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# PolarityBio Gets Breakthrough Status for SkinTE
- URL: https://www.fdaweb.com/polaritybio-gets-breakthrough-status-for-skinte/
- Published: 2025-02-20T12:00:00.000Z
- Updated: 2026-09-14T14:53:34.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158694

FDA has granted PolarityBio a breakthrough therapy designation for SkinTE for treating Wagner Grade 1 diabetic foot ulcers (DFU). SkinTE is a human cellular and tissue-based product derived from a patient’s own skin to regenerate full-thickness skin with all of its layers (epidermis, dermis and hypodermis) and appendages, including hair follicles and glands.

The designation was based on data from a Phase 2 trial evaluating treatment of DFUs with SkinTE plus standard of care (SOC) vs SOC alone ([NCT03881254](https://www.globenewswire.com/Tracker?data=rL4KC2ofSQkZR7adtxLrttS4X9f-sv9ODZ5MD%5FKekjRjl71uTJREhh5mUQTDBh3cG55UIM8ATCbz4qf9NQn2-tyhSXCZJ5NTOBa%5FBf3ttQoe%5Fcgpl9YT0bbVrZWRx87M5UHzix4VmdVqJOp9HxsE%5Fg==&ref=fdaweb.com)) in 100 patients, which the company says showed that 70% of patients receiving SkinTE plus SOC had wound closure at 12 weeks versus 34% of patients receiving SOC alone. Additionally, the “percentage area reduction” over eight weeks was significantly greater for SkinTE-treated patients, PolarityBio says. The company has an ongoing Phase 3 trial (COVER DFUS II) that is over 75% enrolled and final results are expected in 2026.