PolarityTE announces FDA regenerative medicine advanced therapy designation granted to SkinTE

PolarityTE

13 May 2022 - PolarityTE today announced that the U.S. FDA granted a regenerative medicine advanced therapy designation to SkinTE under the Company's open IND.

PolarityTE has an open investigational new drug application for SkinTE with the U.S. FDA and is now pursuing the first of two pivotal studies on SkinTE needed to support a biologics license application for a chronic cutaneous ulcer indication.

Read PolarityTE press release

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review