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2 hours ago, kim6288 said:20 hours ago, golfpanther said:Everyone, for the last time... SkinTE DOES NOT have to go through clinical trials. Basically, they're approved for commercial use because they followed the HCT/P regulatory pathway. They meet all the criteria for this so they can just go straight to market after being registered with the FDA. It's the big reason why they blast out that their product is autologous and homologous (for patient, from patient). That insures them this pathway, which allows them to immediately go to market. They will face post-market FDA oversight and regulation, but SkinTE is out right now. Refer to the post I made earlier in the thread of the conversation I had with Dr. Swanson of PolarityTE for more info.They have a limited release in 15 burn centers right now and will roll out to more, if not all, of the 126 burn centers in America. Again, as a product.
Really, just go their site. It has under News/Press Releases the fact that they're registered as a product with the FDA and going to market.
This is exactly why they just leased (for five years) a 200,000 sqft facility in Utah; to meet the demand for the product and continue to work on their development pipeline for other bodily structures. This was announced and posted here in the last 3 days. And there are no machines that nurses and derms/surgeons will need training on. Their only job will be to excise the skin biopsy and send it back to PolarityTE for processing. You just need to watch the presentation video on their site for the explanation of how it will work.
I made an appointment today with a plastic surgeon in TN that staff told me is currently using skin te in surgery. She said I do not know if he will use it on you. For some reason they are always like well he might recommend something better like this laser we have. That is so depressing. I was like what could be better than regenerating your own tissue! Whatever I don'tlike it when the office staff is giving their opinion and trying to somehow place seeds of doubt and obstacles. Most of the places I called never heard of it and/or said the docs there are not using it. I just started calling the docs on the list of burn centers and this was the first one I was able to get an appt. Its kind of far for me to go without knowing what is going so I will probably keep calling to get more info on it or possibly email the doc
If you've ever been to a dermatologist's office for scar 'revision', you wouldn't be surprised by how indifferent and ignorant the staff are about scar treatments. It doesn't surprise me that they would recommend the 'gold standard' procedure (which is burning your skin off or needling your skin and hoping for the best) that doesn't do much at all for scars.
To be fair, the derms offices are in a tough position right now in terms of recommending SkinTE.
1. Its way too early to know the final outcomes right now if patients were first getting treated in early to mid December.
2. While they might use it for scar revision, its been stated repeatedly that due to the invasiveness of the procedure that it will be up to the doctor and patient if its right for them. Id imagine the ones Im using it are preferring burns, burn scars and replacing skin grafts.
3. Staff probably arent super knowledgeable about it and neither is general public so sticking to safer recommendations is prudent on their part.
It does suck that they tried to push a laser on you as better but that likely doesnt indicate my results SkinTE has or has not achieved. It just likely means theyre going with what they know.
Great work regardless! Good on you for being proactive!
1 minute ago, SimpleMutton said:How can they even compare a stupid laser to a product that (should) regenerate full thickness skin? I'm flabbergasted
Anyway good job for having found a surgeon that is doing SkinTE, hope he also uses it on scars and not just burns
Um.. Maybe because we don't know if Skin Te will even work on humans. But then again, lasers don't really do much for acne scars anyway.
23 minutes ago, ScarRight said:Um.. Maybe because we don't know if Skin Te will even work on humans. But then again, lasers don't really do much for acne scars anyway.
In my opinion: regardless of the efficacy of SkinTE, of which we have no idea, lasers should not be recommended for acne scars, since they don't do anything worthwhile for them. Sure, they might 'reshape' scars, but that's really not what people with acne scars want. They simply want them removed or made more shallow. Acne scar 'revision' with laser is just a euphemism for 'this doesn't work but we will take your money gladly, and burn your face off to make you feel like you've done something.' If anybody has seen satisfactory results from lasers, I have yet to see them, and so doctors that recommend such procedures when nobody (as far as I know) has credible results to show in their support are not people I would like to work with.
1 hour ago, RickeyDog1989 said:In my opinion: regardless of the efficacy of SkinTE, of which we have no idea, lasers should not be recommended for acne scars, since they don't do anything worthwhile for them. Sure, they might 'reshape' scars, but that's really not what people with acne scars want. They simply want them removed or made more shallow. Acne scar 'revision' with laser is just a euphemism for 'this doesn't work but we will take your money gladly, and burn your face off to make you feel like you've done something.' If anybody has seen satisfactory results from lasers, I have yet to see them, and so doctors that recommend such procedures when nobody (as far as I know) has credible results to show in their support are not people I would like to work with.
Lasers like CO2 or fraxel are going out of style anyways for acne scars. What seems to be used right now as treatment are mostly dermal fillers like Benefil, microneedling, TCA cross, Infini (which is another microneedling device, I believe, that doesn't do anything on the surface but apparently deep in the dermis) and subcision (in which a dermatologist will use a needle to break down the scar tissue and apparently this raises the pitted hole with the level of the surrounding skin). All these techniques are custom made for different types of acne scars. Between, I never got any scar revision. You can say I am just a silly fool researching for a proven method to rid myself of my own acne scars.
Anyways, some dermatologists are more ahead in terms of technology while others are still stuck with laser resurfacing. Don't forget it can take years before a new approved treatment is accepted by all plastic surgeons or dermatogolists. Also, scar revision falls into cosmetic surgery for the most part and is loosely regulated. Most dermatologists and plastic surgeons will use their own methods and expertise to treat acne scars or scars in general. Once again, some are better at their work than others. Also, even the ones with a solid reputation will push for laser sometimes because they want to make money out of you. Buying those laser machines must cost a fortune. Also, some individuals scar more easily than others. Cosmeticians tend to ignore that many times. Therefore even with all these methods, your acne scars may look worse. Money down the drain.
Some people get a little improvement with laser resurfacing for acne scars, others don't. I believe that burning the face with a laser just covers the acne scars with another more uniform scar and most of the time the acne scars are still there. I would never waste money on lasers. Lasers should be used only for people with extensive pits not shallow acne scars. Lasers however are practical for burn or raised scars because it burns away all that thick scar tissue.
14 hours ago, ScarRight said:Okay, I just hope that laser they are recommending is not Fraxel or CO2 laser. If they seem more promising then Skin TE then that is a big worry. I think though that the Nurse on duty may not be familiar with the product and actually has very little idea and knowledge on scar revision, so I wouldn't call panic stations just yet. Maybe these hospitals already have selected their allocated clients for the human trial and are not wishing to add any more at this current stage, hence why they are not advertising it and playing dumb when asked about it.Just remember, I am just throwing up a few possible reasons. Who knows really. I wish you all the best on your quest.
it was not a nurse it was the receptionist. they really should not be offering their opinion because they do not know!
5 hours ago, ScarRight said:Um.. Maybe because we don't know if Skin Te will even work on humans. But then again, lasers don't really do much for acne scars anyway.
Um... maybe because it was a receptionist answering the phone that does not take any time learning about regenerative medicine and does not know what it even is. Even if they did laser on a scar it should be followed with skin te or any other regenerative medicine. Just removing the scar is not going to regenerate the tissue if you don't give it some support skin te, stem cells, recell, prp, etc would be better than laser alone
5 hours ago, SimpleMutton said:How can they even compare a stupid laser to a product that (should) regenerate full thickness skin? I'm flabbergasted
Anyway good job for having found a surgeon that is doing SkinTE, hope he also uses it on scars and not just burns
Thanks. I really think I am not going to find anything valuable until I meet with the doc. There is no way these people answering the phone know what the deal is with this new technology. Most have never heard of skinte at the burn centers I contacted. At least I did find out this doc is using it they said he uses it in surgery and they were asking me about my insurance. I gave them my insurance but said I will pay if I have to because its my face! I think it is mostly being used when people come into the clinic with a burn or open wound
Regarding Polarity and skin regenerated in pigs, is there any more proof apart from 3 pictures on their website? If I would succeed in regenerating pigsskin, I would be posting at least 100 photos from all different angles and from different healing periods lol.. Also, that regerated skin in the last pic seems whiteish, while all the previous pics have pigs skin look pink outside the wound. Seems pretty strange to only have 1 result pic if they succeeded:/ Didnt they have at least several pigs lol?
5 minutes ago, eekman said:Regarding Polarity and skin regenerated in pigs, is there any more proof apart from 3 pictures on their website? If I would succeed in regenerating pigsskin, I would be posting at least 100 photos from all different angles and from different healing periods lol.. Also, that regerated skin in the last pic seems whiteish, while all the previous pics have pigs skin look pink outside the wound. Seems pretty strange to only have 1 result pic if they succeeded:/ Didnt they have at least several pigs lol?
Why would it matter? 1 picture, 5, 10? It doesnt matter. What matters are the results in humans which is right around the corner anyway.
Yeah, I am still optimistic about them, but it would be nice to have more pics of pigs from different angles and distances. Everyone here is already skeptical about doctors manipulating light and angles to enhance the results.. More pics would just give more hope. Just wanted to ask if I missed some news article where they released more. Lets wait then.
5 hours ago, kim6288 said:it was not a nurse it was the receptionist. they really should not be offering their opinion because they do not know! Um... maybe because it was a receptionist answering the phone that does not take any time learning about regenerative medicine and does not know what it even is. Even if they did laser on a scar it should be followed with skin te or any other regenerative medicine. Just removing the scar is not going to regenerate the tissue if you don't give it some support skin te, stem cells, recell, prp, etc would be better than laser alone Thanks. I really think I am not going to find anything valuable until I meet with the doc. There is no way these people answering the phone know what the deal is with this new technology. Most have never heard of skinte at the burn centers I contacted. At least I did find out this doc is using it they said he uses it in surgery and they were asking me about my insurance. I gave them my insurance but said I will pay if I have to because its my face! I think it is mostly being used when people come into the clinic with a burn or open wound
Very good job, when do you plan to meet this surgeon?
I'll email Polarity after the conference and ask them info about the price, whether they're using it for acne scars too at this time and will ask when they plan to show the first results on human patients
Anyway as for the price, it's not just the product per se (SkinTE), we also have to pay the surgeon for excising the skin....and if they do it in a OR then we have to pay for the use of the OR, anesthetist, staff ecc....
It looks very expensive to me.....
9 minutes ago, SimpleMutton said:Very good job, when do you plan to meet this surgeon?
I'll email Polarity after the conference and ask them info about the price, whether they're using it for acne scars too at this time and will ask when they plan to show the first results on human patientsAnyway as for the price, it's not just the product per se (SkinTE), we also have to pay the surgeon for excising the skin....and if they do it in a OR then we have to pay for the use of the OR, anesthetist, staff ecc....
It looks very expensive to me.....
I put this up before, but I think the cost of ReCell is a good indicator. In terms of their processes they're quite similar: skin biopsy, processing, excision of scar tissue/debridement of wound, application of product and dressing. SkinTE has the shipping cost and processing at their labs to factor in so it will run a bit more.
ReCell (kit and procedure) runs around 2,500 to 4,000, roughly $3,500-$5,500 from what I've read. Adding in the extra step of sending it away to PolarityTE's labs I'm guessing it will be slightly more than that. They could try to charge more if it attains complete regeneration but I think that might draw some unneeded criticism their way.
20 minutes ago, golfpanther said:I put this up before, but I think the cost of ReCell is a good indicator. In terms of their processes they're quite similar: skin biopsy, processing, excision of scar tissue/debridement of wound, application of product and dressing. SkinTE has the shipping cost and processing at their labs to factor in so it will run a bit more.ReCell (kit and procedure) runs around 2,500 to 4,000, roughly $3,500-$5,500 from what I've read. Adding in the extra step of sending it away to PolarityTE's labs I'm guessing it will be slightly more than that. They could try to charge more if it attains complete regeneration but I think that might draw some unneeded criticism their way.
Yes but how much area that kit can treat? Just a couple of spots or extensive areas like the entire back?
Polarity said they'll send the construct obtained from the skin biopsy in a syringe but if the area to treat is very big then you'll need more than one syringe.
I guess is like fillers.....for extensive area one vial isn't enough
I wonder how many syringes you need to treat an area like the back....that's a very big area
I planned a budget of 20,000 (25,000$) but I think it's not enough for my condition and the area to treat...hope to be wrong
14 minutes ago, SimpleMutton said:Yes but how much area that kit can treat? Just a couple of spots or extensive areas like the entire back?Polarity said they'll send the construct obtained from the skin biopsy in a syringe but if the area to treat is very big then you'll need more than one syringe.
I guess is like fillers.....for extensive area one vial isn't enoughI wonder how many syringes you need to treat an area like the back....that's a very big area
I planned a budget of 20,000 (25,000$) but I think it's not enough for my condition and the area to treat...hope to be wrong
You are getting way ahead of yourself. Let's wait till it works on humans. I'm pretty much in the same position as you. There are entire areas of my back and shoulders that need to be excised due to my acne cysts leaving me with small raised white scars. It's good to set aside some money for such a procedure but be cautious. Sometimes, things are just to good to be true.
5 minutes ago, Anonymouz1 said:46 minutes ago, SimpleMutton said:Yes but how much area that kit can treat? Just a couple of spots or extensive areas like the entire back?Polarity said they'll send the construct obtained from the skin biopsy in a syringe but if the area to treat is very big then you'll need more than one syringe.
I guess is like fillers.....for extensive area one vial isn't enoughI wonder how many syringes you need to treat an area like the back....that's a very big area
I planned a budget of 20,000‚ (25,000$) but I think it's not enough for my condition and the area to treat...hope to be wrong
You are getting way ahead of yourself. Let's wait till it works on humans. I'm pretty much in the same position as you. There are entire areas of my back and shoulders that need to be excised due to my acne cysts leaving me with small raised white scars. It's good to set aside some money for such a procedure but be cautious. Sometimes, things are just to good to be true.
My back is also covered in small white raised scars 
8 hours ago, eekman said:Yeah, I am still optimistic about them, but it would be nice to have more pics of pigs from different angles and distances. Everyone here is already skeptical about doctors manipulating light and angles to enhance the results.. More pics would just give more hope. Just wanted to ask if I missed some news article where they released more. Lets wait then.
Of course I would like more photographs, from different angles and lighting. If this thing was well and truly a roaring success, I would be posting more than three photos.
2 hours ago, unbreakable1 said:My back is also covered in small white raised scars
I've got them on my shoulders, upper arms, upper back, some on my buttocks and thighs. I even have parts of my jawline with these. They are more prominent under certain light but fairly unnoticeable for an average person. I also have some facial dents but they are fairly small but there nonetheless.
I've struggled with my skin for 25 + years and see no end in sight. Tried everything apart from Accutane. As I'm getting older, acne is subsiding but the scars remain. My face has been clear for some time apart from a few pimples that resolve quickly. My back and thighs still breakout with angry lesions. A few years back, I simply did not care. My confidence though was pretty low but I managed to achieve most of my life goals. I avoided doing many activities and most of my buddies would try to cheer me up but I think they would understand that my skin was a mess.
I did get the occasional bad jokes as a teenager about it but some of my friends also went through severe acne which left them with pretty bad facial scars. Many of them moved on however and don't seem to be bothered by the scars. Then again, it is not a subject we discuss about. I did have one friend who never had pimples but he went bald pretty quickly and had to take steroid pills to suppress his uncontrollable psoriasis. There's at least a benefit to acne, you don't get wrinkles. I have none way into my thirties.
When it comes to skin, I think a lot of people suffer from many conditions which affect everyone's confidence. Nobody has perfect skin.
I believe I'm now stuck with a mild folliculitis on my buttocks, lower back, legs and thighs which was triggered by my past acne conglobata. I was diagnosed with acne conglobata when I was younger but it resolved on its own.
Look it up, it is a severe form of cystic acne which also causes joint inflammation. Surprisingly, my scarring is not so bad. I remember how the cysts would fuse together forming tunnels under my skin and parts would simply fall off. As a teenage boy, you could imagine how I felt like rotting from the inside.
Folliculitis is hard to get rid of. I use different acids and disinfectants to try to suppress the liggering acne on my butt, legs and thighs which I believe is recurrent folliculitis. There is also a pretty nasty mite named demodex which I believe is a cause for many of us with acne. Demodicosis is a real disease with severe acne like symptoms. A lot of doctors simply misdiagnose this illness and treat it as acne.
My only hope would be for someone to find a way to regenerate skin so I can erase the scars. This will be a great boost for me as I can finally conquer my pimples and scars. I'm still young. I would love for others to see a happier me and I would love to go to pools or beaches more often. My skin has definitely improved but the scars are painful to look at. I always have avoided taking pictures because of my previous pimples and acne scars.
With all this younger generation being fixated on social media and taking selfies, one has to wonder why a real acne cure has not been found yet and why scars cannot be simply vaporized. SkinTE looks promising. We should await for the clinical results in a few weeks. If it works, it will be a game changer as others will try to find less invasive techniques to vanish existing scars.
13 hours ago, Anonymouz1 said:14 hours ago, SimpleMutton said:Yes but how much area that kit can treat? Just a couple of spots or extensive areas like the entire back?Polarity said they'll send the construct obtained from the skin biopsy in a syringe but if the area to treat is very big then you'll need more than one syringe.
I guess is like fillers.....for extensive area one vial isn't enoughI wonder how many syringes you need to treat an area like the back....that's a very big area
I planned a budget of 20,000 (25,000$) but I think it's not enough for my condition and the area to treat...hope to be wrong
You are getting way ahead of yourself. Let's wait till it works on humans. I'm pretty much in the same position as you. There are entire areas of my back and shoulders that need to be excised due to my acne cysts leaving me with small raised white scars. It's good to set aside some money for such a procedure but be cautious. Sometimes, things are just to good to be true.
you're right, I'm naturally too optimistic
we have to wait until the first results on human come out
13 hours ago, Candy Says said:14 hours ago, Anonymouz1 said:We should await for the clinical results in a few weeks
why everyone think that results will be published so soon?
Because of the established timelines. In pigs it took about 10 weeks for the initial healing phase that showed maturing pores and hair follicle regeneration. PolarityTE announced on December 15th that SkinTE was on patients (and it likely had been for some time before that press release). They also have that investor conference next week. I'd say there's a good chance we hear something end of January to mid-Feb, good or bad.
So, I have been googling about SkinTE, and thought to look into other forums where the product might be relevant.. On hair loss forum there is some information. The regenerated skin will have the properties of donor skin from biopsy according to Swanson, e.g. hair would not grow if biopsy would be taken from feet. From their videos I thought the regenerated skin would take the properties of surrounding skin.. There is quite a bit of skepticism there as well like people cannot find information about Polaritys statusin public FDA database.. Does anyone know if a similar message boards exist for burn victims? Cannot find it so far. Such serious condition should definitely have an active forums and they should have more information maybe but cannot find one:/
1 hour ago, eekman said:So, I have been googling about SkinTE, and thought to look into other forums where the product might be relevant.. On hair loss forum there is some information. The regenerated skin will have the properties of donor skin from biopsy according to Swanson, e.g. hair would not grow if biopsy would be taken from feet. From their videos I thought the regenerated skin would take the properties of surrounding skin.. There is quite a bit of skepticism there as well like people cannot find information about Polaritys statusin public FDA database.. Does anyone know if a similar message boards exist for burn victims? Cannot find it so far. Such serious condition should definitely have an active forums and they should have more information maybe but cannot find one:/
I don't know about forums for burn victims unfortunately
Anyway I was looking at PolarityTE stock price, in the afterhours is increasing a lot...it's beyond 25$ per share, it closed at 24,06 after having been good in the last couple of days....who know, maybe some insiders have had good news about first results on human patients....
24 minutes ago, eekman said:So, I have been googling about SkinTE, and thought to look into other forums where the product might be relevant.. On hair loss forum there is some information. The regenerated skin will have the properties of donor skin from biopsy according to Swanson, e.g. hair would not grow if biopsy would be taken from feet. From their videos I thought the regenerated skin would take the properties of surrounding skin.. There is quite a bit of skepticism there as well like people cannot find information about Polaritys statusin public FDA database.. Does anyone know if a similar message boards exist for burn victims? Cannot find it so far. Such serious condition should definitely have an active forums and they should have more information maybe but cannot find one:/
I believe SkinTE is what I thought it would be. The skin biopsy that will be taken will depend on which part of the body it is taken from. Normally, a wound will contract as it is healing. I believe, applying this SkinTE paste will stop the skin from contracting and the paste will expand outward thus covering the wound. The idea behind this is normal looking skin. Now it would make sense as to why a margin would exist. The people behind Polarity, already mentioned about the margin. The paste applied on the wound will be compacted skin grown from the biopsy and with the help of LGR5 genes it will expand. Obviously, this will not be rejected by the body. The biopsy will just be grown in a lab using different techniques so if it taken from a leg and applied on a face wound, the healed facial wound would look like skin on a leg.
I have read the technology relies on LGR5 genes. LGR5 genes are crucial to embryonic development and are well known markers in stem cells. LGR5 markers are alsocrucial in wound repair because they tell stem cells present in the skin to become fibroblasts to close the wound. It seems, LGR5 genes are responsible in telling cells what they should divide into.
If the wound is small, you have complete regeneration. This is why small scrapes and cuts don't scar. If the wound is large, the LGR5 genes cannot get the message across for regeneration and thus scar tissue is formed.
I guess it is a trade off. Get a scar in a easily hidden place and erase the scar in a visible area. For burn wounds, It is better to have somewhat normal looking skin than skin grafts or skin substitutes that scar anyway. Burn scars are also hard, thick and inflexible. It would be a better alternative to what exists presently for burn victims provided it will work.
As for FDA approval, I searched for Polarity or SkinTE on the FDA website and couldn't find anything with those search terms. This is in contradiction to what Polarity co-founders are telling us. Although going through stock investor information online, websites seem to indicate the company is FDA approved. I am quite skeptical on this as well.
2 hours ago, Anonymouz1 said:As for FDA approval, I searched for Polarity or SkinTE on the FDA website and couldn't find anything with those search terms. This is in contradiction to what Polarity co-founders are telling us. Although going through stock investor information online, websites seem to indicate the company is FDA approved. I am quite skeptical on this as well.
Exactly what I was thinking. Why would the FDA approve this when we do not know what will happen when humans get the treatment? This is very different to previous biotech companies I have invested in or read about. Seems a bit fishy.