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. -----Original Message----- From: Peggy <pklippe1@nycap.rr.com> To: Multiple recipients of list ADHESIONS <adhesions@talk.obgyn.net> Date: Saturday, October 30, 1999 10:52 AM Subject: FDA
>Hello everyone, In the first post that I wrote yesterday but lost ,due
>to hitting a wrong key. I had mentioned that I e-mailed the FDA and
>questioned them about intergel.Well I forgot to mention it when I posted
>for the second time. I had asked that if anyone could e-mail the FDA
>and tell them thier stories and stress how important it is that a
>barrier be found for us ,THat maybe things would move a little faster. I
>received an e-mail back from the FDA yesterday
>telling me that they have no information on intergel at all. THis is so
>frustrating. HOW can we get people to understand the need for adhesion
>barriers? Any suggestions on where to write ? Maybe to Hiliary Clinton?
>I really feel as though we are a lost cause with adhesions.Hope everyone
>is enjoying the weather.Up here in the Northeast we are having what they
>call our Indian Summer. I have a wedding to go to this afternoon ,Maybe
>it will take my mind off of the pain for a little while :) Peggy
>