Category Archives: Follica

Follica, Jason Bhardwaj, Peter Diamandis

Jason Bhardwaj and Peter Diamandis

30 Comments

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 Likes Me

A funny story: In 2008, I flew cross country to attend the Singularity Summit (initiated by Ray Kurzweil) in 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. 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. I immediately left the room after telling my organizer friend. Even he seemed a bit uncertain and in awe. To this day, I have no idea why he invited me, knowing that I was a young almost poor man at the time.

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.

 

Wounding, Follica, Microneedling, Women's Hair Loss

Scalp Wounding for Hair Growth in Females

40 Comments

A new pilot study on wounding and hair growth just got released online yesterday. The authors found that wounding via Follica’s microneedling device causes new hair growth in women. This is worth reporting because prior research from Follica only entailed studying hair growth in men.

Wounding, Microneedling, Follica and Female Hair Growth
Before and after hair growth photo for wounding via Follica microneedling device in females. Source: International Journal of Women’s Dermatology. Publisher: Elsevier.

In fact, almost all past research on microneedling and hair growth has focused on male pattern hair loss. Balding men are often satisfied with new hair that grows just 1 inch high. Women, on the other hand, often need superior results in order to make for a natural appearance. I did not think that this would be possible via just wounding and intentional scalp injury.

Men are also more likely to  be ok with a shaved or thin appearance on the sides and rear of their heads. And of course many men can get away with just shaving their head entirely.

Scalp Wounding Causes Hair Growth in Women

This latest study was undertaken using Follica’s technology. See the company’s press release from today. The lead researchers were based at Harvard University and at Massachusetts General Hospital. The team was led by Dr. Maryanne Senna.

The study showed that wounding leads to at least some hair growth in all women. See discussion further below. All of the 11 females in the study suffered from mild to moderate female pattern hair loss (FPHL).

The main limitation of the study is obviously the small sample size. All 11 patients underwent six treatments with Follica’s Hair Follicle Neogenesis (HFN) device. Each treatment lasts for just a few minutes. The scalp skin wounding creates an “embryonic window” that allows new hair follicles to form from epithelial stem cells.

Two of the patients were also using Spironolactone for their hair loss during the trial.

Minoxidil Addition

The study summary initially states that on non-treatment days, participants applied a topical “on-market” drug.  However, later on in the study, it states the following:

“Subjects applied topical minoxidil 5% foam nightly to these areas for the duration of the trial. Topical minoxidil foam was not applied on treatment days.”

So I guess it is Minoxidil and nothing else in Follica’s topical? A lot of online discussion in the past centered around the addition of valproic acid, but this now seems unlikely.

100 Percent Success

  • 10 out of 11 patients reported perceived improvement in hair growth at the end of study.
  • All 11 patients demonstrated improvement in physician-graded Sinclair scores after 4 months. The average improvement in Sinclair grade was slightly more than 1 full integer reduction.

The Sinclair Scale for female pattern hair loss was developed by Dr. Rodney Sinclair of Australia. A more commonly used measure in women is the Ludwig Scale. For men, the most common way to classify degree of baldness is the Hamilton-Norwood Scale.

Also see Follica’s announcement of these findings on Twitter.

According to CEO Jason Bhardwaj, their product has the potential to address both male and female androgenetic alopecia. And this study makes clear that the device works well with both longer and shorter hair.

Follica plans to advance its lead program for male pattern hair loss into Phase 3 trials in 2021.