Skinte Has Been Approved By The Fda And Will Go Into Limited Commercialization.

[Tano1]

Hello everyone just here to update on PolarityTE. They are currently marketing for burns, but they stated they will branch out into cosmetic/scar revision and hair regeneration.

https://www.polarityte.com/news-med...e-announces-fda-registration-of-lead-product-

Approved for use in select burn centers as well that will become part of the launch of SkinTE.

https://www.polarityte.com/news-med...ityte-lead-product-skinte-is-approved-for-use

Here is the most recent news from them:

http://www.foxbusiness.com/features...p-grows-real-human-skin-for-burn-victims.html

They are currently undergoing human trials (that they didn't have to do because it wasn't required by the FDA) and entering the market in 2h 2017 which is sooner than their original plan to market in 1h 2018.

Just thought I'd share this since they bypassed phase trials with the FDA and could probably implement the same method for hair regeneration to speed through the whole process and enter commercialization as well.

 

[Jonnyyy]

Hello everyone just here to update on PolarityTE. They are currently marketing for burns, but they stated they will branch out into cosmetic/scar revision and hair regeneration.

https://www.polarityte.com/news-med...e-announces-fda-registration-of-lead-product-

Approved for use in select burn centers as well that will become part of the launch of SkinTE.

https://www.polarityte.com/news-med...ityte-lead-product-skinte-is-approved-for-use

Here is the most recent news from them:

http://www.foxbusiness.com/features...p-grows-real-human-skin-for-burn-victims.html

They are currently undergoing human trials (that they didn't have to do because it wasn't required by the FDA) and entering the market in 2h 2017 which is sooner than their original plan to market in 1h 2018.

Just thought I'd share this since they bypassed phase trials with the FDA and could probably implement the same method for hair regeneration to speed through the whole process and enter commercialization as well.

What are they planning to do when it comes to hair regeneration when it doesn't have anything to do with burns/scars?

 

[Dantes90]

https://www.polarityte.com/news-med...-regenerates-full-thickness-hair-bearing-skin

SALT LAKE CITY, UT -- (Marketwired) -- 06/08/17 -- PolarityTE™, Inc. (NASDAQ: COOL) today announced pre-clinical results demonstrating that the Company's lead product, SkinTE™, regenerated full-thickness, organized skin and hair follicles in third degree burn wounds. The findings represent the first known successful regeneration of skin and hair in full-thickness swine wound models, the standard animal model for human skin. The Company expects to initiate a human clinical trial evaluating the autologous homologous SkinTE™ construct in the third quarter of 2017.

In pre-clinical models of full-thickness burns and wounds, SkinTE™ demonstrated scar-less healing, hair follicle growth, immediate complete wound coverage, and the progressive regeneration of all skin layers including epidermis, dermis and hypodermal layers (www.polarityte.com/products/skinte). The SkinTE™ product, which utilizes the subject's own skin, is prepared and used to treat the wound in less than 24 hours.

 

[Jonnyyy]

https://www.polarityte.com/news-med...-regenerates-full-thickness-hair-bearing-skin

SALT LAKE CITY, UT -- (Marketwired) -- 06/08/17 -- PolarityTE™, Inc. (NASDAQ: COOL) today announced pre-clinical results demonstrating that the Company's lead product, SkinTE™, regenerated full-thickness, organized skin and hair follicles in third degree burn wounds. The findings represent the first known successful regeneration of skin and hair in full-thickness swine wound models, the standard animal model for human skin. The Company expects to initiate a human clinical trial evaluating the autologous homologous SkinTE™ construct in the third quarter of 2017.

In pre-clinical models of full-thickness burns and wounds, SkinTE™ demonstrated scar-less healing, hair follicle growth, immediate complete wound coverage, and the progressive regeneration of all skin layers including epidermis, dermis and hypodermal layers (www.polarityte.com/products/skinte). The SkinTE™ product, which utilizes the subject's own skin, is prepared and used to treat the wound in less than 24 hours.

That's amazing, but what could that possibly do for us, this would only give you a full head of hair if you had one before the burn/scar.

 

[Dantes90]

Lol that is a good question I have no idea what they will do specifically to regenerate hair on a non burned/scarred scalp. I hope they get to it soon and that it works because if so they could have it out pretty damn quick if it is anything like their SkinTE product timeline.

 

[Jonnyyy]

Lol that is a good question I have no idea what they will do specifically to regenerate hair on a non burned/scarred scalp. I hope they get to it soon and that it works because if so they could have it out pretty damn quick if it is anything like their SkinTE product timeline.

I just saw and holy f***, these guys quit their jobs in 2015 December and created their product, got investors, went through the FDA and now almost completely commercialized their product in less than 2 years, but I think Male Pattern Baldness is a bigger badder monster than scarring and burns.

 

[Tano1]

What are they planning to do when it comes to hair regeneration when it doesn't have anything to do with burns/scars?

They haven't revealed that yet, but I'd assume something similar. Skin and hair collaborate to achieve regeneration. Dr. Cotsarelis (co-founder of Follica) states it himself as well as other researchers.

https://www.pennmedicine.org/news/n...y/using-fat-to-help-wounds-heal-without-scars

 

[Dantes90]

I just saw and holy f***, these guys quit their jobs in 2015 December and created their product, got investors, went through the FDA and now almost completely commercialized their product in less than 2 years, but I think Male Pattern Baldness is a bigger badder monster than scarring and burns.

True I do think it will take them longer but they do have some pretty ambitious products in their pipeline like regenerating cartilage which obviously would be awesome for helping people affected with arthritis. I would hope that they understand the complexity and have a solid plan in mind to tackle this beast. It would be both awesome and hilarious though if they did end up regenerating a full head of hair within a short timeframe considering how much trouble it has given others haha.

 

[Jonnyyy]

They haven't revealed that yet, but I'd assume something similar. Skin and hair collaborate to achieve regeneration. Dr. Cotsarelis (co-founder of Follica) states it himself as well as other researchers.

https://www.pennmedicine.org/news/n...y/using-fat-to-help-wounds-heal-without-scars

Hopefully he can do it with a decent amount of thickness.

 

[Jonnyyy]

True I do think it will take them longer but they do have some pretty ambitious products in their pipeline like regenerating cartilage which obviously would be awesome for helping people affected with arthritis. I would hope that they understand the complexity and have a solid plan in mind to tackle this beast. It would be both awesome and hilarious though if they did end up regenerating a full head of hair within a short timeframe considering how much trouble it has given others haha.

Here we are complaining about how little hair loss is looked into, burn and scarrring victims have been with the same technology for 3,000 years, if these guys decided to do it I bet you they could put something together to help regenerate dht resistant hair, them and Tsuji should team up

 

[Bf20]

#MakMyHairGreatAgain pretty plssss

 

[Follisket]

And here I am just enviously staring at Dr. Lough's hair. So low.

Still near impossible for me to fathom there's people out there living their lives well past the age of 25.

 

[champpy]

I watched the video that was posted a few days back, but i never saw any before/ after pics of how this new skin tissue looks on a patient. Has anyone else seen a photo of this?

 

[Trichosan]

And here I am just enviously staring at Dr. Lough's hair. So low.

Still near impossible for me to fathom there's people out there living their lives well past the age of 25.

Life begins at 40. Old cliche, but for some , true.

 

[vraf]

I watched the video that was posted a few days back, but i never saw any before/ after pics of how this new skin tissue looks on a patient. Has anyone else seen a photo of this?

in thier website -scroll a little bit down in this page: https://www.polarityte.com/products/skinte

 

[Tano1]

Their results are from swine, but they're undergoing human trials already so the results should be published before the end of this year.