PolarityBio announced that it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking approval of SkinTE® (autologous cutaneous multicellular units) for the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs). The investigational therapy has previously received both Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy designations from the FDA. The BLA submission follows completion of the company's pivotal Phase III COVER DFUS II trial, which met its primary efficacy endpoint of complete wound closure within 12 weeks.

The multicenter randomized trial enrolled 120 patients with chronic Wagner Grade 1 DFUs that had not responded to standard wound care. Participants received either SkinTE plus standard of care or standard of care alone and were followed for 24 weeks. If approved, SkinTE would represent a new autologous biologic treatment option for eligible patients with diabetic foot ulcers. The company also noted that, under current CMS policy, FDA-approved products licensed through the BLA pathway are generally reimbursed as biologics under existing payment methodologies rather than the payment framework implemented for many skin substitute products in 2026.

See the full press release here.