PolarityBio’s Phase 3 COVER DFUS II Trial Selected for First-to-Podium Presentation at SAWC Fall 2026

• Pivotal SkinTE® data in non-healing Wagner Grade 1 diabetic foot ulcers to be presented by Study Chair Robert S. Kirsner, MD, PhD, on October 16
  

SALT LAKE CITY, Sept. 29, 2026 (GLOBE NEWSWIRE) -- PolarityBio®, a late-stage biotechnology company addressing unmet needs in wound healing through innovation in regenerative multicellular biologics, today announced that results from its pivotal Phase 3 COVER DFUS II trial evaluating investigational autologous cutaneous multicellular units (SkinTE®) in patients with non-healing Wagner Grade 1 diabetic foot ulcers (DFUs) have been selected for a First-to-Podium presentation at the Symposium on Advanced Wound Care (SAWC) Fall 2026.

The abstract will be presented by Robert S. Kirsner, MD, PhD, Study Chair for COVER DFUS II, during SAWC’s First-to-Podium session on Friday, October 16. The session begins at 10:15 a.m. PT immediately following the conference’s Opening Ceremony and Keynote Address. SAWC reserves its First-to-Podium program for new and unpublished clinical or laboratory research, emerging data, and novel innovations with the potential to significantly enhance clinical practice.

“Being selected for the First-to-Podium presentation at SAWC Fall is a tremendous validation of the scientific rigor and clinical significance of the COVER DFUS II trial and the significance of being a first-in-class treatment,” said Robert S. Kirsner, MD, PhD, Study Chair of the COVER DFUS II trial. “Patients with chronic, non-healing diabetic foot ulcers face severe clinical challenges and high risks of amputation. The study design, including a strict two-week run-in period to isolate true non-healing wounds, ensured we evaluated SkinTE in patients with advanced diabetic foot pathology truly in need of advanced treatment. I look forward to sharing these pivotal results with the wound care community in Las Vegas.”

“The selection of COVER DFUS II for First-to-Podium represents an important milestone for PolarityBio and the SkinTE clinical program,” said Nikolai Sopko, MD, PhD, President and Chief Scientific Officer of PolarityBio. “This study represents years of clinical development focused on one of the most persistent challenges in wound care. With our Biologics License Application now accepted for Priority Review by the FDA, we are pleased to share these pivotal Phase 3 data with clinicians and researchers at one of the field’s leading scientific meetings.”

PolarityBio’s Biologics License Application to the U.S. Food and Drug Administration for SkinTE for the treatment of Wagner Grade 1 diabetic foot ulcers was accepted for Priority Review with a PDUFA date of March 16, 2027. SkinTE previously received both Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy designations from the FDA.

Members of the PolarityBio leadership and scientific teams will be present throughout SAWC Fall 2026, taking place October 15-18 in Las Vegas, to engage with clinicians, researchers, and industry stakeholders. Full presentation details, poster locations, and digital access information are available on the official SAWC conference portal.

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 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
PolarityBio, headquartered in Salt Lake City, Utah, is a biotechnology company developing regenerative multicellular biologics. PolarityBio’s lead product is autologous cutaneous multicellular units (SkinTE®), a first-in-class autologous cutaneous multicellular therapy. PolarityBio’s 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, has been accepted for Priority Review with a PDUFA date of March 16, 2027. 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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