PolarityTE, Inc. (NASDAQ:PTEIQ) is a clinical-stage regenerative medicine company developing a proprietary biofabrication platform designed to transform human tissue treatments. The company’s technology enables the creation of personalized, autologous organs and tissues directly from a patient’s own cells, with a focus on cutaneous and musculoskeletal applications. By harnessing cellular agriculture and scaffold-free biomanufacturing techniques, PolarityTE aims to address significant unmet needs in wound care and orthopedic repair.
The company’s flagship product, SkinTE, is an autologous homologous skin construct intended to promote complete healing of chronic and acute skin wounds, including diabetic ulcers and burns. SkinTE received 510(k) clearance from the U.S. Food and Drug Administration and is distributed through a network of hospitals and wound care centers. PolarityTE is also advancing additional pipeline programs, such as AuriNovo, an autologous cartilage therapy for ear reconstruction, and is exploring novel tissue types for orthopedic and cosmetic indications.
Founded in 2015 by Dr. Denver Lough, PolarityTE transitioned to a publicly traded company in November 2020 via a business combination with a special purpose acquisition company. Headquartered in Salt Lake City, Utah, the company operates a cGMP manufacturing facility and collaborates with leading clinical partners across the United States. PolarityTE has initiated discussions with regulatory authorities and strategic partners to expand its geographic footprint into Europe and Asia-Pacific markets.
PolarityTE is led by its founder and Chief Executive Officer, Dr. Denver Lough, whose background in developmental biology underpins the company’s scientific vision. The executive team includes seasoned professionals in medical device development, regulatory affairs, and commercial operations, supported by a board of directors with expertise in biotechnology, healthcare finance, and healthcare delivery systems. Through its integrated approach, PolarityTE seeks to bring next-generation regenerative therapies from the laboratory to the patient bedside.
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