https://finance.yahoo.com/news/polarityte-provides-business-updates-clinical-140000513.html
SALT LAKE CITY, Feb. 05, 2018 (GLOBE NEWSWIRE) -- PolarityTE, Inc. (COOL), today announced that initial results from the clinical applications of the commercially launched SkinTE are yielding outcomes that are correlative with the Companys preclinical research (as highlighted in the Companys recently filed Annual Report on Form 10-K), which resulted in regenerative healing of full-thickness hair-bearing skin, including all layers (epidermis, dermis, and hypodermis) and glands.The first group of patients treated with SkinTE are currently at an interim stage of healing and regeneration, and as previously announced, the Company expects final results from the initial clinical applications of SkinTE to be available in the first half of 2018, with peer-reviewed publications to follow.
SkinTE has now been used at multiple medical facilities across the country to treat the entire spectrum of wounds, including: chronic wounds, surgical wounds, reconstructive wounds, acute burns, and the replacement of scarred and contracted skin grafts with SkinTE. The initial scale-up of manufacturing operations is nearly complete, facilitating capacity to respond to ongoing demand. The Company also expects to release additional preclinical data from its OsteoTE bone regeneration development program inthe first quarter of 2018.
I have used SkinTE to partially resurface extensive burn scars and skin graft contractures in an adolescent patient. Although early in the post-operative period, the product has quickly regenerated skin with minimal marginal wound contracture and areas of regenerated skin are re-pigmenting rapidly, said Gerhard S. Mundinger, MD, Director of Plastic Surgery at Childrens Hospital in New Orleans, Assistant Clinical Professor of Plastic Surgery, and Assistant Professor of Cell Biology and Anatomy at LSU Health New Orleans. The parents, who have already been through so much in caring for their child after a terrible accident, are pleased with the results at this point. In our ongoing discussion about optimizing their childs functional recovery, we plan to use the product again in the near future to resurface more remaining scarred skin and contracted skin grafts. I am continuing to follow the patients recovery closely, and do not have any concerns with the product at this time, although, again, it remains early in the recovery period. Dr. Mundinger continues, I look forward to the advent of Polaritys bone regeneration product [OsteoTE] given my main clinical practice and research focus as a craniofacial surgeon.
Upon review of initial SkinTE results in humans, C. Scott Hultman, MD, MBA, FACS, the Ethel and James Valone Distinguished Chair ofPlasticSurgery, Chief Emeritus and Professor, UNC Division of Plastic Surgery, said, "Having reviewed some of the preliminary in-human clinical results, I am impressed with the degree to which the melanocytes have repopulated the wound, restoring pigment where it was once absent. Furthermore, there appears to be dynamic healing: the texture and biomechanics of the grafted areas appear to change over time, during the early phases of wound healing, for the better. I am very excited to see the long-term clinical results, when available. Polaritys SkinTE may be the first real option we have for truly bioengineered skin replacement."
What i would like to know is if this could be used in conjunction with a deep ablative Laser ? ...
Sadly i had Laser resurfacing done 4 years ago and my face has scarred because of it , Polarity does indeed sound promising and makes me hopeful of the future of skin regeneration and scarless healing ..... however would using a laser that damaged your skin be used to REVERSE the damage of the said laser hasinflicted in the first place ? , if indeed SkinTE does work / working as it's being implied , thank you.
I don't think anyone can answer that question with authority currently. Sorry to hear laser resurfacing damaged you further.
Thank you ScarRight , I've had scars ranging from acne ( admittedly i picked and squeezed and obsessed over due to OCD disorder ) , fights , and the aforementioned laser " treatment " , even though this does get me down and depressed i am hopeful of the future , hang in there as they say.
An article referring to the treatment of the burned child being using SkinTE
And an article on " living bandage "
https://phys.org/news/2018-02-scientists-biocompatible-anti-burn-nanofibers-bandages.html
We will get there friends :).
2 hours ago, Scarred555 said:And an article on " living bandage "
https://phys.org/news/2018-02-scientists-biocompatible-anti-burn-nanofibers-bandages.html
Don't want to disappoint you, but "in vitro" results is far away than even mice data. And "Russian scientists", or saying better "students" developed smth like this...Don't think it would give any scarless results. The science in this country today is totally destroyed tnx to the coruption, so evenacademician RAN or leading scientist are payedabout 1000-2000$ in general, so if you have "brain" you will emigrate. But this is not political forum, so just skip it. Comparing with Polarity team this is "scam", sorry. If this gonna happen, it would be a real miracle. But it wont. It's even "Novosibirsk" (poor city, can't imagine some modern technology being there), not Moscow or St. Petersburg. But journalists make up a good story.
I actually think Polarity and Skin Te will be a success, in terms of generating revenue for the company and its shareholders. Early results look promising, and it will be just as effective as current treatments. I have changed my mind about this one.
My doubts now shift in its effectiveness on consmetic scars, which is most of us on this board. This will not be simple in developing an application, and could take a while to come into reality.That's a bit of a downer for us.
The company would try everything though, because you would think the cosmetic market would absolutely dwarf the Burns/trauma scars market.
If successful, the problem will be implementation. How will the paste be applied? How many patients can the company accomodate? How much will it cost?
Remember that people with skin problems, from enlarged pores to acne scars to stretch marks, balding people, burn victims, eczema sufferers-- they will all want a slice of the pie. I'm actually interested in how the company can scale their operations.
9 hours ago, Scarred555 said:What i would like to know is if this could be used in conjunction with a deep ablative Laser ? ...
Sadly i had Laser resurfacing done 4 years ago and my face has scarred because of it , Polarity does indeed sound promising and makes me hopeful of the future of skin regeneration and scarless healing ..... however would using a laser that damaged your skin be used to REVERSE the damage of the said laser hasinflicted in the first place ? , if indeed SkinTE does work / working as it's being implied , thank you.
I agree with ScarRightno one can really answer this definitively.
However, if SkinTE works the process shouldn't really come down to what damage was done to your existing skin. Simply because all of that skin would be removed anyway. The key, at least from my understanding of the science, is that you couldn't have your healing compromised by some other condition and the wounds couldn't go deeper than skin (i.e. into fat tissue and muscle).
If those tissues are intact and you excise the existing damaged/scarred skin... well, there is no more skin. I'm not sure an ablative laser would be the answer or not. No one knows how Mundinger resurfaced the young patient's scars.
7 minutes ago, ScarRight said:I actually think Polarity and Skin Te will be a success, in terms of generating revenue for the company and its shareholders. Early results look promising, and it will be just as effective as current treatments. I have changed my mind about this one.
My doubts now shift in its effectiveness on consmetic scars, which is most of us on this board. This will not be simple in developing an application, and could take a while to come into reality.That's a bit of a downer for us.
The company would try everything though, because you would think the cosmetic market would absolutely dwarf the Burns/trauma scars market.
I mostly agree with you. Cosmetic derivatives will likely need some optimization and additional research even if SkinTE gets complete regeneration right out of the gate. I've personally wondered aloud on this board about how a strict injectable would even be possible given that the idea would be to make the process far less invasive, but as far as I know the injectable would still need a biopsy of healthy skin.
You can bet with 100% certainty that if SkinTE provides substantial improvement, or fingers crossed complete regeneration, for 3rd degree burns that PolarityTE will put everything they have to explore the cosmetic market ASAP. Two big reasonsmoney, as you wrote because the cosmetic market is applicable to almost every person on Earth. If suddenly there was a way to get rid of stretch marks, scars, restore hair etc. even people that aren't on a board like this all the time like we are would find themselves intrigued and likely willing to fork over good money to make something go away for good.
The other reason is competition. If SkinTE merely displaces skin grafts and provides far better outcomes, every single company involved with wound healing will scramble to mimic (with slight variations of course) the process and make improvements. Big cosmetic companies will immediately want a piece of the pie, which would be good news for us.
I'm still waiting on actual pictures, results and peer-reviewed papers before I believe SkinTE is what they claim it is, but all signs are pointing very positively right now for it.
8 minutes ago, Raster said:If successful, the problem will be implementation. How will the paste be applied? How many patients can the company accomodate? How much will it cost?
Remember that people with skin problems, from enlarged pores to acne scars to stretch marks, balding people, burn victims, eczema sufferers-- they will all want a slice of the pie. I'm actually interested in how the company can scale their operations.
To me, PolarityTE will either find a way to do this (or hopefully have a plan in place if they believe in the product as much as they claim) or other companies will copy their methods, improve them where possible and overtake them. I don't wish this on PolarityTE if SkinTE provides complete regeneration; I'll want them to get all the accolades and money possible. But selfishly, I want to get rid of my scars and won't be picky about which company's product gives me the treatment. PolarityTE will either be able to meet the demand or get run over by big cosmetic companies with more money for production, delivery and scalability.
4 hours ago, Raster said:If successful, the problem will be implementation. How will the paste be applied? How many patients can the company accomodate? How much will it cost?
Remember that people with skin problems, from enlarged pores to acne scars to stretch marks, balding people, burn victims, eczema sufferers-- they will all want a slice of the pie. I'm actually interested in how the company can scale their operations.
4 hours ago, ScarRight said:I actually think Polarity and Skin Te will be a success, in terms of generating revenue for the company and its shareholders. Early results look promising, and it will be just as effective as current treatments. I have changed my mind about this one.
My doubts now shift in its effectiveness on consmetic scars, which is most of us on this board. This will not be simple in developing an application, and could take a while to come into reality.That's a bit of a downer for us.
The company would try everything though, because you would think the cosmetic market would absolutely dwarf the Burns/trauma scars market.
The feeling is its working which was probably the biggest hurdle to get over. Now its a matter how well and all we have to go by is this report about this 10 year old boy who has bad burn scars to his chest.
On Seekingalpha its says he has gone from badly burned scars (3rd degree) to normal skin pigmentation with minimal scarring and contracture. Its a vague statement because you dont know if 'minimal scarring' is referring to the wound edge/margin or the new skin, but thats still only 20 days into healing. Still from bad burn scar/contracture to that sounds good. Its all guess work unless you have seen it yourself. But there was no mention that it was his chest or his age was 10 in PolarityTe release so maybe they did some more digging.
My question is if it can take bad burn scar from that to that what will it do for acne scars. Will acne scars be better suited with better results if there is more surrounding good skin with safer derivative approaches or will it not have the dramatic effect like it can with a complete larger area of burn scar/wound. Time will tell
It comes back to chasing "scarless" or "scar free" skin. The smaller the wound/scar the better skin will look following SkinTe? or for example what if this 10 year old boy had this same healed SkinTe skin resurfaced just in a few areas of minimal scarring (not the margin) with SkinTe again in 12 months would it heal even better again improving his overall result? My point is if it can regenerate normal appearing full thickness skin whats stopping a person from achieving almost "scarless" skin... $$$, margin, unpredicatble results?
Cantor Fitzgerald also predicting the cost of SkinTe kit will be $7300...seems steep but if results are very good and it can be seen as a one and done treatment leaving patients happy then its worth every cent. Whispers of images being released in March at an event, looking forward to that.
Ive said it before all SkinTe has to do is show it can regenerate normal appearing full thickness skin then the other hurdles in the way will not seem so difficult.
6 hours ago, Sniffy said:The feeling is its working which was probably the biggest hurdle to get over. Now its a matter how well and all we have to go by is this report about this 10 year old boy who has bad burn scars to his chest.On Seekingalpha its says he has gone from badly burned scars (3rd degree) to normal skin pigmentation with minimal scarring and contracture. Its a vague statement because you dont know if 'minimal scarring' is referring to the wound edge/margin or the new skin, but thats still only 20 days into healing. Still from bad burn scar/contracture to that sounds good. Its all guess work unless you have seen it yourself. But there was no mention that it was his chest or his age was 10 in PolarityTe release so maybe they did some more digging.
My question is if it can take bad burn scar from that to that what will it do for acne scars. Will acne scars be better suited with better results if there is more surrounding good skin with safer derivative approaches or will it not have the dramatic effect like it can with a complete larger area of burn scar/wound. Time will tell
It comes back to chasing "scarless" or "scar free" skin. The smaller the wound/scar the better skin will look following SkinTe? or for example what if this 10 year old boy had this same healed SkinTe skin resurfaced just in a few areas of minimal scarring (not the margin) with SkinTe again in 12 months would it heal even better again improving his overall result? My point is if it can regenerate normal appearing full thickness skin whats stopping a person from achieving almost "scarless" skin... $$$, margin, unpredicatble results?
Cantor Fitzgerald also predicting the cost of SkinTe kit will be $7300...seems steep but if results are very good and it can be seen as a one and done treatment leaving patients happy then its worth every cent. Whispers of images being released in March at an event, looking forward to that.
Ive said it before all SkinTe has to do is show it can regenerate normal appearing full thickness skin then the other hurdles in the way will not seem so difficult.
Where have you heard whispers about pictures coming in March?
The boy's age is also listed as ten in the article written for The Salt Lake Tribune. My guess is that as a member of the press, writing a favorably article, PolarityTE was willing to share that info. Seeking Alpha, depending on the timeline, might just be quoting that article or it's possible they had access to Cantor's report for investors.
My honest belief is that PolarityTE will likely need to optimize SkinTE for humans in order to get complete regeneration with appendages. I hope I'm wrong, and we should know pretty soon, but going off what they told me on the callthey had a paste that worked in mice but it needed to be optimized to work in pigs.
In terms of the cost, that is steep but not too out of line with their main competitors. And if it's a substantial improvement, or hopefully complete regeneration, burn patients would jump at the chance. Plus, PolarityTE has stated they're working on getting the procedure covered by insurers. That would obviously only apply to burns or other tissue damage that presents a significant reduction in movement or quality of life, not cosmetic scars.
In terms of healing, at 20 days (going off pig results) there should still be some areas that don't appear to have complete regeneration in the wound bed. There's a pic on their presentation of mid-stage wound healing in a pig and there are still areas of redness and what appears to be scar forming tissue, but by the end of the healing it's all gone and looks just like normal skin except for the margin. No way of knowing if it will do that for the boy and the other human patients, but at that early in the healing I think it coincides with their preclinical results. Or as they say, correlative.
I think PolarityTE should have most of the hurdles they might face figured out, or as I said in the previous post, they will get overtaken. This happens in all industries. Someone has a groundbreaking idea that works and everyone in the field comes rushing to exploit, improve and obliterate the competition. I'm sure they know this, but if it really does turn out to achieve complete regeneration, they're in for a wild, tumultuous ride.
1 hour ago, golfpanther said:Where have you heard whispers about pictures coming in March?The boy's age is also listed as ten in the article written for The Salt Lake Tribune. My guess is that as a member of the press, writing a favorably article, PolarityTE was willing to share that info. Seeking Alpha, depending on the timeline, might just be quoting that article or it's possible they had access to Cantor's report for investors.
My honest belief is that PolarityTE will likely need to optimize SkinTE for humans in order to get complete regeneration with appendages. I hope I'm wrong, and we should know pretty soon, but going off what they told me on the callthey had a paste that worked in mice but it needed to be optimized to work in pigs.
In terms of the cost, that is steep but not too out of line with their main competitors. And if it's a substantial improvement, or hopefully complete regeneration, burn patients would jump at the chance. Plus, PolarityTE has stated they're working on getting the procedure covered by insurers. That would obviously only apply to burns or other tissue damage that presents a significant reduction in movement or quality of life, not cosmetic scars.
In terms of healing, at 20 days (going off pig results) there should still be some areas that don't appear to have complete regeneration in the wound bed. There's a pic on their presentation of mid-stage wound healing in a pig and there are still areas of redness and what appears to be scar forming tissue, but by the end of the healing it's all gone and looks just like normal skin except for the margin. No way of knowing if it will do that for the boy and the other human patients, but at that early in the healing I think it coincides with their preclinical results. Or as they say, correlative.
I think PolarityTE should have most of the hurdles they might face figured out, or as I said in the previous post, they will get overtaken. This happens in all industries. Someone has a groundbreaking idea that works and everyone in the field comes rushing to exploit, improve and obliterate the competition. I'm sure they know this, but if it really does turn out to achieve complete regeneration, they're in for a wild, tumultuous ride.
nobody knows if it is complete regeneration or scarring but havee in mind that the paste may not go everywhere if the paste doesn't cover all the wound then this place may have minimal scarring my opinion is that if it can replace X amount of scars then it can replace 100% amount of scars except of margin
14 minutes ago, damnBOY said:1 hour ago, golfpanther said:Where have you heard whispers about pictures coming in March?The boy's age is also listed as ten in the article written for The Salt Lake Tribune. My guess is that as a member of the press, writing a favorably article, PolarityTE was willing to share that info. Seeking Alpha, depending on the timeline, might just be quoting that article or it's possible they had access to Cantor's report for investors.
My honest belief is that PolarityTE will likely need to optimize SkinTE for humans in order to get complete regeneration with appendages. I hope I'm wrong, and we should know pretty soon, but going off what they told me on the callthey had a paste that worked in mice but it needed to be optimized to work in pigs.
In terms of the cost, that is steep but not too out of line with their main competitors. And if it's a substantial improvement, or hopefully complete regeneration, burn patients would jump at the chance. Plus, PolarityTE has stated they're working on getting the procedure covered by insurers. That would obviously only apply to burns or other tissue damage that presents a significant reduction in movement or quality of life, not cosmetic scars.
In terms of healing, at 20 days (going off pig results) there should still be some areas that don't appear to have complete regeneration in the wound bed. There's a pic on their presentation of mid-stage wound healing in a pig and there are still areas of redness and what appears to be scar forming tissue, but by the end of the healing it's all gone and looks just like normal skin except for the margin. No way of knowing if it will do that for the boy and the other human patients, but at that early in the healing I think it coincides with their preclinical results. Or as they say, correlative.
I think PolarityTE should have most of the hurdles they might face figured out, or as I said in the previous post, they will get overtaken. This happens in all industries. Someone has a groundbreaking idea that works and everyone in the field comes rushing to exploit, improve and obliterate the competition. I'm sure they know this, but if it really does turn out to achieve complete regeneration, they're in for a wild, tumultuous ride.
nobody knows if it is complete regeneration or scarring but havee in mind that the paste may not go everywhere if the paste doesn't cover all the wound then this place may have minimal scarring my opinion is that if it can replace X amount of scars then it can replace 100% amount of scars except of margin
also the article says about minimal scarring but in polarity's news they don't say it
To be honest even with margins once the skin is 100% healed they can be blended with lasers and cosmetic tattoo for pigmentation. Scar tissue is the hard bit because the collegan bundles lay flat in a row rather thsn meshed like in healthy skin. Its the difference between using make up on true scars vs red marks. No comparison. Im very hopeful in skinTE and will fly to usa from uk to have in on a surgical scar. Luckily my acne doesnt scar.
14 hours ago, Sniffy said:Cantor Fitzgerald also predicting the cost of SkinTe kit will be $7300...seems steep but if results are very good and it can be seen as a one and done treatment leaving patients happy then its worth every cent. Whispers of images being released in March at an event, looking forward to that.
I will happily drop $7300 to remove my scars lol. I know a lot of sufferers are younger and maybe from more undeveloped countries so $7300 sounds a lot to them. Hopefully, there is some installment plan to pay back for them.
2 hours ago, AI3forever said:I will happily drop $7300 to remove my scars lol. I know a lot of sufferers are younger and maybe from more undeveloped countries so $7300 sounds a lot to them. Hopefully, there is some installment plan to pay back for them.
Say if this can achieve a predictable 75+ improvement with a less riskier side effect profile than say fully ablative lasers or infini rf, I would be more than happy to pay that. Lasers can be 3-4k and they sometimes don't do anything!
Is that 7300 for a full face? So if someone had only a couple of scars to treat, maybe a part of the face could be less?
12 hours ago, golfpanther said:Where have you heard whispers about pictures coming in March?The boy's age is also listed as ten in the article written for The Salt Lake Tribune. My guess is that as a member of the press, writing a favorably article, PolarityTE was willing to share that info. Seeking Alpha, depending on the timeline, might just be quoting that article or it's possible they had access to Cantor's report for investors.
My honest belief is that PolarityTE will likely need to optimize SkinTE for humans in order to get complete regeneration with appendages. I hope I'm wrong, and we should know pretty soon, but going off what they told me on the callthey had a paste that worked in mice but it needed to be optimized to work in pigs.
In terms of the cost, that is steep but not too out of line with their main competitors. And if it's a substantial improvement, or hopefully complete regeneration, burn patients would jump at the chance. Plus, PolarityTE has stated they're working on getting the procedure covered by insurers. That would obviously only apply to burns or other tissue damage that presents a significant reduction in movement or quality of life, not cosmetic scars.
In terms of healing, at 20 days (going off pig results) there should still be some areas that don't appear to have complete regeneration in the wound bed. There's a pic on their presentation of mid-stage wound healing in a pig and there are still areas of redness and what appears to be scar forming tissue, but by the end of the healing it's all gone and looks just like normal skin except for the margin. No way of knowing if it will do that for the boy and the other human patients, but at that early in the healing I think it coincides with their preclinical results. Or as they say, correlative.
I think PolarityTE should have most of the hurdles they might face figured out, or as I said in the previous post, they will get overtaken. This happens in all industries. Someone has a groundbreaking idea that works and everyone in the field comes rushing to exploit, improve and obliterate the competition. I'm sure they know this, but if it really does turn out to achieve complete regeneration, they're in for a wild, tumultuous ride.
I read about images in March from an investor claiming this on Stocktwits. Its a good source of Information Stocktwits for daily updates all things concerning PolarityTe. Also alot of speculation like here keep in mind.
Im not sure what the gap is between Mice skin and Pig skin vs Pig skin and Human skin but even if SkinTe needs optimizing it can also be seen as a good thing just it could delay future full scale release thats all. However PolarityTe did say early stages of healing were yielding correlative outcomes to Pig pre clinical results.
The redness from Pig photos in mid stage healing could be scar tissue or could be just prolonged redness as they do mention "progressive healing" often. From memory this is from a fully excised deep wound down to the muscle so this an extreme case. Acne scars dont compare to such wounds or burns thus healing should be more favorable for less severe defects one would think.
4 hours ago, ScarRight said:Say if this can achieve a predictable 75+ improvement with a less riskier side effect profile than say fully ablative lasers or infini rf, I would be more than happy to pay that. Lasers can be 3-4k and they sometimes don't do anything!Is that 7300 for a full face? So if someone had only a couple of scars to treat, maybe a part of the face could be less?
$7300 is for the kit regardless of how much skin is being treated I guess...A standard biopsy for SkinTe kit is 2cm and that is enough to cover an entire arm. That will likely fill the syringe from the kit I guess. So a kit should easily do an entire face and maybe some of back for people who have scars there also.
https://stocktwits.com/ChessHere/message/113284964
This might be the post Sniffy is referring to.
5 hours ago, Sniffy said:$7300 is for the kit regardless of how much skin is being treated I guess...A standard biopsy for SkinTe kit is 2cm and that is enough to cover an entire arm. That will likely fill the syringe from the kit I guess. So a kit should easily do an entire face and maybe some of back for people who have scars there also.
With a kit how much skin can you treat at the maximum? It depends on the size of the biopsy? Thank you