Follica Presents Topline Data From FOL-004 Treatment

Updated 12/19/19

Today, I received an email from Follica management which shared the company’s latest press release. The company has just announced positive topline data from its FOL-004 safety and efficacy optimization study which was carried out in 2019. According to the release, the study was designed to determine the optimal treatment regimen involving Follica’s wounding device and topical drug application. In the study, three separate groups of male subjects received a unique treatment regimen of FOL-004.

Here are the highlights from today’s press release:

The best performing treatment group/regimen in the study produced a 44% improvement in non-vellus hair count compared to baseline after 3 months of treatment . Non-vellus hairs include terminal and intermediate hairs. These are hairs which are visible and cosmetically significant.

Across all three of the treatment groups, the overall improvement of non-vellus hairs was 29% compared to baseline after 3 months.

The safety and efficacy optimization study comprised 48 male subjects, ages 18-40 years old with a Norwood 3 or 4 degree of baldness.

Follica’s skin disruption device is now called the Hair Follicle Neogensis (HFN) device.

A phase 3 or pivotal study for FOL-004 is expected to commence in the first half of 2020.

We know that Follica’s treatment begins with a 5 minute office procedure where the HFN device is administered to a patient’s scalp. Here’s an interesting quote from today’s press release which gives more insight into the daily maintenance routine of FOL-004. “Follica’s approach is based on generating an “embryonic window” in adults via a series of skin disruptions, stimulating stem cells and causing new hair follicles to grow. This process of hair follicle neogenesis involves minimal daily interruption and is enhanced through the application of a topical compound as part of the treatment regimen following HFN.”



For a visual example of the FOL-004 treatment on the crown of a male subject please review the article below.

Original Post on 11/21/19

Follica has released its first before and after images from an optimization study of its lead candidate hair growth therapy FOL-004.

The slide below was shared in a PureTech Health corporate presentation on November 1, 2019. PureTech is the parent company of Follica, a well-known hair growth startup based on the research of Dr. George Cotsarelis of the University of Pennsylvania. Follica has been incorporated since around 2007, but this is the first time hair growth result images have been shared from the company.

Points of interest from the slide:

The in-office duration of FOL-004 is slated to be only a 5 minute procedure.

Pharmaceutical compound (still undeclared) is applied following skin-disruption treatment.

No mention of the ‘at-home’ portion of the FOL-004 treatment.

As noted, Follica’s treatment is now referred to as “FOL-004” instead of the previous acronym RAIN which stands for regeneration abrasion induced neogenesis.

Application to the FDA for commercial approval planned for 2020.

For an extreme close-up of the results images click here.

For those that clicked on the close-up image, let us know your feedback in the comments section below. One observation I will share, in the before image I notice what I would consider to be a “bald spot”, the center of the crown is mostly just scalp with a few sparse hairs growing in. In the after photo, even though the angle is not the same, the crown displays hair that has thinned, but there is no bald spot anymore, there is no area of the crown that is predominantly just scalp. For a little under 3 months, this is a noteworthy result.

Of all the companies developing hair loss treatments, Follica has one of the shortest paths to market with a potential to reach consumers in late 2020/ Q1 2021 if all goes well.

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