Summary of Jason Bhardwaj’s video at the bottom of this post:
- Follica FDA approval targeted for 2023.
- Seems like Phase 3 trials should start shortly. They were supposed to start in 2019-2020, but got delayed.
- 6 brief in-office treatments.
- Cost = $3,000.
- 75% chance of strong hair growth effect. 25% chance of modest effect.
Follica
Of all the companies that I have covered on this blog, Follica (majority owned by PureTech) is by far the most frustrating. The company was founded in 2005 and its CEO is Jason Bhardwaj. I have covered Follica regularly since this blog was incepted in August 2013.
Regular readers (and myself) expected Phase 3 clinical trials of Follica’s drug-device to have been completed at least 2-3 years ago. Yet here we are in 2022, getting a poster instead. The company’s invention (a scalp wounding device) is relatively straightforward in concept.
The purposeful scalp wounding and injury phenomenon has been proven to grow hair in numerous studies (see my post on at-home microneedling). Not entirely surprising, since even friction from long-term cast use has often grown hair in people.
Follica’s device is unlikely to require any kind of hurdles in being approved by the US FDA, as the potential for side effects seems negligible. Moreover, all signs are that the company will initially only use Minoxidil in combination with the device. Minoxidil was already approved by the FDA to treat male pattern hair loss in 1988. In fact, people are now increasingly taking off-label oral Minoxidil to treat their hair loss.
Jason Bhardwaj Presentation
Yet I keep covering Follica and giving them the benefit of doubt. Future hair cloning and hair multiplication related hair loss cures will always have the potential of major side effects. Not to mention major cost in the initial years. New medications will also be met with some trepidation when in comes to long-term side effects. In contrast, wounding related side effects will most likely be limited to minor scalp bleeding. And some scalp skin deterioration in the worst cases.
Recently, I discovered the below (see bottom of post) video presentation from Follica CEO Jason Bhardwaj. It is on Peter Diamandis’s YouTube channel. The presentation happened fairly recently and it is the first time that I have seen Mr. Bhardwaj talk. I am assuming that Mr. Diamandis arranged the conference where the below video was filmed.
Peter Diamandis Needs my Money
A funny story. In 2008, I flew across the country to attend the Singularity Summit (initiated by Ray Kurzweil) in San Jose, California. After the event was over, one of the younger guys that I befriended invited me to a mini-conference and dinner that he was organizing in a large private room in a restaurant.
Little did I know that just 20 or so people would be in that room. As soon as I entered, Mr. Peter Diamandis (at the head of the table ) approached me and shook my hand vigorously and gave me a huge smile. Within a few minutes, it became clear to me that this was a major donor meeting based on Mr. Diamandis’ intro. I was totally out of place with my lower middle class living standard.
I immediately left the restaurant after telling my organizer friend that I knew no-one in the room. Even he seemed a bit uncertain and had the deer-in-headlights look after witnessing the list of accomplished attendees. To this day, I have no idea why he invited me in the first place.
Having said that, Mr. Diamandis is known as Mr. Optimism. He is always smiling and overly optimistic about everything. You never read or hear even one pessimistic statement from him on Twitter or in his numerous YouTube video appearances.
A bit disappointing that we’ve only gotten a poster. In the spirit of trying to remain positive, it was nice to see that 75% of people will have a strong response (…assuming that’s an actual stat and not just something they used for the survey).
oh – just watched the video. yep, they’re reporting 75%. Q1 2024 release date. 6 treatments – $3k.
That’s just from the minoxidil lol jk
I’ve given up on them. Some of the others (Stemson etc) are moving and not playing games like this. I get there are setbacks but the communication is lacking and I can no longer take them seriously (I never really did to begin with as I never saw them as a real contender with a real cure).
Admin. Are you sure it was a major donor meeting in that private room or something else “Mr. Optimism” and his twenty friends had in mind? Whichever way, I’d say you dodged a bullet mate. (Also; the least they could’ve done is given you a poster on the way out.)
Funny, but it was in a fairly public place so doubt it.
Kidding aside. I haven’t really paid much attention to this company. Wouldn’t there need to be an anti-androgen included to maintain whatever results are produced?
Here we go king of hair loss came back again lol. Looks like it’s saying the strong responders rate is 77% but regarding the result seems only 35% had a strong result and 42% had moderate result.
In this case Follica + HT would give you a good coverage.
Admin you write really well, but no one believes in this company, and we expect hair cloning by now. Should we get ready for a article about wigs soon?
Hair Systems yes. Wigs no.
Nice find Admin…….I think this provides a few more clues! I share your skepticism regarding Follica yet can’t quite make myself not want to believe. It is very difficult trying to understand how a treatment that is being promoted as a ground breaking advance, according to their statistics, has been moving at such an inept pace for years now. However, it sounds like it may be an issue of money: At about 13:40 of the video, he says the start of the Phase 3 study is dependent upon fund raising timing…….they already missed late 2021 so now we are in the second half of their window for a start date. Bhardwaj did not try to explain any delay as covid related. If funding has been an issue, it could be a sign that either the treatment isn’t as good as what the stats would make it seem, and/or potential investors question the ability of the business model and their ability to protect their intellectual property from counterfeiting. Also, at about the 13:30 mark he says the FDA “wants to see 2 Pivotal studies”. At the pace they are moving, hard to believe they can get 2 pivotal studies and FDA approval completed by 2023.
Great points PinotQ.
Following up on my comment above, to me this probably means that Follica’s treatment has merit. The merit of the treatment might be an average 10% to 20% increase in hair count or an average 44%, each with increased hair diameter…….I have no idea but even at the low end this would be a welcome new tool in the fight not to move backward. I think the dilemma here is that this is a borderline investment proposition from the practical standpoint of having a protectable intellectual property asset.
The story with Diamandis is hilarous. He wanted you to donate for his xprize maybe XD
Good point. I think he even said a few words to me, but quickly realized that “this guy looks out of place” here. Now I forgot the exact details! I was not wearing a blazer like half the people attending.
Kintor second drug update:
https://www.prnewswire.com/news-releases/kintor-pharma-announces-dosing-of-first-subject-in-us-phase-i-clinical-trial-of-gt20029-for-androgenic-alopecia-and-acne-301474837.html
Untill we realise the issue is with the scalp environment mainly the sebum oil glands not in the hair follicles. A complete solution won’t be available.
Bla bla bla …. Follica is nowhere.
At one session per week, that price equals $26 000 per year.
I have been microneedling once per week at 1.5mm since December (that is, tomorrow I will have my sixth session) with a topical 15% minoxidil and 1mg Finasteride combo.
I have had hair thickening and “statistically significant regrowth” I suppose, but as a Norwood 5, I look and feel exactly the same. (I plan to show you guys a picture comparison in the summer, even if I get no results). It cost me $10 for needles so far (I bought a giant bag’s worth when I bought the machine five years ago for a few hundred. —3K would not be worth the price for these results so far.
You can go find a lot of examples of people making big gains with microneedling, once-a-week, 1.5mm, with Minoxidil and Finasteride. But that’s always after 8…12…15… months of consistent weekly effort. At 26K year, after year, after year, after year; get an awesome transplant(s) instead. And thank god we’re in-the-know. They are banking on people that know nothing about AGA treatments.
I have long suspected that Follica knows their business model will have very poor patient retention, which is why they are delaying—they did not invest in a successful treatment.
I think it is 6 treatments for $3000 (spread over a few months). Not sure if you have to continue at same pace for life.
Yes. Toccata is getting it wrong
$3000 for six sessions divides into $500 per session. 1 session per week would be $26000 per year. If instead we follow Dhurat’s study (she is the clinical advisor for Follica), she spaced 15 sessions over 6 months, or $15000 per year. (And they were on Finasteride and Minoxidil which also have a cost). Not by much, but I *can* see a sliding scale on price.
—or Derminator $200 / $5 per needle cartridge.
Interesting Toccata, though I doubt they can expect people to come to a clinic 52 times a year! Or even 20 times.
I know from personal experience years ago; when I stopped, I lost my gains. I was praying on Cots’ research on creating *new* follicles. I hoped they would be immune to AGA. Guys on reddit have also lost after they stopped. (and I was still applying minoxidil when I lost it).
Anyways, I’m trying again. This time for much longer—like once a week for years. I’ll see if that recovers a high norwood.
Remember from Rachita’s Microneedling study:
“All the patients were subjected to microneedling procedure weekly for 4 sessions initially and then fortnightly for subsequent 11 sessions. The total duration of microneedling treatment lasted for 24 weeks.
The response in the form of new hair growth started after 8-10 sessions.”
https://www.e-ijd.org/article.asp?issn=0019-5154;year=2015;volume=60;issue=3;spage=260;epage=263;aulast=Dhurat
Guys
Very interesting experiement with microscopic pictures.
https://youtu.be/Yndah33lyEs
My big question is if this will work on someone who has been using rogaine for 7 years and propecia for 20 yrs. Would this kickstart new regrowth? I feel most of the regrowth is from new users of rogaine with follica maybe some added benefits of wounding.
Based on the info on Follica’s website, the treatment provides a combination of de novo hair growth, as well as the thickening of existing hair. I presume it may also bring back to terminal some hair follicles that were not completely destroyed. If that is correct, and their stats are accurate, I would think you would see a benefit from the treatment as far as new terminal hairs but maybe very little thickening of existing hair in as much as Rogaine and Propecia may have already done that.
Hi Mjones
do you still use rogaine and propecia? If so, do you use them simultaneously? have they lost some of their strength?
Yes Laurence. I still use both. I’m on propecia for 20 yrs, Nizoral for 20 yrs and rogaine for 7 yrs. It definitely lost its power but definitely slowed down my baldness. Brand name only.
What I don’t understand is that if this is truly de novo regeneration, why the plateau at 44% or whatever at 12 weeks? Wouldn’t you expect to continue to regenerate de novo hairs with continued treatment? Just don’t see how something truly de novo can plateau.