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  • Zargis Medical Corp receives FDA clearance ...

    SEE http://www.speedus.com/press_article.php?id=106 or http://www.zargis.com/press_room12.asp
    ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~

    ZARGIS MEDICAL RECEIVES FDA CLEARANCE:
    Energy Display and Timing Annotation Added to Cardioscan

    September 14, 2004 - Princeton, N.J.

    Zargis Medical Corp., a majority-owned subsidiary of Speedus Corp. (NASDAQ: SPDE), announced today it has received U.S. Food and Drug Administration (FDA) clearance to include a graphical display of the median energy level, timing, and duration of suspected heart murmurs during specific segments of the diastolic and systolic intervals of heartbeats recorded through the Zargis Acoustic Cardioscan (CardioscanTM).

    The new displays will better represent the distribution of acoustic energy of the heart for each recorded location and help physicians characterize suspected murmurs in terms of onset, duration and loudness. This clearance represents one of the planned development milestones required for a full commercial rollout of Cardioscan.

    Zargis will be demonstrating Cardioscan, with energy display and timing annotation, at the American Heart Association Scientific Sessions in New Orleans on November 7th- 10th.

    “We have developed the most comprehensive and advanced heart sound analysis and interpretation algorithms in the world. This FDA clearance represents another first for Zargis and demonstrates our commitment to extending the clinical usefulness of cardiac auscultation (listening to heart sounds). Because auscultation is a difficult clinical skill, and with fewer than 28% of internal medicine programs in the United States offering any structured teaching in cardiac auscultation, we see a need for continued innovations in the field of cardiac sound diagnostics,” said John Kallassy, Managing Director of Zargis Medical.

    The acoustic signal generated by the heart contains significant energy at frequencies below the threshold of human hearing. The decline in auscultation skills has also led to a possible over-reliance on costly echocardiography for the diagnosis of heart murmurs. Consequently, a large percentage of echocardiograph studies are performed on patients with innocent heart murmurs.

    About Cardioscan

    Cardioscan is the first and only computer-aided medical device to support physicians in analyzing heart sounds for the identification of suspected murmurs, a potential sign of heart disease. Cardioscan is easy to use, non-invasive, portable, and takes just minutes to perform. Developed by biomedical scientists from Siemens and Zargis over the past seven years, Cardioscan implements voice-guided protocol and graphical user interface while maintaining an efficient physician workflow. The system provides a summary of findings in terms that are readily understood by physicians with more quantitative auscultatory information than is possible through listening alone. Thus, Cardioscan enhances auscultation which has been universally employed through a stethoscope for nearly two hundred years.

    About Zargis Medical Corp.

    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 abnormalities identified through analysis of heart sounds. 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 on Speedus Corp. or Zargis Medical, contact John Kallassy, 718.567.4358, [email protected], or visit their websites at www.speedus.com and www.zargis.com.

    For additional information on Siemens Corporate Research, visit their website at 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.
    Thanks, Tim
    Forum Administrator

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