ATS Dermagraft Approval Breaks Apligraf Monopoly In Chronic Wounds
This article was originally published in The Gray Sheet
Executive Summary
Advanced Tissue Sciences plans a PMA supplement supported by an ongoing 240-patient U.S. trial for expanded use of its Dermagraft tissue-engineered, living dermal substitute to treat venous ulcers. FDA approval for diabetic foot ulcers was received Sept. 28.
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ATS Gives Smith & Nephew Second Skin; Wound Treatment Portfolio Elevated
Smith & Nephew's joint venture with Advanced Tissue Sciences to develop and market Dermagraft bio-engineered skin will be a major driver of S&N growth over the next five years, the British firm anticipates
ATS Gives Smith & Nephew Second Skin; Wound Treatment Portfolio Elevated
Smith & Nephew's joint venture with Advanced Tissue Sciences to develop and market Dermagraft bio-engineered skin will be a major driver of S&N growth over the next five years, the British firm anticipates
Advanced Tissue Sciences
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...