Advanced Tissue Sciences
This article was originally published in The Gray Sheet
Executive Summary
FDA go-ahead enables enrollment of up to 50 patients in a pivotal trial of a peridontal indication for ATS' fibroblast-derived dermal substitute technology, currently approved for treating diabetic foot ulcers (1"The Gray Sheet" October 8, 2001, p. 24). The trial will enroll patients with two oral defects exposing a tooth root. One defect will be covered with the ATS material; the other will be treated with a standard soft tissue graft harvested from the patient's own palatal tissue and covered with a flap of gingival tissue. Each patient will be followed for six months. About 500,000 oral soft-tissue grafts are performed in the U.S. each year...