SALT LAKE CITY — September 29, 2026
PolarityBio announced that results from its pivotal Phase 3 COVER DFUS II trial of investigational SkinTE will be presented as a First-to-Podium presentation at the Symposium on Advanced Wound Care (SAWC) Fall 2026 in Las Vegas. The presentation, scheduled for October 16, will be delivered by study chair Robert S. Kirsner, MD, PhD, and will feature clinical results from the randomized trial evaluating SkinTE in patients with non-healing Wagner Grade 1 diabetic foot ulcers (DFUs). The study evaluated an investigational autologous cutaneous multicellular therapy alongside standard of care, with complete wound closure within 12 weeks serving as the primary efficacy endpoint. The presentation comes as PolarityBio advances its regulatory program for SkinTE, with the company’s Biologics License Application (BLA) accepted by the FDA for Priority Review.
COVER DFUS II Evaluates SkinTE in Non-Healing DFUs
COVER DFUS II is a pivotal Phase 3 multicenter randomized controlled trial designed to evaluate SkinTE in patients with persistent Wagner Grade 1 diabetic foot ulcers. The study enrolled 120 patients across multiple U.S. clinical sites over approximately 14 months, with participants randomized 1:1 to SkinTE plus standard of care or standard of care alone. Patients were followed for 24 weeks after randomization, while the primary efficacy endpoint assessed the incidence of complete wound closure within 12 weeks. To identify wounds that were genuinely non-healing despite optimized treatment, eligible participants were required to have an ulcer lasting at least four weeks and complete a two-week standard-of-care run-in period. Patients qualified for randomization only when wound size decreased by no more than 30% during that run-in period, creating a study population enriched for ulcers that had not responded adequately to conventional wound care.
First-to-Podium Presentation to Reveal Pivotal Results
The COVER DFUS II results have been selected for SAWC Fall 2026’s First-to-Podium program, which features new and previously unpublished clinical or laboratory research and emerging innovations relevant to wound care practice. Kirsner is scheduled to present the data on October 16 during the conference’s First-to-Podium session. PolarityBio said the presentation will provide the wound-care community with the pivotal clinical findings from the SkinTE program. The company is developing SkinTE as an autologous cutaneous multicellular therapy intended to support regeneration in chronic wounds. The reported trial design included a rigorous run-in period and randomized comparison against standard care, while the detailed efficacy and safety results are expected to be disclosed through the conference presentation.
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FDA Priority Review Sets March 2027 PDUFA Date
PolarityBio’s BLA for SkinTE in Wagner Grade 1 DFUs has been accepted by the FDA for Priority Review, with a PDUFA action date of March 16, 2027. SkinTE has previously received Regenerative Medicine Advanced Therapy and Breakthrough Therapy designations from the FDA for the DFU program. The company is also developing SkinTE for other chronic wound indications, including venous leg ulcers and pressure injuries. SkinTE remains investigational and is currently available only for investigational use through an Expanded Access Program. The upcoming COVER DFUS II presentation will provide additional clinical evidence for the regulatory program, while FDA review will determine whether the submitted data support approval. The Phase 3 results therefore represent an important clinical and regulatory data point for PolarityBio’s development of SkinTE in chronic diabetic foot ulcers.
Source :PolarityBio press release
