Yes.
Now lets hope the panel doesnt cancel again. Only kidding. Great move on the stock today. Who agrees that there was a leak of this news? Pretty obvious huh.
INTERGEL Adhesion Prevention Solution PMA Review Scheduled for January 12 Advisory Panel Meeting
CHASKA, Minn.--(BW HealthWire)--Dec. 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, INTERGEL(TM) Adhesion Prevention Solution, at a January 12, 2000 meeting of the General and Plastic Surgery Devices Advisory Panel.
INTERGEL(TM) 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 INTERGEL(TM) 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, INTERGEL(TM) 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 complex 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 lifecore.com
CONTACT:
Lifecore Biomedical, Chaska
612-368-4300
James W. Bracke, President and CEO
Dennis J. Allingham, EVP and CFO
Colleen M. Olson, VP of Corporate Administrative
Operations
KEYWORD: MINNESOTA
BW1633 DEC 09,1999
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