HACKENSACK, N.J.--(BUSINESS WIRE)-- 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 - News) 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.
About ReGen Biologics, Inc.:
ReGen Biologics is an orthopedic products company that develops, manufactures and markets innovative tissue growth and repair products for U.S. and global markets. ReGen’s Menaflex™ collagen meniscus implant employs proprietary biological collagen scaffold technology to facilitate tissue growth, thereby reinforcing and repairing the damaged meniscus of the knee. The Menaflex device has been cleared for sale in Europe and other countries, and is marketed through ReGen’s European subsidiary, ReGen Biologics AG. The FDA cleared the Menaflex device to be marketed in the United States in December 2008. Visit www.regenbio.com and www.menaflex.com for more information.
This press release contains forward-looking statements within the meaning of the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on the current expectations and beliefs of ReGen management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including those discussed in the Risk Factors section of ReGen's 2008 annual report on Form 10-K, its most recently issued quarterly report filed on Form 10-Q and additional filings with the SEC. ReGen's filings with the SEC are available to the public at the Company's website at http://www.regenbio.com, from commercial document-retrieval services and at the website maintained by the SEC at http://www.sec.gov.
ReGen Biologics, Inc.
Brion Umidi, 201-651-3515
Senior Vice President, Chief Financial Officer