- “Autologous Cutaneous Multicellular Units in Non-Healing Wagner 1 Diabetic Foot Ulcers: Results of the Phase 3 COVER DFUS II Trial” honored with top award in Clinical Research category
- Pivotal Phase 3 trial met primary endpoint with full results slated for upcoming peer-reviewed publication
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, particularly 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
COVER DFUS II (NCT06140303) is a pivotal Phase 3 multicenter randomized controlled trial (RCT) investigating SkinTE® in the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs). COVER DFUS II is a registrational study that supported the filing of a Biologics License Application (BLA) for 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 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
PolarityBio, headquartered in Salt Lake City, Utah, is a late-stage 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 U.S. Food and Drug Administration (FDA) for SkinTE® for the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs) has been accepted for Priority Review with a PDUFA date of March 16, 2027. The program also holds Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy designations from the FDA. 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.
Company Contact
connect@polaritybio.com
Investor Relations Contact
Parker Scott
IR@polaritybio.com
801-455-1440
Media Contact
Jessica Starman
media@elev8newmedia.com
888-461-2233
