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In a release, the company noted:
The Menaflex was determined to be substantially equivalent through the premarket notification 510(k) process and is indicated for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus.
The Menaflex implant is a device designed to guide new tissue growth using the body's own healing process following removal of damaged meniscus tissue. It provides a resorbable scaffold for the growth of new tissue in the meniscus. Clinical benefits of the Menaflex product, previously known as the CMI, were recently documented in the July 2008 issue of The Journal of Bone and Joint Surgery (JBJS) and available on the Company's website at regenbio.com/usa/en/publications.php. Additional publications presenting clinical data on use of the Menaflex device are also available on the Company's website.
"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," said Gerald E. Bisbee, Jr., Ph.D., Chairman and Chief Executive Officer of ReGen Biologics. "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," Dr. Bisbee said further.
Dr. Bisbee 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 percent of partial meniscectomies occur on the medial meniscus. The United States currently represents over 50 percent 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 concluded.
ReGen Biologics is an orthopedic products company that develops, manufactures and markets tissue growth and repair products for U.S. and global markets.
((Comments on this story may be sent to health@closeupmedia.com))
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