SALT LAKE CITY, Utah, July 1, 2026
PolarityBio has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for SkinTE®, its investigational autologous cutaneous multicellular therapy designed for the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs). The regulatory submission represents a major milestone for the biotechnology company and could pave the way for the first new biologic approved in the United States for a common chronic wound indication in nearly 30 years. If approved, SkinTE® has the potential to significantly transform chronic wound care by utilizing a patient’s own healthy skin biology to promote tissue regeneration and wound closure. The application follows encouraging results from the pivotal Phase III COVER DFUS II clinical trial, which successfully met its primary efficacy endpoint, further strengthening the company’s regulatory package and reinforcing the clinical potential of this first-in-class regenerative biologic. As diabetic foot ulcers continue to be a leading cause of hospitalization, lower-limb amputations, and healthcare costs worldwide, the submission highlights growing innovation in regenerative medicine aimed at addressing significant unmet clinical needs.
SkinTE® Advances Regenerative Medicine for Chronic Wound Care
SkinTE® is a first-in-class regenerative multicellular biologic developed to harness a patient’s own full-thickness skin tissue to stimulate natural healing and tissue regeneration. Unlike conventional wound care products, the therapy is designed to activate the body’s intrinsic regenerative mechanisms, offering a personalized treatment approach for chronic wounds that have failed to respond to standard therapies. The product has already received both the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and Breakthrough Therapy designation, reflecting its potential to provide substantial improvement over existing treatment options for patients suffering from diabetic foot ulcers.
According to PolarityBio, the BLA submission represents a defining step toward delivering an innovative biologic therapy capable of reducing disease burden while expanding treatment options for clinicians managing complex chronic wounds. Company leadership emphasized that millions of patients experience significant morbidity due to diabetic foot ulcers, making regenerative solutions like SkinTE® increasingly important in modern wound care.
Phase III Trial Success Supports FDA Regulatory Submission
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The COVER DFUS II pivotal Phase III multicenter randomized controlled trial enrolled 120 patients across multiple U.S. clinical sites and compared SkinTE® plus standard of care with standard wound care alone. Participants included individuals whose diabetic foot ulcers had failed to heal despite previous treatment and rigorous standard wound care. The trial achieved its primary endpoint of complete wound closure within 12 weeks, providing the clinical evidence supporting the biologics license application. Investigators also highlighted the rapid patient enrollment achieved during the study, demonstrating strong clinical interest in regenerative therapies for diabetic foot ulcers. Clinical experts involved in the trial noted that patients with non-healing diabetic foot ulcers often face increased risks of infection, hospitalization, amputation, and mortality, underscoring the need for innovative biologic therapies capable of improving healing outcomes. In addition, the company noted that recent changes to the U.S. Centers for Medicare & Medicaid Services (CMS) reimbursement landscape continue to recognize biologics approved under a BLA, potentially supporting future patient access should SkinTE® receive FDA approval.
PolarityBio also plans to advance the therapy for additional chronic wound indications, including venous leg ulcers and pressure injuries, further expanding its regenerative medicine pipeline. The successful FDA BLA submission positions the company for the next stage of regulatory review and represents an important advancement in the evolving field of regenerative biotechnology, with the potential to reshape treatment strategies for chronic wound management and improve outcomes for patients living with diabetic foot ulcers worldwide.
Source: PolarityBio press release
