PRESS
Zargis Medical Files with FDA for Approval of Zargis Acoustic CardioScan System
PRINCETON, N.J., May 21, 2003
Zargis Medical Corp. announced today that it has submitted a PreMarket Notification, 510(k), application to the
Food and Drug Administration (FDA), for clearance to market its Zargis Acoustic CardioScan system, or ZACSsmtm,
in the United States. ZACS is based on a computer-aided analysis of heart sounds and is designed to aid physicians in
identifying sounds which may be indicative of congenital and valvular heart disease. ZACS will initially be targeted
toward primary care physicians who could use it as part of general medical examinations that, according to the National
Center for Health Statistics, totaled 63 million in 2000 for the US alone.
The proprietary ZACS system is a portable unit consisting of an electronic stethoscope and a laptop computer,
which runs the complex analytical software developed at Siemens and Zargis over a period of six years. The system processes
and analyzes the patient's heart sounds, then provides easily interpretable results to the physician. The Company hopes to
receive FDA clearance of the ZACS system by the end of 2003.
"The results we have achieved through our clinical validation trial lead us to believe that ZACS will be a cost
effective clinical tool," said Shahram
Hejazi, President and CEO of Zargis. "We are excited about the ZACS system and expect that, when cleared, it will
be the first reimbursable, non-invasive, automated product available to assist healthcare professionals in detection
of heart murmurs and their referral decision."
In the United States, heart murmurs are estimated to affect 20% of the adult population. A higher prevalence is
found in children and the elderly with reports ranging from 29% to 80%. Given the difficulty in detecting heart murmurs,
the ZACS system is intended to provide better support in the decision whether to refer for further diagnostic tests such
as echocardiograms.
"ZACS covers an important niche in the healthcare system by providing an economical diagnostic tool for aiding
in the early screening and detection of sounds that could indicate valvular heart disease," said Silvano
Dall'Asta, Vice President and CFO at Siemens Corporate Research, and member of the Board of Directors of Zargis
Medical Corp. Mr. Dall'Asta went on to add that he was very excited about reaching this important goal and stated
"the application to the FDA brings ZACS within reach of its great potential."
The 510(k) submission to the FDA includes results from a multi-center clinical study in which patients were
enrolled at leading medical centers in the United States. Centers participating in the study included Children's Hospital
of Philadelphia, Texas Heart Institute in Houston and St. Francis Medical Center in
Rosyln, NY. The Company is continuing research and development to enhance the technology for other cardiac applications.
Zargis Medical Corp. was formed in January 2001 when Siemens Corporate Research Inc. and Speedus Corp. (NASDAQ:
SPDE) co-invested in Zargis to further develop and commercially market an advanced acoustic technology for
detecting heart murmurs and other abnormalities. Based in Princeton, New Jersey, Zargis is developing advanced
diagnostic decision support products and services for primary care physicians and other healthcare professionals.
For more information about the Company, visit their web site at
www.zargis.com. Contact: John Kallassy, (609) 734-6510.
For additional information on Speedus Corp, visit their website at www.speedus.com.
For additional information on Siemens Corporate Research, visit their website at
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Statements contained herein that are not historical facts, including but not limited to statements
about the Company's product, corporate identity and focus, may be forward-looking statements that are subject to a
variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ
materially from those expressed in any forward-looking statements made by the Company, including, but not limited to,
the continuing development of the Company's sales, marketing and support efforts.
The information about this
product is preliminary. The product is under development and not commercially available in the U.S., and its future
availability cannot be ensured.
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