PolarityBio©, a clinical-stage biotechnology company focused on addressing unmet needs in wound healing through innovation in autologous multicellular skin therapy, today announced that the American Medical Association (AMA) has published new Category III CPT® codes (1044T, 1045T, 1046T, 1047T, 1048T, and 1049T) for its flagship autologous heterogeneous skin construct (AHSC) product, SkinTE®. The finalized codes, which become effective in July 2026, provide standardized procedural definitions for both full-thickness skin harvest and SkinTE graft application.

PolarityBio has announced the successful completion of its Phase III pivotal COVER DFUS II trial evaluating SkinTE®, a first-in-class autologous heterogeneous skin multicellular therapy, for the treatment of Wagner Grade 1 diabetic foot ulcers. The multicenter randomized controlled trial reached Last Patient Last Visit on November 12, 2025, and is designed to support a Biologics License Application (BLA) submission. The study enrolled 120 patients across U.S. clinical sites with final trial results anticipated in the first quarter of 2026. Earlier in 2025, the U.S. FDA granted Breakthrough Therapy designation to SkinTE, underscoring its potential to improve treatment for chronic wounds with no new BLA-approved therapies since 1997.

PolarityBio announced the launch of an Expanded Access Treatment Protocol (EAP) to provide continued investigational access to SkinTE® for patients with Wagner Grade 1 diabetic foot ulcers following completion of enrollment in its Phase III pivotal COVER DFUs II study. The FDA-cleared protocol allows broader eligibility reflective of real-world clinical practice and supports continued collection of safety and efficacy data.

PolarityBio has completed patient enrollment in the Phase III pivotal COVER DFUS II multicenter randomized controlled trial evaluating SkinTE® for the treatment of Wagner Grade 1 diabetic foot ulcers. The study enrolled 120 patients across U.S. clinical sites in 14 months, randomizing participants to receive either SkinTE® plus standard of care or standard of care alone, with the primary endpoint measuring complete wound closure at 12 weeks. Final completion and last patient visit are expected by November 2025, with top-line results anticipated in the first quarter of 2026. GlobeNewswire

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). The FDA grants BTD to drug candidates for serious or life-threatening conditions that have preliminary clinical evidence demonstrating potential to provide substantial improvement over existing therapies. The designation provides enhanced regulatory support, increased engagement with the FDA and additional opportunities to engage with the FDA and access to expedited development pathways, including features of the Fast Track program.

PolarityBio has achieved an interim enrollment milestone in the Phase III pivotal study of SkinTE, an investigational autologous skin construct for Wagner Grade 1 diabetic foot ulcers.

PolarityBio announced that it has secured $22.5 million in financing—comprising $12.5 million in equity and a senior secured credit facility—to accelerate its pivotal Phase III COVER DFUS II clinical trial evaluating investigational SkinTE® therapy in Wagner Grade 1 diabetic foot ulcers. The funding strengthens the company’s balance sheet and supports continued enrollment of up to 120 subjects across U.S. clinical sites, with patients randomized to receive either SkinTE® plus standard of care or standard of care alone. The primary endpoint of the study is the incidence of complete wound closure at 12 weeks, with interim data and key trial milestones anticipated as the Phase III program advances.

PolarityBio today announced the screening of the first subject in its Phase III pivotal clinical study evaluating the investigational new drug SkinTE® in patients with Wagner Grade 1 diabetic foot ulcers (DFUs). The COVER DFUS II trial will enroll up to 120 participants at U.S. sites, randomizing patients to receive either SkinTE® plus standard of care or standard of care alone. The study’s primary endpoint is the incidence of complete wound closure at 12 weeks, with key secondary endpoints including percent area reduction, time to closure, and healthcare utilization outcomes. PolarityBio is conducting the trial under an open IND for SkinTE®, which is intended to support future regulatory filings for this chronic wound indication.