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AT THE COMPANY:
John Funkhouser, President, CEO
Paul Storey, Director of Finance
(919) 954-9871
INVESTOR CONTACTS:
Lippert/Heilshorn & Associates, Inc.
Bruce Voss (bruce)
(310) 575-4848
Ruth Abeshaus (ruth)
(212) 838-3777
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FOR IMMEDIATE RELEASE
MAY 25, 1999
PHARMANETICS RECEIVES FDA CLEARANCE FOR TWO NEW PRODUCTS
RALEIGH, N.C. (May 25, 1999) - PharmaNetics, Inc. (NASDAQ NM: PHAR), the holding company of Cardiovascular Diagnostics, Inc. and Coeur Laboratories (CVDI), today announced that the Company has received Food and Drug Administration (FDA) clearance for the Electronic Quality Control (EQC) test card and for a new software upgrade for the Thrombolytic Assessment System (TAS‘). The Company now has FDA clearance for over fourteen devices and tests with eighteen other tests in the development pipeline.
Commenting on the FDA clearance, John Funkhouser, President and Chief Executive Officer, stated, "The FDA clearance of this new software completes another step in PharmaNetics’ corporate strategy to develop and introduce specialty diagnostics based on the versatile TAS system." He continued, "This software also increases data communication potential permitting the TAS instrument to provide patient data throughout a hospital or clinic using Bayer Diagnostics’ Rapidlink Critical Care Information Systems and makes PharmaNetics’ the first point of care coagulation system with this unique feature. This further strengthens the Company’s integration of the TAS with Bayer Diagnostics’ Rapidpoint Critical Care products."
EQC is a unique, reusable test card design that provides a three-level check to the TAS analyzer and augments self-checks performed when the instrument is initially powered up. The EQC test card supplements the Company’s current liquid control product line and could reduce costs associated with routine quality control mandated by laboratory regulatory bodies for the testing facility. EQC has the potential to reduce the frequency that liquid controls are performed, lowering the overall cost of using the TAS system.
The new TAS software expands the menu of tests that can be processed by the TAS analyzer and permits the TAS analyzer to link with the Company’s new instrument, the Accent. A 510k filing for the Accent is currently under FDA review. The new TAS software is designed to support more sophisticated data analysis necessary for the Company’s ongoing menu expansion including test cards currently in clinical trials as well as test cards in development. Bayer Diagnostics is PHAR’s global distribution partner.
Funkhouser continued, "This FDA clearance further adds to the expansion of the extensive menu offered on the TAS. The Company believes it has the premier rapid coagulation technology capable of monitoring a variety of therapeutics for numerous disease states."
PharmaNetics, Inc. develops, manufactures and markets rapid turnaround diagnostics to assess blood clot formation and dissolution. The Company develops tests based on its proprietary, dry chemistry Thrombolytic Assessment System for its principal target market of powerful new drug compounds, some of which may have narrow therapeutic ranges, as well as for monitoring routine anticoagulants. The Company’s therapeutic diagnostics are used to monitor the effect of antithrombotic agents in the treatment of angina, myocardial infarction (heart attack), stroke, deep venous thrombosis, and pulmonary and arterial emboli.
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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