ReGen Biologics submits premarket notification to FDA for collagen scaffold device

By Ted A. Knutson

Washington, Jan. 3 - ReGen Biologics, Inc. announced Tuesday it submitted a 510(k) premarket notification to the Food and Drug Administration for its collagen scaffold device.

FDA clearance of this 510(k) submission would allow ReGen to market in the United States the ReGen family of collagen scaffold products, including an application of the ReGen collagen scaffold for the meniscus.

"The landscape for 510(k) cleared products in the soft tissue area has evolved over the course of the past few years, including recently cleared products in 2005, providing us the opportunity for this 510(k) submission," stated Gerald E. Bisbee Jr., Ph.D., chairman and chief executive officer of ReGen Biologics, in a news release. "We intend to continue to follow patients in the U.S. clinical trial on the meniscus application, which will provide valuable scientific data on long-term patient outcomes."

Franklin Lakes, N.J.-based ReGen Biologics is an orthopedic products company that develops, manufactures and markets innovative tissue growth and repair products.

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