PREVU(x) study to open new markets
10 Maio 2005 - 11:00AM
PR Newswire (US)
PREVU(x) study to open new markets PREVU(x) LT Skin Sterol Test
included in 25,000-participant insurance industry study TORONTO,
May 10 /PRNewswire-FirstCall/ -- IMI International Medical
Innovations Inc. (TSX:IMI; Amex: IME), a leader in predictive
medicine, today announced a major clinical trial in the life
insurance testing industry using IMI's non-invasive cardiovascular
risk assessment technology. The study, called PREPARE (PREVU(x)
Predicts Atherosclerosis Risk and Events) is expected to begin in
the second quarter of 2005. The agreement is for PREVU(x) LT Skin
Sterol Test, the lab-processed format of the company's lead
approved PREVU(x) Point of Care (POC) Skin Sterol Test. The
PREVU(x) family of products is marketed worldwide by McNeil
Consumer Healthcare, Canada. "This trial is intended to confirm the
viability of PREVU(x) LT in the insurance testing market and has
the potential to contribute to its commercial success in multiple
markets," said Dr. Brent Norton, President and Chief Executive
Officer, IMI. "With this study, we will gain valuable new data on
the lab-processed format of our skin sterol test, which will help
to create additional revenue opportunities and position IMI to
receive a milestone payment, possibly as early as later this year."
"The market for insurance testing represents a significant
opportunity for our predictive heart disease test worldwide,"
continued Dr. Norton. "In 2003, approximately 13.5 million
individual life insurance policies were purchased in the United
States, a significant number of which do not include a
cardiovascular disease assessment. With our simple skin test, IMI
and McNeil are poised to capitalize on this opportunity." About the
Study The clinical trial will include approximately 25,000
participants in the United States and will be conducted with the
participation of certain U.S. life insurers. PREVU(x) LT will be
performed on applicants for life insurance coverage who agree to
participate in the study and compared with traditional risk
assessment measures, including high sensitivity c-reactive protein
(CRP). Test results will be collected and analyzed by LabOne, Inc.
Data from the study will determine the correlation between PREVU(x)
LT and Framingham Global Risk Score, a traditional method for
evaluating the risk of coronary artery disease. Previously
published and presented data on PREVU(x) POC has shown that skin
sterol correlates with Framingham Global Risk Score. In addition,
skin sterol has shown to be an independent risk factor for coronary
artery disease as defined by angiography, coronary calcium, carotid
intima-media thickness and stress test. Studies with PREVU(x) LT to
date show that skin sterol values as measured by PREVU(x) LT
correlate to skin sterol values as measured by PREVU(x) POC. About
PREVU(x) Skin Sterol Test PREVU(x) non-invasively measures the
amount of sterol, or skin tissue cholesterol, without the drawing
of blood or a special pre-test diet, and takes minutes to perform.
The lead product in this family, PREVU(x) POC, is cleared for sale
in Canada, the U.S. and Europe, and is currently being
commercialized in North America and select European markets where
it will be made available to medical professionals as a point of
care test. PREVU(x) LT samples skin cells from the palm of the hand
painlessly in seconds using a specially designed adhesive device.
The device is then sent to a laboratory where the amount of skin
sterol is determined. About Cardiovascular Disease According to the
World Health Organization, cardiovascular diseases (CVD), which
include coronary artery disease, stroke and other diseases, account
for about 17 million deaths per year worldwide. By 2025, CVD is
expected to cause 25 million deaths annually. More people worldwide
--- approximately 7 million --- die from coronary artery disease
than any other cause. According to the American Heart Association,
in the United States, about every 26 seconds one American will
suffer a coronary event, and about every minute, someone will die
from one. About IMI IMI is a world leader in predictive medicine,
dedicated to developing rapid, non-invasive tests for the early
detection of life-threatening diseases. IMI's cardiovascular
products, which are branded as PREVU(x) Skin Sterol Test, are
marketed worldwide by McNeil Consumer Healthcare, Canada. The
company's cancer tests include ColorectAlert(TM), LungAlert(TM) and
a breast cancer test. IMI's head office is located in Toronto, and
its research and product development facility is at McMaster
University in Hamilton, Ontario. For corporate and investor
information about IMI, please visit http://www.imimedical.com/. For
more information about PREVU(x), please visit
http://www.prevu.com/. This press release contains forward-looking
statements. These statements involve known and unknown risks and
uncertainties, which could cause the Company's actual results to
differ materially from those in the forward- looking statements.
Such risks and uncertainties include, among others, the lack of
operating profit and availability of funds and resources to pursue
R&D projects, the successful and timely completion of clinical
studies, the successful development or marketing of the Company's
products, reliance on third-party manufacturers, the
competitiveness of the Company's products if successfully
commercialized, the ability of the Company to take advantage of
business opportunities, uncertainties related to the regulatory
process, and general changes in economic conditions. In addition,
while the Company routinely obtains patents for its products and
technology, the protection offered by the Company's patents and
patent applications may be challenged, invalidated or circumvented
by our competitors and there can be no guarantee of our ability to
obtain or maintain patent protection for our products or product
candidates. Investors should consult the Company's quarterly and
annual filings with the Canadian and U.S. securities commissions
for additional information on risks and uncertainties relating to
the forward-looking statements. Investors are cautioned not to rely
on these forward-looking statements. IMI is providing this
information as of the date of this press release and does not
undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information,
future events or otherwise. DATASOURCE: IMI International Medical
Innovations Inc. CONTACT: Company Contact: Sarah Borg-Olivier,
Director, Communications, T: (416) 222-3449, ; U.S. Investor
Contact: Andrea Faville, John Nesbett, The Investor Relations
Group, T: (212) 825-3210, ,
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