Category Archives: PureTech Health

Follica Pivotal Trial in 2019, FDA Filing in 2020.

Update: November 25, 2019 — A few days ago, “Toccata” emailed me a pdf document in which one small part mentioned that Follica was going to use Minoxidil as the compound after the microneedling.

Apparently, this document was also posted on several hair loss forums. However, no-one initially saw the page 46 small Minoxidil part except “Toccata” as far as I could tell. The new HLT thread on last week’s Follica news is already 10 pages deep. At this point, it seems like a few people have realized what was missed before and the pdf has been repasted several times.

I did not want to share this document right away. On Twitter, I first asked several members of the Follica team to contact me as I wanted permission to share the cartridge, dropper and new patient hair growth photos. In the past, several Follica staff members have responded to my requests and questions.

However, I got no response from anyone this time around despite two attempts on November 21 and 22. I did not mention anything about Minoxidil to them, so there must be another reason for the secrecy.

Follica Might Start off with Minoxidil :-(

I have now found the same document available online here. On page 46, it states: “Proprietary Minoxidil cartridges for use with smart dropper”. Crazy to see this after years of speculation.

For many years, most of us have assumed that Follica would use a compound that would at the very least be Minoxidil PLUS something else. Many people assumed that the second compound would be based on valproic acid, since Follica even has a patent in that area. So this news is a disappointment.

However, two important points to note:

  1. The above linked conference call pdf was published around three years ago and is old news. Moreover, things may change further before the end of 2020.
  2. It will be much easier to get initial US FDA approval for a microneedling based treatment that only involves the addition of Minoxidil. After all, topical Minoxidil has been approved as a hair loss treatment for decades. Some people even take the more dangerous oral Minoxidil to treat their hair loss.

Correct microneedling and wounding in combination with Minoxidil seems to give excellent results (e.g., see Rachita Dhurat and her India microneedling work). Most people who are experimenting with at-home microneedling are not doing it correctly. Hopefully, Follica’s micro-needling device in the hands of a professional will be much superior.

Even more hopefully, Follica will add other compounds into the mix down the road. Perhaps even something like wounding plus mesotherapy with Dutasteride.


November 21 2019: New Follica update via Puretech’s latest November 2019 presentation. (h/t “Toccata”).

Follica FDA Filing in 2020

They seem to be calling the product FOL-004. Previously they have used FOL-001, FOL-002 and FOL-003 in various clinical studies. The final name is supposed to be the acronym “RAIN”Note: The unrelated company Follicum labels its hair loss product as FOL-005!

Puretech has now raised its stake in Follica to 78 percent, indicating major optimism.

On page 32 of the presentation, it says that:

  • “Interim clinical readout of optimization study in AGA” was completed in 2019. Checkmark next to it on the left stands for completion.
  • In 2020, the company plans to get “Topline results from pivotal study in AGA” and also go through with FDA filing. Assuming data are supportive.

On page 40, they have a crown hair growth before and after photo. Pretty decent results in my opinion. It says the after photo is 85 days post the “screening” before photo. Not sure how many treatments were required over those 85 days.

The still use the phrase “newly created hair follicles”. Created via the wounding and microneedling procedure using Follica’s proprietary new device.

Apparently, the procedure will just take 5 minutes. Fingers crossed, maybe we will finally get this much touted product to market by the end of 2020.

The below post was published on May 12, 2019. See bottom of page for possible Follica Trial recruitment information.

Puretch Pipeline

Follica Clinical Trial Schedule

A few weeks ago, PureTech released its 2018 annual report. On page 31, you can find the summary for Follica. PureTech owned 62.3 percent of Follica at the end of 2018. Follica also updated its site recently as noted by one of this blog’s astute readers last month.

In the above linked PureTech report, the Follica page mentions that the company will start its “pivotal study” in 2019. They have already conducted three clinical trials in the past.

Per one definition, Pivotal study means Phase 3. Per other definitions that I have read, it means Phase 2b. Either way, we are making major progress. Considering that Follica’s methodology involves wounding and then use of existing drug compounds on the scalp, perhaps they can get away with a faster approval process.

I have covered Follica numerous times on this blog, only to be disappointed at its speed of progress each time. However, I have some interesting news to share about the company that I will split between two posts.

Recruiting Volunteers

While going through their new website in more detail, I noticed that one of their clinical advisers was a Dr. Jeffrey Dover. His was the only name that I did not recognize in the list. A little bit of research, and I found that Mr. Dover works at SkinCare Physicians.

I then went to SkinCare Physicians’ Twitter feed, and lo and behold, the below Tweet from February 14 says it all. I have no idea if this recruitment period is over, but please only call them if you are certain that you fulfill all the requirements, including travel to Chestnut Hill, MA). And do not call them just to ask general questions!

Update: Had to remove the embedded Tweet after a request from one of the company’s representatives. She emailed me and said that they were bombarded with a huge number of calls, with many volunteers not fully realizing the very specific travel requirements. A number of callers even pleaded to get in despite living in different countries! And of course many called just to ask general hair loss questions despite my explicit warning above :-(

Follica Updates its Website and it Looks Encouraging

As always, thanks to commentator “Mike” who regularly seems to find the latest developments with Follica immediately.  He notified us of the updated Follica website earlier today in a comment to the last post.

I have covered Follica (a subsidiary of US-based PureTech Health) many time on this blog before in spite of the fact that until recently I was very skeptical about the company (since it was founded ten years ago, but has yet to commercialize its skin perturbation + topical compound technology despite years or supportive evidence). Moreover, some people on hair loss forums have over the years postulated that the company’s technology is basically just glorified Minoxidil, since skin damage allows for greater penetration of Minoxidil.  However, the company has never specified what compound it is using, and I highly doubt it is just Minoxidil.  In some of their patents they have mentioned various potential ingredients including Minoxidil, but I am too lazy to go through all the links in my past Follica posts at the moment to get the details.

I bolded the words “until recently” above because a few months ago, Follica pleasantly surprised us and announced that it was aiming for a 2018 product release as a best-case scenario.

Now it seems like Follica just made a major upgrade to its previously barren website.  Nothing really of major surprise in there, but much better elaboration of the technology with useful photos/product renditions.  We already knew that the skin disruption process (which requires great precision and knowhow) would be undertaken at a doctor’s office and the compound application would be the responsibility of the patient at his or her home.  Now Follica has provided images of both the in-office and at-home devices.  The company will have a smartphone app to monitor progress (Edit: It seems like the app will also be able to measure the accuracy of your dosage via wirelessly communicating with the at-home device).

No information is provided about the costs, but they do discuss re-ordering of the compound, which makes me wonder if this will be a lifelong commitment just like with Minoxidil?  Assuming that you do get new hair follicles, how susceptible will they be to the ravages of dihydrotestosterone (DHT), and will taking Finasteride or Dutasteride to reduce DHT levels prevent the need for re-ordering Follica’s compound?

Some key quotes from Follica’s new website:

“We’ve teamed up with leading dermatologists with expertise in hair loss and epithelial stem cell biology to develop a new system aimed at not just improving existing hair growth, but also growing new hair”.

“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”.

“Following skin disruption, cells that migrate to help healing are forced to make a decision: Should I make epidermis, or should I make a hair? There is a window of opportunity in which we can potentially push them to choose the latter, and we believe there are multiple biological pathways to target to enhance this outcome. This regenerative effect is called hair follicle neogenesis”.

Dr. George Cotsarelis and his own Hair Loss

Finally, if anyone lives near where Dr. George Cotsarelis (Follica’s co-founder and technology inventor) works in Pennsylvania, it would be good to know if the small bald patch on the back of his head is gone or still there. To see what I mean, check out the below video links that start in the most relevant places. I am very serious and do not mean to belittle Dr. Cotsarelis (and hope he does not mind), but I feel like most people who can fill back a small bald patch on their crown region would always do so if they had the technology at their disposal. Usually, only those who totally shave their heads are comfortable with their hair loss, while those with small bald spots are not.  Maybe I am being too judgmental here and Dr. Cotsarelis does not care about his minor hair loss at all?  But if he were to suddenly have thick hair at the top/rear of his scalp, I would get even more excited about Follica.

Dr. Cotsarelis has been involved in hair loss research for at least 20 years as far as I can tell, and there is no-one in the world who has been cited in hair loss related magazine articles as much as him.  For those who are interested, in some of my past blog posts about Follica, I have discussed and linked to various wounding related patents and studies attributed at least in part to Dr. Cotsarelis.

Link to Dr. Cotsarelis Video 1

Link to Dr. Cotsarelis Video 2