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ReGen Biologics Collagen Scaffold Receives Positive Orthopaedic Panel Recommendations

November 18, 2008

ReGen Biologics Collagen Scaffold Receives Positive Orthopaedic Panel Recommendations

Hackensack, NJ – 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 patented collagen scaffold technology includes applications in orthopedics, general surgery, spine, cardiovascular and drug delivery.  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.  The CMI® name was used during the research and development phase of the Company’s collagen meniscus implant device, and it will continue to be seen in numerous scientific publications and clinical references.  ReGen continues to work to obtain FDA clearance of the Menaflex device in the United States.

For more information on ReGen, visit www.regenbio.com.  For more information on the Menaflex collagen meniscus implant visit www.menaflex.com.
 
Contact:

Brion Umidi    
ReGen Biologics, Inc.    
Senior Vice President, Chief Financial Officer
(201) 651-3515    
bumidi@regenbio.com