PreMD Provides Update on 510(k) Application for PREVU(x) POC
07 September 2007 - 4:00AM
PR Newswire (US)
TORONTO, Sept. 6 /PRNewswire-FirstCall/ -- Predictive medicine
company PreMD Inc. (TSX: PMD; Amex: PME) today announced that it
has received questions from the U.S. Food and Drug Administration
(FDA) regarding its 510(k) application for an expanded regulatory
claim for its POC skin cholesterol test. PreMD submitted the 510(k)
application to the FDA in June 2007. The submission seeks to obtain
broader clearance in the assessment of cardiovascular disease risk
in individuals without known disease. PreMD believes the specific
matters raised by the FDA are fully addressable and the Company
plans to submit a response within the alloted timeline of 30 days.
"Receiving questions from the FDA is a common part of the
regulatory process," said Brent Norton, president and chief
executive officer of PreMD. "Based on our current information and
analysis, we plan to provide the FDA with the information they
requested within 30 days. We are confident that we are on the path
towards expanded regulatory clearance." About PreMD Inc. 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(x)
Skin Cholesterol Test, to be marketed and distributed by
AstraZeneca. 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 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 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. (x) Trademark DATASOURCE: PreMD Inc.
CONTACT: Brent Norton, President and CEO, Tel: (416) 222-3449 ext.
22, Email: ; Ron Hosking, Vice President Finance and CFO, Tel:
(416) 222-3449 ext. 24, Email: ; Michelle Rabba, Manager, Corporate
Communications, Tel: (416) 222-3449 ext. 25, Email:
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