Looking ahead for Dermagraft

WASHINGTON - Last week's positive FDA advisory committee meeting for Advanced Tissue Sciences Inc.'s Dermagraft-TC, a temporary covering for severe burns, sets the stage for what could be a more complex discussion of ATIS's next product, Dermagraft for diabetic foot ulcers. It also broke ground for consideration of engineered tissue from other companies, including Organogenesis Inc. (ORG, Canton, Mass.).

ATIS and the General and Plastic Surgery Devices Panel broke new ground last week by evaluating the safety and efficacy of the first cell-based medical device (see BioCentury Extra Nov. 20). FDA officials, panel members and the company frankly acknowledged that there are no clearly delineated guidelines or standards for assessing such products. ...