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In Brief: Advanced Tissue Sciences Dermagraft

This article was originally published in The Gray Sheet

Executive Summary

Advanced Tissue Sciences Dermagraft: Firm submits premarket approval application to FDA covering use of the bioengineered skin replacement product in the treatment of diabetic foot ulcers. Smith & Nephew plc holds nonexclusive rights to market the product. ATS also submits an investigational device exemption seeking approval to begin a pilot study of its engineered human cartilage product for use in articular cartilage repair in knees. Smith & Nephew and ATS are jointly developing the product. On Nov. 19, FDA's General and Plastic Surgery Devices Panel recommended approval of a PMA for Advanced Tissue Sciences' Dermagraft-TC temporary skin replacement for treatment of full-thickness and deep partial-thickness burns ("The Gray Sheet" Nov. 25, p. 7)...

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