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AT THE COMPANY:
John Funkhouser, President, CEO
Denise Hobbs, VP, Finance & Administration
(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 5, 1998
CARDIOVASCULAR DIAGNOSTICS RECEIVES $2.1 MILLION ORDER FROM KNOLL AG FOR ANALYZERS AND DIAGNOSTIC TEST CARDS
Raleigh, NC - February 5, 1998 -- Cardiovascular Diagnostics, Inc. (Nasdaq:CVDI) announced today that it received a $2.1 million order from the Knoll AG division of BASF Pharma, the pharmaceutical subsidiary of BASF AG. The order is for 450 Thrombolytic Assessment System (TAS() analyzers and 150,000 diagnostic test cards to be used in the Phase III clinical trial for PEG-Hirudin, Knoll’s new thrombin-inhibitor compound.
In December 1996, CVDI and Knoll entered into a collaboration to develop a rapid diagnostic test for the monitoring of PEG-Hirudin. The ecarin clotting time (ECT) test combines CVDI’s proprietary TAS technology with Knoll’s enzyme technology to produce a test which allows a clinician to manage the dosage of this therapeutic agent within safe and effective levels. The ECT’s speed and accuracy should enable dosage modifications to be made quickly, an important advantage over conventional monitoring methods because of the narrow range between over-and under-dosage of PEG-Hirudin. By fostering optimal therapeutic effect and thereby minimizing the risk of complications, the ECT promotes effective, economic patient care.
CVDI’s President and Chief Executive Officer, John Funkhouser, said, “This order demonstrates CVDI’s ability to develop rapid tests to monitor next generation therapeutic drugs and enhance patient outcomes. In addition to providing tests for routine therapies, CVDI has been increasingly focused on developing specialty tests which target difficult-to-measure clotting factors to enable innovative, emerging therapies to be safely and effectively administered. The 450 TAS analyzers placed in the Knoll trials, in addition to introducing CVDI’s specialty test capability, will be available to clinicians for CVDI’s routine coagulation tests.”
Mr. Funkhouser continued, “CVDI’s ECT test was designed to be an integral part of ‘best practice’ treatment for PEG-Hirudin, thereby linking the success of the drug and the diagnostic
test. By developing specialty tests for major pharmaceutical firms, CVDI can leverage its technology and accelerate commercialization and acceptance of its products.”
Under the agreement with Knoll, CVDI received exclusive worldwide licensing rights for diagnostic tests using ecarin, derived from snake venom, to monitor PEG-Hirudin, as well as other anti-thrombin compounds under development by other companies. Knoll’s PEG-Hirudin is being developed for cardiovascular indications and as a supplement or replacement for heparin, the most widely used anti-coagulant or “blood thinner.” PEG-Hirudin is the second compound on which CVDI and Knoll are collaborating. The other drug is Knoll’s Ancrod, being developed to treat ischemic stroke and currently to enter Phase III trials in Europe and North America.
CVDI’s analyzers and diagnostic test cards will be placed in Knoll’s multicenter Phase III clinical trial to investigate the safety and efficacy of PEG-Hirudin for treating unstable angina. The trial, which is expected to continue into 1999, will require patients to be monitored with the ECT test up to eight times during therapy. Unstable angina, which affects nearly 1.8 million people in America and Europe, often precedes myocardial infarction. It is the leading cause of admission to hospital emergency rooms and coronary care units.
The initial shipment calls for 225 analyzers and 70,000 test cards to be delivered by March 31, 1998 and another 225 analyzers delivered by July 1, 1998. CVDI continues to develop rapid diagnostic tests for specific compounds through additional collaborations with Eli Lilly (for a sepsis drug) and Knoll (for a stroke therapy drug).
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.
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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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