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HYPERTENSION DIAGNOSTICS, INC.
FOR IMMEDIATE RELEASE
Contact: Greg H. Guettler,
President
(651) 687-9999
FDA GRANTS HYPERTENSION DIAGNOSTICS 510(k) CLEARANCE TO MARKET THE
CVPROFILOR(TM) DO-2020 SYSTEM, THE NATION'S FIRST CARDIOVASCULAR PROFILING
MEDICAL DEVICE
ST. PAUL, MN, November 3, 2000 - Hypertension Diagnostics, Inc., (NASDAQ
SmallCap: HDII; HDIIW; HDIIU) announced today that it has received clearance
from the U.S. Food and Drug Administration (FDA) to market the CVProfilor(TM)
DO-2020 CardioVascular Profiling System for use by physicians and other health
care providers to non-invasively screen patients for the presence of
cardiovascular disease. Based on interactions with internists and other
physicians familiar with the CVProfilor(TM) DO-2020 System, HDI believes that
routine clinical use of this product may revolutionize the practice of
cardiovascular medicine in the United States.
In addition to measuring blood pressure values (systolic, diastolic and
mean arterial pressure) and heart rate, the CVProfilor(TM) DO-2020 System
calculates pulse pressure, body surface area (BSA) and body mass index (BMI),
and provides indications of arterial elasticity. This unique medical device
determines both large and small artery elasticity indices which can be used as
an initial clinical screening device to determine if patients have potential
underlying vascular disease that might require more specific diagnostic
evaluations.
The CVProfilor(TM) DO-2020 CardioVascular Profiling System utilizes
HDI's patented, proprietary and validated blood pressure waveform analysis
technology. The System is non-invasive, user-friendly, designed for use in
physician offices and clinics, and involves no specific medical risk to the
patient. The System's display screen and printer-generated CardioVascular
Profile Report provide an independent assessment of the patient's arterial
elasticity or flexibility of both large and small arteries (referred to as C1
and C2 parameters, respectively).
Employing prototype Systems of the CVProfilor(TM) DO-2020, clinical
investigators have demonstrated an age-related loss of elasticity of both the
large and small arteries as well as a correlation between hardening of the
arteries and vascular disease. This clinical research, conducted during the last
decade and described in more than 95 scientific abstracts and articles
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Page 2, Hypertension Diagnostics, Inc.
November 3, 2000
published in peer-reviewed medical journals, suggests that "premature
stiffening" of a patient's arteries is a clinically sensitive marker for the
early onset of cardiovascular disease. "Clinical studies have shown that
patients with hypertension, heart failure, coronary artery disease and diabetes
exhibit a loss of arterial elasticity. Even a slight reduction in arterial
elasticity can be measured by the CVProfilor(TM) DO-2020 System, and the early
detection of such reductions appear to precede the overt signs and symptoms of
cardiovascular disease," says Dr. Charles F. Chesney, Executive V.P. and Chief
Technology Officer of HDI.
It is generally recognized by medical experts that healthy arteries are
elastic and flexible, and that hardening or stiffening of arteries is associated
with old age, poor health and cardiovascular disease. Almost 60 million
Americans have high blood pressure, and cardiovascular disease is the leading
cause of death in the United States and a primary cause of more than one million
heart attacks and strokes annually. Every 24 hours, more than 2,600 Americans
die of disease involving the cardiovascular system - an average of one death
every 33 seconds!
Forward-looking statements in this press release are made under the
safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
The Company wishes to caution readers not to place undue reliance on any
forward-looking statements and to recognize that the statements are not
predictions of actual future results. Actual results could differ materially
from those presented and anticipated in the forward-looking statements due to
the risks and uncertainties set forth in the Company's 2000 Annual Report on
Form 10-KSB under the caption "Risk Factors", as well as others not now
anticipated.
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Hypertension Diagnostics, HDI/PulseWave and CVProfilor are trademarks of
Hypertension Diagnostics, Inc. All rights reserved.
Website: www.hdi-pulsewave.com
