TORONTO, Sept. 6 /CNW/ - 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(*) 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(*), please visit 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.
%SEDAR: 00007927E %CIK: 0001179083
For further information:
For further information: Brent Norton, President and CEO, Tel: (416)
222-3449 ext. 22, Email: firstname.lastname@example.org; Ron Hosking, Vice President
Finance and CFO, Tel: (416) 222-3449 ext. 24, Email: email@example.com;
Michelle Rabba, Manager, Corporate Communications, Tel: (416) 222-3449 ext.
25, Email: firstname.lastname@example.org