PolarityBio Completes Phase III Pivotal Study of SkinTE for Diabetic Foot Ulcers
- PolarityBio thanks the clinical trial sites and, most importantly, the participants, for making this milestone in DFU biologic therapy development possible
- Final trial results anticipated in the first quarter of 2026
SALT LAKE CITY, Dec. 02, 2025 (GLOBE NEWSWIRE) -- PolarityBio©, a clinical-stage biotechnology company focused on addressing unmet needs in wound healing through innovation in autologous regenerative skin multicellular therapy, today announced the successful completion of the COVER DFUS II trial, a Pivotal Phase III Multicenter Randomized Controlled Trial (RCT) investigating its flagship autologous heterogeneous skin construct product, SkinTE®, for the treatment of Wagner 1 Diabetic Foot Ulcers (DFUs), with the Last Patient Last Visit occurring on November 12, 2025.
Ashlee Fishleigh, Chief Clinical Officer of PolarityBio, stated, “I want to personally thank our clinical research investigators and the dedicated research coordinators who have supported this program. Your expertise, commitment to high-quality research, and steady focus on patient safety and care have been critical in moving this work forward.
I also want to extend my sincere appreciation to the individuals who chose to participate in this trial. Your willingness to share your time, trust, and personal stories is what makes clinical research possible. We do not take that for granted. Without your participation, bringing new and potentially life-changing therapies to patients simply would not happen.
To all parties involved, thank you. Your collective efforts are making a real impact and bringing us closer to delivering new and potentially life-changing therapies to the patients who need them most.”
Importantly, this registrational study is designed to support the filing of a Biologics License Application (BLA) for SkinTE as a first-in-class autologous skin multicellular therapy. Final trial results are anticipated in the first quarter of 2026.
Dr. Robert Kirsner, Chairman and Harvey Blank Professor of the Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery at the University of Miami Miller School of Medicine, and Chair of the COVER DFUS II study, said, “Ideas are common, but taking those ideas and studying them to prove their validity is much less common. Patient care depends on this, and the COVER II trial is the type of work needed to help reduce the burden and impact of diabetic foot ulcers on patients and society.”
Dr. Jason Hanft, a principal investigator of one of the COVER DFUS II clinical trial sites, commented, “I extend sincere congratulations to PolarityBio for reaching the last patient visit in their Phase III trial for SkinTE as a diabetic foot ulcer treatment.” Dr. Hanft continued, “This marks an impressive milestone and a significant step forward in advancing care for patients with chronic wounds. I wish the company continued success as they move toward the next phase of this important work.”
A patient participating in the study who was treated with SkinTE at Dr. Jason Hanft’s site stated, “Everything was excellent! Thanks to Dr. Hanft’s care and supervision, my wound healed. I had an extra-large wound, and thankfully, my doctor recommended that I participate in this research trial. I really hope the study is a success so other people can share my experience. I had no pain, and I am extremely appreciative that my foot was saved. The staff was also very supportive and really made me feel comfortable.”
Earlier this year, the FDA granted Breakthrough Therapy designation to SkinTE for the treatment of Wagner Grade 1 DFUs, a prestigious status reserved for therapies with the potential to substantially improve treatment for serious or life-threatening conditions.
This designation highlights the significance of SkinTE, which is one of the few regenerative biologics pursuing BLA approval in a chronic wound indication. Given the critical context that there have been no BLA-approved therapies in this indication since 1997, the innovation and science required to adequately impact DFUs are truly substantial.
About COVER DFUS II
COVER DFUS II is a Pivotal Phase III Multicenter Randomized Controlled Trial (RCT) investigating SkinTE® in the treatment of Wagner 1 Diabetic Foot Ulcers (DFUs). COVER DFUS II is a registrational study to support the filing of a Biologics License Application (BLA) of a first-in-class autologous skin multicellular therapy, SkinTE.
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 following randomization.
Participants were required to have a DFU for at least 4 weeks prior to screening, failing to heal with other treatments. In addition, all participants were required to undergo an additional 2-week run-in period with rigorous SOC, only qualifying for randomization if their DFU did not change in size by more than 30% following the 2-week run-in period.
The primary efficacy endpoint is the incidence of complete wound closure within 12 weeks.
Secondary endpoints include time to healing, percent area reduction (PAR), total number of in-clinic or hospital days related to the index ulcer, total days of CAM boot use related to the index ulcer, and proportion of subjects experiencing treatment-emergent adverse events (TEAEs).
Final study results are anticipated in the first quarter of 2026.
About PolarityBio©
PolarityBio, headquartered in Salt Lake City, Utah, is a biotechnology company developing regenerative biologics. PolarityBio’s first regenerative biologic is SkinTE®, an autologous skin multicellular therapy. PolarityBio has an open investigational new drug application (IND) for SkinTE® with the U.S. Food and Drug Administration (FDA) and is now pursuing the final pivotal study on SkinTE® needed to support a biologics license application (BLA) for a Wagner 1 diabetic foot ulcer indication. SkinTE® is available for investigational use only. Learn more at www.polaritybio.com.
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