PreMD Initiates FDA Review Process and Provides Corpor...( TORONTO Feb. 12 / Predictive medi...),Health

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
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