Posted by Michael Wonder on 20 Feb 2025
PolarityBio receives US FDA breakthrough therapy designation for treatment of Wagner grade I diabetic foot ulcers
20 February 2025 - The FDA has granted breakthrough therapy designation for SkinTE based on key positive data from the Phase 2 study in Wagner grade 1 diabetic foot ulcers highlighting the on-going unmet need in this patient population.
PolarityBio announced today that SkinTE has received breakthrough therapy designation from the US FDA for the treatment of Wagner grade 1 diabetic foot ulcers.
