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 our collagen scaffold 510(k) and that the FDA agreed to enable U.S. marketing for this important product. Today’s announcement represents the culmination of many years of effort on the part of the Company and the invaluable contribution of many supportive investors, advisors and surgeons, as we sought to bring the Menaflex product to the U.S. market.”
He continued, “The potential market for ReGen’s Menaflex product includes a large portion of the estimated annual 1.3 million partial meniscectomies taking place world-wide and the growing backlog of patients who have undergone approximately 18 million partial meniscectomy procedures in the past 20 years. The incidence of partial meniscectomies increases for those patients who have had previous procedures. Approximately 65% of partial meniscectomies occur on the medial meniscus. The United States currently represents over 50% of the world market for meniscus procedures.”
“With over a decade of clinical experience, we are proud that the Menaflex is the first device cleared by the FDA for repair and reinforcement of medial meniscus tissue. We look forward to making this important product available to surgeons in the U.S. and giving them a potentially valuable new opportunity to provide benefit for their patients with first time or chronic meniscus injuries,” Dr. Bisbee stated in conclusion.
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