Imi Medical Innovations (AMEX:IME)
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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,
,