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Polarity te8/30/2023 The primary endpoint is the incidence of DFUs closed at 24 weeks. ![]() in COVER DFUs, which will compare treatment with SkinTE plus the standard-of-care to the standard-of-care alone. The first planned pivotal study is a multi-center, randomized controlled trial evaluating SkinTE in the treatment of Wager 2 DFUs entitled "Closure Obtained with Vascularized Epithelial Regeneration for DFUs with SkinTE," or "COVER DFUs." The Company plans to enroll up to 100 patients at up to 20 sites in the U.S. It is important to note that our strategy to pursue a complex chronic cutaneous ulcer indication, which includes the most challenging and cost-intensive wounds, is based on the learnings from our prior commercial experience as a 361 HCT/P and from our previous non-IND DFU and VLU RCTs, which gives us a great deal of confidence as we look forward to commencing our first pivotal study in the very near future." Richard Hague, Chief Executive Officer and President of PolarityTE, commented, "The clearance of our IND is a critical milestone for PolarityTE and a testament to the talent and hard work of our entire team. The approval enables PolarityTE to commence the first of two expected pivotal studies needed to support a biologics license application (BLA) seeking a chronic cutaneous ulcer indication for SkinTE. This follows the Company satisfactorily addressing clinical hold items that the FDA had previously identified. 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. ![]() ![]() (Nasdaq: PTE), a biotechnology company developing regenerative tissue products and biomaterials, today announced that the U.S.
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