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Organogenesis Predicting Apligraf Approval For Diabetic Ulcers In Early 2000

This article was originally published in The Gray Sheet

Executive Summary

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.

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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.

Organogenesis Apligraf Approvable For Diabetic Foot Ulcers With Conditions

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.

Apligraf Reduces Healing Time For Diabetic Foot Ulcers By 30%

Organogenesis' Apligraf living skin construct reduces the time it takes diabetic foot ulcers to heal by almost one-third, the company says.

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