Lifecore to Seek FDA Dispute Resolution Panel Review of Adhesion Prevention Solution Product PMA.

Business Editors & Health Writers

CHASKA, Minn.--(BUSINESS WIRE)--Dec. 20, 2000

LIFECORE BIOMEDICAL, INC. (Nasdaq:LCBM) announced today after the close of trading that it has determined to pursue formal dispute resolution by the Food and Drug Administration's Medical Devices Dispute Resolution Panel (MDDRP) in connection with the Company's PMA application for its ferric hyaluronate product, GYNECARE INTERGEL(a) Adhesion Prevention Solution.

The dispute resolution process is outlined under the provisions of the FDA Modernization Act of 1997 and was recently discussed at an introductory meeting of the MDDRP on October 31, 2000. Les Weinstein, Ombudsman in FDA's Center for Devices and Radiological Health (CDRH) and Panel Executive Secretary, is authorized to convene a meeting of the MDDRP when he deems it appropriate to resolve issues of scientific dispute between a PMA applicant and the FDA. The Panel consists of eight members: three permanent scientific voting members, three temporary voting members with specialized expertise in the ad hoc scientific areas of dispute, and two non-voting members representing both the medical device industry and consumer interests.

GYNECARE INTERGEL Solution has been under evaluation in pivotal human clinical trials since March 1996. The current premarket approval application was filed with the FDA in March 1999 and formally accepted for expedited review in May 1999. The product was initially determined to be not approvable by a recommendation of the January 12, 2000 General and Plastic Surgery Devices Advisory Panel. In June of 2000 the Company filed a major amendment to the PMA to address the concerns raised at the January Panel meeting. After review of the amendment, FDA's Office of Device Evaluation (ODE) determined that, while the results of clinical testing may appear to be encouraging, in their opinion there was not sufficient information to demonstrate reasonable assurance of safety and effectiveness. Thus, ODE concluded that the PMA is not approvable at this time and notified the Company of options for agency review of ODE's determination.

Lifecore and its outside experts dispute the scientific findings of ODE's review. As a result, Lifecore has held discussions with FDA concerning the various options for review of ODE's decision. After discussing the matter with the CDRH Ombudsman and concluding that the MDDRP was a viable option for seeking to resolve the scientific matters in dispute, Lifecore has determined to request that the matter be referred to the MDDRP. The Company's formal request for MDDRP review will be filed shortly. FDA has confirmed that the PMA remains open pending that review. The Company expects that Panel to convene within the first quarter of 2001 to make a determination and recommendation to the FDA's Director of the Center for Devices and Radiological Health, Dr. David W. Feigal.

GYNECARE, the women's healthcare division of ETHICON, INC. a Johnson & Johnson Company, currently markets Lifecore's ferric hyaluronate outside the US in selected countries under the trademark GYNECARE INTERGEL Adhesion Prevention Solution, and has US marketing rights, pending FDA approval.

Certain statements in this release are forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Statements implying timing or outcome of the FDA review process and the MDDRP are subject to change. Because of numerous risks and uncertainties in the complex regulatory 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 Forms 10-Q and 10-K.

Lifecore Biomedical manufactures biomaterials and surgical devices for use in various surgical markets and provides specialized contract aseptic manufacturing services.

A conference call is scheduled for 4:30 PM today. To participate callers should dial 719.457.2617. The passcode is 701465. The replay is available at 719.457.0820 until January 3, 2001. In addition, the Company will accept e-mail questions during the conference call addressed to [e-mail].

Additional general corporate information about Lifecore is available on the Internet at http://www.lifecore.com

(a) Trademark of ETHICON, INC.