PolarityBio ads

A significant recognition for PolarityBio's pivotal Phase 3 COVER DFUS II trial at #SAWCFall2026. PolarityBio received the Highest Scoring Abstract Award in the Clinical Research category for its pivotal Phase 3 study evaluating investigational SkinTE® in patients with non-healing Wagner Grade 1 diabetic foot ulcers. The award recognizes this research among 399 abstracts submitted to SAWC Fall 2026 across all categories. The recognition follows Study Chair Robert S. Kirsner, M.D., Ph.D.'s First-to-Podium presentation, where he shared results demonstrating that the trial met its primary efficacy endpoint of complete wound closure within 12 weeks. This milestone also follows the FDA's recent acceptance for filing of PolarityBio's Biologics License Application (BLA) for SkinTE with Priority Review. We thank the patients, investigators and study teams behind COVER DFUS II, along with the SAWC committee for this recognition. Read the announcement: https://lnkd.in/e3zmYPBU SkinTE is an investigational product and has not been approved by the FDA for any indication. Symposium on Advanced Wound Care (SAWC) #ClinicalResearch #DFUs #WoundCare #SAWC2026

Today marks another meaningful milestone for PolarityBio. Results from our pivotal Phase 3 COVER DFUS II trial have been selected for a First-to-Podium presentation at #SAWCFall2026. Our study evaluating investigational autologous cutaneous multicellular units (SkinTE®) in patients with non-healing Wagner Grade 1 #DFUs represents years of clinical development focused on one of the most persistent challenges in wound care. With a BLA now accepted for Priority Review by the FDA, we are looking forward to sharing these pivotal Phase 3 data with clinicians and researchers at #SAWC2026. Study Chair Robert S. Kirsner, M.D., Ph.D., will present on Friday, Oct. 16, at 10:15 a.m. PT, immediately following the Opening Ceremony and Keynote Address. SAWC reserves First-to-Podium for new and unpublished research with the potential to significantly enhance clinical practice. Read the full announcement here: https://lnkd.in/en6fzEgU SkinTE is an investigational product and has not been approved by the FDA for any indication. #WoundCare #DFU #ClinicalResearch Symposium on Advanced Wound Care (SAWC)

We are pleased to announce that the FDA has accepted for filing of SkinTE® BLA with Priority Review in Diabetic Foot Ulcers and a PDUFA target action date of March 16, 2027. SkinTE is a first-in-class autologous cutaneous multicellular therapy for Wagner Grade 1 #diabeticfootulcers, supported by COVER DFUS II, our pivotal Phase III randomized controlled trial, which met its primary endpoint of complete wound closure within 12 weeks. Priority Review sets an FDA goal of acting within six months rather than 10, bringing us one step closer to potentially offering a new option to patients. SkinTE is investigational and has not been approved by the FDA for any indication. Read the full announcement: https://bit.ly/4A8UvEp #DFUs #WoundCare #Biologics

Today marks a defining moment for PolarityBio with the submission of a BLA to the U.S. FDA for SkinTE® for the treatment of Wagner Grade 1 diabetic foot ulcers and, more importantly, for the millions of patients living with the burden of diabetic foot ulcers (DFUs). With successful completion of our pivotal Phase III COVER DFUS II trial, if approved, SkinTE would be the first new biologic commercially available in the U.S. for a common chronic wound indication in nearly 30 years and a first-in-class autologous cutaneous multicellular therapy designed to harness a patient's own skin biology to support wound healing. Read more: https://bit.ly/4ayqGC5 #Biotech #DFU #DFUs #DiabeticFootUlcers #RegenerativeBiologics SkinTE is currently available for investigational use only.

Last week, in recognition of #WoundHealingAwarenessMonth, we asked the wound care community to identify the myth among three common statements about wound healing. The answer? "Antibiotics close wounds." Antibiotics play an important role in treating infection, but wound healing depends on much more than infection control alone. Blood flow, pressure offloading, debridement, moisture balance and nutrition all contribute to the healing process. In the latest Polarity Perspective, President and CMO Ned Swanson, MD explores this and six other common misconceptions about chronic wounds and the evidence behind them. Read more: https://bit.ly/43GCsGN #WoundCare #DFU #ChronicWounds #WoundHealingAwarenessMonth

Last week, we asked the wound care community about the lifetime risk of developing a diabetic foot ulcer (DFU). The answer: 19–34% of adults with diabetes will develop a DFU during their lifetime. But that's only one part of the story. Our latest "DFU by the Numbers" Polarity Perspective highlights the broader clinical impact of diabetic foot ulcers, including recurrence rates, infection burden, amputation risk, mortality, and healthcare resource utilization. Discover more in the blog: https://bit.ly/4x3KqHi #DFU #WoundCare #Diabetes #RegenerativeMedicine