PreMD Provides Update on 510(k) Application for PREVU(x) LT
14 March 2007 - 7:00AM
PR Newswire (US)
TORONTO, March 13 /PRNewswire-FirstCall/ -- Predictive medicine
company PreMD Inc. (TSX: PMD; Amex: PME) today announced that it
has received feedback from the U.S. Food and Drug Administration
(FDA) regarding its 510(k) application for PREVU(x) LT for use in
the insurance industry. The FDA has additional inquiries to which
PreMD is responding. PreMD believes the specific matters raised by
the FDA are fully addressable and the Company plans to meet with
the FDA at the earliest opportunity to review the planned
responses. PreMD submitted the 510(k) application to the FDA in
November 2006. "We plan to work closely with the FDA to provide
them with the information they request. The agency has provided us
with guidance as to the specific information they require and we
are diligently preparing our response," said Dr. Brent Norton,
President and Chief Executive Officer of PreMD. "PREVU(x) LT has
already been cleared for sale in Canada and CE marked in Europe.
This application is a priority for us and we anticipate that the
additional material will be submitted following the FDA meeting.
Since the FDA is already familiar with the application, the review
could proceed more rapidly than a typical 510(k)." 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/. 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. 24,
Email:
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