PolarityBio Submits BLA for SkinTE, a First-in-Class Autologous Therapy for Diabetic Foot Ulcers
核心洞察
PolarityBio (搜索) has submitted a Biologics License Application to the FDA for SkinTE, an autologous cutaneous multicellular therapy for Wagner Grade 1 diabetic foot ulcers (搜索).
If approved, SkinTE would be the first new biologic commercially available in the U.S. for a common chronic wound indication in nearly 30 years.
The BLA is supported by the pivotal Phase III COVER DFUS II trial, which met its primary efficacy endpoint of complete wound closure within 12 weeks.
PolarityBio (搜索), a late-stage biotechnology company headquartered in Salt Lake City, Utah, announced on July 1, 2026 the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for SkinTE, a first-in-class autologous cutaneous multicellular therapy developed for the treatment of Wagner Grade 1 diabetic foot ulcers (搜索) (DFUs). If approved, SkinTE would represent the first new biologic commercially available in the U.S. for a common chronic wound indication in nearly three decades.
"Today's BLA submission for SkinTE marks a defining moment for PolarityBio (搜索) and, more importantly, for the millions of patients living with the burden of diabetic foot ulcers (搜索)," said Dr. Nikolai Sopko, Chief Operating Officer and Chief Scientific Officer of PolarityBio. "Chronic wounds like DFUs are a leading cause of morbidity, and our mission has always been to provide a regenerative solution that uses a patient's own biology to provide a path to closure."
A Regenerative Approach to Chronic Wound Care
SkinTE is designed to harness a patient's own healthy full-thickness skin to activate regeneration, addressing the persistent unmet need in chronic wound care. The therapy has previously received both Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy designations from the FDA, underscoring its potential to address a significant therapeutic gap.
Robert Kirsner, MD, PhD, chair of the COVER DFUS II trial, emphasized the clinical urgency driving the development: "The BLA submission of SkinTE is a meaningful step toward giving clinicians a new, biologically distinct option for patients who have exhausted existing therapies. When standard of care or other advanced wound care fails to heal DFUs, or they are left untreated, ulcers often progress – increasing mortality risk and increasing costs while causing morbidity that often leads to amputation."
Pivotal Phase III Trial Design and Results
The BLA submission is supported by data from COVER DFUS II (NCT06140303), a pivotal Phase III multicenter randomized controlled trial. The study enrolled 120 patients across multiple U.S. clinical sites in just 14 months, achieving an average enrollment rate of 8.6 patients per month — a pace that outpaced historical enrollment timelines for DFU trials reported on clinicaltrials.gov.
Participants were randomized 1:1 to receive either SkinTE with standard of care (SOC) or SOC alone, with follow-up extending for 24 weeks following randomization. The primary efficacy endpoint was the incidence of complete wound closure within 12 weeks. To ensure a rigorous patient population, participants were required to have a DFU for at least four weeks prior to screening that had failed to heal with other treatments, followed by an additional two-week run-in period with rigorous SOC. Only those whose DFU did not change in size by more than 30% during the run-in period qualified for randomization. The trial successfully met its primary efficacy endpoint.
Reimbursement Landscape
The chronic wound care reimbursement environment underwent significant restructuring when the Centers for Medicare & Medicaid Services (CMS) implemented major changes effective January 1, 2026. Under current CMS policy, products approved under a BLA are generally excluded from those changes and would continue to be reimbursed as biologics under existing payment methodologies, a factor that may support market access should SkinTE receive approval.
Beyond Diabetic Foot Ulcers (搜索)
PolarityBio (搜索) is also advancing SkinTE for additional chronic wound indications, including venous leg ulcers (搜索) and pressure injuries (搜索). The product is currently available for investigational use only through an Expanded Access Program. The company continues to engage with the FDA throughout the review process for the Wagner Grade 1 DFU indication.