Preliminary results from procedural review of Menaflex released by the FDA

The U.S. Food and Drug Administration (FDA) yesterday released preliminary results of a review of its internal procedures surrounding the review of ReGen Biologics’ (OTC: RGBO) Menaflex™ collagen meniscus implant for use in the U.S.

“The FDA indicated in a telephone conversation with us that its review was a procedural assessment of the process by which Menaflex received clearance,” said Gerald E. Bisbee, Jr., Ph.D., Chairman and Chief Executive Officer of ReGen. “The FDA did not consider or re-evaluate the scientific evidence demonstrating the safety and efficacy of Menaflex, and our product’s performance was not the focus of this review. The FDA will conduct a separate reevaluation of the scientific basis of the clearance but has not yet determined the exact process by which such an evaluation will be made. ”

The FDA cleared Menaflex to be marketed for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus in December 2008. The 510(k) review process itself has been under attack internally at the FDA and externally from Congress for some time. In fact, just this week, the FDA announced plans for the Institute of Medicine to conduct an in-depth evaluation of the 510(k) device clearance process, expected to culminate in a final report in 2011.

Preliminary results from the procedural review were provided yesterday to Congress. Pending the review process, ReGen plans to continue marketing the Menaflex and training surgeons to provide patients the benefit from this important treatment option.

“ReGen stands behind Menaflex and believes that the scientific evidence for its collagen scaffold is solid,” said Bisbee. The best evidence of the safety and efficacy of Menaflex comes from the published results of a large multicenter clinical trial published in The Journal of Bone and Joint Surgery in July 2008 and the nearly 3,000 patients in Europe and the U.S. who have had successful Menaflex surgery.