Monday February 1, 8:36 am Eastern Time
Company Press Release
Imatron's Ultrafast CT to Play Pivotal Role in $54 Million National Institutes of Health Study
NIH Initiates 10-Year Multicenter Subclinical Atherosclerosis Study
SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--Feb. 1, 1999-- Imatron Inc. (Nasdaq:IMAT - news) announced today that the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) has initiated a $54 million, 18,000 person, ten-year multicenter study into the progression of subclinical to clinical cardiovascular disease. Participants will be screened for evidence of subclinical coronary atherosclerosis using Imatron's electron-beam
computed tomography (EBCT) as the principal method of screening. In its description of this major study, the NIH has characterized EBCT as identifying persons with five- to twenty-fold increased risk for coronary heart disease events, and is thus the best available non-invasive technique for quantifying subclinical atherosclerosis.
S. Lewis Meyer, CEO of Imatron, stated, ''The inclusion of Imatron's EBCT by the National Institutes of Health in this pioneering study represents further recognition of the diagnostic and predictive power of the Coronary Artery Scan to quantify coronary calcification, which has been described in peer-reviewed literature as the single most powerful predictor of coronary events in the asymptomatic population. Unlike previous studies which evaluated EBCT, this study uses
the Coronary Artery Scan to identify the at-risk population to be monitored over the course of the study, and firmly establishes assessment of baseline cardiac risk by EBCT as the current 'gold standard.'''
In conjunction with this study, the NIH has announced awards to ten university sites which will conduct research designed to ''identify factors related to newer measures of subclinical disease and examine their relationship to established measures'' and, to ''identify techniques suitable for application in future screening and
intervention studies which identify asymptomatic persons at highest risk of clinical events.''
Approximately 18,000 men and women between the ages of 35 and 84 will be recruited at six principal field centers, which include UCLA, Columbia University in cooperation with St. Francis Hospital in Roslyn, New York, Johns Hopkins University in Baltimore, University of Minnesota in Minneapolis, Northwestern University in partnership with the University of Illinois in Chicago, and Wake Forest University in North Carolina. The study will be coordinated by the University
of Washington in Seattle. Collection and reading of data from specific diagnostic tests will be provided by the University of Vermont, New England Medical Center, Johns Hopkins University and the Harbor-UCLA Research and Education Institute.
Approximately 2,700 participants determined to be at highest risk for coronary heart disease events, based upon the EBCT coronary artery calcification study or an equivalent test or combination of tests, will then be selected for a comprehensive examination and follow-up approximately six months later. Results will be compared
with a randomly selected sample from the remainder of the population. All participants will undergo subsequent annual follow-up examinations for five years following their first examination.
Mr. Meyer continued, ''We look forward to working with these cutting-edge research institutions in the United States which will be involved in the project, and believe that the heightened visibility of Ultrafast CT® resulting from this study will facilitate its widespread adoption around the country. We are also very confident that this study will demonstrate the cost-effective role that Coronary Artery Scanning by EBCT can play in identifying those most at risk well before they develop symptoms.''
Commenting on the NIH's decision to fund this research, Meyer stated, ''As we have said all along, we believe that the major benefit of our technology will be for those individuals whose first symptom of coronary artery disease could well be a heart attack. We are confident that this research will solidify the Coronary Artery Scan by EBCT as the single most powerful tool to screen for subclinical therosclerosis and to predict subsequent clinical coronary artery disease.''
Imatron, Inc. is primarily engaged in designing, manufacturing, marketing, and supporting high performance computed tomography (CT) scanners based on the Company's proprietary scanning electron beam technology. Ultrafast CT is a registered trademark of Imatron. Imatron's Ultrafast CT scanner is now in use at major
medical centers around the world, including The Mayo Clinic, University of Iowa, National Institutes of Health, UCLA, Stanford University, University of Illinois, The Arizona Heart Institute, The Royal Brompton Hospital in London, Tokyo University Hospital and Beijing Hospital.
Except for the historical information contained herein, the matters discussed in this news release may contain forward-looking statements that are based on current expectations and estimates about the industry in which Imatron operates, the estimated impact of certain technological advances, the estimated impact of published
research studies on scanner sales and procedures, as well as management's beliefs and assumptions. It is important to note that the Company's actual results could differ materially from those projected in such forward-looking statements. The factors that could cause actual results to differ materially include, among others: failed
clinical demonstration of certain asserted technological advantages and diagnostic capabilities; reliance on product distributors; competition in the diagnostic imaging market; failure to improve product reliability or introduce new product models and enhancements; delays in production and difficulty in obtaining components and
sub-assemblies from limited sources of supply; inability to meet cash-on-delivery or prepayment terms from vendors; determinations by regulatory and administrative government authorities; patent expiration and denial of patent applications; the high cost of the scanner as compared to commercially available CT scanners; and the risk factors listed from time to time in the Company's Securities and Exchange Commission reports, including their reports on Form 10-K for their current fiscal year. |
