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.
They have said they plan on polarityTE for AGA in cosmetics but for a “later time” we received those emails last year.. they dont realize AGA market dwarfs burn market by tens of billions. They are already doing “the cure” technically and here we are confused. Incompetent people reign supreme if you disagree take a good look at the richest man in the world.
Because direct hair loss cures are an enemy to the establishment hair loss industry, I’ve always thought that a hair loss cure could be a tag-along to a different type of treatment (like skin regeneration) that couldn’t be secretly squelched by the hair mafia. I hope PolarityTE is legit. My only concern is that, to the best of my knowledge, I think that their skin product grows in the person’s wound. I’m not sure what type of wound would be required on the scalp for an AGA treatment. Please correct me if I misunderstand their skin regrowth process. I believe it’s on the body.
@Slick, perhaps dermarolling would create a sufficient enough “wound.”
There is not a secret hair mafia, vaccines don’t cause autism and the world is not flat.
Scott,
Is there an oil industry establishment? Do they actively eliminate competition?
BTW.. “hair mafia” was a cynical joking term.. I’m just disenchanted after 20 years of hearing “5 years from now”. It just seems like there are unknown forces inhibiting progress. Anyway, the negativity isn’t helpful, so my apologies to all.
I’m still wondering if anyone actually knows the PolarityTE process. I don’t think new hair bearing skin is grown outside the body. If it requires an open wound, then that affects changes for AGA applications. Am I mistaken??
Such an attitude is just pitiful.
There is no hair mafia and noone is deliberately hindering anti-hairloss technological progress.
We can’t treat hair loss effectively. Not now, not in the foreseeable future, because we haven’t advanced enough.
That’s it!
Nonetheless, we are not deprived of reasonable hope. Tsuji, Jahoda-Christiano, Terskikh and even TissUse are involved in stem-cell-based follicular regeneration. That’s unprecedented.
There are also drug-based approaches, such as Samumed’s anti-WNT drug and Cassiopea’s Glascoterone.
That’s a half-filled bottle. Some see it as half-empty, others as half-full.
Either perception does not justify such a pitiful whining.
Man up!
I hope it is Replicel that find the cure because of their other projects concerning skin regeneration for aging and burns victims, plus the other one for ligament and tendon regeneration.
Suppose you all get your hair back. It won’t look right on an old face and you won’t be moving like a younger person can.
I can already guarantee ya RepliCel won’t be anything close to a cure.
A waste of money and time for Shiseido.
Hate da BS,
What are you basing yourself on?
Their technology.
If they were amplifying stem cells, my outlook would be completely different.
They are not amplifying stem cells. To be more precise, they isolate stem cells and it’s them they start the amplification from, but as the amplification progresses, those stem cells lose most of their stem cell properties, of which the two most important are self-induction/proliferation and differentiation.
I don’t think their technology is total crap. Don’t get me wrong. I just firmly believe It’s definitely not going to be a cure.
At the same time, we don’t see the entire picture of what’s going on there. No doubt they have a good deal of research going on and lot of man-labor that translates poorly into press released, particularly with trade secret concerns.
I haven’t lost hope yet but I also don’t need a cure. I’d be happy if we could just stop the thinning for myself. Which seems to have happened with a blood thinner I’m taking anyway (or maybe on its own idk).
Mjones your boys over at follica are throwing in another delay. Pivotal study was supposed to begin 1st half 2019. They changed it to any time in 2019.
Nice catch…………….If they can’t determine which of several optimization options works best after at least 1.5 years, they probably don’t have anything that works very well.
No way!
And I thought they had such a solid tech.
Go figure!
It’s hard to be optimistic after 27 years of waiting … I started losing my hair when I was 20 … sometimes I wonder if it will still be possible to live without having to worry about this damn condition called baldness … I just can’t let it go, without hair I look too weird :(
There is most definitely competitive forces blocking new treatments for every market including hair loss. Now is there a full blown cure they are keeping behind closed doors? Who knows? Maybe maybe not. I am most positive Rogaine, ht docs, etc don’t want a solution that will put them out of business. These scientists can definitely grow hair guys. They can grow teeth, vaginas, organs in other animals, ear hairs, etc. The human hair follicle is the most challenging thing to grow for them? Come on. It’s all money and greed at the end of the day. I wouldbt be surprised one day we wake up and some XYZ company we never heard of releases a full blown mpb cure of of nowhere. They were given the green light to release and billions will be made for all those involved.
They have cars that can run 200mpg gas and yet they don’t release it to the market. Oil companies want to keep us paying at the pump as soon as possible. It’s all business.
All I have been asking for the past 17 years of waiting is a solution to get us all to a nw2 with stabilization. If I can’t get my thick ass 17yr density back that’s fine, I just don’t want to live life with a horseshoe or shaved head when the other half of the guys can rock full heads. That’s just not acceptable in 2019.
Sorry for the rant…
But when you were 17 with that full head of hair, were you happy?
I am the one personally blocking new treatments! If we are going to subscribe to conspiracy theories Yoda wants in!!
When hair follicles are “regenerated” , whether it’s through this Polarity deal or anything else, it is no advantage to simply replace your old top of scalp follicles with your new top of scalp follicles, because they share the same programmed genetics to stop producing viable hair at an age and rate. If follicles from non-dht sensitive skin are used, then fine, but that’s basically just a transplant
That’s enough though, since you can just keep replacing it. I don’t think it works for us unless they have a scarring solution too. But it may improve hair transplants if you no longer need to harvest from another part of your body and have an unlimited supply of follicles to transplant.
Aclaris could report any day now on their AGA results. We will know soon enough, very soon.
Nasa, you have been saying this for the past 3 years! Bore off!
Nasa is in on the conspiracy with me to block new treatments. His love of JAK is jut a cover.
I do not think “New Treatments” ever need to be blocked since none ever work.
Its big JAK news any day now and I will stay positive and leave it at that. Remember Failure is Not an Option.
October 30 -2019 phase 2 completion date which is on their trial application
At this point very soon it’s never soon enough…
we can clone sheep and anything else … but they can’t make hair grow back… Mhmmm … something certainly stinks
Well they have the technology for quite some time now and all we can see is breaking news then they start the process and suddenly silence. Either disappointments, no more news or anything like that. They kinda figured out why people lose hair. They found more things to target for that. As we know is a hormonal process involved but other companies targeted some proteins for that so in the end we have more opinions about hairloss process. Whatever, we evolved so much in the past 20 years and yet they can t clone some goddamn follicles while they figured how to clone other organs. Should I mention that is 2019 already? I agree that something stinks indeed. Maybe in 5 years and then 5 more and why not another 5 cause why not.
Chinese hospitals set to sell experimental cell therapies
Under a draft proposal, patients would be able to buy some therapies without regulatory approval.
https://www.nature.com/articles/d41586-019-01161-2
Scott- I was happy at 17 and I am happy now. Losing hair and having to apply Rogaine, blow drying each morning, not being abe to jump in pools and dive in water is a pain to deal with. I still go to the beach and pools etc but hate having to blow dry my hair to make it look normal. When I was 17 I would get it wet and just slick it up and air dry and done. Now it takes 45 min lol
Be happy you have hair at your age to blow dry Bro. Some of these youngsters don’t get on the approved treatments in time or at all and it’s a very painful thing to endure. While it’s hard to loose hair at any age it’s more traumatic at an earlier age. While my hairline and density is far from perfect, I’ve been fighting this for 35 years and am grateful for the hair I’ve been able to keep. In my 20’s and 30’s it was much harder to keep my perspective even though treatments were working.
Totally agree with you yoda. I’m 10000% happy with what I have. I hopped on Propecia at 20 when I noticed 40 hairs all over my hands and losing density. I’m happy I acted quick. So for all young folks here thinking a new treatment is around the corner, don’t rely on it. Hop on meds now and at least maintain or slow down the loss. I’ve been waiting since 2001 for a new fda treatment. Lol. It might be another 18 years lol
Excellent advice Mjones. Grateful that we have maintained a decent amount of hair yet always wanting more!
if they invent a pill that cures all diseases pharmaceutical industry is finished … I find it very difficult for a definitive baldness cure to come out … I mean, if such a thing happens then all those doctors who deal with transplants can go home…
This is an email a user got from someone working on rch-01 after asking about phase II results:
Dear *****,
The results will be open in two months.
However, I will not able to inform you personally.
Regards,
***********************************************
Ryoji Tsuboi, MD, PhD
It is not someone working on RCH-01, It is Professor and Doctor Ryoji Tsuboi, the main investigator of the Shiseido’s clinical trial ! And this is an email from a member on HLT (McBald)
Mjones be happy you are able to hold what you have. Lots of dudes cant handle fin or minox. Sometimes you go a little too far.
Do we actually have any hope rch01 is a full blown cure? Ive read so many different reviews on forums that im kind of confused where it could possibly stand?
No, it is not going to be a cure.
That’s certain.
Will it be another mildly effective treatment?
We shall see in two months.
So at what state is this company at for hair loss?
Stage 0 :-( But maybe Stage 2 for hairy skin.
Why there are comments from 2019 in this post?
Bottom half of post is from 2019. See blue font dates :-) Unfortunately, if I write many small posts on the same subject, Google penalizes all. Or gets confused about which one is the most important.
No offense to the admin, but there’s nothing new cover and there won’t be until someone does human trials for hair cloning period!
Functioning follicles but no aga effort huh?… Their market cap justifies their smarts.
Agreed egghead. How’s the stock market treating you bud? It’s been a wild ride since Jan.
Half way through 2021 and we had better pipeline in 2001 lol. In 2031 all the newbies here will say what I am saying now but for 2021 pipeline. Gotta love this bs mpb industry.
I covered a bunch of new companies recently and we await another few final trials. 2001 was nowhere near as good.
Whose trials are we waiting for?
It has been crazy yeah. So crazy that you can make riskless profit in the chaos of those meme stocks. The zoomers bulldoze the underlying stock but don’t touch the derivative so it’s just free money on the table. I saw a guy close a synthetic conversion arbitrage spread on YouTube. Blew my mind.
Do you have a link to the Youtube video? Not that I understand “synthetic conversion arbitrage spread”!
Doesn’t matter admin because those will all fail. If any of those companies have political ties or ties to some billionaire then it may get released. I would say Bayer is our best bet. All those other companies are preclinical and wont make it far. Two bit biotech companies with weak funding is all they are. The big dogs are the ones that might pull through. SM, Bayer. Tsuji was a liar and is broke, stemson in 10 yrs will still say he is researching etc. You get my point:) oh Kintor is another one that might have something but I wont use any drug from China. Zero regulation in that country. I know this because my neighbor is chinese and he doesn’t even buy vitamins from china let alone use drugs from there. He is a doctor btw.