Ortec skin product looks for quick approval:
This article was originally published in Clinica
Executive Summary
The FDA has said Ortec's Composite Cultured Skin (CCS) qualifies as a humanitarian use device for the treatment of dermal ulcers in epidermolysis bullosa, a rare genetic disease which causes the skin to become fragile and blister. This means that New York-based Ortec can apply for accelerated approval of the device, which is made of bovine collagen seeded with dermal cells.