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The US FDA has received the BLA of SkinTEĀ for the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs)
BLA submission follows the P-III (COVER DFUS II) trial assessing SkinTEĀ + 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 patientās own skin tissue to promote wound healing in diabetic foot ulcers
Ref:Ā Globenewswire Ā | Ā Image:Ā PolarityBio | Press Release
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The post PolarityBio Reports the US FDA BLA Submission of SkinTEĀ for Wagner Grade 1 Diabetic Foot Ulcers appeared first on PharmaShots.
PolarityBio Reports the US FDA BLA Submission of SkinTEĀ for Wagner Grade 1 Diabetic Foot Ulcers | PharmaVoice