Embargoed For Release 3/30/98

Contacts
John T. Oxaal, CEO
Volumetrics Medical Imaging, Inc.
919/688-0112 X220

Charles S. Versaggi, Ph.D.
Versaggi Biocommunications
415/547-1320
[email protected]

VOLUMETRICS MEDICAL IMAGING INC. UNVEILS FIRST COMMERCIAL REAL-TIME VOLUMETRIC ULTRASOUND SYSTEM BREAKTHROUGH ALLOWS INSTANT SCANS OF ENTIRE HEART AND OTHER ORGANS

ATLANTA and DURHAM, N.C., March 30, 1998 -- The first fundamental breakthrough in diagnostic ultrasound in more than a decade was introduced today at the annual meeting of the American College of Cardiology (ACC) in Atlanta. The Model 1, real-time volumetric ultrasound imaging system, developed by Volumetrics Medical Imaging, Inc. (formerly 3D Ultrasound, Inc.), of Durham, N.C., ushers in a new era of diagnostic imaging that provides instantaneous, quantifiable ultrasound scans of a whole organ, rather than a single slice.

Utilizing Volumetric Sonography(tm), the Model 1 scans an entire organ in the time it takes a conventional ultrasound system to acquire a single, two-dimensional (2D) slice of data. Studies presented by leading clinicians at the ACC demonstrate the technology may enable accurate, repeatable, low-cost volume measurements for cardiology and other applications. Providing backward compatibility through state-of-the-art 2D-image quality, the Model 1 is the world's first commercial, real-time volumetric ultrasound system.

"Early clinical trials indicate that Volumetric Sonography may provide better understanding of a patient's cardiac physiology, and thus more precise treatment," said John T. Oxaal, CEO and co-founder of Volumetrics Medical Imaging. "This, combined with the higher patient throughput seen in these studies, will help reduce health care costs." Echocardiography with the Volumetrics Model 1

Traditionally, ultrasound has been a front-line tool for the evaluation of patients with heart disease. However, conventional 2D ultrasound has a number of limitations that prevent it from fulfilling the clinical objectives of cardiologists. Quantitative measures of the heart such as the ejection fraction (EF)*, for example, have heretofore only been accurately calculated with expensive modalities like MRI, or by subjecting the patient to increased risk with angiography. *EF is a measure of the amount of blood remaining in the left ventricle after a beat. If too much blood remains, the volume of blood going to the body is dangerously low for other organs to function.

"Three-dimensional echocardiography is the next logical step in the evolution of cardiac ultrasound," said Anthony DeMaria, M.D., professor of medicine, chief of cardiology at the University of California San Diego School of Medicine and a past president of the American College of Cardiology. "The real-time volumetric image acquisition accomplished by Volumetrics Medical Imaging's Model 1 can render this technique clinically feasible and applicable in daily clinical practice."

Studies by the world's leading cardiologists have shown Volumetric Sonography removes the limitations of 2D ultrasound in the assessment of cardiac function. Experts say this will enable ultrasound to become a more trusted tool in the evaluation of important clinical decisions, such as whether or not to perform a cardiac bypass, when to replace a faulty valve, or to gauge if a patient's heart is strong enough to withstand chemotherapy. Volumetric Sonography holds the prospect that these and other clinical decisions can be made more precisely, in a patient-friendly way, and at low cost.

Slated for availability later this year, the Model 1 also can visualize and calculate volume blood flow -- not just velocity -- in three dimensions (color flow, pulsed Doppler). Volumetric Sonography(tm)

Standard ultrasound systems transmit and receive high-frequency sound waves in two dimensions. These machines are limited by the speed of sound to produce a single, flat, pie-shaped image. A major disadvantage of 2D ultrasonography is its inability to measure accurately the irregular 3D volume of an organ. Accurate, repeatable volume measure-ments are essential for monitoring the size and shapes of normal, as well as diseased organs such as the heart.

By contrast, Volumetrics' Model 1 circumvents the problems imposed by the speed of sound to instantaneously acquire data from a 3D volume. Volumetric Sonography may thus permit the non-invasive quantitative assessment of tumor and organ volumes, as well as cardiac chamber volumes. Such measurements are needed for better patient care.

"The next generation in ultrasound technology, Volumetric Sonography opens the door to many clinical advantages -- some yet to be realized," said Olaf T. von Ramm, Ph.D., a co-founder and the father of conventional 2D-phased array ultrasound which underlies 90 per-cent of today's ultrasound systems.

The Model 1 integrates many design innovations in its ultrasound transducer signal pro-cessing and display. These include:

* The matrix-array transducer, which steers the ultrasound beam in three dimensions, con-tains 2000 elements. 512 are used for image formation -- 4 times more than the most advanced 2D system.

* The beam-forming system forms 4096 lines of image 30 times per second (i.e., pyramidal volumes 30 times/second). This 16-to-1 improvement in the image-formation rate is achieved by patented Explososcanning(tm): 16 ultrasound scan lines are formed for each transmission and reception. This requires as much ultrasound signal processing power as eight Acuson Sequoia systems.

* The patented display contains a 10 giga operations/second processor (about 30X faster than the highest-end Pentium processor).

To make use of volumetric data, as well as to provide backward compatibility with 2D images, the Model 1 displays multiple simultaneous planes of the internal anatomy such as the heart.

Economic Benefits of Volumetric Sonography

Early Model 1 users have found patient throughput increases by a factor of two to three times, thus substantially reducing operational costs. Because it easily captures all the heart's volume data-points within several beats, the user does not have to capture the 'right' slice during a patient scan. Later, off-line, one can access and analyze the exact slice and image needed from the system's computer memory. Leading Cardiac Installations

The world's leading cardiology centers have installed the Model 1. These include: The Cleveland Clinic, the National Institutes of Health, University of California San Diego, Mayo Clinic, University of Alabama Birmingham, Columbia University, Northwestern University, the European Space Agency, University of Freiburg, Osaka City University, and the University of Texas Medical Branch.

Volumetrics Medical Imaging Inc. is the developer of Volumetric Sonography(tm) -- a breakthrough in diagnostic ultrasound that allows the beating heart or other whole organ to be scanned instantaneously, rather than one slice at a time. The company's Model 1 is the world's first commercial, real-time volumetric ultrasound system, delivering the next generation of medical sonography to the $2.4 billion worldwide ultrasound market.

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