Acne.org Products
28 minutes ago, Binga said:R,
We received your inquiry about Skin TE.
I am a medical monitor for the clinical studies, and I have reviewed some of the preliminary data, but the product is not yet approved by the FDA for human use.Polarity TE expects clinical use in humans to begin possibly later this year, after their trials are concluded and analyzed.Would definitely be worth looking into then.Best wishes,CSH
C. Scott Hultman, MD, MBA, FACS
Ethel and James Valone Distinguished Chair ofPlasticSurgery
Chief Emeritus and Professor, UNC Division of Plastic Surgery
Founder and Senior Advisor, UNC Aesthetic, Laser, and Burn Center
Chair, UNC Patient Complaints Monitoring CommitteeMember, UNC Faculty Physicians Fiduciary Committee
yeah so anyone else NOT associated with SkinTE used this product?
17 minutes ago, Binga said:Rick,
We received your inquiry about Skin TE.
I am a medical monitor for the clinical studies, and I have reviewed some of the preliminary data, but the product is not yet approved by the FDA for human use.Polarity TE expects clinical use in humans to begin possibly later this year, after their trials are concluded and analyzed.Would definitely be worth looking into then.Best wishes,CSH
C. Scott Hultman, MD, MBA, FACS
Ethel and James Valone Distinguished Chair ofPlasticSurgery
Chief Emeritus and Professor, UNC Division of Plastic Surgery
Founder and Senior Advisor, UNC Aesthetic, Laser, and Burn Center
Chair, UNC Patient Complaints Monitoring CommitteeMember, UNC Faculty Physicians Fiduciary Committee
Ah, this and was basically my thought in the previous post. The FDA still has the post-market approval process.
I will say that this sort of is at odds with PolarityTE. It doesn't really raise any red flags for me at the moment, but they've made it sound like it's commercially available. It's a fine line because it's definitely true that SkinTE is not approved by the FDA (they are merely registered through the 361 arm), it also sounded like it was available if you wanted to go seek it out. Perhaps there is some disconnect between PolarityTE and Hultman but I think he's probably right. Interesting that other posters had doctors ask to see photos and such. But maybe they were just willing to look and then say check back during the back half of this year.
24 minutes ago, Rez77 said:yeah so anyone else NOT associated with SkinTE used this product?
Rez77, that makes no sense. If they've used SkinTE, they are definitely associated with it and PolarityTE. It's not like the product materializes before them with no packaging and they have no knowledge of where it came from. PolarityTE had to create a clinical advisory board that would use the product. This would be the same if they were doing trialsif someone is using the product they are associated with it.
Also, it's important for everyone to note that Hultman is NOT part of PolarityTE's clinical advisory board. Since he's a medical monitor there's no way he could have that conflict of interest. I just want to make sure people get that since Rez77 seemed to imply he was on the advisory board.
5 hours ago, Binga said:R,
We received your inquiry about Skin TE.
I am a medical monitor for the clinical studies, and I have reviewed some of the preliminary data, but the product is not yet approved by the FDA for human use.Polarity TE expects clinical use in humans to begin possibly later this year, after their trials are concluded and analyzed.Would definitely be worth looking into then.Best wishes,CSH
C. Scott Hultman, MD, MBA, FACS
Ethel and James Valone Distinguished Chair ofPlasticSurgery
Chief Emeritus and Professor, UNC Division of Plastic Surgery
Founder and Senior Advisor, UNC Aesthetic, Laser, and Burn Center
Chair, UNC Patient Complaints Monitoring CommitteeMember, UNC Faculty Physicians Fiduciary Committee
Binga, what types of scars did you ask about for treatment or did you just send a general inquiry. Would be interesting to know if you asked about acne scars or some other type.
Expect at least a year to gain post human trial approval from the FDA. Bureaucracy will ensure it is not quick. It wouldn't be available commercially straight away, even with the 361 method.
That if it even works. It could be a flop or even a scam, just like how Rez said it would be.
3 minutes ago, ScarRight said:Expect at least a year to gain post human trial approval from the FDA. Bureaucracy will ensure it is not quick. It wouldn't be available commercially straight away, even with the 361 method.
That if it even works. It could be a flop or even a scam, just like how Rez said it would be.
Sorry, but if anyone thinks this is a scam at this point they're being delusional.
Dr. Mundinger went on the record stating he'd used the product, that it had regenerated skin quickly with pigmentation and minimal contracture early in the wound healing process. There is zero reason to believe that a doctor would risk his reputation and practice by just blatantly lying. Just because he's on the advisory board doesn't mean he'll just go around making stuff up.
Couple that with Hultman's comments (who again, is not affiliated with PolarityTE in any known or observable way) and it's clear the product is real and not just scam to rip off investors and make money.
I doubt it will be a flop either given that Mundinger and Hultman both were impressed thus far and Mundinger is going to use it on the rest of the child patient's burn scars.
Will it achieve complete regeneration right off the bat? No one has any clue. But given the statements by the two docs in the press release, it's a decent bet that it will not be a flop, and will offer an improvement over existing methods.
A note about the FDAthe regulation process for HCT/P 361 regulatory arm lists that it takes 1-2 years for a product to get approval under this pathway from the time the company applies. Keep in mind that PolarityTE got registered in October of last year and likely applied a while before that.
In addition, since this is also a regenerative medicine product they will be affected by the easier FDA guidelines. As part of this a company can bypass efficacy testing and go straight to post-market review (just as PolarityTE has done with SkinTE).
So far, I've not read anything that changes PolarityTE's timelines. If it provides any improvement it will almost certainly reach the market the back-half of this year, just like Hultman intimated in his response to Binga.
Seriously though, we just need to be patient and await results. That's all that matters.
At this point, I think these are the things that should be established:
1) The company is NOT a scam, there IS a product, however...
2) The results are to be determined. They could be successful, semi-successful or a failure
3) At this point, you most likely won't be treated for cosmetic scarring until after the human trials are at least comprehensive enough to give results
Everything else is conjecture, guessing, paranoia and what not.
guys i'm not all pessimist i just found this and it actually looks promising.
i have more faith that this technology will do something considering it was bought up by a big company like allergan.
follow the money guys --these guys have something. my fear is they'll make it into something you need to continually
get like botox so they keep making money instead of a one time fix https://www.businessinsider.com.au/botox-maker-allergan-buys-elastagen-2018-2
1 hour ago, Rez77 said:guys i'm not all pessimist i just found this and it actually looks promising.
i have more faith that this technology will do something considering it was bought up by a big company like allergan.
follow the money guys --these guys have something. my fear is they'll make it into something you need to continually
get like botox so they keep making money instead of a one time fix https://www.businessinsider.com.au/botox-maker-allergan-buys-elastagen-2018-2
Good find! Posts like this are great.
However, I do find it odd that you have more faith in a company like Allergan than say PolarityTE. Simply because big companies rarely want truly disruptive technology to take off because the status quo (like a frequent need for injections as you fear) is far more profitable than a permanent fix.
Regardless, it's another interesting product to discuss.
However, found this article about Allergan:
https://www.statnews.com/pharmalot/2018/02/08/celexa-forest-allergan-trials/
You nee to be a subscriber to read the entire article, bu the first line is:
"Nearly eight years ago, an Allergan (AGN) unit paid $150 million tosettle criminal charges of illegally marketing three drugs. Now, the U.S. attorney in Boston is being asked to reopen its investigation after newly unsealed documents suggest the company may have deliberately misled federal officials about a key clinical trial for one of the medicines, undermining the basis for the settlements."
I would think something like this would make you extremely cautious (rightfully so in this case) about anything to do with this company or products they acquire. The science of Elastagen seems aimed at increasing Elastin in tissues to the levels it was at during late stage fetal development in the hopes that will allow for better healing outcomes. To your point about being worried they'd turn it into a frequent injection, I don't see how with this idea they could possibly hope to maintain that level of Elastin without regular injections. Maybe it wouldn't matter if you got rid of the scar that way with the first injection, or a series of them, but I'm skeptical about this idea.
On 2/8/2018 at 9:31 AM, sousou_bella said:Hi Kim,As soon as I find a doctor who uses the product and is willing to use it on new patients even if they say they wouldn't recommend it for me but they would be willing to use it on a different candidate, I will 100% for sure come back and tell you all. Yes, the doctor I have reached out to in New Orleans is Dr. Mundinger. His nurse hadn't heard of the product but she said she would forward my email and pictures to him and ask him. The thing is we already know that he uses the product because it says in the article that he revised a child's burn scar with SkinTE so it's just a matter of seeing if he would be willing to use it on anyone else. Maybe he's only using it on patients who have had previous skin grafts etc or in cases which in his opinion are "extreme" for lack of a better term.
Not sure how I got a response from Dr. Hickerson so quickly maybe it was just luck. I was quite surprised as well when he emailed me back on the same night that I sent the pictures to him. I then sent him a response because he said he would give me some recommendations on my scars and even said he would recommend some good doctors in my area which I thought was very sweet of him (he asked me for some more info so that he could give me some recommendations). I spoke to Precious as well..very nice lady.
Precious is very nice however I am really frustrated because have been going back and forth for like a month trying to get a reply. I know he looked at my pics that I sent to Precious. Its so weird that they gave you his email direct. It would have been a lot easier for me to just email my pics direct to him instead of this whole thing trying to call them Precious is never there now
On 2/8/2018 at 3:38 PM, damnBOY said:I have the same problem with you ....... we wait the results of skinte on humans if skinTE rwgenerate the skin then stretch marks could be vanished 1) removal of the dermis and application of skinTE 2) directly propagation of skinte into stretch marks I don't know how....maybe with injections I say about the second option because polarityTE told that skinTE propagates and axpands into old scars and regenerates healthy skin, from what they are saying I understand that they don't remove the scar and then put the skinTE into the wound bed but somhow they put the skinTE into the scar that's the meaning of propagation also one guy from here spoke with polarityte and they told him that they create derivatives to treat smaller scars with no aggressive procedures don't forget that stretch marks are a type of scars ''skinTE propagated and expanded into the residual burn scar that remained in addition to regenerating full-thickness, hair-bearing skin'' words from polarityTE what do you understand from these words guys?
I never thought of injections. I was thinking they would use laser or micro-needling on the stretch marks so they could get down into the dermis before applying the the paste.
9 hours ago, Rez77 said:So basically we're a year away from figuring out if SkinTE works in burns good enough to hope that a future cosmetic product is released.
SNNNOOOOOOZZZZzzzzzzzzzzzzzz........WAKE ME UP IN A YEAR. Smell ya later.
Patience is a virtue.
They will know soon when results are released first half this year. Why would you say they wont know for a year? Can you show me the press release stating this please....you wont report back in a year!....smell ya in a few days
PolarityTe are scaling up manufacturing right now in there new facility so they are ready for demand of SkinTe. Thats the reason why only a handful of hospitals are listed to use SkinTe. Swanson said they would then slowly release the product one by one to more hospitals 2nd half this year and 2019 it will be in full swing across America. Cosmetic use for smaller problems like yours will be likely 2019 pending how good results are, derivatives for the product etc. Its not impossible but unlikely anyone will have this done on their acne scars 2nd half 2018.
I'm encouraged by last weeks release about the young boy having his scarred skin resurfaced with SkinTe and it regenerating his skin and already re-pigmenting so early in stages of healing. I can only assume "regenerated skin" means it was new skin or close to scarless or at least a big improvement even though its early stages otherwise why else would the doctor say hes going to do the rest of his scars, you just wouldnt put a young kid through that unless its worth the results. But i still need to see to believe.
Everyone will be put out if their misery one way or another by mid 2018. PolarityTe have been true to their timelines up till now.
Its promising so far we have heard good results so lets imagine its a big success. The demand would be huge 2nd half 2018 and thats just for burns patients in hospitals. They couldn't cope with cosmetic use 2nd half this year if they opened the flood gates and give anyone access to SkinTe.
Try meditating while you wait.. haha
Close your eyes. Now think about the positive early results being reported back by Doctors. Its working. PolarityTe are excited about releasing final outcome patient images and your excited to. You see and are very happy with SkinTe results in burns scars and other large wounds/scars so imagine what it will do for a small acne scar.
On 2/9/2018 at 8:51 PM, Giselle1625 said:On 2/8/2018 at 7:38 AM, damnBOY said:I have the same problem with you ....... we wait the results of skinte on humans if skinTE rwgenerate the skin then stretch marks could be vanished 1) removal of the dermis and application of skinTE 2) directly propagation of skinte into stretch marks I don't know how....maybe with injections I say about the second option because polarityTE told that skinTE propagates and axpands into old scars and regenerates healthy skin, from what they are saying I understand that they don't remove the scar and then put the skinTE into the wound bed but somhow they put the skinTE into the scar that's the meaning of propagation also one guy from here spoke with polarityte and they told him that they create derivatives to treat smaller scars with no aggressive procedures don't forget that stretch marks are a type of scars ''skinTE propagated and expanded into the residual burn scar that remained in addition to regenerating full-thickness, hair-bearing skin'' words from polarityTE what do you understand from these words guys?I never thought of injections. I was thinking they would use laser or micro-needling on the stretch marks so they could get down into the dermis before applying the the paste.
The injections are something Swanson brought up on my call with him, but I have no idea how long it would take to develop and bring to market something like that. I'm not sure they do either because an injectable is only something that will happen if SkinTE works.
Your idea sounds like it would work if SkinTE proves successful, but again, I think the invasiveness issue with SkinTE as it is right now isn't the excision, debridement, micr-needling etc. of the existing wound, but rather the skin biopsy. If you're burned over a large % of your body, taking a small skin biopsy of healthy skin is a no brainer if SkinTE works. But if you have cosmetic/superficial scars or stretch marks that don't interfere with daily activities (i.e. movement of your limbs), I think PolarityTE rightfully thinks that the skin biopsy could be a non-starter for those applications.
1 hour ago, golfpanther said:The injections are something Swanson brought up on my call with him, but I have no idea how long it would take to develop and bring to market something like that. I'm not sure they do either because an injectable is only something that will happen if SkinTE works.Your idea sounds like it would work if SkinTE proves successful, but again, I think the invasiveness issue with SkinTE as it is right now isn't the excision, debridement, micr-needling etc. of the existing wound, but rather the skin biopsy. If you're burned over a large % of your body, taking a small skin biopsy of healthy skin is a no brainer if SkinTE works. But if you have cosmetic/superficial scars or stretch marks that don't interfere with daily activities (i.e. movement of your limbs), I think PolarityTE rightfully thinks that the skin biopsy could be a non-starter for those applications.
WhY not CO 2 your skin and put Skin TE on after?
1 hour ago, nikkigirl said:3 hours ago, golfpanther said:The injections are something Swanson brought up on my call with him, but I have no idea how long it would take to develop and bring to market something like that. I'm not sure they do either because an injectable is only something that will happen if SkinTE works.Your idea sounds like it would work if SkinTE proves successful, but again, I think the invasiveness issue with SkinTE as it is right now isn't the excision, debridement, micr-needling etc. of the existing wound, but rather the skin biopsy. If you're burned over a large % of your body, taking a small skin biopsy of healthy skin is a no brainer if SkinTE works. But if you have cosmetic/superficial scars or stretch marks that don't interfere with daily activities (i.e. movement of your limbs), I think PolarityTE rightfully thinks that the skin biopsy could be a non-starter for those applications.
WhY not CO 2 your skin and put Skin TE on after?
I'm not saying you can't. I'm sure that would be a viable method if SkinTE works.
Again, the invasiveness of SkinTE is two-folda skin biopsy and the removal (by whatever means) of existing scar tissue or wounded tissue. The former is the bigger issue from PolarityTE's perspective in terms of using it on more cosmetic scars.
I honestly think (judging from the reactions on this board) that they might be wrong about that. Again, they will actually have little control over that aspect because they've repeatedly stated that it would be up to provider and patient to determine if SkinTE is right for a particular person's scars.
The injectable idea is a separate issue. While it would remove the need for excision of the existing scars (in theory), I don't see how the product would be created without a skin biopsy. And if it was possible to do it without the skin biopsy, I don't think they could bring it to market as quickly because barring some new way of getting a patient's own cells, it wouldn't be an autologous/homologous product.
Swanson didn't share any real details on our call, but I'm just going off what the science of SkinTE is at the moment. Perhaps they could figure out a way to extract the cells they needed from the person to create an injectable for smaller areas of scarring that wouldn't need a biopsy.
5 hours ago, golfpanther said:I'm not saying you can't. I'm sure that would be a viable method if SkinTE works.Again, the invasiveness of SkinTE is two-folda skin biopsy and the removal (by whatever means) of existing scar tissue or wounded tissue. The former is the bigger issue from PolarityTE's perspective in terms of using it on more cosmetic scars.
I honestly think (judging from the reactions on this board) that they might be wrong about that. Again, they will actually have little control over that aspect because they've repeatedly stated that it would be up to provider and patient to determine if SkinTE is right for a particular person's scars.
The injectable idea is a separate issue. While it would remove the need for excision of the existing scars (in theory), I don't see how the product would be created without a skin biopsy. And if it was possible to do it without the skin biopsy, I don't think they could bring it to market as quickly because barring some new way of getting a patient's own cells, it wouldn't be an autologous/homologous product.
Swanson didn't share any real details on our call, but I'm just going off what the science of SkinTE is at the moment. Perhaps they could figure out a way to extract the cells they needed from the person to create an injectable for smaller areas of scarring that wouldn't need a biopsy.
they should create a injectable paste which need a skin biopsy so they can bring it to the market so simple
1 hour ago, damnBOY said:6 hours ago, golfpanther said:they should create a injectable paste which need a skin biopsy so they can bring it to the market so simple
SkinTe needs to show it can propagate into scar tissue to replace it with normal skin structure as it did in pre-clinical testing, that would really help push Injectables of SkinTe.
24 minutes ago, damnBOY said:3 hours ago, Sniffy said:SkinTe needs to show it can propagate into scar tissue to replace it with normal skin structure as it did in pre-clinical testing, that would really help push Injectables of SkinTe.hopefully
but needling and subcision to break up tissues and create a bed under the skin for SkinTe to be injected into is also viable you would think.
Hello,Today it is an interesting day for PolarityTE stock with an increase over 10% and also good news from renovacare skingun and fda submission,See the link here : http://markets.businessinsider.com/news/stocks/renovacare-announces-successful-fda-meeting-1015894120
55 minutes ago, Ps93 said:Hello,Today it is an interesting day for PolarityTE stock with an increase over 10% and also good news from renovacare skingun and fda submission,See the link here : http://markets.businessinsider.com/news/stocks/renovacare-announces-successful-fda-meeting-1015894120
Great news! I'm very eager to see if RenovaCare can get approval soon. The more products that come to market for wound healing the more innovation we should see.
Also, related to PolarityTE's stock increase, Cantor Fitzgerald's research analysts gave their stock an overweight rating (better value compared to other stocks) and set a target stock price of $70.
https://seekingalpha.com/news/3331512-buying-ramps-polarityte-shares-ahead-18-percent
Cantor had a representative on the call with them back in June and I believe he was the one who asked about the cosmetic market. I don't know enough about investing to know how big of a deal this is but it can only be interpreted as good news.
