Intergel update

From: Sue Ann Murray (murraysa@penn.com)
Sun Oct 3 19:03:28 1999


I was looking at Lifecore's web site recently and found this press release from May. Though others might be interested. It looks like it could be ready next year after all. It's now been over 5 months since it was used on me and so far, so good. Haven't noticed any problems (at least those related to the adhesions) recurring.

Sue Ann

CHASKA, MN. MAY 5, 1999 -- LIFECORE BIOMEDICAL, INC. (Nasdaq:LCBM) announced today that the Food and Drug Administration has accepted the Company’s filing of a premarket approval (PMA) application for its ferric hyaluronate product, INTERGELTM Adhesion Prevention Solution. In addition, the FDA granted the Company’s request for expedited review status of INTERGELTM Solution. Allowance of expedited review status was based on the potential for an adhesion prevention solution to provide a specific public health benefit by reducing the incidence, extent, and severity of newly formed adhesions, which may present a risk of serious morbidity. The product PMA is currently being reviewed by the FDA’s General and Plastic Surgery Devices panel, which will establish a subsequent public review date. Lifecore’s ferric hyaluronate is marketed in Europe by the Gynecare Division of Ethicon, Inc., a Johnson & Johnson Company, under the trademark, INTERGELTM Adhesion Prevention Solution.


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