PreMD's PREVU(x) LT Cleared For Sale in Canada
28 September 2006 - 12:00AM
PR Newswire (US)
TORONTO, Sept. 27 /PRNewswire-FirstCall/ -- Predictive medicine
company PreMD Inc. (TSX: PMD; Amex: PME) today announced that
PREVU(x) LT Skin Sterol Test, a lab-processed format of the
PREVU(x) technology, has been cleared for sale by Health Canada's
Therapeutic Products Directorate (TPD). The Technical File for this
product included clinical data from the recently completed PREPARE
(PREVU(x) Predicts Atherosclerosis Risk and Events) study,
conducted in the life insurance industry with the participation of
selected U.S. life insurers. PREVU(x) LT has been developed for use
within the life insurance industry and diagnostic laboratories and
its clearance in Canada allows the test to be sold as a risk
assessment tool for cardiovascular disease. "This marks PreMD's
second PREVU(x) product to be cleared for sale in Canada,
representing a significant achievement for the company," said Dr.
Brent Norton, President and Chief Executive Officer of PreMD. "We
are excited by the prospects for this new laboratory test format
and have already forged relationships with selected life insurers,
laying the ground work for the launch of the product. Furthermore,
we are excited to be in full control of the commercialization
effort for PREVU(x)LT following our reacquiring the rights to the
technology from McNeil Consumer Healthcare due to take place at the
end of December. This will enable us to reap the full economic
benefits in a market we believe to have tremendous potential." In
addition to Canada, PREVU(x) LT was recently CE-marked in Europe
and the Company is currently preparing a 510(k) for submission to
the U.S. Food and Drug Administration (FDA), to further expand the
PREVU(x) product line into the United States. About PREVU(x)LT
PREVU(x) LT non-invasively measures the amount of cholesterol
(sterol) that has accumulated in the skin tissues, as opposed to
blood, by painlessly collecting skin cells from the palm of the
hand using a specially designed adhesive strip, which is then sent
to a laboratory for processing. No fasting or other patient
preparation is required for the test. The lead product in this
family, PREVU(x) Point of Care (POC) Skin Sterol Test, is cleared
for sale in Canada, the U.S. and Europe. About PreMD PreMD Inc. is
a world 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(x) Skin Sterol Test. The company's cancer tests
include ColorectAlert(TM), LungAlert(TM) and a breast cancer test.
PreMD'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.premdinc.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 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. (x)Trademark DATASOURCE: PreMD Inc. CONTACT: Brent
Norton, President and CEO, Tel: (416) 222-3449 ext. 22, Email: ;
Ron Hosking, Chief Financial Officer, Tel: (416) 222-3449 ext. 34,
Email:
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