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 |
