Zargis Medical Updates on FDA Submission

Zargis Medical Updates on FDA Submission 


PRINCETON, N.J., April 6  /PRNewswire/ -- Zargis Medical Corp. today announced
an update on the status of its Premarket Notification, 510(k), application to
the Food and Drug Administrationfor clearance to market the Zargis Acoustic
Cardioscan (ZAC) System, filed in May 2003. The ZAC System, Zargis' first
clinical device, will initially be targeted toward physicians to be used as part
of general medical examinations and physicals to detect murmurs.

Zargis continues its dialogue with the FDA and has submitted additional clinical
data in support of the application. The FDA does not provide timelines or the
likelihood of approvals. "Our most recent data is encouraging and we remain very
optimistic on gaining FDA clearance on our 510(k) submission," stated Dr.
Shahram Hejazi, President and CEO of Zargis.

Published studies report a prevalence of heart murmurs alone in up to 80% of
children and the elderly, and approximately 20% in the adult population in the
U.S. Given these statistics, an aging population and budget pressures on
healthcare, there is a need for accurate auscultatory detection of heart
murmurs.

Zargis Medical Corp. was formed in January 2001 when Siemens Corporate Research
Inc., a subsidiary of Siemens AG (NYSE:SI), 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, cardiologists and
other healthcare professionals.

For additional information about Zargis Medical Corp., contact Shahram Hejazi,
609.734.6510, , or visit their website at http://www.zargis.com/.

For additional information on Speedus Corp., contact John Kallassy,
718.567.4358, , or visit their website at http://www.speedus.com/.

For additional information on Siemens Corporate Research, visit their website at
http://www.scr.siemens.com/.

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. 

DATASOURCE: Zargis Medical Corp.



CONTACT:  Shahram Hejazi of Zargis Medical Corp., [phone]



Web site:  http://www.zargis.com/

http://www.speedus.com/

http://www.scr.siemens.com/ 

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