ReGen Announces Completion Of CMI Clinical Trial Surgeries

Business Wire, Nov 20, 2002

Business Editors

FRANKLIN LAKES, N.J.--(BUSINESS WIRE)--Nov. 20, 2002

ReGen Biologics, Inc. (OTC: RGBI), today announced that all surgeries have been completed for the required enrollment in its U.S. clinical trial for the Collagen Meniscus Implant ("CMI"), the largest-ever U.S. based multicenter clinical trial involving the meniscus of the human knee.

ReGen has enrolled over 288 patients in a randomized, controlled multicenter clinical trial of its CMI product. Data for this trial are being collected at sixteen sites across the United States, and will be submitted to the FDA after the required two-year clinical follow-up. Submission of a Premarket Approval Application ("PMA") to the FDA is expected to occur by the end of Q4 2004.

"We are delighted to have reached this important milestone in the conduct of the CMI Multi-center Clinical Trial," stated Gerald E. Bisbee, Jr., Ph.D., Chairman and CEO of ReGen Biologics. "We appreciate the important contribution made by the 23 surgeons and 16 centers around the U.S." Dr. Bisbee continued, "Completion of the surgeries keeps ReGen on-track for submission of the PMA application to the FDA immediately following the two year follow-up time period."

About ReGen Biologics, Inc.

ReGen is a biological remodeling company that designs, develops, manufactures and markets minimally invasive human implants and medical devices for the repair and remodeling of damaged human tissue. ReGen's headquarters are located in Franklin Lakes, New Jersey and it operates an ISO 9001 certified manufacturing facility in Redwood City, California. ReGen's biological remodeling scaffold material has been applied to a variety of therapeutic applications and the Company plans to continue to develop

and introduce biologically based tissue remodeling products using its patented technologies.

ReGen's flagship product, the Collagen Meniscus Implant (CMI), is focused in orthopedics. The CMI is marketed in Europe and Australia through a distribution agreement with Centerpulse AG (NYSE: CEP). ReGen also sells the SharpShooter Tissue Repair System, an arthroscopic device used for meniscus repair procedures, through a distribution agreement with Linvatec, a division of CONMED Corporation (NASDAQ: CNMD).

Cautionary Note Regarding Forward-Looking Statements

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 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 the Company's current report on Form 8-K/A, filed with the Securities and Exchange Commission on September 4, 2002. The Company's filings with the SEC are available to the public from commercial document-retrieval services and at the Web site maintained by the SEC at http://www.sec.gov.