PolarityTE Announces FDA Regenerative Medicine Advanced Therapy Designation Granted to SkinTE
PR Newswire “Press Releases US – English”
SALT LAKE CITY, May 13, 2022 /PRNewswire/ — PolarityTE, Inc. (Nasdaq: PTE) today announced that the U.S. Food and Drug Administration (FDA) granted a Regenerative Medicine Advanced Therapy (RMAT) designation to SkinTE under the Company’s open IND.
Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising regenerative medicine products, including human cellular and tissue-based therapies. A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such disease or condition. Similar to Breakthrough Therapy designation, RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with the FDA to discuss potential ways to support accelerated approval and satisfy post-approval requirements, potential priority review of the biologics license application (BLA), and other opportunities to expedite development and review.
