RALEIGH, N.C., April 25 /PRNewswire/ -- Cardiovascular Diagnostics, Inc.
("CVDI") (Nasdaq-NNM: CVDI) announced today that it has signed a development
agreement with Eli Lilly and Company ("Lilly") of Indianapolis, Ind. Under
the agreement, CVDI will use its innovative dry chemistry technology (the
Thrombolytic Assessment System, or TAS) to develop a rapid point of care test
to monitor a therapeutic anticoagulant ("TA") presently under development at
Lilly for use in the treatment of sepsis. Because of the unmet medical need
for a therapeutic treatment for sepsis, the market opportunity is significant
provided the drug and CVDI's diagnostic monitoring test can be developed. In
the United States and Western Europe, there are over one and a half million
patients who develop sepsis per year and the demand for a monitoring test for
TA is estimated at four million cards annually. Based on current pricing of
specialty test cards, CVDI believes it could reasonably expect to sell
recurring orders of test cards at between $15 and $20 each to the hospital.
Sepsis is caused by pathogens circulating in the blood that can result in
serious complications such as organ failure. With a 30-50 percent mortality
rate, sepsis is the 13th most frequent cause death in the United States, and
the intensive management of affected patients is estimated to cost the U.S.
healthcare system in excess of $5 billion to $10 billion per year.
Due to a past successful working relationship and utilization of CVDI's
TAS analyzer and specialty test cards, Lilly has selected CVDI to develop a
specialty test card for use in conjunction with their therapeutic
anticoagulant in development. Lilly will provide funding based on milestone
payments that coincide with the successful completion of CVDI's five phases of
design review for development projects. It is CVDI's goal to complete
clinical trials and submit a 510K application to the FDA by the end of
January, 1998 (completion of Design Phase IV for the diagnostic.) Lilly has
the option to purchase TA cards, analyzers and controls to support its Phase
III clinical trials. Lilly's TA is presently in Phase II clinical trials
in over 40 major medical centers. It is anticipated that upon successful
completion of the Phase II therapeutic anticoagulant trial, as well as test
card development, Lilly will begin Phase III clinical trials in over
80 hospital sites.
"The CVDI point of care assay is a potentially valuable improvement over
existing diagnostic options because it has the promise to be rapid and less
costly, while maintaining a high degree of accuracy," said Michael D. Clayman,
M.D., vice president, cardiovascular research and decision phase medical,
Lilly Research Laboratories. "If clinical trials of our therapeutic
anticoagulant prove to be successful, and if marketing clearance is obtained,
we anticipate that the addition of a point of care test will enable clinicians
to better manage the disease state of sepsis by accurately identifying the
subsets of patients most likely to benefit from treatment with our therapeutic
anticoagulant, as well as to monitor their progress."
CVDI's President, John Funkhouser, said, "It is exciting for CVDI to
initiate development of a rapid monitoring test for therapeutic treatment of a
life threatening disease. By identifying and monitoring patients who are the
best candidates for effective therapeutic intervention, Lilly is pursuing its
strategy to contribute to hospital cost containment through disease state
management. This has provided CVDI the opportunity to utilize its rapid
technology platform to effect therapy, and expand its test card menu through
an additional pharmaceutical collaboration. CVDI is presently working with
Knoll AG and Bayer AG on rapid tests for thrombin inhibitors and anti-
thrombin, respectively. Many of CVDI's future specialty tests may uniquely
monitor the next generation of therapeutics affecting coagulation.
Cardiovascular Diagnostics, Inc. develops, manufactures and markets
systems designed to deliver rapidly and accurately, blood test results at the
point-of-care ("POC"). CVDI's novel technology platform has allowed the
company to develop a menu of diagnostic tests, including new specialty tests.
The company believes that its Thrombolytic Assessment System ("TAS")
technology is the only POC system capable of monitoring both the formation and
dissolution of blood clots -- a critical factor in treating heart attacks,
strokes and a variety of other medical conditions.
To receive CVDI's latest news release and other corporate documents via
FAX -- no cost -- please dial 1-800-PRO-INFO. Use company code "011."
This press release contains forward-looking statements regarding future
events and the future performance of Cardiovascular Diagnostics that involve
risks and uncertainties that could cause actual results to differ materially
from those projected in the forward-looking statements. Information
concerning factors that could cause actual results to materially differ from
those in the forward-looking statements is contained in the Company's SEC
filings, including Form 10-K, Form 10-Q and Form 8-K reports.
SOURCE Cardiovascular Diagnostics
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CONTACT: John Funkhouser, CEO, or Denise Hobbs, CFO of Cardiovascular Diagnostics, 919-954-9871, or general - Paula Schwartz, 212-661-8030, or analysts - Kathy Brunson, 312-266-7800, both of The Financial Relations Board
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