http://www.lifecore.com/press_release_056.htm
CHASKA, MN. October 5, 2001 -- LIFECORE BIOMEDICAL, INC. (Nasdaq: LCBM) announced today that it has received notice that Dr. David W. Feigal, Director, FDA's Center for Devices and Radiological Health, has concurred with the unanimous recommendation for approval of Lifecore's adhesion prevention product PMA made by the FDA's Medical Devices Dispute Resolution Panel ("MDDRP") on September 6, 2001. Under FDA guidelines, Dr. Feigal evaluated the MDDRP's Statement of Findings and recommendations prior to making his determination that the PMA should be approved. The current action is Dr. Feigal's concurrence with the MDDRP's conclusion that Lifecore's scientific data successfully demonstrated that GYNECARE INTERGEL Adhesion Prevention Solution is a safe and effective surgical adjuvant for reducing the incidence, extent, and severity of post-surgical adhesions after gynecological surgery. After finalization of the labeling and the summary of safety and effectiveness, the Company will be approved to market GYNECARE INTERGEL Adhesion Prevention Solution in the US.
Lifecore President and CEO, Jim Bracke, commented "We are very pleased with the speed of the Director's response and the completion of this chapter in the research and development of this product. We are in the process of working with FDA to complete product labeling. As soon as we complete this final FDA administrative action, we can begin working to change surgery."
GYNECARE INTERGEL Adhesion Prevention Solution has been in research and development status since 1989. The initial pivotal human clinical trial, which was the source of the scientific dispute that led to the MDDRP, began in March 1996. The PMA application which included 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. Lifecore estimates that GYNECARE will begin US marketing in early 2002.