INTERGELTM ADHESION PREVENTION SOLUTION PMA REVIEW SCHEDULED FOR NOVEMBER 16 ADVISORY PANEL MEETING CHASKA, MN. October 8, 1999 -- LIFECORE BIOMEDICAL, INC. (Nasdaq:LCBM) announced today that the Food and Drug Administration has scheduled a review of the Company’s premarket approval (PMA) application for its ferric hyaluronate product, INTERGELTM Adhesion Prevention Solution, at a November 16, 1999 meeting of the General and Plastic Surgery Devices Advisory Panel. INTERGELTM Solution has been under evaluation in pivotal human clinical trials since March 1996. The studies are designed to evaluate the reduction of post-surgical adhesion formation after gynecological laparotomy and laparoscopy procedures. The PMA application currently under review represents the laparotomy portion of those clinical evaluations and was filed with FDA in March 1999. The FDA formally accepted the PMA for expedited review in May 1999. The laparoscopy clinical trial is expected to be filed as a PMA supplement at a later date. Lifecore believes that the laparotomy clinical trial data currently under PMA review demonstrates that INTERGELTM Solution is safe and effective in significantly reducing the incidence, extent, and severity of post-surgical adhesions. The Gynecare Division of Ethicon, Inc., a Johnson & Johnson Company, currently markets Lifecore’s ferric hyaluronate outside the US in selected countries under the trademark, INTERGELTM Adhesion Prevention Solution. 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 are subject to change. Because of numerous risks and uncertainties in the 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
CONTACT: 612-368-4300
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-- This information was obtained from an Interim Report form ML LAbs Adept-A solution of Icodextrin to prevent post-operative adhesions. As a result of tissue damage during surgery, post-operative adhesions can occur resulting in the binding together of tissue surfaces. Adhesions are of a particular problem following gyn procedures and can be extremely disconcering for patients. Adept has been shown in pre-clinical experiments to significantly inhibit the formation of pos-surgical adhesions when compared to buffer washing solutions commonly used in surgical procedures. The low viscosity of the product allows it to be used for all types of abdominal surgery, without any change to surgical tecnique. Adept will be regulated as a device and therefore, because of the safety and phamaceutical information available to us as a result of the extensive use of the active ingredient Icdextrin in daily peritoneal dialysis prescriptions, we have been able to initiate the CE mark product approval process in Europe. In addition a five center evaluation of the product is currently ongoing in the U.S. and should be completed at the end of the year.