Apligraf Reduces Healing Time For Diabetic Foot Ulcers By 30%
This article was originally published in The Gray Sheet
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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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.
Treatment investigational device exemption for the bioengineered human skin graft in the treatment of diabetic foot ulcers is approved by FDA, according to Advanced Tissue Sciences, which says it will focus on a "small number of centers" while working with the Health Care Financing Administration and other payers to address reimbursement. The treatment IDE study will be conducted concurrently with the firm's ongoing clinical trial ("The Gray Sheet" Aug. 10, In Brief). FDA requested the additional study in June to support the firm's premarket approval application for Dermagraft ("The Gray Sheet" June 15, p. 5)
Organogenesis Apligraf skin graft shipments are scheduled to begin in June following FDA approval May 22 for treatment of venous ulcers.