|
|
|
|
|
|
|
|
|
 |
|
 |
AT THE COMPANY:
John Funkhouser, President, CEO
Paul Storey, Director of Finance
(919) 954-9871
|
|
|
|
|
|
FOR IMMEDIATE RELEASE
August 3, 1998
CVDI COMPLETES PHASE II DEVELOPMENT OF TEST DESIGNED TO EVALUATE A NEW SEPSIS DRUG AND ENTERS CLINICAL FIELD TRIALS.
Raleigh, NC - August 3, 1998 - Cardiovascular Diagnostics, Inc. (Nasdaq: CVDI) today announced that it has completed its Phase II development of a new dry chemistry test to screen patients for a new therapeutic anticoagulant ("TA") currently under development by Eli Lilly and Company for the treatment of sepsis. Sepsis is a condition caused by pathogens circulating in the blood that can result in serious complications such as organ failure and death. With a 30% to 50% mortality rate, sepsis is the 13th most frequent cause of death in the United States. The intensive management of affected patients is estimated to cost the U.S. healthcare system in excess of $5 to $10 billion per year.
Using its dry chemistry format, CVDI successfully completed laboratory testing of samples collected from patients with or at risk of developing sepsis. This was a milestone goal of the project and as anticipated, the test demonstrated good correlation to the complex and time consuming predicate devices being used as standards. The results at this stage were determined to be sufficiently encouraging to support a decision to enter field trials. The clinical field trials of the test are being initiated at major centers throughout the US and Canada and are expected to run for two to three months. During this time data will be collected from subsets of patients at high risk for sepsis and used to optimize and finalize the test format.
Optimizing the test card parameters and format, demonstrating the ability to screen and evaluate the levels of this sepsis marker in the targeted patient population are critical milestones in preparing for the FDA submission. Mr. John Funkhouser, President and Chief Executive Officer commented that, "while there is still a significant amount of work to be done before the test can be used commercially , progress to date reinforces our belief that given the high incidence of the disease state and associated risk of mortality, the market is promising." This ongoing collaboration with Lilly is part of CVDI’s strategy of providing rapid tests for new developmental drugs.
CVDI 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 compounds, some of which have narrow therapeutic ranges which represent CVDI’s principal target market. CVDI refers to these as theranostic tests to differentiate them from its standard coagulation diagnostic tests that have historically been performed in the central laboratory. CVDI’s theranostic tests are used in the treatment of angina, myocardial infraction (heart attack), stroke, deep venous thrombosis, and pulmonary or arterial emboli.
# # # #
This press release contains forward-looking statements regarding future events and the future performance of Cardiovascular Diagnostics, Inc. 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.
|
|
| |