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RGBI (OTCBB) ReGen Biologics Announces 2002 Accomplishments

MONDAY , JANUARY 06, 2003 08:00 AM

FRANKLIN LAKES, N.J., Jan 6, 2003 (BUSINESS WIRE) -- ReGen Biologics, Inc. (OTC:RGBI), today announced major achievements during 2002, including the completion of required enrollment in the largest-ever U.S.-based multicenter clinical trial involving the meniscus of the human knee.

"We're pleased with the successes we enjoyed in 2002," stated Gerald E. Bisbee, Jr., Ph.D., Chairman and CEO. "We wrap-up the year with the satisfaction of accomplishing important objectives during 2002 and establishing a clear set of milestones for 2003, including sales goals, growth in the research and development pipeline, and an increase in our intellectual property portfolio."



ReGen's achievements in 2002 included:
-- In November, we completed enrollment and surgeries of the 288
patients required in the U.S. Multicenter Trial. This is the
most significant milestone until submission of the PMA to the
FDA, scheduled for December 2004, once all patients have
undergone the two year follow-up required by the FDA;
-- Since the U.S. clinical trial began several years ago, we have
results on over 60% of the patients, and clinical results
to-date are positive. A five-year follow-up study of the
feasibility patients was completed, including a relook
arthroscopy, and results are also quite positive. These
results have been submitted for publication;
-- In June, we completed a financial transaction that brought
approximately $7 million in new capital to ReGen. As part of
that transaction, we merged with a publicly traded company and
we are now traded under the ticker symbol RGBI; and
-- Centerpulse (NYSE:CEP), our distributor outside the U.S.,
formed its sales teams in Europe and Australia in the second
half of 2002. Sales are underway in Italy, Spain, Germany,
Switzerland, and Australia, and the process for introducing
the CMI has begun in Canada and Chile.
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 is headquartered in Franklin Lakes, New Jersey, and it operates an ISO 9001 certified manufacturing facility in Redwood City, California.

ReGen's biological remodeling scaffold has been applied to a variety of therapeutic applications and the Company plans to continue to develop and introduce tissue regrowth products based on 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 (NYSE:CEP) (formerly Sulzer Medica, Inc.), and it has recently completed the required enrollment in a major Multicenter Clinical Trial in the United States.

ReGen also sells the SharpShooter Tissue Repair System, an arthroscopic device used for meniscal 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 the managements of ReGen 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 current report on Form 8-K/A, filed with the Securities and Exchange Commission on September 4, 2002.

ReGen'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.


CONTACT: ReGen Biologics, Inc., Franklin Lakes
Brion D. Umidi, 410/349-2431
[e-mail]

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