PolarityBio Announces Submission of its Biologics License Application for SkinTE® for the Treatment of Wagner Grade 1 Diabetic Foot Ulcers
SkinTE® would be the first new biologic commercially available in the U.S. for the treatment of a common chronic wound indication in nearly 30 years, if approved.
SkinTE® is a first-in-class autologous cutaneous multicellular therapy designed to harness a patient's own skin biology to support wound healing in diabetic foot ulcers.
SALT LAKE CITY, July 1, 2026 -- PolarityBio®, a late-stage biotechnology company addressing unmet needs in wound healing through innovation in regenerative multicellular biologics, today announced the submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for SkinTE® (autologous cutaneous multicellular units). Developed for the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs), SkinTE® has previously received Regenerative Medicine Advanced Therapy and Breakthrough Therapy designations from the FDA.
“Today’s BLA submission for SkinTE® marks a defining moment for PolarityBio and, more importantly, for the millions of patients living with the burden of diabetic foot ulcers,” 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. We look forward to continuing our productive engagement with the FDA throughout the review process.”
Designed to address the persistent unmet need in chronic wound care, SkinTE® is intended to leverage a patient’s own healthy full-thickness skin to activate regeneration. The submission follows the successful completion of the pivotal Phase III trial, COVER DFUS II, which met its primary efficacy endpoint of complete wound closure.
“The BLA submission of SkinTE® is a meaningful step toward giving clinicians a new, biologically distinct option for patients who have exhausted existing therapies,” said Robert Kirsner, MD, PhD, chair of the COVER DFUS II trial. “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.”
The chronic wound care reimbursement landscape shifted significantly when CMS implemented major restructuring 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 the existing payment methodologies.
About COVER DFUS II
COVER DFUS II (NCT06140303) 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 cutaneous 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.
The primary efficacy endpoint is the incidence of complete wound closure within 12 weeks. 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.
About PolarityBio
PolarityBio, headquartered in Salt Lake City, Utah, is a biotechnology company developing regenerative multicellular biologics. PolarityBio’s lead product is SkinTE®, a first-in-class autologous cutaneous multicellular therapy. PolarityBio has submitted a Biologics License Application (BLA) to the FDA for SkinTE® for the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs) — a program that holds Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy designations. Beyond DFUs, PolarityBio is advancing SkinTE® for additional chronic wound indications, including venous leg ulcers (VLUs) and pressure injuries. SkinTE® is currently available for investigational use only through an Expanded Access Program. Learn more at www.polaritybio.com.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements are based on management's current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. PolarityBio undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
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