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ReGen Regains Exclusive Worldwide Distribution Rights for its CMI
FRANKLIN LAKES, NJ -- March 07, 2005 -- ReGen Biologics, Inc. (OTC:RGBI) an orthopedic products company that develops, manufactures and markets innovative products for human tissue repair in the U.S. and abroad, announced today that the company has regained its rights to exclusively market and distribute its patented CMI throughout the world.
“This is a very positive development for ReGen as we continue to build a marketing and distribution foundation for the CMI,” stated Gerald E. Bisbee, Jr., Ph.D., Chairman and Chief Executive Officer of ReGen Biologics.
Dr. Bisbee said, “We are establishing a wholly owned subsidiary in Switzerland, from which we plan to market and distribute the CMI in Europe, principally through a network of independent local market distributors.” Dr. Bisbee continued, “ReGen now has the opportunity to build a branded presence in Europe and other markets outside the U.S. We will be able to operate closer to our surgeon customers and patients, and provide them with services targeted to their successful use of the CMI.”
ReGen Biologics, Inc. and Zimmer, Inc., the successor-in-interest to Allo Pro AG (Sulzer Medica and most recently Centerpulse) were parties to a Distributor Agreement dated February 16, 1996 whereby Zimmer, through its acquisition of Centerpulse, was the exclusive distributor of the CMI outside the United States, subject to certain minimum sales requirements. In 2003, ReGen exercised its rights under the Agreement to make the Agreement non-exclusive, when Zimmer did not satisfy certain sales obligations. On February 15, 2005, ReGen received notice from Zimmer of its intent to terminate the Agreement effective August 11, 2005.
The Company also reported that Richard Fritschi, the President of Centerpulse Orthopedics Ltd., a unit of Zimmer, resigned his position as a director of ReGen Biologics effective February 15, 2005.
Dr. Bisbee concluded, “We thank Mr. Fritschi for his service on the Board of Directors and appreciate Zimmer’s continued interest as a stockholder.”
About ReGen Biologics, Inc.
ReGen Biologics is an orthopedic products company that develops and manufactures innovative tissue repair products for unmet markets, both in the U.S. and globally. ReGen's first product using its patented core technology is the CMI, which uses the body's own healing process to grow new tissue in the meniscus, and restore activity levels for patients with meniscus loss. The Company’s Multicenter Pivotal Clinical Trial is the largest clinical trial ever conducted involving the human meniscus. The manufacturing module was submitted to the FDA on July 8, 2004. The Company expects to follow with its pre-clinical module in Q1 or Q2 2004, and to conclude with the filing of the CMI clinical module in the second half of 2005.
ReGen is headquartered in Franklin Lakes, NJ and manufactures the CMI in its ISO Certified facility located in Redwood City, CA. For more information on ReGen, visit www.regenbio.com, call (201) 651-5140, or email info@regenbio.com.
Contact:
Brion Umidi Al Palombo
ReGen Biologics, Inc. Cameron Associates
Chief Financial Office Investor Relations
(201) 651-3515 (212) 245-8800 Ext. 209
bumidi@regenbio.com al@cameronassoc.com
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 annual report on Form 10-K, filed with the Securities and Exchange Commission on March 30, 2004. 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 Web site maintained by the SEC at http://www.sec.gov.











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