Integra LifeSciences Corp. said Monday it received approval tomarket the Integra Artificial Skin, which is indicated for treating full-thickness or deep partial-thickness burns in cases where conventionalautograft is not available or desirable.
The approval calls for the Plainsboro, N.J., company to provide atraining program for physicians and to do post-approval studies.Integra will conduct a series of regional training programs in selectedcenters over the coming months, said John Emery, Integra's seniorvice president, operations and finance.
The product already is being sold in limited quantities in Hong Kong,Singapore and Switzerland, Emery said, with Denmark and Irelandupcoming. The Artificial Skin has been under regulatory review inthe U.S. for five years.
The product is a purified bovine tendon-derived implantable matrix,which is sold in sheet form and applied to an excised burn woundsite. The product induces the body to regenerate the dermal layer intothe matrix. An outer layer of the matrix, which is a silicone-basedsubstitute for the epidermis, is peeled off after 14 days and replacedwith a thin, widely meshed epidermal autograft.
The company plans to sell the product itself in the U.S. It has twoother tissue regeneration products under development: a jointcartilage for defects of the knee, which involves seeding of patients'cartilage cells into the matrix; and a product candidate in the area ofperipheral nerve regeneration.
The company's stock (NASDAQ:IART), after reaching $13.50,closed unchanged Monday at $12. _ Jim Shrine
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