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Autologous cell therapy - PolarityBio

Drug Profile

Autologous cell therapy - PolarityBio

Alternative Names: SkinTE®

Latest Information Update: 16 Sep 2025

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At a glance

  • Originator PolarityTE
  • Developer PolarityBio
  • Class Cell therapies
  • Mechanism of Action Tissue replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase III Diabetic foot ulcer
  • Clinical Phase Unknown Leg ulcer
  • Preclinical Burns; Wounds

Most Recent Events

  • 16 Sep 2025 Autologous cell therapy is still in clinical trials for Leg ulcer (Adjunctive treatment) in USA (PolarityTE pipeline, September 2025)
  • 02 Sep 2025 PolarityBio received US FDA clearance for expanded access treatment protocol for Diabetic foot ulcer
  • 02 Sep 2025 PolarityBio plans a expanded access programme for Diabetic foot ulcer

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