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July 14th, 2005
PRESS RELEASE
PEGASUS/HEARTVIEW'S REVOLUTIONARY
HEART SCREENING
TECHNOLOGY PROVES ITS SPEED AND ACCURACY DURING
NEW YORK PILOT STUDY.
(Please
note that the name of the Cardiovisor 6S System has
since been changed to HeartVue™ 6S System) Palm Beach
Gardens , Fla. , Business Wire, June 10 th , 2005
. Pegasus Pharmaceuticals
Inc. (Symbol: PGUZ-OTC) today
announced that its Cardiovisor 6S System performed
extremely well during a recent blind pilot study which
compared the Company's ground-breaking technology with
standard electrocardiogram (ECG) machines.
The Cardiovisor
6S System is an advanced
screening technology that provides physicians with
a rapid 60 second solution for early, non-invasive
screening of heart disease. This technology uses only
6 standard leads from wrists and ankles. (Only four
electrodes make it possible to examine a fully clothed
patient.) The device includes proprietary software
that converts the electric conductivity of the cardiac
tissue into a three dimensional color coded visual
portrait, which is simple for physicians to interpret.
It allows testers to observe the condition of the heart
muscle as well as the intensity of the heart stress
load. The device provides a portrait of the patient's
heart and an electrocardiogram, the mainstay in the
screening of acute and chronic heart disease (CHD).
The Pegasus/Heartview
ECV unit represents
a new method of computer analysis for the screening
of ischemic heart disease and other cardiac diseases
with a highly sensitive analysis of the re-polarization
phase, which is the most challenging phase of heart excitement
in clinical interpretation. Data yielded by this new
method on changes of just the re-polarization phase
in various medical disorders have obvious differential
screening features.
The pilot study
was performed recently in a major New York hospital
by heart specialists and physicians in an actual Emergency
Room environment. The blind study compared the Pegasus/Heartview
prototype, six-lead ElectroCardioVison (ECV) device
to a twelve-lead traditional ECG unit on 109 patients.
The Pegasus/Heartview
ECV showed substantially
greater sensitivity than the traditional ECG with respect
to ischemia and potentially superior screening capabilities.
With respect to screening for heart abnormalities,
the ECV almost
matched the sensitivity of a 12-lead ECG that was read
by an experienced cardiologist, and was significantly
superior on specificity. The ECV showed
the potential for improving the speed and accuracy
of screening for ischemic heart disease and other cardiac
diseases that may not be identified using the traditional
ECG unit. Despite the vast diagnostic value of the
traditional ECG unit, having a faster, more portable
automated device has the tremendous potential in cutting
costs associated with ischemic heart disease.
Earlier
clinical trials performed in Europe with the Pegasus/Heartview
ECV device
involved tests of 213 heart patients. The research
was aimed at identifying the capacities of the ECV in
the detection of heart disease and any changes in myocardium
during treatment. The average sensitivity and specificity
of the ECV were 79% and 76% respectively.
The standard ECG unit was lower in sensitivity, ranging
from 25% to 50%
It is important to note that when all
age groups are considered, ischemic heart disease
(IHD) is the most common cause of death both in men and
women. Postmortem studies on accident victims have shown
that coronary arteriosclerosis often begins to develop
prior to the age of 20 and is widespread even among adults
who are asymptomatic. Sudden death may occur without
advance warning and is a common presenting manifestation
of IHD.
The blind study
performed in New York produced similar results for
the Pegasus/Heartview ECV device
with a 72% result for sensitivity and a 66% result
for specificity from a relatively small test group
but which featured a blind result read by cardiologists,
which is in their terms "a very demanding real world
test." Based
on their findings in New York , the study stated, "The
ECV device
merits further testing for both identifying specific
heart conditions and for screening populations."
The ECV unit
demonstrated its potential for improving the speed
and accuracy of diagnosing heart disease and other
cardiac diseases that may not be identified using
the traditional ECG unit. The portable, easy-to-use ECV device
also demonstrated that its speed, portability and its
automated response has a tremendous potential in providing
a non-invasive screening procedure for the early detection
of heart disease and for cutting costs in the screening
processes of patients. Earlier clinical trials in Europe
and the pilot study recently completed in New York
have proven the tremendous market potential of the Pegasus/Heartview
Cardiovisor 6S System and its application to cardiologists,
general practitioners, clinics, hospitals, the fitness
industry and emergency medical facilities. Further
tests of the Pegasus/Heartview ECV device
are now underway.
Pegasus Pharmaceuticals
Inc., of Palm Beach Gardens , Florida recently acquired
51% interest in Heartview LLC Inc., based in Cleveland
, Ohio , which holds the worldwide patent, manufacturing
and marketing rights of the innovative heart-screening
system, the Cardiovisor
6S System. An earlier version of this
screening system has already been cleared for sale
in Europe and there is a patent pending for the Pegasus/Heartview
ECV device
in the United States .
For more information,
please contact Daniel P. Kesonen, Chairman & CEO
of Pegasus Pharmaceuticals Inc. at (561) 626-9901.
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