PreMD Initiates FDA Review Process and Provides Corporate Update
13 February 2008 - 1:00AM
PR Newswire (US)
TORONTO, Feb. 12 /PRNewswire-FirstCall/ -- Predictive medicine
company PreMD Inc. (TSX: PMD; Amex: PME) today provided an update
on the company's business direction in light of the recent decision
from the U.S. Food and Drug Administration (FDA). Appeal to the FDA
PreMD today filed a request for a second level review of the 510(k)
submission, in accordance with the following Code of Federal
Regulations 21 CFR part 10.75(c). As announced on Jan. 15, the
company received a non-substantially equivalent (NSE) letter from
the FDA regarding the 510(k) submission for an expanded regulatory
claim on its point-of-care (POC) skin cholesterol test. PreMD
continues to believe that its skin cholesterol test merits 510(k)
clearance. "We have acted as quickly as possible in initiating the
process and will continue to evaluate the best strategies to help
achieve FDA clearance," said Brent Norton, president and chief
executive officer of PreMD. PreMD is working with AstraZeneca
Pharmaceuticals, which has licensed the test for marketing and
distribution in the United States, to fully explore the issues
raised by the FDA and address the appropriate steps going forward.
Additional Company Information In light of PreMD's financial
status, the company also has taken actions to maximize company
value. These actions include a workforce reduction of approximately
33% and other general and administrative expense decreases. The key
members of PreMD are concentrating their efforts on the FDA review
and assessing strategic alternatives to maximize shareholder value.
PreMD will continue to realign its organization and optimize the
company's cost structure and cash resources. PreMD continues to
advance the development programs for other product candidates in
its oncology pipeline, which remain unaffected by the FDA decision.
PreMD also recently appointed Ronald Henriksen as Chair of the
Audit Committee. Mr. Henriksen has been a director of PreMD since
2004 and is the chief investment officer of Twilight Ventures.
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 include a line of non-invasive skin cholesterol tests.
PreMD's other skin cholesterol products include PREVU(x) LT, a test
designed for use in the life insurance industry. 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 PreMD,
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: 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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