(IMAT) News!
Imatron Receives 510k Market Clearance From FDA For Electron Beam Angiography;
Opens 3,500 Cath Lab Market to Imatron EBT Scanner
Business Editors and Health/Medical
SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--Nov. 17,
1999--Imatron Inc. (Nasdaq:IMAT) announced today that it has received
510(k) clearance from the Food and Drug Administration (FDA) to market
and sell the angiographic capabilities of its Electron Beam Tomography
(EBT) scanner. Imatron's EBT scanner can now be marketed to perform
Electron Beam Angiography (EBA) of the coronary arteries, a minimally
invasive procedure. EBA is unique to EBT and is made possible due to
the scanner's unparalleled scan speed. EBA is significantly less
invasive and less expensive than the alternative cardiac
catheterization procedure, or coronary angiography, and is anticipated
that it will be routinely performed in medical facilities worldwide.
Imatron's EBT scanner, when used angiographically, is intended to
function as a diagnostic x-ray system that can produce two- and
three-dimensional images of the heart, blood vessels, or lymphatic
system from a data set of cross-sectional anatomical images. In
addition, the EBA application can also present three-dimensional
images of the heart in a time-sequenced or cine fashion; in essence, a
four-dimensional evaluation of cardiac function, with the fourth
dimension being time.
S. Lewis Meyer, Imatron's CEO, stated, "We are extremely pleased
to announce that Imatron has received clearance from the FDA to market
and sell its EBT technology to perform electron beam angiography
applications. Currently, there are more than 3,500 cardiac
catheterization laboratories in the U.S. performing nearly two million
coronary angiograms every year. Numerous studies from major medical
and clinical research centers around the world support the application
of EBA and also provide validation that this application is both
highly sensitive and specific as compared to coronary angiography. It
has been estimated that EBA can eliminate approximately 20% to 40% of
conventional coronary angiogram procedures annually. Imatron's new EBA
application is minimally invasive, requiring only a simple,
intravenous injection of a contrast agent; painless; approximately
one-fifth of the cost of an angiogram; and virtually risk-free. The
alternative, coronary angiograms, require a puncture to be made in the
patient's groin, a catheter threaded into the coronary arteries and
the injection of a contrast agent. In addition, there is a 1-2 percent
risk of serious complications from coronary angiography."
Mr. Meyer continued, "We are confident that coronary EBA, which,
because of our scanner's unparalleled scan speed and ability to
"freeze" heart motion, is unique only to EBT, will open up a
tremendous new market opportunity for Imatron to sell its EBT scanner
for a significantly broader range of applications within the medical
community. One of the many potential uses for coronary EBA is in the
area of evaluating the function of coronary artery bypass grafts. More
than 500,000 coronary artery bypass surgical procedures are performed
in the U.S. annually, and we believe that this new diagnostic imaging
capability will be instrumental in assisting clinicians in the
follow-up and monitoring of coronary artery bypass graft patients."
Imatron, Inc. is primarily engaged in designing, manufacturing,
marketing, and supporting high performance EBT scanners based on the
company's proprietary electron beam tomography (EBT) technology.
Imatron's EBT scanner is now in use at more than 110 major medical
centers around the world, including the Mayo Clinic, Cedars-Sinai
Medical Center, Mount Sinai Medical Center, University of Iowa,
National Institutes of Health, UCLA Medical Center, Stanford
University, Cooper Clinic, HealthScan of La Jolla, Vital Imaging
Diagnostic Clinic, University of Illinois, Arizona Heart Institute,
Landeskrankenhaus Graz in Graz, Austria, Daniel den Hoed Klinik in
Rotterdam, Netherlands, Cardiology Research Centre in Moscow, Russia,
Fau Erlangen-Nurnberg in Erlangen, Germany, Zentralklinik Bad Berka in
Bad Berka, Germany and Beijing Hospital in China.
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.
--30--dc/sf*
CONTACT: Imatron Inc.
S. Lewis Meyer, 650/583-9964 (CEO)
Robin Kelley, 650/583-9964 (Investor Relations) |
