COOL:PolarityTE(TM) Announces Application of SkinTE(TM) on F
Dec 15, 2017 14:23:36 GMT
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Post by c2crusher on Dec 15, 2017 14:23:36 GMT
ir.polarityte.com/news/detail/416/polarityte-announces-application-of-skinte-on-first-patients
PolarityTE(TM) Announces Application of SkinTE(TM) on First Patients
SkinTE™ applied to a variety of indications and wounds
SALT LAKE CITY, Dec. 15, 2017 (GLOBE NEWSWIRE) -- PolarityTE, Inc. (NASDAQ:COOL) announced that human use of SkinTE™ is underway, and the product is now on patients, at multiple centers, within a variety of wound types and indications including acute and chronic wounds, burn wounds, surgical reconstructions and scar revisions. In addition, several patients with healed skin grafts, the gold standard treatment, have undergone removal of those grafts and replacement with SkinTE. Multiple medical centers have scheduled additional procedures through the end of 2017, and the Company expects an increasing number of applications during the first half of 2018 to meet market demand for the product. As clinical application grows, results and outcomes from the first group of treated patients are expected to be published throughout the first half 2018, addressing the many different patient populations treated.
“Application of SkinTE across this wide spectrum of cutaneous defects demonstrates the broad utility of this novel product beyond burn care, and we look forward to the results for all of the amazing patients being treated with SkinTE,” said Dr. Denver Lough, Chief Executive Officer of PolarityTE. “We are confident and believe that SkinTE will replicate its preclinical success and help patients regenerate their own full-thickness, hair-bearing skin. We did not set out to bring another iteration to the field of regenerative medicine—we set out to change it entirely. Welcome to the Shift™.”
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.
Crusher
PolarityTE(TM) Announces Application of SkinTE(TM) on First Patients
SkinTE™ applied to a variety of indications and wounds
SALT LAKE CITY, Dec. 15, 2017 (GLOBE NEWSWIRE) -- PolarityTE, Inc. (NASDAQ:COOL) announced that human use of SkinTE™ is underway, and the product is now on patients, at multiple centers, within a variety of wound types and indications including acute and chronic wounds, burn wounds, surgical reconstructions and scar revisions. In addition, several patients with healed skin grafts, the gold standard treatment, have undergone removal of those grafts and replacement with SkinTE. Multiple medical centers have scheduled additional procedures through the end of 2017, and the Company expects an increasing number of applications during the first half of 2018 to meet market demand for the product. As clinical application grows, results and outcomes from the first group of treated patients are expected to be published throughout the first half 2018, addressing the many different patient populations treated.
“Application of SkinTE across this wide spectrum of cutaneous defects demonstrates the broad utility of this novel product beyond burn care, and we look forward to the results for all of the amazing patients being treated with SkinTE,” said Dr. Denver Lough, Chief Executive Officer of PolarityTE. “We are confident and believe that SkinTE will replicate its preclinical success and help patients regenerate their own full-thickness, hair-bearing skin. We did not set out to bring another iteration to the field of regenerative medicine—we set out to change it entirely. Welcome to the Shift™.”
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.
Crusher