They didn't do clinical trials. But they register

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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.

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.

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