Back to Newsroom

PolarityTE™ Announces FDA Registration of Lead Product – SkinTE™

SALT 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.
READ MORE…