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MAR 16 2027
UPCOMING · 168 DAYS TO PDUFA

PolarityBio — SkinTE

for Wagner Grade 1 diabetic foot ulcers

BLA · Priority Review

Accepted SEP 15 2026.

About

Diabetic foot ulcers are chronic sores on the foot that can become infected and often lead to amputation. SkinTE is a treatment made from a patient's own skin cells, which are processed and applied to the wound. This may help heal these difficult ulcers by providing a living scaffold that supports the regeneration of new, healthy skin tissue.

Pivotal trial

NCT06140303 Phase 3 active not recruiting NCT06140303

The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.

Source: ClinicalTrials.gov

Also in development