Drugs / SkinTE
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | SkinTE | Wagner Grade 1 diabetic foot ulcers | 2026-07-01 | “today announced the submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for SkinTE®” polaritybio.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT06140303 | Feb 2024 → Dec 2025 overdue | — | PolarityTE | Active not recruiting | Met primary |
| Phase 3 | NCT05372809 | Apr 2022 → Feb 2024 | — | PolarityTE | Terminated | No outcome recorded Stop: Enrollment |
| Phase not stated1 trial · 1 met primary | ||||||
| — | NCT07222540 | — | ulcer of lower limbs | PolarityTE | Temporarily not available | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-09-15 | PolarityTE | Regulatory PolarityBio Announces FDA Acceptance for Filing of SkinTE® BLA with Priority Review in Diabetic Foot Ulcers polaritybio.com ↗ |
| 2026-06-30 | PolarityTE | Regulatory PolarityBio Announces Submission of its Biologics License Application for SkinTE® for the Treatment of Wagner Grade 1 Diabetic Foot Ulcers polaritybio.com ↗
today announced the submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for SkinTE® (autologous cutaneous multicellular units). |
| 2026-01-05 | PolarityTE | Regulatory PolarityBio Announces AMA Publication of New Category III CPT Codes for SkinTE® Procedures polaritybio.com ↗ |
| 2025-09-02 | PolarityTE | Regulatory PolarityBio Announces Launch of Expanded Access Treatment Protocol to Provide Continued Access to SkinTE® for Patients with Wagner 1 Diabetic Foot Ulcers polaritybio.com ↗
The FDA cleared PolarityBio to initiate this protocol following the successful completion of enrollment in the company’s pivotal Phase III study, COVER DFUs II. |
| 2025-02-20 | PolarityTE | Regulatory PolarityBio Receives U.S. FDA Breakthrough Therapy Designation for Treatment of Wagner Grade I Diabetic Foot Ulcers (DFU) polaritybio.com ↗
PolarityBio, a clinical-stage biotechnology company developing regenerative tissue products, announced today that SkinTE has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of Wagner Grade 1 Diabetic Foot Ulcers (DFU). |
All press releases naming this drug 10 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SkinTE | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07222540 ↗ |
| Known as | Autologous Heterogeneous Skin Construct | “SkinTE is an Autologous Heterogeneous Skin Construct (AHSC)” NCT07222540 ↗ |
| Modality | Cell therapy | “SkinTE is an Autologous Heterogeneous Skin Construct (AHSC)” NCT06140303 ↗ |