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Autologous cell therapy - PolarityTE

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Drug Profile

Autologous cell therapy - PolarityTE

Alternative Names: SkinTE®

Latest Information Update: 28 Feb 2024

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At a glance

  • Originator PolarityTE
  • 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
  • Preclinical Burns; Wounds
  • No development reported Leg ulcer

Most Recent Events

  • 27 Feb 2024 PolarityTE initiates a phase III (COVER DFUS II) trial for Diabetic foot ulcer (Adjunctive treatment) in February 2024 (Topical) (NCT06140303)
  • 28 May 2023 No recent reports of development identified for clinical-Phase-Unknown development in Leg ulcer(Adjunctive treatment) in USA (Topical)
  • 11 Aug 2022 PolarityTE announces intention to submit NDA to the US FDA for Diabetic foot ulcer

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