PolarityTE

Split- and full-thickness skin grafts face a biological race between ischemia and revascularization. In plantar DFUs, that race is often lost — and procedural risk compounds the problem. Here's what clinicians need to understand.

The AMA published Category III CPT codes for SkinTE, an investigational autologous heterogeneous skin construct for wound care. The codes distinguish it from skin substitutes and support BLA development; Phase 3 data are expected in Q1 2026.

PolarityBio's news includes clinical updates on SkinTE, an investigational autologous regenerative skin multicellular therapy for diabetic foot ulcers, Phase III milestones, FDA interactions, expanded access, financing, reimbursement, and corporate updates.

PolarityBio completed enrollment of 120 patients in its Phase III COVER DFUS II pivotal trial evaluating SkinTE for Wagner Grade 1 diabetic foot ulcers. Full data are expected in Q1 2026 and will be used to file a BLA.

PolarityBio announces successful completion of the pivotal Phase III COVER DFUS II trial evaluating its autologous SkinTE therapy for Wagner Grade 1 diabetic foot ulcers, advancing toward potential BLA filing with final data expected Q1 2026.

PolarityBio's leadership team includes biotechnology executives, clinical development scientists, and wound care professionals working on investigational regenerative biologics, including SkinTE, for chronic wounds and diabetic foot ulcers.

PolarityBio's publications cover SkinTE, including peer-reviewed clinical research, diabetic foot ulcer study results, chronic wound healing data, interim and final analyses, and historical publications.

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