ReGen Biologics, Inc. (RGBO.OB) Receives FDA 510(K) Clearance for Collagen Scaffold Device
Today an hour before the opening bell, ReGen Biologics announced that the U.S. Food and Drug Administration (FDA) has given the company clearance to market its collagen scaffold device, the Menaflex™ collagen meniscus implant. This device was designed to be used in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus (a band that spans the knee joint). Gerald E. Bisbee, Jr., Ph.D., Chairman and Chief Executive Officer of ReGen Biologics, stated, “We are extremely pleased that the FDA has considered the recommendations of the Orthopaedic and Rehabilitation Devices Advisory Panel in support of…