In Brief: Advanced Tissue Sciences
This article was originally published in The Gray Sheet
Executive Summary
Advanced Tissue Sciences: Premarket approval application submission for the firm's Dermagraft-TC engineered human dermal tissue planned for "the first half of 1996," the company announces Dec. 19. The La Jolla, California company says its 65-patient pivotal clinical trial comparing Dermagraft to cadaver skin for the treatment of severe burns has yielded "statistically significant results" with respect to the trial's primary endpoint -- "the ability of the coverings to adequately prepare the wound beds for successful autograft take." In June, FDA notified ATS that its PMA would receive expedited review ("The Gray Sheet" June 12, In Brief)...