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| Cardiovascular Diagnostics Files 510(k) Applications For Two Therapeutic Diagnostics |
RALEIGH, N.C., Feb. 12 /PRNewswire/ -- Cardiovascular Diagnostics, Inc.
(Nasdaq: CVDI) announced today that the Company has filed 510(k) submissions
with the FDA for its Ecarin Clotting Time test (ECT) and Low Range Heparin
Management Test (LHMT). These tests are based on CVDI's Thrombolytic
Assessment System (TAS(TM)) technology platform.
The ECT test is a "specialty" diagnostic designed to monitor the action of
PEG-Hirudin, a new thrombin inhibitor developed by Knoll AG (BASF Pharma).
The test combines CVDI's proprietary dry chemistry technology with Knoll's
ecarin enzyme technology, which has been licensed exclusively to CVDI for
broad application. The speed and accuracy of the ECT test is intended to
enable dosage modifications to be made quickly, which is necessary because of
the narrow range between over- and under-dosage of PEG-Hirudin. In
preparation for its Phase III trial of PEG-Hirudin for treatment of unstable
angina, Knoll placed an order with CVDI for 450 analyzers and 150,000 test
cards, a development which was announced last week.
"The ECT test exemplifies the evolution of CVDI's corporate strategy
towards developing high-margin specialty diagnostics, based on its versatile
TAS system, which enables the safe and effective administration of next
generation therapeutics," said John Funkhouser, CVDI's President and Chief
Executive Officer. "This strategy opens up opportunities for CVDI tests and
analyzers to be introduced during the clinical trials and, if the drugs are
approved, to become a part of the recommended standard practice to monitor
their administration. Another benefit of the strategy is that TAS analyzers
placed in specialty diagnostic trials and critical care sites will be
available to process other CVDI tests."
The LHMT is designed to measure heparin levels in the therapeutic ranges
desirable during cardiac catheterization. CVDI believes the less than five
minute turnaround time associated with this test is a significant advantage
over conventional tests for this acute setting, where heparin dosage
modifications must be made quickly. The LHMT will supplement CVDI's PT, aPTT,
and HMT "routine" diagnostics in providing continuous anticoagulation
monitoring of the patient from emergency room to cardiac catheterization lab
to the operating room to intensive care unit, and as an outpatient.
Mr. Funkhouser continued, "As the corporate strategy has evolved toward
specialty test development with greater value-added pricing and the potential
for direct distribution, CVDI is seeking long-term distribution partner
arrangements for routine anticoagulant monitoring tests and/or the sale of
manufacturing rights to routine tests. Although a brokerage report estimated
the sale of these manufacturing rights at between $3.00 and $5.00 per share,
at this time the Company has no letter of intent or any agreement relating to
the sale of tests or other assets."
Cardiovascular Diagnostics, Inc. develops, manufactures and markets rapid
turnaround, point-of-care diagnostics to assess blood clot formation and
dissolution. CVDI develops tests based on its proprietary, dry chemistry
Thrombolytic Assessment System (TAS) for powerful new therapeutics with narrow
ranges between over- and under-dosage, which represent CVDI's principal target
market, as well as for routine anticoagulation tests. CVDI is currently
collaborating on diagnostics with Eli Lilly for a sepsis marker, and with
Knoll AG for two compounds in clinical trials, PEG-Hirudin and Ancrod. CVDI's
therapeutic diagnostics are used in the treatment of angina, myocardial
infarction (heart attack), stroke, deep venous thrombosis, and pulmonary and
arterial emboli.
To receive CVDI's latest news release and other corporate documents via
FAX -- no cost -- dial 1-800-PRO-INFO. Use company's ticker, CVDI. Or visit
The Financial Relations Board's web site at http://www.frbinc.com.
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, Inc.
back to topRelated links:
John Funkhouser, President, CEO, or Paul
Storey, Director of Finance, both of Cardiovascular Diagnostics,
919-954-9871; or Paula Schwartz, general info, 212-661-8030, or
Kathy Brunson, analysts, 312-266-7800, both of The Financial
Relations Board for Cardiovascular Diagnostics, Inc.
