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AT THE COMPANY:
John Funkhouser, President, CEO
Paul Storey, Director of Finance
(919) 954-9871
AT THE FINANCIAL RELATIONS BOARD
General Info: Paula Schwartz (212) 661-8030
Analyst Info: Kathy Brunson (312) 266-7800
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FOR IMMEDIATE RELEASE
February 12, 1998
CARDIOVASCULAR DIAGNOSTICS FILES 510 (K) APPLICATIONS FOR TWO THERAPEUTIC DIAGNOSTICS
Raleigh, NC - February 12, 1998 -- 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() 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.
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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.
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