PolarityTE, which is using a novel approach to tissue regeneration, announced the FDA registration of its skin-regeneration platform, SkinTE. The company will introduce the product in a limited release to select medical institutions.
Skin grafts are the standard treatment for burn patients, but they may be unsuitable for patients with large burns who require extensive coverage. SkinTE regenerates full-thickness skin from a patient’s own tissue. A patient’s skin is acquired via biopsy and then expanded in a lab. The regenerated skin is applied to the wound in less than 24 hours, the company says.
“The FDA registration of SkinTE is an important regulatory step that sets the stage for commercialization and a staged market entry of this revolutionary technology into clinical application,” said Denver M. Lough, M.D., Ph.D., chief executive officer of PolarityTE. “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 constructs.”
This summer, the Salt Lake City-based company revealed preclinical data showing the platform regenerated all skin layers, promoting scarless healing, hair follicle growth and immediate complete wound coverage.
PolarityTE will introduce the product first in high-volume burn and wound-care centers and plans to ramp up commercialization in 2018, said Chief Operating Officer Ned Swanson, M.D. The company will add centers one at a time as it scales up its manufacturing capabilities and plans to go nationwide in 2019, he said.
While the company has focused on the burn and wound-care market, it also has a bone-regeneration platform, OsteoTE, in its pipeline. It is beginning large animal trials for the product and will pursue a similar FDA registration as a human cells, tissues, and cellular and tissue-based product, Swanson said.