PreMD Submits 510(k) to the FDA for Expanded Regulatory Claim for PREVU* POC

    Intended to aid in the assessment of carotid wall thickness (CIMT) and in
    the identification of the presence of carotid plaque - markers of future
    risk for heart attack and stroke

    TORONTO, June 6 /CNW/ - Predictive medicine company PreMD Inc. (TSX: PMD;
Amex:   PME) today announced that it has filed a 510(k) application with the
U.S. Food and Drug Administration (FDA) seeking an expanded claim for its skin
cholesterol test PREVU(*) POC. The submission seeks to obtain broader clearance
for PREVU(*) POC in the assessment of cardiovascular disease risk in individuals
without known or suspected disease. The approval of a broader claim would make
PREVU(*) POC the first cost-effective, non-invasive test on the market to aid in
the assessment of carotid wall thickness (CIMT) and the presence of carotid
plaques - established markers for future heart attacks and strokes - in
patients without known coronary artery disease, cerebrovascular disease or
peripheral artery disease.
    "This is an important milestone for PreMD and reinforces the strength and
utility of the PREVU(*) technology," said Dr. Brent Norton, President and Chief
Executive Officer of PreMD. "An expanded claim could dramatically increase the
market potential of PREVU(*) POC and provide the healthcare community with an
inexpensive tool that could save lives. Our discussions with potential
marketing partners are advancing and the compelling PASA data used in the
510(k) helps to underpin the importance and value of the PREVU(*) product line.
One of our stated goals for this year is to increase the market opportunity
for PREVU(*) and an expanded regulatory claim is a core piece of this strategy.
This filing demonstrates that we are executing on our strategic initiatives
and on track to achieve our stated objectives."
    The FDA submission included data from the PASA (Predictor of Advanced
Subclinical Atherosclerosis) study, which examined the relationship between
PREVU(*) POC and carotid intima media thickness (CIMT), an established predictor
of heart attack and stroke. Results from this study have been submitted for
publication in the scientific literature. Typical response times for 510(k)
submissions are approximately 90 days if there are no questions or other

    About PREVU(*) POC Skin Sterol Test

    PREVU(*) non-invasively measures the amount of cholesterol (sterol) that
has accumulated in the skin tissues, as opposed to blood. There is no fasting
or other patient preparation required for the test. 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 (CAD). PREVU(*) POC is cleared
for sale in Canada, the U.S. and Europe.

    About PreMD

    PreMD Inc. is a leader in predictive medicine, dedicated to developing
rapid, non-invasive tests for the early detection of life-threatening
diseases. PreMD's cardiovascular products are branded as PREVU(*) Skin
Cholesterol Test. The company's cancer tests include ColorectAlert(TM),
LungAlert(TM) and a breast cancer test. PreMD's head office is located in
Toronto, Ontario and its research and product development facility is at
McMaster University in Hamilton, Ontario. For further information, please

    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 success of a plan for regaining compliance with certain continued
listing standards of the American Stock Exchange, successful development or
marketing of the Company's products, the competitiveness of the Company's
products if successfully commercialized, the lack of operating profit and
availability of funds and resources to pursue R&D projects, the successful and
timely completion of clinical studies, product liability, reliance on
third-party manufacturers, 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. PreMD 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.

    (*) Trademark

    %SEDAR: 00007927E          %CIK: 1179083

For further information:

For further information: Brent Norton, President and CEO, Tel: (416)
222-3449 ext. 22, Email:; Michelle Rabba, Manager,
Corporate Communications, Tel: (416) 222-3449 ext. 25, Email:; Rhonda Chiger, Rx Communications Group, LLC, Tel: (917)
322-2569, Email:

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