PolarityTE – Phase III Pivotal Study Evaluating Investigational New Drug SkinTE ® in Diabetic Foot Ulcers

Dr. Nik Sopko, Chief Scientific Officer of PolarityTE, a company leading the way in the development of regenerative tissue products to address significant unmet medical needs in chronic wounds like diabetic foot ulcers (DFU), discusses the enrollment of the first subject in the Phase III pivotal study evaluating SkinTE ® in the investigational use of treatment of Wagner grade 2 diabetic foot ulcers (DFUs), entitled “Closure Obtained with Vascularized Epithelial Regeneration for DFUs with SkinTE,” or “COVER DFUs.” SkinTE ® is an innovative alternative made of a patient’s own full-thickness skin, which retains the endogenous regenerative cellular populations found throughout his/her skin within multicellular segments. 

Dr. Nikolai Sopko obtained his MD with honors from Case Western Reserve University and PhD in stem cell biology at the Cleveland Clinic as a graduate of the National Institutes of Health Medical Scientist Training Program. He completed his surgical training at the Johns Hopkins James Buchanan Brady Urologic Institute as a Physician Scientist Scholar where he focused on regenerative reconstruction, tissue engineering, gene therapy, transplant modulation and tumor biology. He has over 60 published peer-reviewed articles and book chapters and is a speaker on regenerative medicine. Dr. Sopko is currently the Chief Scientific Officer and Vice President of Research and Development of PolarityTE where he applies his passion for patient care and basic science research to develop novel regenerative therapeutics for clinically challenging diseases.