Follica Surprises yet Again and Targets a Best Case Scenario Release Date of 2018

Two days ago, someone named “Xaser94” on the hairlosstalk forums started an extremely interesting thread related to a company named Follica (which I have covered on this blog before).  The main point behind that thread is that PureTech Health (the majority owner of Follica) just released a lengthy and insightful year-end 2015 summary document (125 pages long) of all their subsidiaries on their website.  Also see this alternative summary document here.

Key quotes from that document regarding Follica:

  • Follica’s product concept originated from basic science demonstrating new hair follicle formation in adult mice following skin disruption, the results of which were published in Nature.
  • Follica’s three clinical studies of patients with androgenetic alopecia demonstrated hair follicle neogenesis via biopsy following skin disruption and/or hair growth through target area hair count.  One of these studies demonstrated that skin disruption alone was safe and generates new follicles as well as new hair, but did not achieve its primary endpoint as the chosen investigational compound (lithium gluconate 8 percent gel) did not further enhance the effect.  A separate clinical study, published by third-party academics, indicated that the combination of skin disruption and an approved hair-growth compound, minoxidil, showed a 4x enhancement versus the efficacy of the compound alone. [My note: Maybe referring to this 2013 study from India?].
  • Follica plans to initiate a registration study in the second half of 2016, with data read-out in 2017.
  • If the data are favourable, Follica would potentially plan to seek FDA clearance in 2017, with commercial release to follow as soon as 2018.

It should be noted that prior data released by Follica has generally been favorable, so there is a good chance that the new data will also be positive.

Follica Background & Technology

I have discussed Follica a few times on this blog before even though the company was formed in 2006 and I have been skeptical about it going anywhere after a decade of being in the news.  The last time I discussed Follica was in September of last year when the company’s patents were finally approved.  At the time, it seemed like Follica might add FGF-9 into the product mix after the wounding, although this is not as yet a given.  FYI — also, make sure to reread my old post on dermarolling.

The science behind Follica’s technology is very interesting and seems to make logical sense even to a non-scientist such as myself. In the word’s of the main researcher behind Follica’s technology, the renowned Dr. George Cotsarelis:

When cells move in to close a wound, they are trying to make a decision: Should I make epidermis or should I make a hair? There is a window of opportunity in which we can push them to make hair.

While over the years I have become dissuaded with both Follica and Dr. Cotsarelis due to numerous delays in their work (along with Dr. Cotsarelis making some pessimistic statements about competing technologies), I have nevertheless continued to be a proponent and follower of this company’s science.  It is extremely hard to create permanent NEW hair follicles in humans.  Numerous scientists have failed to do so over the years when trying to clone or multiply hair follicles in a lab.  Follica’s wounding technology is highly unlikely to cause any serious side effects such as cancer and will most likely be much faster to get government approval in comparison to cloning or multiplication type procedures.

It should be noted that Follica’s technology does not only entail wounding, but also the application of some kind of proprietary compound containing “various drugs and chemicals” once the scalp has been wounded.

And finally, a word from commentator Mike:

Around exactly the same time that I read the original HLT forum new thread on this development, one of this blog’s commentators named Mike also sent me the below pasted insightful e-mail and I should give him credit too:

Usually post as Mike and would’ve posted this but to be honest, I am sick of myself banging on about Follica but here’s something potentially worthwhile I found here (and I saved the best bit until last):

In the section titled External Validation, Follica received funding in 2015…

During 2015, Gelesis (twice), Tal Medical, Follica, and Karuna all closed financing rounds with external partners, with Akili closing a round post-period end. External financing rounds provide further validation for the technology plus, in the case of equity financings, validation of the business values, as was the case for Gelesis, Akili, and Tal Medical. In July 2015, Karuna received the Wellcome Trust’s Translation Fund Award, comprising a low-interest, unsecured convertible note of up to $3.8 million to fund Karuna’s combination proof-of-concept study, to demonstrate the potential of Karuna’s lead therapy, KarXT.

But they obviously didn’t advertise this. Question is why? I still think they’re up to something (good I hope!)

Now, that’s not the only bit of news. Under the section “Late Stage Pipeline”, look what it says:

Follica is progressing towards its registration study, and is expected to initiate its registration study in the second half of 2016.

I don’t know what that is but it sounds good right? But things are progressing, albeit very very much on the QT.

Perhaps that blog title might need to shave a couple years off it? Maybe too optimistic?? Or because here’s the last little tidbit I found:

Follica has also performed and funded preclinical work which, together with research from the University of Pennsylvania, serve as the foundational observations on which the technology is based. Follica plans to initiate a registration study in the second half of 2016, with data read-out in 2017. If the data are favourable, Follica would potentially plan to seek FDA clearance in 2017, with commercial release to follow as soon as 2018.

It’s under the section, “growth stage businesses”

Who knows but they’re going to an awful lot of trouble to say virtually nothing at all. And they’ve done 3 clinical trials. We only know about one because that’s the only one available to the public. There’s a couple of big ifs there. The data being favorable in particular but they have come this far.

I know you don’t like being emailed but I think this was worth it.

Fingers and toes crossed for 2018!!!!

All the best,


105 thoughts on “Follica Surprises yet Again and Targets a Best Case Scenario Release Date of 2018”

  1. Very exciting stuff. I had a good feeling about Follica from the beginning. Both Follica and Christiano’s research seem like the only legitimate research going on.

  2. Is anyone having any luck with dermarolling?
    I believe it could have positive effects even on receding front hair line if done right, but there is so much contradicting information in regard to frequency, needle size, pressure, etc.

  3. Great news! No new treatments for 30 yrs and now all of a sudden we’ll have a bunch released in 2018. Follica, Replicel, Histrogen all stated 2018 as possible. Will be exciting to see who wins the race.

  4. I think that wounding with a topical compound is a very promising cure. An experienced member from a Greek forum combined dermarolling with a tone of topicals and achieved excellent results. Here is the link where in the 1st page you can see the results and all the topicals used (thread is in Greek ):
    I think he is now trying to find out which ones work.

  5. I have doubt with follica treatements specially for high norwoods. It may be effective for low norwood but for high norwood it will not be applicable. It’s my opinion.

  6. Has this famous Dr. Cots ever produced any pictures or other solid results of any of the many things hes been involved in? So this treatment could come out like a DIY Hair Loss Kit containing some sort of roller for wounding and a fomular to smear on after wounding?

  7. Why do some of you guys even bother posting or come on this site? Always negative comments. If you don’t believe in a cure then say nothing. Great work admin, sorting through all the bs as per usual.

    1. yeah its kind of crazy how some people here have the need to post negative or pessimism stuff to reinforce their thoughts

  8. Hair follicle neogenesis through wounding and the application of a peptide? Sounds far too east.

    Follicum (the Swedish team) rule out peptides for hair neogenesis. (The product they are working on uses a compound that grows non-permanent hairs like minoxidil only better.)

    I’m intrigued as to what kind of growth Follica have achieved. Is it full complete hair regrowth and original density? A total ‘scalp reboot’? I hope so.

    This is definitely encouraging news and we’ll see what happens. My money is still on Tsuji labs finding a cure.

  9. @Jimmy, whos being negative. Im only reading comments from ppl whos (from my perspective) trying to get a constructive but critical discussion going about the many news coming from different companies.

      1. It IS constructive criticism. He’s asking for proof and that’s the very definition of criticising in a constructive and meaningful fashion.

        Now if you take everything that you read in press releases / website updates at face value then MPB is already cured!

  10. Lol, thanks Admin! And No I’m not Xazer94 though we were obviously up to the same thing, snooping for info! Hadn’t seen his post until much later in fact.

    Follica, despite the doubters (and I’ve been one of them at times), has always been the best bet in the near term. There are some obvious “big ifs” to confront but as you pointed out, prior data has taken them this far.

    Most likely everyone is asking when can we see some pics but that’s unlikely to happen for some time. We can’t forget that this isn’t something Puretech has gone public about per say. There’s no media coverage of this and Follica haven’t even updated their own website yet with the patent news from last year.

    So I think this is very positive news but cautious optimism is advised. It’s not 2018 yet and there is this next trial to come and I’d guess it’s with fgf9???

    The other positive that immediately springs to mind is the relative silence. Histogen for instance released pics waaaay before they even had an idea of a timeline (and is that still in play even?) but Follica haven’t.

    Why? I don’t know but my best guess would be that if you’re sitting on tech that works and has billion(s!) dollar potential, wouldn’t you sit on it until the last possible moment? For fear of copycats or whatever aside, it’s pretty big news to have a treatment that could get you your hair back. If it works, expect a media blitz in 2017! And what of negative comments by Cots at that hair congress where he said funding was a problem? Clearly disinformation. And for good reason, this is a race to make billions of dollars! As someone else commented on a previous post here, it’s a money thing. Follow the money!

    But there’s a ways to go and more milestones that Follica need to hit. Now though, there is a potential timeline in place and that feels good! We can maybe, just maybe be positive about hairloss finally having a proper treatment on the horizon.

    1. This assessment is pretty spot on in my opinion. Read through the patent issued at the end of 2015 it is very interesting, and covers a lot. If you were sitting on “the cure” you would be very silent until you absolutely had to say something… it’s simple economics. Fgf9, the other patent which Cotsarelis was issued, is known to stimulate Wnt and SHH pathways. From Christiano’s recent study pictures, JAK-stat inhibition and the SHH pathway had virtually identical results in inducing anagen growth phase powerfully. Perhaps fgf9 is indeed the compound that is applied for a short time after wounding. Let’s not forget this company was founded in 2006, so if something gets released in 2018 that is 12 years and sounds about right time wise for how long it can take something like this to make it from lab science to practical use.

  11. Has anyone from Follica addressed how these new follicles are supposed to be resistant to miniaturization?

    The reason why occipital hairs don’t miniaturize is because they have a much lower number/much less active androgen recepitors in their follicle stem cells.

    If Follica is used to generate follicles in scalp that has higher levels of androgen receptors, won’t these new follicles be just as vulnerable as the old ones?

    I suppose they could get around this by transplanting hairs from the occipital scalp to the balding area, and then using Follica to restore the donor area, but its concerning that they haven’t seem to have addressed this potential flaw in the treatment.

  12. So, is follica’s method for creating new long LASTING hair?…or do they likely only reach a level just above peach fuzz and wither away unless you keep greasily shining up your head with minidoxal continuely?

  13. I like how all of these companies that I’ve been following for 5+ years are all coming out at the same time: replicel, histogen and follica

    I’m a bit suspect with that fact even though it makes me much more excited. They are finally pushing each other to produce something… A “let’s see what you’re holding” moment. Undoubtedly some of these guys are going to bust but if even one comes through with something remotely useful I think we can all call that a success.


  14. I concur with Johnson and Guest99. I think Follica’s methods are suspect without some kind of unique enhancement compound. Even then, what is the likelihood of the hair remaining vibrant and healthy unless the compound is a high strength, topical anti-androgren?

    I do not have great hope in Follica. I think people would have had greater success with dermarolling if it were a viable treatment option. If wounding is eventually a viable treatment option, it will only be because a new compound is discovered that is already successful without wounding. Wounding may help, like with minoxidil, but it will not be vital.

  15. I think another big reason we have more hope invested in Follica and JAK is because both have large, reputable research institutions behind them: Follica’s Cotsaraelis with UPenn and Christiano with Columbia. They both seem more legit and less like snake oil for those reasons alone.

    1. This is by far the best news of the year!! BY FAR the best news of the last 8-9 years, since that famous interview in CBS… Some of you could do us a favor and stop complaining a little… for Christ..

      We’ve been waiting this news forever and when it finally comes there is still people to say BS! people really suck !!!

      1. How is this the best news from the last 8 – 9 years? We have no pictures yet, no statistics, no nothing. We have also known for a long time now that wounding causes hair regrowth, this is nothing new. We also knew that minoxidil would be more effective with wounding (2013 study from India). All we know right now is that Follica is working on some kind of treatment that might be released in 2018. We have no idea if it is going to be an effective treatment or just another mediocre treatment.

  16. So let me get this right: wounding the skin creates new follicles (something amazing in its own right I think) but the new follicles do not sustain because of missing growth factors?
    So Follica adds these to their compound which makes the follicles create hair?
    When true I understand @Johnson’s remark. New follicles could also be sensitive to DHT. In that case I can imagine that MPB sufferers would require microneedling and Follica top-ups, maybe in combination with Fin and Minox.
    Wounding that causes NEW follicles is good news for senior NW7’s I think, no need to stimulate dormant old follicles, just get some new ones!
    @Admin, what strikes me from your linked report on dermarolling + minox is that after dermarolling subjects where instructed to wait 24 HOURS before applying minox. Maybe lots of folks are dermarolling and apply minox immediately after, which could null the effect.

    1. Maybe patients have to wait 24h in order to prevent the minox + Follica chemicals going to deep in your system / bloodstream. For instance, some state that minox should never be applied directly after showering due to the possible side effects.

  17. Cotsarelis has always been my favorite. I am still trying to set up an appointment with him this summer. Hopefully he can divulge how much new growth we can expect with his treatment. This will probably be a treatment where you would have to do every couple years. Doubt the new hair will be dht resistant unless it takes it 18yrx to be affected like how it did for most of us. I was thinking maybe he will apply jak with wounding? What do you guys think? I remember on the Dr Oz show they said university of PA is testing a great hair loss treatment with igf lithium that grows a ton of hair but it will take 8 years to be available. That showed hair in 2012. Looks like time lines are adding up. I just hope jak lives up to its hype, follica replaces ht, and topical like follicum, SM and histogen get released for early stage mpb.

  18. Ladies and gentlemen, for who says the king of hair loss is doing nothing and Cristiano is better please shut up! Welcome back follica.
    Thanks for the news admin

  19. I had a hair transplant with loads of wouding and grafting. Nothing grow up apart from the transplanted hair.
    This sounds like b*llsh*t to me. Cotsarelis has only created false expectations to get investors and then selling the shares. Cristiano is my favourite!

    1. @Lucas
      Pretty sure it’s something else, can’t be that simple

      I mean when you get an SMP by example, there’s a chance that you’ll bleed A LOT, your scalp is wounded from the needle.
      And no, that doesnt create new hair follicles..

      And you’re basically saying that any hair transplant should make new hair grow again lol..

  20. I Think companys want investors money …. 3 years away…they invest ….all these years ….ZERO Hair….Mars mission Soon god …Harward This…university that… All bullshit

    Investment needed. …please pay in Dollars

  21. Hi All,

    I am 27 years old and started getting hair loss since two years ago, last year I started using Laser Therapy product and for now it has been a full year, my experience was ~~~ its ok but its not as powerful and results are not as strong as expected, I started using rogaine before two months, and the same time last month I started using hair massager(I ordered it after reading an article that was published here which had a link to a paper about scalp massage help hair regrowth), as well, I am using a 3$ manual scalp massager, I also have been using Isogensis Product B for 3 months.
    I bought the massager since the article mentioned it instead of manual massager, on amazon there was two version, US and Japanese that was used in the article, I bought the US version since it would be easy to communicate with the manuafactor in case of warrenty issues.
    what I noticed now after 30 days of using the massager, I have new hair being regrown on the front, my hair looks fine since I started losing it recently, so in pictures the difference is not noticeable at all but what I know for sure that I am regaining all my hair back, not sure which of the above really helped regaining but mainly I think the massager- though too early to stop using any of the above and isolate the real cause, however, reading this article and technology proposed with what I am doing makes sense.

    I am not trying to promote any products, thats why I didnt mention specific brands, I am just sharing my experience with the community.

    Thank you admin/all

  22. A company that stays silent all this time and now release this news… should be celebrated I guess!

    They’re getting there…

  23. Man I thought I was negative and depressing , but after reading some of these posts it’s just sad lol. Look this guy has been studying the exact mechanisms of hair knows the ins and outs of hair follicles. I am pretty sure he will release a treatment that will be highly effective. Pictures will come out probably in 2017 when they finalize their product. Let’s stop speculating and just wait and see. There is nothing else we can really do right? Or just a have it bro lol

  24. I’m following up on my treatment progress. Mind you I’m taking fin. Been using undiluted tea tree oil/minoxidil 5% topical only at night, and hair is growing in thicker on scalp. I also ordered some rice bran supercritical CO2 extract from a company in Scotland, and will start incorporating that into my regimen starting in 2 weeks. I also use revita shampoo daily (contains ketoconazole and t-Flavanone), and taking fish oil (raises HDL, and inflammatory) and an iron/magnesium (adequate rbc production, and magnesium for mood) supplement.

    1. Rather, I meant to say that the fish oil (taking PO) acts as an anti inflammatory. While the topical tea tree oil also has anti inflammatory properties.

  25. If a viable treatment finally comes out, how will the team behind it cope with all the millions of men rushing to get treated?

    It will be like the biggest rock concert of all time selling out within five minutes.

    I cannot see how there wouldn’t be a waiting list of multiple years to get treated, especially if the procedure is complex and requires a scalp biopsy and cell culturing that can only be undertaken by the team who made the breakthrough.

    Even if the discovers foresee this and train up more people, it would take more time and even then there would still be huge waiting lists.

    This aspect has me worried almost as much as hoping a cure is found soon lol.

    1. Well I’d imagine readers of this and the other forums will be first to know when ‘sign up’ is available. We’d be one of the first to be treated

      1. The company might release big news directly to the media and only open sign up after that, which would mean those on forums would not be at an advantage for being first in line for treatment.

        Besides, even if those online did learn about it first and were able to sign up early, it might not be practical or even healthy for us to be constantly checking hair cure news on a daily basis for years until a cure comes. And it would need to be checking on a daily basis, because big news could come at any time.

        Then there are those who might don’t want to be the first to get it and would rather wait a few years to see others’ results. But if you do that, what’s to say the waiting list won’t be 5-10 years once you want to have it done?

        I just hope that whoever finds a successful treatment is able to commercialise it on a very large scale so that everyone can benefit with minimal waiting times.

  26. Phil Collins I am putting a couple drops of tea tree oil on my scalp like you said and my hair growing straighter and healthier. No new growth obviously but the hair is Def thicker. It’s been a week or so. I also add peppermint rosemary and castor on my thinning right temple. Hopefully I can get some regrowth and thickening there

    1. Yea I heard peppermint helps but be careful, you don’t want to get a chemical burn. My scalp is starting to feel soar again and I’ve been using the tea tree oil for 2.5 weeks. And hasn’t felt soar like this in a few years. I think I also might have tinea capititis, so I might need to go to the derm and get an oral azole anti fungal (which interacts with almost every drug known to man)

  27. @RoboC, very good point. If what comes out is something that needs biopsy amd stuff like that its almost sure that 1. It will probably cost 10 times more than a FUE and 2. There will be a 10 year waiting list. No, we need treatment that can be applied by ourselves at home. Histrogen have talked about their aim to make their product kinda like BOTOX, which would also be great.

    1. You are wrong about the price. Susheido said their treatment will cost around 2 to 3k, I believe or some low number. It’s a quicker procedure injecting cells than doing an ht where they rip up your scalp like an apache Indian lol

  28. This is the best Bald News of all time!! Knowing with certainty now that Follica is alive and kicking… All of us had this fear that they had failed and now we know for sure that they’re going well… this is what matters… Wonderful news! Couldn’t be better! They’re moving on! It’s awesome !!

  29. Hostogen for early stage baldness, follica and jak for late stage balding. Then everything else is more than welcome, follicum, sisheido etc:) We need at least 4 different effective treatments for baldness just in case one doesn’t work for everyone.

  30. Id feel a lit more optimistic if I knew for sure that they aren’t relying on wounding and minox. If they are im screwed.

  31. mjones, if one method works consistently enough, there’s no need to add others, in fact I see no point in that thought, really…

  32. Idk I kind of agree with mjones. There are so many reasons people can start losing hair, I dont think one treatment would be able to treat them all. And what works for some people doesnt for others as weve seen with so many other drugs out there. Follica may be the end all for one person and have minoxidil like effects on the next guy, whereas histogen or Jak completely stops and reverses his. Idk, I just think the more flavors in the pot, the better off the end result will be for everyone. Especially since I dont think flying to the bahamas, or japan, or w.e to get treated with one of these in the near future will be mine, or most people on heres way out. Im a 25 yr old college student living on my own – how the hell do I come up with even 3k for an injection? And possibly follow up injections?

    Idk- I can’t get hyped up about any of these injections or stem cell, lab growing follicles, etc etc. None of it seems like it will be the answer, at least not in the next 10 years. Yeah it may be released and work for most people but the cost is going to be insane, demand equally insane since you know all these rich baldies will jump on the bandwagon asap and actually have the money to do it, and having to travel for these is also just an added cost. I still think the answer is much simpler. The follicles are not dead, just dormant, and previously they grew long luscious hair. I feel like the answer will be something that just restores them to their previous state- not creating new ones in a lab and implanting them or having cultured stem cells injected. Knowing younger teens have an insanely thick amount of hair, and reading posts on HGH reversing hairloss in some cases lead to me believe that. ..idk. Just my two cents.

  33. My point is: if a treatment is able to restore your hair, be it by creating completely new follicles or by just reviving your old ones, what for do you need another treatment?

    I mean, it’s good to have others competing, off course but, once one reaches the spot and gets it right, that’s it, end of the game!!

    I guess Follicas method is intended to work consistently for anyone.. And now we finally know for sure that that informal interview Cotsarelis gave to Desmond was misleading, a disguise, so good to know now! lol

  34. @mjones, haha Im ready to scalp someone if some sort of treatment is not here soon;-) Im also up for injecting myself with all sort of stem cells and smearing my body in Voodo’ish esoteric olis and wierd mixtures…as long as some of it halts my hair loss, lmao.
    On the serious side, good to know that yet another company is moving forward. Now we know they really are working on something so I hope to god that they’ll succeed with 2018 and keep us updated as they go along . All this speculation is driving all of us Lovecraftian mad.

  35. Hey tom, I highly doubt they will be using minox as part of their protocol. I think it’s going to be another topical. Fgh1 lithium or whatever it’s called. I’m waiting to see pictures of a nw4 turned into a solid nw1.5 or 2 then I will be ecstatic!

  36. The best would be topical jak, and it reboots the follicle to anagen phase with full regrowth. Easy and no surgery involved. Would creating new follicles damage the dormant ones? Is there room for new follicles? Confused by that. Whatever, as long as it works and grows back our hair. I am still in favor of multiple treatments. Jak, follicle, histogen, follicum. For those who are low Norwoods, histogen or follicum would be best. If you have coverage on top with just temple recession and thinning crown, follica won’t be necessary..shoot some histogen in the thinning areas and it should fill up .

  37. Mjones what was the name of the topical they used in the trials that was ineffective which caused them to turn to minox?

  38. It’s good to have different kind of treatments since under some conditions hair follicles can be permanently destroyed, like several types of scarring alopecia, full thikness scarring, burnt injuries. In those cases, people needs new hair follicles and i was thinking about the study which hypothesis that hair follicles turn into the skin cells after awhile. Maybe high norwoods need new follicles to be created too. Its always good to have more than one option, so the prices could be regulated and lower also

    1. One problem though is even if they successfully can generate new follicles, they will be generated in an area which has a genetic propensity to elevated androgen-receptors, so likely the new follicles will have the same propensity to miniaturization as the follicles its replacing.

      So if this treatment does work its possible it will only be useful in conjuction with hair transplant, i.e. you transplant miniaturization resistant hairs from the occipital region to the top of the scalp, and then use Follica to regenerate follicles in the occipital region.

      Still is impossible to know in advance which methods will work and be effective on a large scale so all attempts are welcome

  39. I wonder if Follica’s wounding treatment will also be effective for diffuse thinners and those with hair that is just thinned a bit but they who would like more of it/thicker hair.

    Would this wounding/skin layer peeling technique risk damaging existing surrounding healthy hair follicles? Like if you wanted your entire scalp treated which still has many hairs left?

  40. Will the follica treatment be possible to use on areas of thinning hair to thicken those areas up? Or only on slick bald areas?

    Also, I wonder if the new hairs will grow in a natural manner, evenly and uniformly spaced out like natural hair or in a more random formation.

  41. I am looking forward to different treatments since I have traction alopecia it is difficult to find any treatment that will grow my hair back. I don,t care how the hairs grow in as long as they grow.

  42. hair cloning will be when? It will be history when baldness? Why not make statements recently by Replicel Samumed Follie? d. When will the angel products? Did they all lie?

  43. Bla bla bla. And where are the results of the clinical trials? we want to see facts, science! not words.
    I would like to see a baseline picture and another with the results.

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