Submission also made to Health Canada, plan to CE-Mark in Europe TORONTO, July 26 /PRNewswire-FirstCall/ -- Predictive medicine company PreMD Inc. (TSX: PMD; Amex: PME) today announced that it has submitted a special premarket notification, or Special 510(k), to the U.S. Food and Drug Administration (FDA) for regulatory clearance of a second-generation spectrometer, or color reader, for the PREVU(x) Point of Care (POC) Skin Sterol Test, the Company's commercially available diagnostic to assess risk of heart disease. "This standalone, portable reader is designed to offer users greater flexibility," said Dr. Brent Norton, President and Chief Executive Officer. "We believe that these improvements will enhance the market appeal of PREVU(x) POC." The new reader, which does not need to be attached to a computer, enables PREVU(x) POC to operate in a greater variety of healthcare settings. The new reader was developed in conjunction with Boehringer Ingelheim microParts GmbH, a specialist in micro-system technology and a leading supplier of micro-structured components and systems in the biomedical field. The reader will be manufactured in the United States by Jabil Circuit Inc. (NYSE:JBL), an electronic product solutions company that provides electronics design, manufacturing and product management services to companies in a range of industries around the world. A Special 510(k) is submitted for a modification to a device that has been previously cleared for marketing under the 510(k) process. The FDA's review process for Special 510(k) submissions typically requires 30 days unless there are questions that need to be addressed. PreMD has also submitted an Amendment to its Class II Medical Device License for PREVU(x) POC to Health Canada's Therapeutic Products Directorate (TPD). The TPD is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use. The review process for Class II license Amendments typically requires up to 30 days unless there are questions that need to be addressed. PreMD also intends to CE (Conformite Europeene)-Mark the new reader, which will allow it to be marketed in the European Union. About PREVU(x)POC Skin Sterol Test PREVU(x) non-invasively measures the amount of cholesterol (sterol) that has accumulated in the skin tissues, as opposed to blood. There is no fasting or other patient preparation required for the test. Clinical studies have shown that as cholesterol accumulates on artery walls it also accumulates in other tissues, including the skin. High levels of skin sterol are correlated with higher incidence of coronary artery disease (CAD). PREVU(x) POC is cleared for sale in Canada, the U.S. and Europe where it is available for sale to medical professionals. 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, which are branded as PREVU(x) Skin Sterol Test, are licensed worldwide to McNeil Consumer Healthcare. 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/. For more information about PREVU(x), please visit http://www.prevu.com/ or call 1-866-283-8328 (North America) or 00-800-8283-8328 (Europe), or email . 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, Chief Financial Officer, Tel: (416) 222-3449, Email: ; Sarah Borg-Olivier, Director, Communications, Tel: (416) 222-3449, Email:

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