PolarityTE Reports FDA Designation Granted to SkinTE

May 13, 2022 By MarketDepth

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FDA Approval

PolarityTE, Inc. (NASDAQ: PTE) has reported that the U.S. Food and Drug Administration has granted a Regenerative Medicine Advanced Therapy designation to SkinTE under the Company’s open IND.  RMAT is a dedicated program that is designed to expedited drug development and review processes for regenerative medicine products, which include human cellular and tissue based therapies.  

“FDA granting our request for an RMAT designation for SkinTE validates not only the strength of the preliminary clinical evidence we have developed to date but also demonstrates the seriousness of the conditions that we seek to treat and the substantial nature of the unmet needs among the patient populations that we aim to serve.  We were pleased to receive this news from the FDA nearly two weeks in advance of the 60-day time period that the Agency has to make such decisions.  The Agency has offered—and we look forward to capitalizing upon—a multidisciplinary, comprehensive discussion between PolarityTE and the FDA regarding the SkinTE development program, including planned clinical trials and plans for expediting the manufacturing development strategy.  We are eager to work closely with the Agency to identify potential means to accelerate our development program and help bring a much-needed potential new treatment to patients suffering from substantial unmet medical needs.”

Richard Hague, Chief Executive Officer