Intergel review

From: Sue Ann Murray (murraysa@penn.com)
Tue Dec 14 13:43:56 1999


Note the most recent press release from Lifecore about intergel: and note that it is the laparotomy use that is under evaulation, not the laparoscopic use (which is the trial I was in).

CHASKA, MN. December 9, 1999 -- LIFECORE BIOMEDICAL, INC. (Nasdaq: LCBM) announced today that the Food and Drug Administration has reported in the Federal Register that it has scheduled a review of the Company’s premarket approval (PMA) application for its ferric hyaluronate product, INTERGELTM Adhesion Prevention Solution, at a January 12, 2000 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 the 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.


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