Organogenesis Apligraf Approvable For Diabetic Foot Ulcers With Conditions
This article was originally published in The Gray Sheet
Executive Summary
Physicians using Organogenesis' Apligraf for treatment of diabetic foot ulcers should be cautioned that clinical studies of the living skin substitute compared the product to standard care only, FDA's General and Plastic Surgery Device Advisory Panel recommended May 8 in considering the company's application to expand labeling.
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Advanced Tissue Sciences
Firm announces submission of a premarket approval application to FDA for its Dermagraft wound dressing to treat diabetic foot ulcers. Clinical trials for the Dermagraft, which will be marketed by Smith & Nephew, indicate that the product heals significantly more ulcers than control treatment, the firm says in an Aug. 25 release. Competitor Organogenesis received an approvable recommendation from FDA's General and Plastic Surgery Devices panel in May (1"The Gray Sheet" May 15, 2000, p. 8)
Advanced Tissue Sciences
Firm announces submission of a premarket approval application to FDA for its Dermagraft wound dressing to treat diabetic foot ulcers. Clinical trials for the Dermagraft, which will be marketed by Smith & Nephew, indicate that the product heals significantly more ulcers than control treatment, the firm says in an Aug. 25 release. Competitor Organogenesis received an approvable recommendation from FDA's General and Plastic Surgery Devices panel in May (1"The Gray Sheet" May 15, 2000, p. 8)
Organogenesis Predicting Apligraf Approval For Diabetic Ulcers In Early 2000
Organogenesis plans to file a premarket approval application supplement in late 1999 that would expand the indications for its Apligraf living skin graft to include diabetic foot ulcers, Chief Strategic Officer Alan Tuck told the New York Society of Security Analysts March 16 in New York.