12/26/2023 0 Comments Polarity te![]() The Company believes this trial will provide supporting data that can be incorporated into its IND application.Īs previously reported, PolarityTE finished the quarter ended Septemwith cash, cash equivalents and short-term investments of approximately $23.19 million. On JanuPolarityTE announced it has completed target enrollment of 100 subjects in a randomized controlled trial (RCT) evaluating SkinTE plus standard of care (SOC) versus SOC alone for the treatment of diabetic foot ulcers (DFUs) and plans to report topline data via press release and presentation at the Symposium on Advanced Wound Care (SAWC) Spring 2021 to be held May 12-16, 2021, barring any unforeseen scheduling or other disruptions due to COVID-19. ![]() Through these interactions the Company gained valuable insight regarding the critical information it expects to include in the IND, and believes it remains on track to file the IND for SkinTE in the second half of 2021.Ĭompletion of Enrollment in Diabetic Foot Ulcer Randomized Controlled Trial Over the last several months, the Company has had meaningful interactions with the FDA regarding the Company’s planned IND for SkinTE. Food and Drug Administration (FDA) through submission of an investigational new drug application (IND) and eventual biologics license application (BLA), and protecting our intellectual property. Our focus is on building shareholder value by pursuing pre-market approval for SkinTE® from the U.S. (Nasdaq: PTE), a biotechnology company developing and commercializing regenerative tissue products and biomaterials, is pleased to provide this update. SALT LAKE CITY-( BUSINESS WIRE)- PolarityTE, Inc. ![]()
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