SALT LAKE CITY, Utah — October 20, 2026
PolarityBio®, a late-stage biotechnology company developing regenerative multicellular biologics for wound healing, announced that its pivotal Phase 3 COVER DFUS II trial abstract received the Highest Scoring Abstract Award in the Clinical Research category at the Symposium on Advanced Wound Care (SAWC) Fall 2026. The award recognized the study, titled “Autologous Cutaneous Multicellular Units in Non-Healing Wagner 1 Diabetic Foot Ulcers: Results of the Phase 3 COVER DFUS II Trial.” The recognition followed a First-to-Podium presentation on October 16, during which study chair Robert S. Kirsner, MD, PhD, presented results showing that the trial met its primary efficacy endpoint of complete wound closure within 12 weeks. The award was formally presented by the SAWC Abstract Chair during the poster reception on October 17 in Las Vegas, Nevada.
Phase 3 COVER DFUS II Trial Meets Primary Endpoint
COVER DFUS II (NCT06140303) is a pivotal, multicenter, randomized controlled Phase 3 trial evaluating SkinTE®, PolarityBio’s investigational autologous cutaneous multicellular therapy, in patients with Wagner Grade 1 diabetic foot ulcers (DFUs). The study enrolled 120 patients across multiple U.S. clinical sites in 14 months, averaging 8.6 patients per month. Participants were randomized in a 1:1 ratio to receive either SkinTE plus standard of care (SOC) or standard of care alone and were followed for 24 weeks after randomization. The primary efficacy endpoint was the incidence of complete wound closure within 12 weeks. Eligible participants had ulcers that had persisted for at least four weeks despite prior treatment. Before randomization, participants completed a two-week run-in period involving rigorous standard care and qualified for randomization only if their wound size had not decreased by more than 30% during that period. PolarityBio reported that the study met its primary endpoint, while full trial results and comprehensive subgroup analyses are planned for publication in a peer-reviewed journal.
SkinTE Advances Through FDA Regulatory Review
The award comes as PolarityBio advances the regulatory review of its Biologics License Application (BLA) for SkinTE for the treatment of Wagner Grade 1 diabetic foot ulcers. According to the company, the U.S. Food and Drug Administration (FDA) accepted the application for Priority Review in September 2026, establishing a six-month review target and a Prescription Drug User Fee Act (PDUFA) target action date of March 16, 2027. SkinTE has also received the FDA’s Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy designations for this indication. These designations and the Priority Review timeline represent regulatory milestones, but they do not constitute marketing approval. PolarityBio said it plans to share complete COVER DFUS II findings and detailed sub-analyses in an upcoming peer-reviewed publication to preserve future publication opportunities. The company has not disclosed the full numerical efficacy results in this announcement.
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Regenerative Multicellular Biologics Target Chronic Wounds
PolarityBio is headquartered in Salt Lake City, Utah, and focuses on developing regenerative multicellular biologics for conditions with unmet medical needs. Its lead product, SkinTE, is an autologous cutaneous multicellular therapy being investigated for diabetic foot ulcers and additional chronic wound indications, including venous leg ulcers and pressure injuries. The company described the SAWC recognition and First-to-Podium presentation as important milestones following the trial’s reported primary endpoint success and the FDA’s acceptance of the SkinTE BLA for Priority Review. Kirsner highlighted the scientific and clinical significance of the trial, while Nikolai Sopko, MD, PhD, president, chief operating officer and chief scientific officer of PolarityBio, noted the recognition as positive momentum for the program. SkinTE remains available for investigational use only through an Expanded Access Program, according to the company. Full clinical findings will be important for evaluating the treatment’s efficacy and safety as the regulatory review proceeds.
Source::PolarityBio,press release
