LIFECORE RECEIVES FDA FINAL APPROVAL TO MARKET GYNECARE INTERGEL ADHESION

From: Hchalm@aol.com
Mon Nov 19 21:42:07 2001


<A HREF="http://www.lifecore.com/Investor_Info/Resource_Files/HTML/press_release_061.htm"> http://www.lifecore.com/Investor_Info/Resource_Files/HTML/press_release_061.htm </A>

FOR IMMEDIATE RELEASE

LIFECORE RECEIVES FDA FINAL APPROVAL TO MARKET GYNECARE INTERGEL ADHESION PREVENTION SOLUTION IN THE UNITED STATES CHASKA, MN. November 19, 2001-- LIFECORE BIOMEDICAL, INC. (Nasdaq: LCBM) announced today that it has received final notice of approval to market GYNECARE INTERGEL Adhesion Prevention Solution (“INTERGEL Solution”) in the United States. Lifecore had previously received notice of approvability on October 5, 2001 from Dr. David W. Feigal, Director, FDA Center for Devices and Radiological Health. At that time, Dr. Feigal indicated his concurrence with the unanimous recommendation for approval of Lifecore’s adhesion prevention product PMA which had been made by the FDA’s Medical Devices Dispute Resolution Panel (“MDDRP”) on September 6, 2001. The final approval announced today indicates agreement by the FDA and Lifecore as to the final terms surrounding the labeling of the product in the US marketplace. Lifecore President and CEO, Jim Bracke, commented: “We are pleased to have completed the regulatory approval process for this exciting new product. We particularly appreciate the efforts of Dr. David Feigal and Mr. Les Weinstein of FDA in making the MDDRP process available to Lifecore. Now we will work to improve the outcome of gynecological surgery in the US.” INTERGEL Solution has been in research and development since 1989. The initial worldwide pivotal human clinical trial of the product began in March 1996. INTERGEL Solution has been marketed outside the US since 1998 by Lifecore’s global marketing partner, GYNECARE, the women’s healthcare division of ETHICON, INC., a Johnson & Johnson Company. GYNECARE is expected to commence the US product roll out during first quarter 2002. Certain statements in this release are forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Statements implying timing, outcome, or the extent of marketing success with the adhesion prevention solution are subject to change. Because of numerous risks and uncertainties in the complex regulatory and competitive aspects of Lifecore’s business activity, actual results may differ materially from those implied. Investors are strongly cautioned to review more detailed discussions of those risks presented in the Company’s reports on Forms 10-Q and 10-K. Lifecore Biomedical develops, manufactures, and markets biomaterials and medical devices for use in various surgical markets. Additional general corporate information is available on the Internet at <A HREF="http://www.lifecore.com/"> http://www.lifecore.com</A>.

> CONTACT: 952.368.4300
>
> >> Jim Bracke, President and CEO
>> Dennis J. Allingham, EVP and CFO
>> Colleen M. Olson, VP Corporate Administrative Operations
>>
>

GYNECARE INTERGEL Adhesion Prevention Solution; GYNECARE; and ETHICON, INC., are trademarks of ETHICON, INC.


Enter keywords:
Returns per screen: Require all keywords: