Polarityte Announces Fda Registration Of Lead Product - Skinte

[vernon]

"side" effect

 

[CharAblaze]

well we're officially moving backwards in terms of hairloss treatments, Finasteride is poison, but alot of you could live with the potential of death... makes sense.

We are already dead. Might as well spin the Russian roulette 2nd time to ressurect.

How many people actually died in trials? I'm curious and I doubt that many died or anyone at all, they could be saying that involves risk since similar procedures include the same risks, 1 in million people die in simple surgeries when they get full anesthetic.

We don't even know a damn thing about their statistics if this turns out to be unsafe I doubt it will get FDA approval. They mention that the technique must be properly executed if it is not the patient may die, that is all.

 

[Tano1]

We are already dead. Might as well spin the Russian roulette 2nd time to ressurect.

How many people actually died in trials? I'm curious and I doubt that many died or anyone at all, they could be saying that involves risk since similar procedures include the same risks, 1 in million people die in simple surgeries when they get full anesthetic.

We don't even know a damn thing about their statistics if this turns out to be unsafe I doubt it will get FDA approval. They mention that the technique must be properly executed if it is not the patient may die, that is all.

Currently undergoing human trials now and should be finished soon.

FDA phase trials were bypassed since their construct uses all autologous tissue and homologous factors.

I now actually think that the reason death is posted as a side effect may be because this treatment is commercializing for burn victims which can potentially die anyway because of the burn itself. So maybe it's a way to avoid a law suit? Too soon to tell I guess.

https://www.polarityte.com

They have a lot of information there in their investor presentation and in the SkinTE section as well.

 

[glammetal]

Well well well...........
1)So is this the end??are we cured???
2)Does this company have aby pics for before and after for hairloss cases???

 

[Dat5Years]

Is there a potential release date for the hair stuff?

 

[H]

Well well well...........
1)So is this the end??are we cured???
3)Does this company have aby pics for before and after for hairloss cases???

1)No
3) refer to 1)

 

[Xaser94]

Im pretty excited about these guys. We need to find out their time line for hair regeneration asap!

 

[Dantes90]

Well from this video that I saw not too long ago it seems like their next product that they are working on is OsteoTE, which is the second item on the pipeline so hopefully that doesn't mean they have to accomplish every project listed on their pipeline before they get to hair, I would hope not though. In regards to the time line for hair regeneration yes, hopefully we can find that out.

 

[Dat5Years]

Anyone e-maield them? lol. WE know they love e-mails

 

[Tano1]

Well from this video that I saw not too long ago it seems like their next product that they are working on is OsteoTE, which is the second item on the pipeline so hopefully that doesn't mean they have to accomplish every project listed on their pipeline before they get to hair, I would hope not though. In regards to the time line for hair regeneration yes, hopefully we can find that out.

They've been working on the other products independently. They stated that if SkinTE was successful in the burn market, then they would explore entry into other markets such as cosmetic/scar revision and hair regeneration.

http://www.polarityte.com/products

 

[Pepe with hair]

They've been working on the other products independently. They stated that if SkinTE was successful in the burn market, then they would explore entry into other markets such as cosmetic/scar revision and hair regeneration.

http://www.polarityte.com/products

We know, the question is when

 

[Xaser94]

I wonder if @Swoop or @Admin can set up an interview.

 

[bboy]

Preclinical tests -> Made available to those most in need -> Market commercialisation.

And no FDA.... Jesus why can't all startups do this. Talk about being serious about time to market advantage.

 

[CharAblaze]

Regenarate full thickness hair barring skin.
It seems that they are ready to release their skin burn treatment product.
They are in marketing stages.

 

[Jonnyyy]

So basically you can get a full head of hair back if you had one before a burn, why are people getting so excited, am I missing something?

 

[JimmyB]

So basically you can get a full head of hair back if you had one before a burn, why are people getting so excited, am I missing something?

Because it could in theory give you an endless donor supply, similar to Tsuji. If they take a skin sample of your scalp, grow it (including follices), they could extract those follicles and implant them. You could keep doing this until back to NW1.

But the fact that theyre bypassing FDA approval makes me skeptical. Also don't know if they'd need trials to do what I just described (similar to piloscopy). Probably would to see how the follicles survive.

Also, how do they ensure the new follicles are DHT resistant, if using for hair loss? We might assume the hair is consistent with the donor area, but might not be the case.

 

[Jonnyyy]

Because it could in theory give you an endless donor supply, similar to Tsuji. If they take a skin sample of your scalp, grow it (including follices), they could extract those follicles and implant them. You could keep doing this until back to NW1.

But the fact that theyre bypassing FDA approval makes me skeptical. Also don't know if they'd need trials to do what I just described (similar to piloscopy). Probably would to see how the follicles survive.

Also, how do they ensure the new follicles are DHT resistant, if using for hair loss? We might assume the hair is consistent with the donor area, but might not be the case.

If they do what you described I don't see why there would be a problem? It's basically a hair transplant but it includes the skin, so if anything wouldnt that make it an even better chance that the follicles would survive?

 

[JimmyB]

Preclinical tests -> Made available to those most in need -> Market commercialisation.

And no FDA.... Jesus why can't all startups do this. Talk about being serious about time to market advantage.

Cause these guys are practitioners - I believe the 2 founders are former surgeons. Most hair researchers are academic types that are more focused on understanding things and publishing papers. If they can consult/make some $$ along the way, then great. But I feel like if someone like Cotsarelis had the same kill or be killed mindset of someone like Bezos, they could have a much bigger impact on the industry.

 

[BaldyBalderBald]

I don't recall they even talked about possible Androgenetic Alopecia application for their product.
Only thing they mention is possible "cosmetic application" after their pipeline products approval and market release

I guess it's more for scarless healing and scar revision, because their SkinTE product is meant to be use during healing process, you have to remove all skin layers and use your own autologous tissue to regenerate full-thickness skin, hair follicles and appendages.They are not growing your skin in a lab or whatsoever here.

So, basically, being scalped for treatment

 

[CharAblaze]

I don't recall they even talked about possible Androgenetic Alopecia application for their product.
Only thing they mention is possible "cosmetic application" after their pipeline products approval and market release

This image on their site basically tells me that they intend to use this for alopecia.
They mentioned that they will pursue hair market if it is a success in skin market and I believe that may take a long time.