Press Releases

Back to previous page

ReGen Biologics Provides Update on 510(K) Regulatory Submission

FRANKLIN LAKES, NJ -- April 28, 2006 -- ReGen Biologics, Inc. (OTC:RGBI) provided an update today indicating that it is responding to a request for additional information from the FDA with respect to its 510(k) submission for its collagen scaffold device.

“We submitted the 510(k) on December 28, 2005 and our guidance relating to the 510(k) indicated that we expected a timeline of six to nine months before a decision from the FDA,” stated Gerald E. Bisbee, Jr., Ph.D., Chairman and Chief Executive Officer of ReGen Biologics.  “We are currently responding to a request for additional information from the FDA and our timeline guidance has not changed.”

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.  The Company’s first approved product using its collagen scaffold technology is the CMI™, which is cleared for sale in Europe and marketed through the Company’s European subsidiary ReGen Biologics AG. 

ReGen is headquartered in Franklin Lakes, NJ and manufactures its collagen scaffold products in its ISO Certified facility located in Redwood City, CA.  For more information on ReGen, visit www.regenbio.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 management 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 2005 annual report on Form 10-K and additional filings with the SEC. 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.

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

Cameron Associates
Al Palombo
Investor Relations
(212) 554-5488
al@cameronassoc.com