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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
Current Report Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 15, 1997
Lifecore Biomedical, Inc.
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(Exact name of Registrant as specified in its charter)
Minnesota 41-0948334
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(State or other jurisdiction of (IRS Employer
incorporation or organization) Identification No.)
0-4136
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(Commission File Number)
3515 Lyman Boulevard
Chaska, Minnesota 55318
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(Address of principal executive (Zip Code)
offices)
Registrant's telephone number, including area code: 612-368-4300
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ITEM 5. OTHER EVENTS
The press release included as Exhibit 21.1 is incorporated herein by
reference.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS Page No.
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(c) Exhibits
21.1 Press Release dated December 15, 1997 4-5
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
LIFECORE BIOMEDICAL, INC.
Dated: December 30, 1997 /s/ Dennis J. Allingham
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Dennis J. Allingham
Executive Vice President &
Chief Financial Officer
(Principal Financial Officer)
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Exhibit 21.1
LIFECORE BIOMEDICAL, INC.
LIFECORE REPORTS INTERGEL-TM- SOLUTION RESULTS
CHASKA, MN. DECEMBER 15, 1997-- LIFECORE BIOMEDICAL, INC. (NASDAQ:LCBM)
announced today that it has completed an initial analysis of the data obtained
from its pivotal clinical trial evaluating the use of INTERGEL-TM- Adhesion
Prevention Solution in female abdominal surgery patients.
The third-party blinded, placebo-controlled, pivotal clinical trial
reconfirms the observations of an earlier pilot clinical trial of 23 patients.
The data indicate that patients who received INTERGEL-TM- Adhesion Prevention
Solution at the conclusion of an abdominal surgery procedure experienced a
statistically significant reduction in the incidence, severity, and extent of
post-surgical abdominal adhesions when compared to control patients. In
addition, no serious safety issues were identified during the study.
The clinical study data were obtained from two discrete patient populations
encompassing multiple clinical testing centers in both Europe and the United
States. Patients enrolled in the study underwent abdominal surgery via
laparotomy with a primary goal of preserving fertility. Control patients
received a conventional treatment with lactated Ringer's solution.
Post-surgical adhesion formation was evaluated at 24 internal anatomical sites
after several weeks during a second-look laparoscopic examination.
The data revealed that a significantly higher level of pre-existing
adhesions were present in the European patients prior to surgery compared to the
U.S. patients. Therefore, although the patient data from the European arm of the
study support the efficacy of INTERGEL-TM- Solution in post-surgical adhesion
reduction, those data are not likely to be combined with the U.S. patient data
in support of an FDA premarket approval application. Instead, only U.S. data
will be used to support the premarket approval application. European data will
be used in technical publications to support product marketing efforts.
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Lifecore expects to discuss this data analysis with the FDA during first
quarter of 1998 to assess its suitability for filing for pre-market approval.
Pending a favorable outcome of that review, filing is anticipated to occur in
June of 1998. The Company's worldwide exclusive marketing partner for
INTERGEL-TM- Adhesion Prevention Solution is Ethicon, Inc., a subsidiary of
Johnson and Johnson. Lifecore expects Ethicon to begin selling product in Europe
in June of 1998.
Certain references in this release represent forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995. Such
statements may imply continued financial improvement. Because of numerous risks
and uncertainties in Lifecore's business activity, actual results may differ
materially from those implied. Investor's are cautioned to refer to more
detailed discussions of those risks presented in the Company's reports on Forms
10Q and 10K.
Lifecore Biomedical, Inc., produces medical and surgical devices for use in
dentistry, drug delivery, ophthalmology, veterinary, and wound care
applications.
Lifecore Biomedical, Inc., Company news and general information are
available through its website at http://www.lifecore.com.
CONTACT: 612-368-4300
James W. Bracke, President and CEO
Dennis J. Allingham, V.P. and CFO
Colleen M. Olson, V.P., Corporate Administrative Operations
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