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ReGen Biologics Collagen Scaffold Receives Positive Orthopaedic PanelRecommendations

^{Published on 2008-11-18 14:33:34 - Market Wire}
 

HACKENSACK, N.J.--([ BUSINESS WIRE ])--ReGen Biologics (OTC: RGBI) ("ReGen") announced today that the Orthopaedic and Rehabilitation Devices Advisory Panel ("Orthopaedic Panel") of the Food and Drug Administration ("FDA") met on Friday, November 14, 2008 to provide advice and recommendations regarding the ReGen collagen scaffold device in the context of its 510(k) submission. At the meeting, ReGen and FDA staff made presentations to the Orthopaedic Panel and members of the Orthopaedic Panel asked questions and deliberated on the presentations and other information. The Orthopaedic Panel discussed and commented on questions provided by the FDA. A summary of the panel meeting is available on the FDA website at [ http://www.fda.gov/cdrh/meetings/111408-summary.html ].

ReGen expects the FDA will use input from the Orthopaedic Panel to make a formal decision regarding its 510(k) submission.

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 first approved product using its collagen scaffold technology is the Menaflex™ collagen meniscus implant, which is cleared for sale in Europe and other countries and marketed through ReGen's European subsidiary, ReGen Biologics AG. ReGen is seeking FDA clearance in the U.S. for the Menaflex device through its collagen scaffold 510(k) submission. 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 2007 annual report on Form 10-K 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 ].