica guys, we will see photos. That´s for sure, I have no doubt at all.

However, I wonder how effective and expensive this is going to be.

I just want to buy my device and have it at home, so I don´t have to go to a clinic.

 

[That Guy]

I remember that (if it works) it could/should somehow repair scarred areas like FUE scars, what's your opionen about that?

Well, I know they've used dermarolling for scars and such for years, so it could work. I don't really know so much about the success rate with scarring so I can't really say.

 

[Xaser94]

But this is Follica guys, we will see photos. That´s for sure, I have no doubt at all.

However, I wonder how effective and expensive this is going to be.

I just want to buy my device and have it at home, so I don´t have to go to a clinic.

They seemed to remove references to the home device on their website and on their new powerpoints. It may have noit added much benefit in their optimization trial.

 

[GrowPro]

They seemed to remove references to the home device on their website and on their new powerpoints. It may have noit added much benefit in their optimization trial.

Interesting.

I believe their “at-home” device is just a less invasive stamp type device the also releases at the same time whatever at-home compound or topical they want patients to apply, I guess they didn’t see any value in it.

 

[Rho Gain]

Yeah, see...
People have thrown this around for at least the last couple of years, but the thing is: It's entirely baseless. The entire thing seems to stem from the fact that, many years ago, there was something about X amount of hair per cm2 and somehow people translated that into "only good for X norwoods", but haven't backed that up with anything

Well, that "something" came directly from Follica's own study, and the "X" was 25 hairs per cm^2. A healthy head has somewhere between 124 to 200 hairs per cm^2 (https://www.ncbi.nlm.nih.gov/pubmed/10417585), which means that 25 hairs is roughly 1-2 NWs, depending on your natural density. So, it's backed up directly from Follica's own data released thus far. I suppose we could assume they've achieved better results, but that would truly be making things up.

and failed to consider that if it were only good for "low norwoods" then it's actually useless for everyone given the concept of the treatment.

Well, all available protocols thus far have proven to be more effective for lower NWs; all the science thus far has shown us that it is easier to keep hair than grow it. That doesn't mean Follica is "useless," only that it probably follows similar efficacy patterns; the more hair you have, the more you grown, and the more resilient your remaining hairs are. Granted, that is an assumption, but one informed by previous research, and if Follica could transform NW7's to 0's, they probably would have said as much (or at the very least alluded to it). Instead, the only hard data they've released are those previously discussed above, gathered from men 18-40 with NWIII-IV. They must have chosen those parameters for the cohort for a reason, the most likely one being they didn't feel they would have gotten great results from older, higher NWs.

So like, if you get this and you're NW7, it magically stops when you've recovered to say NW4? Why would it do something like that?

Because there are limitations to the body's healing response. One can lose the tip of a finger, but with the right care and application of healing agents, it's possible to fully regrow it. However, the same can not be said if one loses the whole finger - the body cannot regenerate that much and that complex a structure - we aren't lizards.

Are we saying that it's diffuse? Where are the pictures supporting that? If it's only diffuse, then it's sh*t even if you're NW3 because now you're NW1 will be diffuse. We know it's repeatable, so why can't it just be done again and fill in those areas? In order for what you're saying to be true "an average of 1-2 norwood improvement" the treament would have to be ineffective at growing hair on certain areas of the scalp. Yet, not one person has provided a shred of proof that this the case, mainly because they don't know.

No, not that it's incapable, but, again, the slick areas of NW2-3's are relatively newly slick, and thus more receptive to the intervention. If you're a NW7, and you followed a traditional pattern of loss, the areas that have been slick the longest are those that go first - the temples and and the crown.

However, since there is no reason to assume this WOULD be the case, it is therefore more logical to assume that if the concept works as hypothesized reliably in most individuals to cause neogenesis upon application to an area, then it SHOULD be able to work for any stage of hairloss.

Again, there is reason to assume this, because that is what the research has shown us thus far - the longer your hair remains miniaturized, the harder it is to revitalize it. While Follica's hair is De Novo, any synergistic effect those new hairs will have on the miniaturized hairs surrounding them will be limited if they have been in that state for a long time. And if Follica can only achieve 25 hairs per cm^2 - and they have yet to give us a reason to believe they can do better than that - then covering a high Norwood with hair is unlikely.

So it remains to be seen exactly how effective it is at growing hair, but this idea of "it's only going to be good for a couple norwoods" literally makes no sense at all.

Follica's own data says otherwise; the only data they've released re. grown hair is the 25 number. In a sense, either opinion is uninformed, as we don't have all the data, but of the data we have (and from what Follica has said), it's far more likely that this won't grow 100k hairs. That being said, two NWs is nothing to sneeze at - nothing short of a transplant or a 95th percentile response to finasteride/min can produce that sort of result. And if they can develop novel compounds that result in better gains than minoxidil, then anything is possible.

 

[Kev123]

Well, this isn't going to be a "cure" - I would guess on average a 1-2 Norwood improvement, with better results for those who are lower NWs to begin with (which is why it's so important to do everything you can to keep as much hair as you can). The $65k question is: Is the new hair DHT resistant, or just as sensitive as their miniaturized friends? If it's still susceptible to DHT, a Big Three regimen will still be necessary. But this is it - it's happening. Follica is coming to market, and maybe sooner than I thought.

But how do you know it will be 1-2 norwood on average?

Follica is up to something, that’s all I know. And that something looks like it’s coming to market. But people went crazy because Fidia bought the Brotzu lotion and look where we are now.

If people can just wait for actual results before making any claims of a cure or predicting what results will look like, I think people would be less disappointed when something doesn’t work.

I seek results on their website and all I see is words and numbers. No actual evidence. I’m not saying this isn’t going to work...my god I hope it does...but damn...cure...1-2 norwood gains....jee-zus.

 

[That Guy]

Well, all available protocols thus far have proven to be more effective for lower NWs; all the science thus far has shown us that it is easier to keep hair than grow it. That doesn't mean Follica is "useless," only that it probably follows similar efficacy patterns; the more hair you have, the more you grown, and the more resilient your remaining hairs are.

The available protocols do not operate via this mechanism.

The resilience of remaining hair is also totally irrelevant here.

Because there are limitations to the body's healing response. One can lose the tip of a finger, but with the right care and application of healing agents, it's possible to fully regrow it. However, the same can not be said if one loses the whole finger - the body cannot regenerate that much and that complex a structure - we aren't lizards.

Your analogy is completely off.

Because this therapy is akin to regrowing a whole finger.

No, not that it's incapable, but, again, the slick areas of NW2-3's are relatively newly slick, and thus more receptive to the intervention. If you're a NW7, and you followed a traditional pattern of loss, the areas that have been slick the longest are those that go first - the temples and and the crown.

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

Again, there is reason to assume this, because that is what the research has shown us thus far - the longer your hair remains miniaturized, the harder it is to revitalize it. While Follica's hair is De Novo, any synergistic effect those new hairs will have on the miniaturized hairs surrounding them will be limited if they have been in that state for a long time. And if Follica can only achieve 25 hairs per cm^2 - and they have yet to give us a reason to believe they can do better than that - then covering a high Norwood with hair is unlikely.

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.

 

[HairSuit]

Well, that "something" came directly from Follica's own study, and the "X" was 25 hairs per cm^2. A healthy head has somewhere between 124 to 200 hairs per cm^2 (https://www.ncbi.nlm.nih.gov/pubmed/10417585), which means that 25 hairs is roughly 1-2 NWs, depending on your natural density. So, it's backed up directly from Follica's own data released thus far. I suppose we could assume they've achieved better results, but that would truly be making things up.



Well, all available protocols thus far have proven to be more effective for lower NWs; all the science thus far has shown us that it is easier to keep hair than grow it. That doesn't mean Follica is "useless," only that it probably follows similar efficacy patterns; the more hair you have, the more you grown, and the more resilient your remaining hairs are. Granted, that is an assumption, but one informed by previous research, and if Follica could transform NW7's to 0's, they probably would have said as much (or at the very least alluded to it). Instead, the only hard data they've released are those previously discussed above, gathered from men 18-40 with NWIII-IV. They must have chosen those parameters for the cohort for a reason, the most likely one being they didn't feel they would have gotten great results from older, higher NWs.



Because there are limitations to the body's healing response. One can lose the tip of a finger, but with the right care and application of healing agents, it's possible to fully regrow it. However, the same can not be said if one loses the whole finger - the body cannot regenerate that much and that complex a structure - we aren't lizards.



No, not that it's incapable, but, again, the slick areas of NW2-3's are relatively newly slick, and thus more receptive to the intervention. If you're a NW7, and you followed a traditional pattern of loss, the areas that have been slick the longest are those that go first - the temples and and the crown.



Again, there is reason to assume this, because that is what the research has shown us thus far - the longer your hair remains miniaturized, the harder it is to revitalize it. While Follica's hair is De Novo, any synergistic effect those new hairs will have on the miniaturized hairs surrounding them will be limited if they have been in that state for a long time. And if Follica can only achieve 25 hairs per cm^2 - and they have yet to give us a reason to believe they can do better than that - then covering a high Norwood with hair is unlikely.



Follica's own data says otherwise; the only data they've released re. grown hair is the 25 number. In a sense, either opinion is uninformed, as we don't have all the data, but of the data we have (and from what Follica has said), it's far more likely that this won't grow 100k hairs. That being said, two NWs is nothing to sneeze at - nothing short of a transplant or a 95th percentile response to finasteride/min can produce that sort of result. And if they can develop novel compounds that result in better gains than minoxidil, then anything is possible.

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.

 

[tomJ]

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.