Drug Profile

Autologous cell therapy - PolarityBio

Alternative Names: SkinTE^®

Latest Information Update: 07 Jul 2026

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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

Preregistration Diabetic foot ulcer
Clinical Phase Unknown Leg ulcer
Preclinical Burns; Wounds

Most Recent Events

01 Jul 2026 Preregistration for Diabetic foot ulcer (Adjunctive treatment) in USA (Topical)
01 Jul 2026 Efficacy data from the phase III COVER DFUS trial in Diabetic foot ulcer released by PolarityBio
02 Dec 2025 PolarityBio announces intention to submit BLA for Diabetic foot ulcer in the first half of 2026

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