Imi Medical Innovations (AMEX:IME)
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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,
,