- Last Month
Hasnt Trump overhauled the FDA just recently to process trials and new drug approvals much faster?
10 years as some have stated doesnt seem right. Each phase takes roughly 15 months from what I read on average. You could put your hand up during phase 3 as one of a few thousand patients if your lucky and desperate. Stage 4 its basically widespread but continued observations of the product still happen and data is still collected. Should be within 5 years by my maths from whenever they start phase 1. Im not so familiar with the FDA process, this is just what i gather from research.
PolarityTe took a huge punch today. They are on the ropes if this is true that patent was rejected and they kept this hush hush...
Who knows, skinte could still offer something for small defects. Better to sit back and let the dust settle on this one.
Does anyone know if Sunogel hyrdogel goes to trials will it be classified as a device? And if so can that fast track everything?
- More Than a Month
Continued showing of black patient images is a worry. Its true nobodys face will look like these patients wounds so its hard to compare
my concern is if Skinte can actually do as they say because to me its looking more like a aided healing product not a regenreation product.
maybe the surface texture needs more time to blend with native skin, i hope its the case.
4 hours ago, beautifulambition said:@nikki_gargin Exactly I think it's perfect for you, and I am excited you can get it. Nothing that great out there. Any type of improvement for acute cases would be great as some of them have life threatening disabilities and health concerns.
I also think skinte would be great for major body scars and for say Acne conglobata or lupus or other auto immune stuff it would save cutting out the grafts. Even failed surgical closures where the skin will not heal properly.
For the face I don't think this product will give many what they want of perfect flawless scarless healing. For the highly skeptical aesthetics market. If you look at the boards where we help people with traditional treatments (for acne scars) people are often not pleased by tiny imperfections of treatment, there is a different mindset of perfection. So many on these boards and on this mega post have perfectionist ideals (BDD, etc) where their "very minor" scars could be improved by traditional methods, but they are all or nothing (it must be perfect or they want nothing). This is not healthy.
This product will help what it is intended to do give functionality back to burn and traumatic scar victims.
Any options are better than no options right, you must evolve the outcome of treatments through improvement. What I think most people are interested in for aesthetics is if it could be a replacement to fat grafting though injecting under other tissue layers or controlled damage (laser) - these items it would not matter how it looks as they would act as filler.
Also for older patients the outcome will be interesting, as younger patients tend to heal well from invasive traditional grafting.
The whole idea of using Skinte is for...
1. Less scarring and better function
2. Saves taking large donor grafts creating more defects (critical for burn patients with not much good skin left)
So if Skinte can reduce contraction and scarring in large body scars....why cant it do the same for a very small scar?....I don't get it.
this product either regenerates and improves scars or it doesnt....simple
42 minutes ago, royaume said:
Where are the experts here? Tano? What do you think about their latest presentation and on one slide they compare native skin with skinte but the skinte looks damn scarred.
because that slide is replacement of split thickness graft so they only took epidermis and part of dermis perhaps as they said they partially removed scarred skin. Leaving fibrotic scar tissue then applying SkinTe to reduce the boys keloid scars and contraction and also compare it to skin graft i guess as the standard of care
14 minutes ago, rudy1986 said:
The result in slide where there is pinching is really disappointing
what slide number?...The chest results dont concern me as much because its comparing to split thickness grafts so final results shouldt be as impressive. But then they took a full thickness biopsy from chest if im correct and it shows full regeneration...how can that be if they only did partial removal?
its all blurry for me...cant even read text on slides
1 hour ago, RickeyDog1989 said:
What I'm interested in is why is there such a big difference between the results on the child (chest injury) and the man (leg injury)? The dermascopic pictures of the leg are nearly completely similar in appearance to natural skin, whereas the pictures of the chest are clearly different from natural skin. You can tell from the pictures taken farther away as well. The leg is on its way to looking normal, whereas the chest seems like it's not going to look natural even when it's fully healed. Worth noting that the leg has been healing for a lot less time than the chest. The leg had been healing for 12 weeks when picture was taken, while the chest, at least in the pinch video has been healing for 6 months.
without seeing the results i do think the leg was a fresh wound. The young boys chest had only partially removed top layers of damaged skin so he still uas scar tissue under skin.
where can we find a link to watch it again if possible?
15 hours ago, royaume said:
It really seems like PolarityTE will present the desired results. If we see super results tomorrow, waiting will no longer be a problem because we can be sure that they aee able to treat acne scars if they wre able to get amazing results on these severe injuries.
Swanson clearly said to Tano in the interview that the margins are not visible to the naked eye. Maybe if you get reaaaaallly close. Its the same like your pores. They are not visible from distancr and if you get closer and closer you see them.
Tomorrow is a big day guys.
Yes today is a big day! (We hope)...in a matter of hours PolarityTe will present SkinTe. They say on Facebook page they will present an overview so I hope they dont just say everything we already have been told. They really need to present something substantial or people will start losing hope. Im worried they will just show more early healing photos if any at all. They say early stage healing for human photos at 49 days (7 weeks) and say mid stage healing at day 54 for pigs strangely. I think we havent seen enough photos yet especially later stage healing because they want to compile them all for a presentation like this one or in 2 weeks.
Asides from early stage photos of horriffic wounds which I still believe are Impressive the testimonies from Doctors, patients and a young patients mother saying it grows skin like magic and looks amazing have been nothing but positive. I havent heard any negative reports as yet other then from people who have never seen SkinTe, used SkinTe or spoken with anyone who has used it.
The stock price has climbed over $30 so maybe something big is brewing. Im not convinced the margin will be the only scar tissue left after treatment. If you see some of the pig models photos it looks more like 80% regenerated skin. Still amazing if it cant quite regenerate 100% first go... the left over or reduced scarring can be treated again. The key is it regenrates normal skin not whether its a one and done procedure.
Everyone has their reason for being here and everyone has their struggles with scars. No different from forums for people with balding hair, they want their hair back like we want our skin back. Im trying my best to forget the past and focus on a future with new developments and products at our fingertips. 10 years ago when this all started i was offered Laser and that was considered the best thing available...the outlook was miserable really. Fast forward to today and we have a company with a group of excellent Doctors and researchers who say they can now regenerate full thickness skin all layers and appendages something that was i was told was impossible many times. BirchBioMed and Sunogel are pressing their claims also in a race for a solutuon with all 3 very different products.
lets be honest no current treatment can significantly reduce or prevent scarring. Current treatments can reorganise and soften scars so if SkinTe does truly regenerate, reduce and prevent scarring even to a significant degree i would be very excited about getting this treatment. And so what if it needs to be repeated to reach an optimal result.
On 01/06/2018 at 11:18 PM, Binga said:On 01/06/2018 at 1:06 AM, golfpanther said:
None of us can give you that answer, Rudy. I think it will be an improvement over skin grafts at least, but beyond that it's just guessing.
Im not sure just injecting it will work wonders unless it really does propagate into scar tissue, time will tell if it does this like it showed in Pigs.
The unknown for smaller scars that are not so deep is Whether scar tissue needs to be completely removed first or it can just be disrupted to create a wound bed to trigger new healing with SkinTe introduced. The latter is a far more appropriate approach to acne scars.
It will be interesting to see the 10 year old boys final results after he had only top layers of scarred skin removed. How much does it improve the look of the skin both contraction and texture with deeper fibrotic scar tissue still sitting under his new SkinTe
1 hour ago, Anish004 said:
This has already been discussed before. There have been many terms used from Reduced, Scarless, Complete Regeneration, Full thickness skin, Far less Scarring......
keep in mind some of these descriptions were used before human trials. Most recent they have been saying "grown full thickness skin" and the young guys mother described it as "far less scarring" so make what you will of that. We have already heard of sweat glands and hair growth from deep wounds so there are definitely some positives without seeing finals results yet or use on small defects that are more relevant to us.
2 hours ago, SimpleMutton said:
We're almost in June and still no announcement about possibilities of getting this treatment for patients with acne scars.
How much longer do we have to wait? My life is ruined if I can't fix my scars. So tired of waiting.
I hope we can get this done by the end of the year or fuck it....it also takes 6 months to regenerate the skin, it's not quick
Lough said SkinTe will be available across the country within 12 months. If your desperate and cant wait for derivative product whenever that will be im sure you could find a plastic surgeon but whether they will excise on your face is another thing. Im sure when this becomes more widely available there will definately be people seeking treatment for acne scars and surgical scars through different methods ie; excision, needling, injection, subcision. No way id go ahead with excision unless i did a sample on scar on arm first and was satisfied even if more photos come through snd it looks good.
Remember these guys are burn surgeons primarily and their focus has been helping them first and fair enough.
On 22/05/2018 at 4:56 AM, nikki_gargin said:
I am saving as we speak for the day to fly to USA from UK to have my scar removed. 2 years time i reckon. Just a feeling....or a wish
Hopefully you dont have to fly to America. They are in talks with major Biopharma companies now about possible distribution of Skinte Internationally which makes sense. At least for elective treatments like acne scars it makes sense to send them your biopsy and then have them send back your Skinte kit to country you live in. Any treating doctor can use the kit thats why they designed the real time app for doctors using Skinte.
Unless they are looking at labs to process skinte in other coutries or they will just process everything from Utah.
10 minutes ago, Anish004 said:
some time ago somebody said that healed area will take properties of donor area skin...so i guess for face we have to give a small piece of skin for face i think lower jawline..will be perfect ..and fhat donor area will also be covered by paste
stilll imagining these things ..hope it all come true soon
No. Skinte biopsy can be taken from anywhere, preferably hidden places like groin and armpit. SkinTe applied to any wound on face or body grows skin that takes on the properties of the surrounding skin of where it grows.
5 hours ago, Anish004 said:$50 per cm square ????
i cant understand what that mean
previouslt they said a 2 cm skin graft converted to paste and then it can be applied to a large area
so that 50$ is the cost for a amount of paste which can cover 1 cm injured area ?
Yeh I guess so if you had 1 small acne scar its 1cm by 1cm so $50 but i doubt that would be the case for just 1 or 2 small scars. There will be a minimum processing fee i would think just to get the paste/jelly.
If SkinTe is a big success for smaller cosmetic purposes PolarityTe really need to be ready for the demand. Hopefully Skinte can be sent internationally for elective treatments also for people outside of America.
interesting article with Lough couple days ago. Here are some key points.
"He noted that the product also needs to be cost-efficient. While most skin substitutes are priced between $100 and $250 per square centimeter, PolarityTE sells its system for close to $50 per square centimeter, according to Lough"
"The company is also in talks with major biopharma companies, Lough said, to set up potential distribution deals nationally and internationally."
"Over the next year, PolarityTE plans to continue its limited release of SkinTE, as well as disclose data from its clinical work. Early data show great promise for the company’s first commercial product, according to Lough, who described a case in which doctors used SkinTE to treat a 45-year-old patient who had burns permeating 75% of their body."
“The patient was coding the night before the SkinTE product was put onto them,” he said. “Typically these patients, if they do live, they’re in the burn center for over a year. And the average cost for that type of burn care is usually $1.3 to $1.5 million, per the National Burn Repository data that’s out there. Following application of the SkinTE product, the patient was ambulating, grew full-thickness skin and was discharged six weeks later.”
16 minutes ago, damnBOY said:2 hours ago, rudy1986 said:
Please read completely what i stated, i said that even though we are more shallow in depth, we have to eventually excise it to full thickness
What page is that conversation on with Swanson?
1 hour ago, rudy1986 said:
Please read completely what i stated, i said that even though we are more shallow in depth, we have to eventually excise it to full thickness
We dont yet know if Excision will be the preference for Acne scars. If its regenerating skin close to 100% its no problem i guess. Otherwise a less invasive approach is the goal and if repeat treatments are needed so be it. It comes down to removing scar tissue completely or just breaking it down to create a new wound. My understanding is the scar tissue is removed with SkinTe at least for large graft areas which makes sense but small defects with surrounding good skin we await their plans.
5 hours ago, jac3 said:
This is awesome! I am genuinely elated for the people that it can and will help.
But it says it pretty clearly here - 'far less scarring'. It doesn't say 'no scarring'. I don't mean to undermine SkinTE's achievements, but this thread is and has always been about healing without scars. I just don't think SkinTE is going to achieve that, despite how much we hang on to the idea that it will. None of the results thus far have indicated scar free healing. Again, they are amazing, yes. But they aren't scar free.
The problem is not the results being 100% perfect new skin but rather people trying to compare whats currently happening with these patients to Acne scars...these patients with wounds down to muscle and bone are not even in same ball park as us, not even the same League. We are hearing positive results yes but Im waiting to see it tackle much smaller problems like small acne scars with derivative applications for purely cosmetic goals. Sweat Glands, sensation, hair follicles etc so early after such deep injuries is huge and an indication of at least better appearing skin without scar tissue present.
If "Far less scarring" means getting skin back to 80-90% for acne scars then its going to make alot of people with acne scars very happy. A small acne scar replaced or treated with SkinTe you would think heals over with "far less" scarring with some appendages and basically becomes invisible to the eye. That's what we hope anyway...i can find a small acne scar and imagine it with far less scarring and it would basically vanish. Remembering Skinte is designed to regenerate new skin not aided scarring.
Do yourself a favour and check out Facebook page "The recovery for ausome"..
Actual skinte patient with details of healing but no photos. He had a wound down to bone and it now has skin over it and he has sensation in skin and sweat glands in new skin.
33 minutes ago, Raster said:
Some dates that might reveal info on PolarityTE:
SkinTE™ – a human cellular and tissue-based product derived from a patient’s own skin to regenerate full-thickness, functionally-polarized skin with all its layers (epidermis, dermis and hypodermis) and appendages, including hair follicles and glands. SkinTE, for the repair, reconstruction and replacement of full-thickness skin, has been used in the treatment of chronic wounds during the limited-market release, and it has the potential to change the wound care field by providing a novel, full-thickness treatment option.
They are not backing away from their claims at least.
12 hours ago, Acnesucksforgood said:I never took Accutane and those blobs you are referring too are called perifollocular elastolysis, popular acne scars or mid dermal elastolysis. I have hundreds of these on my jawline, buttocks, thighs, shoulders and sides of my back from years of severe acne. I must say I was diagnosed with acne conglobata but was put on antibiotics and saw a gradual improvement while I was a teenager.
I was the only kid amongst my friends, who had it bad. All had a few pimples on their faces but my pimples were angry, infected and covered large parts of my body. Most of my friends knew about my suffering but didn't talk about it. It didn't really hold me back however. I was handsome and scored many times. At the end it was all in my head.
I also used extensive chemicals on my skin to kill all kinds of bacteria. I'm almost reaching my forties and still breakout time to time on my back.
Unfortunately, I am left with white blobs that are slightly raised from all those boils. I don't believe Accutane, any of these topicals or antibiotics make your skin more prone to scarring.
Scarring depends on each individual. Some people scar easily while others don't. More severe acne means more inflammation which means more scarring. I had it pretty bad on my face but my scarring is barely noticeable. These blobs you speak of are there but are only noticeable to me. To others, they are too small to be noticed.
Anyways, these white blobs are a consequence of inflammation, your skin is stretched to its limit by the pimple. Once the pimple heals, your skin has lost its elastic fibers in the dermis and it leaves you with a wrinkled slightly raised white hypertrophic scar. Some of mine have flattened over time, others have disappeared completely. Many however remain. Think of them as miny stretchmarks. They are related to another skin condition known as anetoderma which is spontaneous and not caused by inflammation.
These white blob scars are fairly common but they are neglected by the medical community. As acne is becoming more prevalent and more people develop them, modern medicine has now limited documentation on it. There is no known treatment but some dermatologists are experimenting with lasers which seem to make them less noticeable.
I don't care about the scars to be honest. All I want is for my nightmare to end with these breakouts. A functional acne cure would be more than welcomed.
Regarding Birchmedical, phase 2 is still a long way before we see their product on the market. They have to go through 3 more stages which means failure is very high. Even if phase 2 is succesful, phase 3 and phase 4 are far away. It can take a few years, so for many people with scars, they have to wait a little longer. However, a topical cream is the way to go to improve or eliminate scarring. They look more promising than Sunogel or SkinTE. They are taking the traditional approach of conducting clinical trials but again we are lacking peer reviewed documentation as well.
Yes Phase 2 could take anywhere from several months to 2 years unfortunately. Phase 3 involves alot more people (a few thousand) so if things go well in Phase 2 there will be many people scrambling to sign up because phase 3 could also take 1-4 years...
The success rate during phase 3 is 50% which will compare this anti scar drug against the 'gold standard' of care for scars which is I dont know what lol.....lets just say this FS2 cream doesnt have much competition to worry about with todays cosmetic trratments offering little if any improvement much of the time.
You can get the drug treatment in Phase 4 without enrolling in study. In Phase 4 you are helping researchers learn more about the treatment.
I emailed them about timelines and enrolling more so to see what they say.
26 minutes ago, Tano1 said:
Great find I didn’t know they were already set with phase 2.
As much as I wish topicals would be the answer, I don’t know if something such as their ointment would work; at least not by itself anyway.
I had researched a long time ago on why there were so many creams and products like snake oils that got popularized in the market and so I wondered why most of them turned up as frauds. So I investigated the scar creams specifically and wondered how they could even deliver from the surface down into the dermis where scars form. I had discovered Liposomes and how they carry the topical and penetrate down through the skin to get absorbed by the deeper layers.
Sadly I found that not too long ago studies were done on the effectiveness of drug absorption through Liposomes and discovered they had now verified that they can’t break through into the skin’s layers.
The vesicles in the skin were observed to actually dissolve and diffuse the topical before it could ever begin penetrating the skin. On the bright side it’s unknown if the topical agents are eradicated once they are dissolved by the vesicles or if they undergo some form of absorption that get carried into the deeper tissue.
Topicals could also be transported into the deeper layers via the hair shafts (follicles), but it’s not very effective for absorption since the shaft takes up most of the space from the exiting pathway on the surface of your skin. Plus most scars usually don’t have hair follicles so you could count this method of transport out.
My opinion is that there is an easy way for topical absorption despite what was mentioned above and it’s through simple microneedling. There’s a wide variety of studies that prove it is much more effective for topical absorption one of them actually being a hair growth study. It’s also obvious that if you make many holes in your skin extending into the depths of the dermis that anything you put on will more than likely get absorbed into where the scar tissue resides.
I do still think it’s worth keeping an eye on this especially since they’ve said it is reverting alopecia (hair loss type) since as most of us probably know by now that hair and skin are linked. Also stated that it can even treat Type I Diabetes.
Aside from them saying they have the means to prevent and eliminate scarring as stated in the link above, they are partnering with Sensus Healthcare to do it.
Applying a topical or taking it orally to break down scar tissue under the skin seems dubious at best lol...surely topical and orally are in reference to a fresh wound unless as you say Microneedling is possible yes for this product if it were succesfull in upcoming trials in order to break down and remove scar tissue.
Does anyone know what animal models did they achieve this in in pre-clinical trials?...i thought i read online somewhere it was rabbits.
They state that it breaks down and removes scar tissue and doesnt hinder healing. So essentially its a another way of saying normal skin regeneration. Its another step in the right direction and hopefully we are on the cusp of something great.
11 hours ago, Ps93 said:
Interesting article about the antiscarring drug of birchbiomed:http://www.ceocfointerviews.com/interviews/BirchBioMed18.htm
Looks interesting going into phase II trials. They claim it can break down existing scar tissue and be injected. Really does sound lile a magic cream lol...
No hype like with PolarityTe. Cant seem to find photos or any evidence from pre-clinical trials?
Just when you think Sunogel has the best looking model these researchers claim this FS2 cream can break down scar tissue.
its all positive signs anyway with more and more competition to crack the wound care market which is only getting bigger and doesnt have any real decent solutions. After 2 decades of lasers being overhyped and offering minimal results it would be nice to see the next advancement make a real difference. Good luck to them and we will keep track of how results fair. Its a busy year for "Scarless healing" 2018. We just need Sunogel to up their game if they are genuine.
Pros- people behind the product with impressive backgrounds. Finalists at hello tomorrow convention in Paris. And of course the pre-clinical results of flawless healing in swine models.
Cons- working from strip mall. Crappy website. Dr Sun not the most business savvy person in the industry taking so long to get even to trials let alone market.