ReGen Biologics, Inc. Signs Exclusive Distribution Agreement For Italy

FRANKLIN LAKES, N.J.--(BUSINESS WIRE)--Oct. 31, 2005--ReGen Biologics, Inc. (OTC:RGBI - News) an orthopedic products company that develops, manufactures, and markets innovative tissue growth and repair products, announced today an exclusive distribution agreement with Xmedica to market the ReGen® CMI(TM) in Italy. The CMI is a type I collagen implant designed to facilitate growth of new tissue to replace removed or missing meniscus tissue in the human knee. Xmedica will also market ReGen’s SharpShooter® Tissue Repair System on a non-exclusive basis. The agreement runs through 2007, and includes provisions to renew and extend the relationship.

“We are delighted to be working with Xmedica in Italy,” said Gerald E. Bisbee, Jr., Ph.D., Chairman and Chief Executive Officer of ReGen Biologics. “Xmedica has extensive industry knowledge, excellent clinical relationships, and a reputation for providing high quality products and service to the orthopedic and sports medicine communities.”

Commenting on the Italian market and the newly announced agreement, Paolo Curradini, Chief Executive Officer of Xmedica stated, “There are over 1200 orthopedic surgeons in Italy, and they are performing a large number of meniscectomy procedures. The CMI and SharpShooter allow us to present a compelling solution to these surgeons, and to patients with meniscus injuries. We’re looking forward to making these products more readily available to both existing and new customers.”

Earlier this year ReGen founded a wholly owned subsidiary in Switzerland, ReGen Biologics AG and announced plans to market and distribute the CMI and other products directly and through a network of local market distributors. The agreement with Xmedica is the first step in successfully implementing this strategy. The company continues to seek additional strategic relationships to further the availability and adoption of the CMI in key EU markets, which ReGen believes represent an estimated 15% of the worldwide CMI potential.

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 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 in Q3 2004. The Company expects to conclude the PMA submission with the filing of the CMI clinical module, targeted by year end 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.

About Xmedica

Xmedica is a privately held company with an extensive expertise in marketing and selling tissue engineering solutions for bone and cartilage as well as a variety of other goods and services for orthopedists and neurosurgeons in the Italian market. Xmedica’s activities are mainly focused on innovative, minimally invasive products, targeting younger, more active patients with higher functional demands.

Xmedica is headquartered in Milano, Italy. For more information on Xmedica visit www.xmedica.com.

Contact:

ReGen Europe: Thomas B. Fischer ReGen Biologics AG Appenzell, Switzerland +41 (0) 79 500 79 54 thomas.fischer@regenbio.com

or

ReGen USA: Brion Umidi Chief Financial Officer ReGen Biologics, Inc. 201-651-3515 bumidi@regenbio.com

or

Investor Relations: Al Palombo Cameron Associates Investor Relations 212-245-8800 Ext. 209 al@cameronassoc.com

or

Xmedica Paolo Curradini Chief Executive Officer Xmedica S.r.l. 02/89124617 info@xmedica.com

Source: ReGen Biologics, Inc.

MORE ON THIS TOPIC