IMI announces new PREVU(x) study with Montreal Heart Institute
November 23 2004 - 8:00AM
PR Newswire (US)
IMI announces new PREVU(x) study with Montreal Heart Institute
Successful completion of study could lead to additional regulatory
approvals TORONTO, Nov. 23 /PRNewswire-FirstCall/ -- IMI
International Medical Innovations Inc. (Amex: IME; TSX: IMI), a
leader in predictive medicine, today announced a new multi-center
skin sterol study, led by the prestigious Montreal Heart Institute.
The study will determine whether skin sterol values measured by
PREVU(x) Point of Care Skin Sterol Test are substantially
equivalent to skin sterol values as measured by IMI's new
lab-processed format of the test, PREVU(x) Skin Sterol Test LT.
Prominent cardiologist Dr. Jean-Claude Tardif, Director of Clinical
Research at the Montreal Heart Institute and Associate Professor of
Medicine at the University of Montreal, is the principal
investigator of the study. The Montreal Heart Institute, which is
recognized internationally as a cardiology leader, promotes
cardiology research, develops new technologies and contributes to
the prevention, rehabilitation and treatment of cardiovascular
disease. "We already know that skin sterol provides a snapshot of
the body's overall accumulation of cholesterol and can be used to
predict the extent of plaque build up inside the coronary arteries.
This new trial, with the inclusion of the lab test, will
significantly extend the scientific validation of our technology to
new test formats," said Dr. Brent Norton, President and Chief
Executive Officer, IMI. "Most importantly, the successful
completion of this trial will pave the way for additional product
approvals in key markets as well as milestone payments." "PREVU(x)
POC is non-invasive and delivers results quickly, which makes it a
potentially effective tool to help identify patients who are at
higher risk of coronary artery disease --- the number one cause of
heart attack," said Dr. Tardif. "PREVU(x) LT is even simpler to
administer, and, if proven successful, will make skin sterol
testing even more widely available. Simply, skin sterol testing
offers important opportunities to target prevention strategies to
the people who need them most." About the Study The study, to
include 600 patients scheduled for coronary angiography and 100
healthy age- and gender-matched controls, will be performed at
multiple sites in Canada, including the Montreal Heart Institute.
Patients will be tested with PREVU(x) POC and PREVU(x) LT. A
fasting serum sample will also be taken and tested for traditional
risk factors. About PREVU(x) PREVU(x) Point of Care Skin Sterol
Test, which does not require fasting or the drawing of blood, tests
for the amount of sterol in the skin, also known as skin tissue
cholesterol. Clinical studies have shown that as cholesterol
accumulates on artery walls it also accumulates in other tissues,
including the skin. High levels of skin sterol are correlated with
higher incidence of coronary artery disease. The PREVU(x) POC
system has been developed into two additional test formats.
PREVU(x) Skin Sterol Test LT, a lab-processed test, samples skin
cells from the palm of the hand using a patent-pending device with
medical-grade adhesive. The device is then sent to a laboratory
where the surface is assessed for skin sterol. IMI is also
developing a single-use, three-minute home test, called PREVU(x)
PT. 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, branded as PREVU(x) Skin Sterol Test, will be marketed
and distributed worldwide by McNeil Consumer Healthcare. 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 further information, please
visit http://www.imimedical.com/. This press release contains
forward-looking statements. These statements involve known and
unknown risks and uncertainties, which could cause IMI'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 IMI's
products, reliance on third-party manufacturers, the
competitiveness of IMI's products if successfully commercialized,
the ability of IMI to take advantage of business opportunities,
uncertainties related to the regulatory process, and general
changes in economic conditions. In addition, while IMI 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 IMI'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, (416)
222-3449, ; U.S. Investor Contact: Jane Lin/Andrea Faville, The
Investor Relations Group, (212) 825-3210, ,
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