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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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): May 25, 1999
Minntech Corporation
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(Exact name of registrant as specified in its charter)
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Minnesota 0-11278 41-1229121
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(State or other jurisdiction of (Commission (I.R.S. Employer
incorporation or organization) File Number) Identification No.)
14605 28th Avenue North
Minneapolis, Minnesota 55447 (612) 553-3300
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(Address of principal (Zip Code) (Registrant's telephone
executive offices) number, including area code)
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Item 7. FINANCIAL STATEMENTS AND EXHIBITS
Exhibits:
99.1 Press release relating to execution of letter of intent regarding
proposed acquisition.
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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 hereunto duly authorized.
Date: May 26, 1999
MINNTECH CORPORATION
Registrant
By /s/ Thomas J. McGoldrick
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Thomas J. McGoldrick
President and Chief Executive Officer
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INDEX TO EXHIBITS
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Exhibit Description Method of Filing
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99.1 Press release relating to execution of letter of
intent regarding proposed acquisition Electronic Transmission
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Exhibit 99.1
May 25, 1999
CONTACT:
Minntech Corporation Padilla Speer Beardsley
Thomas J. McGoldrick Diane Rose/Nancy A. Johnson
President and CEO 612/871-8877
612/553-3300
FOR IMMEDIATE RELEASE
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MINNTECH CORPORATION SIGNS LETTER OF INTENT TO ACQUIRE RIGHTS TO PROMISING
ULTRAPHERESIS-TM- CANCER THERAPY
MINNEAPOLIS, May 25 - Minntech Corporation (Nasdaq: MNTX), a medical
device manufacturer, today announced that it has signed a letter of intent
with oncologist M. Rigdon Lentz, M.D., to acquire the rights to commercialize
the physician's patented UltraPheresis-TM- cancer therapy, as well as the
physician's clinic in Nashville, Tenn. Under terms of the letter of intent,
Dr. Lentz would act as a consultant to Minntech and would continue as the
lead investigator for ongoing human clinical trials. In clinical trials,
UltraPheresis has acted to stimulate patients' natural immune response to
fight cancer cells.
Minntech would pay an undisclosed amount of cash, stock, and
warrants to license the patent for the UltraPheresis technology from
Immutherapeutics, Inc., in which Dr. Lentz is a shareholder, and purchase the
Lentz Apheresis Center in Nashville. Dr. Lentz's work would be expanded to
develop the clinic as a training center for UltraPheresis treatments. One of
Minntech's hollow fiber membrane filtration products has been tested and
would be used in the UltraPheresis procedure. The acquisitions are subject to
completion of due diligence, the negotiation and execution of definitive
agreements, approval by the shareholders of Immutherapeutics, Inc., and other
material conditions.
"Our proposed investment in UltraPheresis technology represents a
long-term growth opportunity for Minntech and an exciting new application of
our existing technology," said Thomas J. McGoldrick, president and CEO of
Minntech. "We plan to use the strong foundation of scientific results
established by Dr. Lentz and his colleagues to expand and accelerate the
UltraPheresis clinical trials and move this important new therapy toward
commercialization.
(more)
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Minntech Corporation
May 25, 1999
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We believe that UltraPheresis has the potential to become the first-line
treatment for certain types of cancer and complementary treatment to existing
cancer therapies."
McGoldrick continued, "Depending on the results and pace of early
clinical trials, the investments required to commercialize UltraPheresis
could decrease earnings, but could enhance revenue growth during the fiscal
year ending March 31, 2000. We would expect to achieve accelerated revenue
and earnings growth in subsequent years as a result of these investments,
pending U.S. Food and Drug Administration (FDA) clearance of the devices used
in the treatment."
ULTRAPHERESIS: AN INNOVATIVE APPROACH TO CANCER THERAPY
UltraPheresis is a selective form of apheresis, a well-established
technique of separating and processing blood components. UltraPheresis
removes immunosuppressive components, known as tumor necrosis factor (TNF)
inhibitors, from the blood of a cancer patient. TNF inhibitors both "protect"
the cancer and suppress the immune system by inhibiting inflammation. When
TNF inhibitors are removed, the patient's natural immune system can recognize
and attack the cancerous tissue. This therapy stimulates the natural immune
response that the cancerous cells suppress.
The TNF inhibitors were discovered by Dr. Lentz and his associates;
their findings have been published in the JOURNAL OF LYMPHOKINE RESEARCH,
CELL and THE PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCE. Dr. Lentz
discussed clinical results to date in an April 17 presentation at the
International Society for Apheresis meeting in Saarbrucken, Germany.
CLINICAL TRIAL PROGRESS
Minntech would expect to expand the human clinical trials for
UltraPheresis to as many as three additional centers in order to generate the
data to support an FDA filing. Current trials in melanoma, colon and breast
cancers have shown promising preliminary results. In phase I clinical trials,
UltraPheresis demonstrated clinical responses in a variety of cancers.
Following the conclusion of pivotal clinical trials, Minntech would submit
the data to the FDA, which must grant pre-market approval (PMA) for the
devices which are utilized in the treatment to be commercialized in the
United States.
(more)
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Minntech Corporation
May 25, 1999
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Minntech Corporation is a leading medical device manufacturer,
applying advanced technologies in electronics, solutions, fibers and
plastics. The company's core technologies are used in dialysis, reprocessing
and sterilants, cardiosurgery and filtration and separation. To learn more,
visit Minntech on-line at http://www.minntech.com.
Certain statements made in this press release are forward-looking
statements that involve risks and uncertainties, and actual results may
differ. Those statements and factors that could cause actual results to
differ, include those identified below:
Acquisitions. There is no assurance that the proposed acquisitions
will be completed at all or on the terms set forth in the letter of intent.
Growth Opportunity; Competition. The oncology market in which the
company would be competing is highly competitive and is characterized by
innovation and technological change. The company would be competing with a
number of companies that have capital resources, research and development
staffs, facilities, experience in conducting clinical trials and obtaining
regulatory approvals, and experience in manufacturing and marketing medical
devices and providing services that are significantly greater than those of
the company.
Uncertainty of Technological Change; Reliance on Patents and
Proprietary Technology. New technologies to treat cancer are presently being
developed by other companies which may obsolete the technology proposed to be
acquired by the company. Further, the company's competitors in this market
may achieve patent protection that would limit the company's ability to
compete successfully.
Treatment Potential; Market Acceptance. The company believes that
market acceptance of the UltraPheresis treatment will depend on the ability
of the company to replicate the results that Dr. Lentz has achieved in
clinical trials to date and the acceptance of the medical community as to the
safety, efficacy, convenience, and cost effectiveness of the therapy as
compared to existing competitive products and therapies.
Reimbursement. Reimbursement rates for the UltraPheresis treatment
vary depending on the provider and may fluctuate or decrease with time
affecting the revenues the company derives from the treatment.
Effect on Earnings and Revenue. The effect on the company's earnings
and revenue would depend on the early results of clinical trials, the ability
of the company to expand the clinical trials to additional sites, and market
acceptance of the therapy.
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