SALT LAKE CITY — A Utah-based biotech firm has been federally registered to use its patented process on injured patients to help them regrow their own skin.
PolarityTE Inc. this week announced that the company’s lead product, SkinTE, has been registered with the U.S. Food and Drug Administration, which regulates the use of human cells, tissues, and cellular and tissue-based products.
SkinTE is a product harvested from an individual. The cells are then processed for various uses of skin tissues.
Now federally registered by the FDA, SkinTE can be made available for appropriate human use in the United States. The company is launching a limited-market release of the product to select medical institutions, with increased commercialization expected in 2018.
“The FDA registration of SkinTE is an important regulatory step that sets the stage for commercialization of this revolutionary technology into clinical application,” Dr. Denver Lough, CEO of PolarityTE, said in a prepared statement. “This achievement enables us to deliver an entirely new and pragmatic solution for skin regeneration as well as the ability to change the face and practice of regenerative medicine toward patient-tailored tissue (solutions).”
Launched earlier this year, the platform developed at PolarityTE allows the company's products to regenerate a patient’s tissues using their own cells, he said. The company's first product, SkinTE, is being optimized for clinical use in skin regeneration, with all layers, hair and appendages, he added.
Lough is credited with inventing the initial skin product while at Johns Hopkins — where he was in medical residency as a plastic reconstructive surgeon. The process involves the combination of stem cells and biological growth factors. Currently, manufacturing is taking place at the company's University of Utah facility, but will soon move to the firm's soon to be purchased West Jordan facility.
In preclinical studies, SkinTE demonstrated full-thickness regenerative healing, hair follicle formation, immediate and complete wound coverage, as well as the progressive regeneration of all skin layers, said Dr. Edward Swanson, PolarityTE's chief operating officer.
“The FDA registration of SkinTE is an important milestone that enables us to bring this revolutionary technology into clinical practice," he said. "This achievement enables us to deliver our new and pragmatic solution for skin regeneration, and to change the face and practice of regenerative medicine toward patient-tailored tissue products.”