PolarityTE  announced the Screening of the first subject in the Phase III pivotal study evaluating SkinTE in the investigational treatment of Wagner grade 1 diabetic foot ulcers (DFUs), entitled "Closure Obtained with Vascularized Epithelial Regeneration for DFUs with SkinTE II," or "COVER DFUS II."  COVER DFUS II will enroll up to 120 subjects at up to 20 clinical sites in the United States.  Subjects will be randomized to one of two treatment groups, receiving either SkinTE plus the standard of care (SOC) or the SOC alone.  The primary endpoint is the incidence of DFUs closed at 12 weeks.  Secondary endpoints include percent area reduction (PAR) at 4, 8, and 12 weeks; Total number of in-person wound care clinic visits and/or hospital days related to the index ulcer from Randomization Visit (RV1); Total days of CAM Boot use related to the index ulcer from Randomization Visit (RV1); Time to closure within 24 weeks; and Proportion of subjects experiencing treatment-emergent AEs between SOC and SkinTE arms. COVER DFUS II is a pivotal study that PolarityTE will conduct under its open IND for SkinTE.