Acne.org Products
I'm guessing it's a good sign that they purchased this facility: https://www.deseretnews.com/article/865690100/Utah-biotech-firm-to-purchase-former-semiconductor-facility.html
It didn't take years as some of you pessimist were saying and willing to bet money on!!!!!
ALT LAKE CITY, Oct. 03, 2017 (GLOBE NEWSWIRE) -- PolarityTE„, Inc. (NASDAQ:COOL) today announced that the Company™s lead product, SkinTE„, has been registered with the U.S. Food and Drug Administration (FDA) pursuant to applicable regulations governing human cells, tissues, and cellular and tissue-based products (HCT/Ps). SkinTE„ is an autologous, minimally manipulated construct intended for homologous uses of skin tissues. As an FDA-registered HCT/P, SkinTE„ may now be made available for appropriate human use in the United States. PolarityTE„ has initiated a controlled, limited-market release of the product to select medical institutions, and expects to accelerate commercialization in 2018 as the company scales up manufacturing efforts.
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œThe FDA registration of SkinTE„ is an important regulatory step that sets the stage for commercialization and a staged market entry of this revolutionary technology into clinical application, said Denver M. Lough, M.D., Ph.D., Chief Executive Officer of PolarityTE„. œThis achievement enables us to deliver an entirely new and pragmatic solution for skin regeneration as well as the ability to change the face and practice of regenerative medicine toward patient-tailored tissue constructs.
In pre-clinical studies, SkinTE„ demonstrated full-thickness regenerative healing, nascent hair follicle formation, cutaneous appendage development, immediate and complete wound coverage, and the progressive regeneration of all skin layers including epidermis, dermis and hypodermal layers. (www.PolarityTE.com/products/SkinTE).
œThis progressively-staged market release of SkinTE„ to select institutions will give the Polarity team time to scale manufacturing processes and facilities to meet future demands of SkinTE„ as well as other tissue substrate technologies we have in our translational development pipeline, said Edward W. Swanson, M.D., Chief Operating Officer of PolarityTE„.
About SkinTE„ and FDA Tissue Establishment Registration
SkinTE„ is regulated by the FDA as an HCT/P solely under Section 361 of the Public Health Service Act and 21 CFR 1271. The FDA has specific regulations governing HCT/Ps. HCT/Ps that meet the criteria for regulation solely under Section 361 of the Public Health Service Act and 21 CFR 1271 (361 HCT/Ps) are not subject to pre-market clearance or approval requirements, but are subject to post-market regulatory requirements.
SkinTE„ is processed and marketed in accordance with the FDA™s requirements for human tissue and current good tissue practices (21 CFR 1271) and is manufactured by American Association of Tissue Banks (AATB)- and Foundation for the Accreditation of Cellular Therapy (FACT)-accredited facilities.
Important Safety Information
Poor general medical condition or any pathology that would limit the blood supply and compromise healing, as well as nonvascular surgical sites, should be considered when selecting patients for SkinTE„, as such conditions may compromise successful outcomes or lead to sub-optimal results.
Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures must be taken. Unused or expired tissue product should be discarded according to local, state, federal and institutional requirements. Utilization of the SkinTE„ construct, process and/or technology is limited to healthcare professionals and facilities that are capable of handling such tissue products.
Proper aseptic procedural and/or surgical handling is mandatory when using SkinTE„. Failure to ensure proper aseptic technique may result in contamination of the tissue product and wound bed. Contamination of the tissue product and/or wound bed due to failure to ensure aseptic technique could result in local, regional, or systemic infection, partial or complete failure of graft take, healing, and/or regeneration, serious injury, and/or death. Failure to follow instructions may lead to sub-optimal outcomes and/or product failure.
Potential adverse effects may include but are not limited to the following: local tissue, wound bed, regional tissue, or systemic infection, hypersensitive, allergic, or other immune response to the product or trace amounts of antibiotic retained from primary harvest, deleterious effects on potential surrounding or adjacent autologous, allogeneic, or xenogenic grafts, skin substitutes, or other reconstructions including infection and/or failure of adjacent grafted material to take and heal, requirement for further surgical operation(s) and/or debridement, or death.
About PolarityTE„
PolarityTE„, Inc. is a regenerative medicine company, and the first to successfully regenerate full-thickness tissue. The Company's novel regenerative medicine platform and proprietary technology employs a patient's own cells for the healing of full-thickness, functionally-polarized tissues. If clinically successful, the PolarityTE„ platform will provide medical professionals with a truly new paradigm in wound healing and reconstructive surgery by utilizing a patient's own tissue substrates for the regeneration of skin, bone, muscle, cartilage, fat, blood vessels and nerves. The PolarityTE„ platform leverages natural and biologically-sound principles which are readily adaptable to a wide spectrum of organ and tissue systems. This revolutionary technology, paired with the Company's world-renowned clinical advisory board, position PolarityTE„ to drastically change the field and future of translational regenerative medicine. More information can be found online at www.PolarityTE.com.
Forward Looking Statements
Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements contained in this release relate to, among other things, the Company's ongoing compliance with the requirements of The NASDAQ Stock Market and the Company's ability to maintain the closing bid price requirements of The NASDAQ Stock Market on a post reverse split basis. They are generally identified by words such as "believes," "may," "expects," "anticipates," "should'" and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company's beliefs and assumptions as of the date of this release. The Company's actual results could differ materially due to risk factors and other items described in more detail in the "Risk Factors" section of the Company's Annual Reports and other filings with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.
3 hours ago, SimpleMutton said:It didn't take years as some of you pessimist were saying and willing to bet money on!!!!!
ALT LAKE CITY, Oct. 03, 2017 (GLOBE NEWSWIRE) -- PolarityTE„, Inc. (NASDAQ:COOL) today announced that the Company™s lead product, SkinTE„, has been registered with the U.S. Food and Drug Administration (FDA) pursuant to applicable regulations governing human cells, tissues, and cellular and tissue-based products (HCT/Ps). SkinTE„ is an autologous, minimally manipulated construct intended for homologous uses of skin tissues. As an FDA-registered HCT/P, SkinTE„ may now be made available for appropriate human use in the United States. PolarityTE„ has initiated a controlled, limited-market release of the product to select medical institutions, and expects to accelerate commercialization in 2018 as the company scales up manufacturing efforts.
SkinTE
œThe FDA registration of SkinTE„ is an important regulatory step that sets the stage for commercialization and a staged market entry of this revolutionary technology into clinical application, said Denver M. Lough, M.D., Ph.D., Chief Executive Officer of PolarityTE„. œThis achievement enables us to deliver an entirely new and pragmatic solution for skin regeneration as well as the ability to change the face and practice of regenerative medicine toward patient-tailored tissue constructs.
In pre-clinical studies, SkinTE„ demonstrated full-thickness regenerative healing, nascent hair follicle formation, cutaneous appendage development, immediate and complete wound coverage, and the progressive regeneration of all skin layers including epidermis, dermis and hypodermal layers. (www.PolarityTE.com/products/SkinTE).
œThis progressively-staged market release of SkinTE„ to select institutions will give the Polarity team time to scale manufacturing processes and facilities to meet future demands of SkinTE„ as well as other tissue substrate technologies we have in our translational development pipeline, said Edward W. Swanson, M.D., Chief Operating Officer of PolarityTE„.
About SkinTE„ and FDA Tissue Establishment Registration
SkinTE„ is regulated by the FDA as an HCT/P solely under Section 361 of the Public Health Service Act and 21 CFR 1271. The FDA has specific regulations governing HCT/Ps. HCT/Ps that meet the criteria for regulation solely under Section 361 of the Public Health Service Act and 21 CFR 1271 (361 HCT/Ps) are not subject to pre-market clearance or approval requirements, but are subject to post-market regulatory requirements.SkinTE„ is processed and marketed in accordance with the FDA™s requirements for human tissue and current good tissue practices (21 CFR 1271) and is manufactured by American Association of Tissue Banks (AATB)- and Foundation for the Accreditation of Cellular Therapy (FACT)-accredited facilities.
Important Safety Information
Poor general medical condition or any pathology that would limit the blood supply and compromise healing, as well as nonvascular surgical sites, should be considered when selecting patients for SkinTE„, as such conditions may compromise successful outcomes or lead to sub-optimal results.Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures must be taken. Unused or expired tissue product should be discarded according to local, state, federal and institutional requirements. Utilization of the SkinTE„ construct, process and/or technology is limited to healthcare professionals and facilities that are capable of handling such tissue products.
Proper aseptic procedural and/or surgical handling is mandatory when using SkinTE„. Failure to ensure proper aseptic technique may result in contamination of the tissue product and wound bed. Contamination of the tissue product and/or wound bed due to failure to ensure aseptic technique could result in local, regional, or systemic infection, partial or complete failure of graft take, healing, and/or regeneration, serious injury, and/or death. Failure to follow instructions may lead to sub-optimal outcomes and/or product failure.
Potential adverse effects may include but are not limited to the following: local tissue, wound bed, regional tissue, or systemic infection, hypersensitive, allergic, or other immune response to the product or trace amounts of antibiotic retained from primary harvest, deleterious effects on potential surrounding or adjacent autologous, allogeneic, or xenogenic grafts, skin substitutes, or other reconstructions including infection and/or failure of adjacent grafted material to take and heal, requirement for further surgical operation(s) and/or debridement, or death.
About PolarityTE„
PolarityTE„, Inc. is a regenerative medicine company, and the first to successfully regenerate full-thickness tissue. The Company's novel regenerative medicine platform and proprietary technology employs a patient's own cells for the healing of full-thickness, functionally-polarized tissues. If clinically successful, the PolarityTE„ platform will provide medical professionals with a truly new paradigm in wound healing and reconstructive surgery by utilizing a patient's own tissue substrates for the regeneration of skin, bone, muscle, cartilage, fat, blood vessels and nerves. The PolarityTE„ platform leverages natural and biologically-sound principles which are readily adaptable to a wide spectrum of organ and tissue systems. This revolutionary technology, paired with the Company's world-renowned clinical advisory board, position PolarityTE„ to drastically change the field and future of translational regenerative medicine. More information can be found online at www.PolarityTE.com.Forward Looking Statements
Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements contained in this release relate to, among other things, the Company's ongoing compliance with the requirements of The NASDAQ Stock Market and the Company's ability to maintain the closing bid price requirements of The NASDAQ Stock Market on a post reverse split basis. They are generally identified by words such as "believes," "may," "expects," "anticipates," "should'" and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company's beliefs and assumptions as of the date of this release. The Company's actual results could differ materially due to risk factors and other items described in more detail in the "Risk Factors" section of the Company's Annual Reports and other filings with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.
This is amazing but why hasn't anything been published on actual human tests? I'm a little confused.
No. This definitely means human trials were already started or just finished.
Limited market entry WILL be happening in 2H 2017 as they said. The good thing is they say they will be expanding market in 2018 so that means it will be made widely available pretty quickly.
As for the human trial results, they will definitely publish them soon.
21 minutes ago, Tano1 said:No. This definitely means human trials were already started or just finished.
Limited market entry WILL be happening in 2H 2017 as they said. The good thing is they say they will be expanding market in 2018 so that means it will be made widely available pretty quickly.
As for the human trial results, they will definitely publish them soon.
It amazes me why people continue to doubt this company which is publicly traded. A company that continues to invest tens of millions of dollars into this brand and has team consisting of some of the most talented people in the world.
2 hours ago, mjg713 said:2 hours ago, Tano1 said:No. This definitely means human trials were already started or just finished.
Limited market entry WILL be happening in 2H 2017 as they said. The good thing is they say they will be expanding market in 2018 so that means it will be made widely available pretty quickly.
As for the human trial results, they will definitely publish them soon.
It amazes me why people continue to doubt this company which is publicly traded. A company that continues to invest tens of millions of dollars into this brand and has team consisting of some of the most talented people in the world.
After much research I had optimistic views on this company I won't deny that. I can't blame some of the people who were so pessimistic about it though.
There have been plenty of companies that start out strong and look very promising who had even shown some pre-clinical results only to end up as a washed up failure.
The physician argument someone had made had no validity to it either. Just because you're a physician doesn't mean you can't do your own research. In fact a physician has first hand experience with all of that stuff and could not only potentially create something new, but could figure out how to make it cost effective and efficient as well. That's why Denver Lough (CEO of Polarity) said it is by physicians and for physicians. The CEO left a prestigious well known place because he believed so strongly in his idea becoming a reality that he was willing to put it all on the line. Those are truly the people who can revolutionize and give birth to a new era.
I've never got so excited about a treatment before.
SkinTE look like it's the ultimate cure for scarring, I will wait until we see results on humans but their method seems solid and makes sense
Of course even if the market release is in 2018, it will be used only for burn victims and maybe it will take a couple years before it will available for fixing acne scars, but still....at least we would have a solid option.
All the options available today are scam or simply don't work, especially on serious scarring like mine
2 hours ago, rudy1986 said:Well yeah but it is definitely large.. talking face to face with someone , they will definitely notice those margins..
Kinda makes your face like folding papers
We do not know yet in which she is visible this margin, maybe she is invisible to the naked eye. Let us wait for the results and let us not worry us anymore about that. Dsl for my English
2 hours ago, JohnRottenSkin said:If you care about this margin then your scars are very very minor. Nothing offensive. I just can not understand how anyone in this forum can care about such a small thing. I really think that this margin looks cool and badass. Like some biotech semi plastic humans from 3017. Really cannot understand your worries.
I think it's more so just dealing with imperfect skin for so long, we are striving for perfection and don't want even small margins there to remind us of the scars we had already battled with.
Worrying and remaining distressed with the margin tells me you guys are still unaware of the event that is taking place now.
I know we shouldn't pop open the champagne bottles just yet, but this means that human trial results should be getting published somewhere soon for the world to see. That's not even the exciting part.
If they succeeded as it very well looks like they did, then we are in the BIRTH of the Biotech Era. The BIRTH of Bio-engineered Regeneration!
EDIT: They succeeded. Time to go out and have a nice dinner with a glass of red wine from South Dakota that I've been saving for a long time =)
18 minutes ago, Tano1 said:Worrying and remaining distressed with the margin tells me you guys are still unaware of the event that is taking place now.
I know we shouldn't pop open the champagne bottles just yet, but this means that human trial results should be getting published somewhere soon for the world to see. That's not even the exciting part.
If they succeeded as it very well looks like they did, then we are in the BIRTH of the Biotech Era. The BIRTH of Bio-engineered Regeneration!
don't care about the margin the margin happened because they made a full excision ...
(and it is on microscope also) .they will not make excision for your scars they will just put the skinte there and it will propagate into the scar.....
4 hours ago, Tano1 said:Worrying and remaining distressed with the margin tells me you guys are still unaware of the event that is taking place now.
I know we shouldn't pop open the champagne bottles just yet, but this means that human trial results should be getting published somewhere soon for the world to see. That's not even the exciting part.
If they succeeded as it very well looks like they did, then we are in the BIRTH of the Biotech Era. The BIRTH of Bio-engineered Regeneration!
EDIT: They succeeded. Time to go out and have a nice dinner with a glass of red wine from South Dakota that I've been saving for a long time =)
Succeeded with what?
4 hours ago, damnBOY said:the dream is real!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
This is incredible, I'm not going to lie. It makes me feel like I'm living in the future. I love how they're working on bone regeneration too. But I'm confused... the regenerated skin got hair follicles and skin appendages, but they said it healed "like a normal wound" and they got "deep, NEARLY SCARLESS healing"
tbh, I think that this is incredible for burn victims, but for anyone that wants scar-free healing this isn't our solution. not just yet. unless they tested on non-full thickness skin and see what happens. maybe that will heal without scar.
PolarityTE is geared toward SEVERELY burned/damaged skin that doesn't even close properly. PolarityTE is not trying to create SCAR-FREE skin. I'm not trying to sound pessimistic, but this is what I'm getting from that youtube video.
Regardless, we are approaching a new era of medicine, and I'm so ready to witness it.
Something else, although I don't believe they've achieved scar-free healing, but who knows.
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Also, it's odd, with such a huge advancement in the medical field, you would think PolarityTE would be getting way more attention and news coverage.
If Sunogel had half a brain, they would see what PolarityTE is doing and branch out into merely scar-free healing of acne scars, abrasion scars, etc. The burn victim market is PolarityTE's to take. Sunogel, go into the scarring market only!!