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PolarityTE™ Lead Product, SkinTE™, is Approved for Use by Multiple Medical InstitutionsSALT LAKE CITY, Oct. 19, 2017 (GLOBE NEWSWIRE) -- PolarityTE, Inc. (NASDAQ:COOL) today announced that multiple value analysis committees have approved SkinTE™ for use at their respective medical institutions as the Company continues its commercialization efforts and manufacturing scale-up. Clinical application is expected in the fourth quarter of 2017, and data is planned to be released through multiple channels in the first half of 2018. “The approval of SkinTE™ by multiple medical institutions’ value analysis committees validates our belief that the medical community is eager to employ our technology and the SkinTE™ product,” said Denver M. Lough, M.D., Ph.D., Chief Executive Officer of PolarityTE™. Dr. Lough continued, “we have received tremendous interest from surgeons and other medical providers, and we are committed to executing on our manufacturing and commercialization strategy leading into 2018 to meet the significant demand we are seeing and anticipating, and to address the unmet needs of patients suffering from burns, wounds, and other defects of skin tissues.” About SkinTE™ and FDA Tissue Establishment Registration SkinTE™ is processed and will be marketed in accordance with the FDA’s requirements for human tissue and current good tissue practices (21 CFR 1271) and is manufactured for PolarityTE by American Association of Tissue Banks (AATB) and Foundation for the Accreditation of Cellular Therapy (FACT)-accredited facilities. Important Safety Information Whenever clinical circustances require use in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures must be taken. Unused or expired tissue product should be discarded according to local, state, federal and institutional requirements. Utilization of the SkinTE™ construct, process and/or technology is limited to healthcare professionals and facilities that are capable of handling such tissue products. Proper aseptic procedural and/or surgical handling is mandatory when using SkinTE™. Failure to ensure proper aseptic technique may result in contamination of the tissue product and wound bed. Contamination of the tissue product and/or wound bed due to failure to ensure aseptic technique could result in local, regional, or systemic infection, partial or complete failure of graft take, healing, and/or regeneration, serious injury, and/or death. Failure to follow instructions may lead to sub-optimal outcomes and/or product failure. Potential adverse effects may include but are not limited to the following: local tissue, wound bed, regional tissue, or systemic infection, hypersensitive, allergic, or other immune response to the product or trace amounts of antibiotic retained from primary harvest, deleterious effects on potential surrounding or adjacent autologous, allogeneic, or xenogenic grafts, skin substitutes, or other reconstructions including infection and/or failure of adjacent grafted material to take and heal, requirement for further surgical operation(s) and/or debridement, or death. About PolarityTE™ Forward Looking Statements Contacts: John Stetson Scott Santiamo |