SkinTE® Met Primary and Secondary Endpoints in Multicenter, Randomized Controlled Trial in Venous Leg Ulcers
PolarityTE announced results from a multi-center randomized controlled trial evaluating treatment of Venous Leg Ulcers (VLU) with its investigational product SkinTE® plus standard of care (SOC) vs SOC alone (NCT03881267).
PolarityTE Announces Allowance of Fourth U.S. Patent
PolarityTE, Inc. announced the U.S. Patent and Trademark Office (USPTO) recently issued a Notice of Allowance for U.S. Application No. 17/326,734 filed on May 21, 2021.
PolarityTE Announces U.S. FDA Approval of IND for Pivotal Phase 3 Study of SkinTE® to Support Chronic Cutaneous Ulcer Indication
PolarityTE, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug (IND) application for the evaluation of SkinTE for the treatment of chronic cutaneous ulcers.
PolarityTE Announces Submission of Complete Response to FDA’s Clinical Hold Correspondence for SkinTE® Investigational New Drug Application
PolarityTE has submitted its complete response to the U.S. FDA clinical hold correspondence regarding its Investigational New Drug (IND) Application for SkinTE® with a proposed indication for chronic cutaneous ulcers.
PolarityTE Reports Third Quarter Financial Results and Provides Business Update
PolarityTE, Inc. recently provided a business update and reported financial results for the three and nine-month periods ended September 30, 2021.
PolarityTE Provides Update on U.S. FDA Investigational New Drug Application for SkinTE®
PolarityTE, Inc. today provided an update regarding correspondence from the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug Application (IND) for SkinTE® with a proposed indication for chronic cutaneous ulcers, which was filed on July 23, 2021.
