I first covered hairy skin regeneration company PolarityTE (PTE) in 2017. I did not update their work for two years as their were some concerns. However, it seems like the company is still active and holds potential. So it is time for an update.

Update: June 2021

SkinTE Biologics License Application

PolarityTE plans to file for a Biologics License Application (BLA) for SkinTE in the second half of 2021. In the meantime, the company will (temporarily) cease sales of SkinTE and wind down commercial operations.

Note that this issue is related to the US FDA’s recent announcement that enforcement discretion related to 361 HCT/P products will not be extended beyond May 31, 2021. A development that has also adversely impacted the marketing and use of exosomes in hair loss patients.

Despite a limited team of just eight sales agents, PolarityTE reported record SkinTE sales of $1.73 million in the first quarter of 2021. Per CEO David Seaburg, the company will still try to help physicians who are treating severe wounds in patients through compassionate use programs. Possibility via the FDA’s Expanded Access IND program.

So all in all, it seems like SkinTE is at least a modest success. Future sales will depend on the BLA approval. Note that in May 2021, PolarityTE announced positive results in initial trials of using SkinTE to treat diabetic foot ulcers.

May 1, 2019

My past posts on skin regeneration company PolarityTE are worth a reread for background information. The only reason I keep covering this Utah-based company is because the new skin they claim to be able to regenerate includes new hair follicles. The company is also led by some highly reputable and experienced scientists.

In the past, PolarityTE even had a photo of a balding man on their site getting treatment on his scalp. Although this photo has since disappeared, we all hope that the company can regrow scalp hair by regrowing scalp skin.

PolarityTE and Hair Follicles

In March, scientists from PolarityTE in collaboration with others published an important new study: In vivo expansion and regeneration of full‐thickness functional skin. The below caught my eye:

Moreover, in a recent Australian radio interview, PolarityTE’s (now ex) CEO Dr. Denver Lough said the following:

All of this is very encouraging. Skin regeneration is a far greater area of research than hair regeneration, since burn and accident victims can become irreparably disfigured.

I have covered PolarityTE (original ticker symbol “COOL”) and its SkinTE product a number of times on this blog in the recent past. Make sure to read my original post about the company from last year.

The SkinTE product is meant to regenerate skin and help burn victims and others with damaged skin. However, there is also a potential application for a hair growth product down the road. For more on the latter, read the second half of my post from earlier this year.

PolarityTE has always maintained that its SkinTE product can regenerate damaged skin that also comes with intact new hair follicles. They even updated their site with the below image of a balding head a few months ago. In addition to mentioning the potential future application of SkinTE to treat hair loss.

PolarityTE Gets Positive Feedback from Test Patient

Earlier today, I got an e-mail from PolarityTE with a link (now dead) to an update. Apparently, they recently tested the SkinTE product on a patient with major leg wounds from a motorcycle accident. The patient, named “Devon”, is extremely happy with the results. The money quote is below, with the key part in bold:

“My leg feels as close to normal skin as I can imagine, and there is even some hair growth. If I had to choose between SkinTE and another skin graft, I would choose SkinTE every time because it is actually working.”

If “Devon” is definitely not imagining things, this is extremely encouraging. Only one data point of course, but well worth a new post on my part.

As I have mentioned in the past, the PolarityTE team is composed of high quality experienced scientists who have decades of experience working in renowned plastic surgery centers. The company has few problems in getting new funding; has been expanding its facilities in Utah; and CEO Denver Lough keeps getting great media coverage.

As if all the above is not enough, the SkinTE product represents an autologous therapy, which means that it will not require extensive clinical trials. In fact, it is already being used in various clinical settings from early adopters as this latest update mentions.