PolarityTE is dedicated to advancing regenerative medicine through its innovative research focused on the complex biology of skin regeneration. The company aims to develop personalized autologous therapies to address significant unmet medical needs, particularly for patients suffering from chronic and complex wounds. Their lead investigational product, SkinTE®, is an Autologous Heterogeneous Skin Construct (AHSC) that utilizes the patient's own viable tissue, minimizing the risks associated with allogeneic or xenogeneic products. This technology is designed to engraft multicellular segments into the wound bed, promoting the regeneration of functional tissue and facilitating the healing process in challenging wound environments.

The clinical development of SkinTE® has shown promising results in various trials, particularly for diabetic foot ulcers and venous leg ulcers. In randomized controlled trials, SkinTE® demonstrated significantly higher wound closure rates compared to standard of care treatments, indicating its potential effectiveness in treating complex wounds. The product has received designation as a Regenerative Medicine Advanced Therapy (RMAT) by the FDA, underscoring its potential to address serious medical conditions. PolarityTE's commitment to understanding skin's regenerative capabilities and its patient-specific approach positions the company at the forefront of wound care innovation.

United States

PolarityTE, Inc., headquartered in Salt Lake City, Utah, is a biotechnology company developing regenerative tissue products.  PolarityTE's first regenerative tissue product is SkinTE®.  PolarityTE has an open investigational new drug application (IND) for SkinTE® with the U.S. Food and Drug Administration (FDA) and is now pursuing the first of two pivotal studies on SkinTE® needed to support a biologics license application (BLA) for a chronic cutaneous ulcer indication.  SkinTE® is available for investigational use only. Learn more at www.PolarityTE.com.

PolarityTE

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