SPDE Speedus Corp (CE)

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., +1-609-734-6510 Web site: http://www.zargis.com/ http://www.speedus.com/ http://www.scr.siemens.com/

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