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PolarityBio Highlights Highest Scoring Abstract Award and Presentation of Phase 3 COVER DFUS II Trial Results at SAWC Fall 2026
SALT LAKE CITY, Oct. 20, 2026 (GLOBE NEWSWIRE) -- PolarityBio®, a late-stage biotechnology company addressing unmet needs in wound healing through innovation in regenerative multicellular biologics, today announced it has received the Highest Scoring Abstract Award in the Clinical Research category at the Symposium on Advanced Wound Care (SAWC) Fall 2026, held October 15-18 in Las Vegas, Nevada. PolarityBio’s abstract for its pivotal Phase 3 study, titled “Autologous Cutaneous Multicellular Units in Non-Healing Wagner 1 Diabetic Foot Ulcers: Results of the Phase 3 COVER DFUS II Trial,” was selected as the top abstract in the Clinical Research category. The award was formally presented by the SAWC Abstract Chair during the Poster Reception on October 17. The recognition follows the trial’s selection for SAWC’s prestigious First-to-Podium presentation on October 16, where Study Chair Robert S. Kirsner, MD, PhD, presented data demonstrating that the COVER DFUS II trial successfully met its primary efficacy endpoint of complete wound closure within 12 weeks. “Receiving the Highest-Scoring Abstract Award in the Clinical Research category at SAWC Fall is a distinct honor that emphasizes both the scientific rigor and clinical significance of the COVER DFUS II trial,” said Robert S. Kirsner, MD, PhD, Study Chair of the trial. “Sharing these positive top-line results during the First-to-Podium session provided an important platform to discuss how innovative autologous multicellular therapies such as SkinTE® can benefit patients with chronic, non-healing diabetic foot ulcers.” “We are thankful to the SAWC committee for recognizing the work behind COVER DFUS II,” said Nikolai Sopko, MD, PhD, President, Chief Operating Officer, and Chief Scientific Officer of PolarityBio. “Completing our First-to-Podium presentation and receiving this category award represent exciting momentum, particulaly following the FDA’s recent acceptance for filing of our Biologics License Application (BLA) for SkinTE with Priority Review. To preserve the integrity of future journal publication opportunities, full trial data and comprehensive sub-analyses will be shared in an upcoming peer-reviewed publication.” The FDA granted Priority Review to the SkinTE BLA in September 2026, establishing a six-month review target with a PDUFA target action date of March 16, 2027. SkinTE previously received both Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy designations from the FDA for the treatment of Wagner Grade 1 diabetic foot ulcers. About COVER DFUS II The trial enrolled 120 patients across multiple U.S. clinical sites in just 14 months, at an average of 8.6 patients per month, outpacing 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. Study participants were followed for 24 weeks after randomization. The study’s primary efficacy endpoint was the incidence of complete wound closure within 12 weeks. Eligible participants were required to have a diabetic foot ulcer that had persisted for at least four weeks despite prior treatment. Participants also completed a two-week run-in period with rigorous standard of care and qualified for randomization only if the size of their wound did not decrease by more than 30% during that period. About PolarityBio Forward-Looking Statements Company Contact Investor Relations Contact Media Contact 
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