PolarityBio Reports the US FDA BLA Submission of SkinTE for Wagner Grade 1 Diabetic Foot Ulcers
Shots:
- The US FDA has received the BLA of SkinTE for the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs)
- BLA submission follows the P-III (COVER DFUS II) trial assessing SkinTE + SoC vs SoC alone in 120 pts with Wagner 1 DFU, which met its 1EP of complete wound closure
- SkinTE is a first-in-class autologous multicellular skin therapy that uses a patient’s own skin tissue to promote wound healing in diabetic foot ulcers
Ref: Globenewswire | Image: PolarityBio | Press Release
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