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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