Lifecore Biomedical - Record Price Breakout/Gap Up/Vol %Change: 3000% - 500 Beiträge pro Seite

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CHASKA, Minn., Sep 6, 2001 (BUSINESS WIRE) -- LIFECORE BIOMEDICAL, INC. (LCBM, Trade) announced today that the FDA`s Medical Devices Dispute Resolution Panel ("MDDRP") has voted unanimously to recommend approval of Lifecore`s PMA application for the ferric hyaluronan product, GYNECARE INTERGEL Adhesion Prevention Solution. A dispute arose after the FDA had issued a not approvable determination in connection with Lifecore`s PMA due to concerns over the interpretation of the Company`s clinical trial data. The product is intended for use as a surgical adjunct in reducing post-surgical adhesion formation after gynecological surgery. In recommending approval of the PMA, the MDDRP determined that the Company`s scientific data successfully demonstrated that the adhesion prevention solution is a safe and effective surgical adjuvant for reducing the incidence, extent, and severity of post-surgical adhesions. Lifecore is seeking approval from the FDA to market the product in the United States.

Lifecore President and CEO, Jim Bracke, commented "We are very pleased with the outcome of the dispute resolution process. We commend Congress for creating the MDDRP process. Our belief that the underlying issues in this dispute were the result of a misunderstanding of the complex clinical dataset has proved correct."

The next regulatory step for Lifecore`s product, under the FDA`s July 2, 2001 guidelines for scientific dispute resolution, will be an evaluation by Dr. David W. Feigal, Jr., Director of the Center for Devices and Radiological Health. Dr. Feigal will consider the MDDRP`s recommendation and Statement of Findings before determining whether to approve Lifecore`s PMA.

GYNECARE INTERGEL Adhesion Prevention Solution has been in research and development status since 1989. The initial pivotal human clinical trial that was the source of the scientific dispute began in March 1996. The PMA application with that clinical trial data was filed with the FDA in March 1999 and formally accepted for expedited review in May 1999. The product has been marketed outside the US in selected countries since 1998 by Lifecore`s global marketing partner, GYNECARE, the women`s healthcare division of ETHICON, INC., a Johnson & Johnson Company.

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 continuing FDA review process or future product development and marketing success 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 reports on 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.

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

GYNECARE INTERGEL Adhesion Prevention Solution; GYNECARE; and ETHICON, INC., are trademarks of ETHICON, INC. CONTACT: Lifecore Biomedical, Chaska James W. Bracke, 612/368-4300 or Dennis J. Allingham, 612/368-4300 or Colleen M. Olson, 612/368-4300 URL: http://www.businesswire.com Today`s News On The Net - Business Wire`s full file on the Internet with Hyperlinks to your home page.

Copyright (C) 2001 Business Wire. All rights reserved.

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