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Strategies & Market Trends : Rande Is . . . HOME -- Ignore unavailable to you. Want to Upgrade?

To: Bucky Katt who wrote (4555)	3/24/1999 10:56:00 AM
From: Rande Is	Read Replies (2) \| Respond to of 57584

News for PHAR . . don't know anything about them. . .but looks like momo in the making. Cardiovascular Diagnostics Files Two 510(k) Applications for Three New Products RALEIGH, N.C. (March 22) BW HEALTHWIRE -March 22, 1999--PharmaNetics, Inc. (NASDAQ NM: PHAR), a holding company of Cardiovascular Diagnostics, Inc., today announced that the Company has filed two 510(k) submissions with the FDA. The first submission is for a new software upgrade for its Thrombolytic Assessment System (TAS(TM)) analyzer and its Electronic Quality Control (EQC) test card. The second submission is for the Accent, a new instrument recently developed for use in monitoring patients during Coronary Artery By Pass Graft and other open heart procedures requiring anticoagulation. The EQC is a unique reusable test card design, which allows TAS users to reduce the cost of maintaining the required levels of daily quality assurance. To assist in accomplishing daily quality control, the EQC can provide a three-level check of the instrument, which previously could only be accomplished using liquid reagent controls. The EQC test card augments the built-in TAS system checks. It is similar in appearance to the TAS reagent test cards. When a Quality Control (QC) test is run with the TAS EQC card, the data collected are analyzed, and a clotting time is reported to the user similar to the chemical controls. The EQC test card may reduce the requirement for chemical controls because it is both reusable and easy to use, and could potentially lower the total cost of using the TAS system and improving the system's competitiveness in the clinical setting. "The new TAS software exemplifies one part of the PharmaNetics' corporate strategy to develop high margin, specialty diagnostics, based on the versatile TAS system. The new TAS software has been designed to support more sophisticated data analysis necessary for ongoing menu expansion as well as provide data processing for test cards currently in clinical trials," said John Funkhouser, PHAR's President and Chief Executive Officer. He continued, "This software opens up opportunities for PHAR test capabilities for future assays and permits the TAS analyzer to link with PHAR's new instrument, the Accent. In addition, it increases data communication potential improving the integration of the TAS system with Bayer Diagnostics' Rapidpoint Critical Care and Rapidlink Critical Care Information Systems." Bayer Diagnostics is PHAR's global distribution partner. The Accent instrument expands the utility of the already versatile TAS analyzer. The Accent is electronically linked to the TAS instrument and receives, stores and processes test results sent by the TAS analyzer. The user interacts with the Accent through a high visibility touch screen. The new Accent is lightweight and portable. Initially, the Accent will be used in conjunction with the heparin management test (HMT), currently 510(k) approved, the heparin titration test (HTT) and the protamine response test (PRT). Both the HTT and PRT tests are currently in clinical trials. Linking the TAS with the Accent creates a powerful test processing and data analysis system and positions the two to enter hospital surgery rooms as a compact, accurate system to aid profusionists in managing a patient's anti-coagulated state during major open heart surgical procedures. Proper management before, during, and after surgery lowers the risk of bleeding complications to the patient. The point-of-care capability of the TAS analyzer to perform rapid accurate tests coupled with the Accent's ability to process test information and improve communication of results, will provide necessary patient information to the profusionist in a quick, easy-to-use, cost-effective and compact system. The filing of the Accent 510(k) is the first step in PHAR's strategy to build on the TAS analyzer's capabilities and expand the systems' potential applications. 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 have narrow therapeutic ranges, as well as for monitoring routine anticoagulants. The Company's therapeutic diagnostics are used 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. -0- sw/ny* CONTACT: COMPANY CONTACTS: PharmaNetics, Inc. John Funkhouser, President and CEO Paul Storey, Director of Finance 919/954-9871 or INVESTOR CONTACTS: Lippert /Heilshorn & Associates, Inc. Bruce Voss (bruce@lhai.com), 310/575-4848 Ruth Abeshaus (ruth@lhai.com), 212/838-3777