TORONTO, Sept. 6 /PRNewswire-FirstCall/ - Predictive medicine companyPreMD Inc. (TSX: PMD; Amex: PME) today announced that it has receivedquestions from the U.S. Food and Drug Administration (FDA) regarding its510(k) application for an expanded regulatory claim for its POC skincholesterol test. PreMD submitted the 510(k) application to the FDA in June2007. The submission seeks to obtain broader clearance in the assessment ofcardiovascular disease risk in individuals without known disease. PreMDbelieves the specific matters raised by the FDA are fully addressable and theCompany plans to submit a response within the alloted timeline of 30 days.
"Receiving questions from the FDA is a common part of the regulatoryprocess," said Brent Norton, president and chief executive officer of PreMD."Based on our current information and analysis, we plan to provide the FDAwith the information they requested within 30 days. We are confident that weare on the path towards expanded regulatory clearance."
About PreMD Inc.
PreMD Inc. is a leader in predictive medicine, dedicated to developingrapid, non-invasive tests for the early detection of life-threateningdiseases. PreMD's cardiovascular products are branded as PREVU(x) SkinCholesterol Test, to be marketed and distributed by AstraZeneca. The company'scancer tests include ColorectAlert(TM), LungAlert(TM) and a breast cancertest. PreMD's head office is located in Toronto, Ontario and its research andproduct development facility is at McMaster University in Hamilton, Ontario.For more information about PREVU(x), please visit www.prevu.com.
This press release contains forward-looking statements. These statementsinvolve known and unknown risks and uncertainties, which could cause theCompany's actual results to differ materially from those in theforward-looking statements. Such risks and uncertainties include, amongothers, the success of a plan for regaining compliance with certain continuedlisting standards of the American Stock Exchange, successful development ormarketing of the Company's products, the competitiveness of the Company'sproducts if successfully commercialized, the lack of operating profit andavailability of funds and resources to pursue R&D projects, the successful andtimely completion of clinical studies, product liability, reliance onthird-party manufacturers, the ability of the Company to take advantage ofbusiness opportunities, uncertainties related to the regulatory process, andgeneral changes in economic conditions.
In addition, while the Company routinely obtains patents for its productsand technology, the protection offered by the Company's patents and patentapplications may be challenged, invalidated or circumvented by our competitorsand there can be no guarantee of our ability to obtain or maintain patentprotection for our products or product candidates.
Investors should consult the Company's quarterly and annual filings withthe Canadian and U.S. securities commissions for additional information onrisks and uncertainties relating to the forward-looking statements. Investorsare cautioned not to rely on these forward-looking statements. PreMD isproviding this information as of the date of this press release and does notundertake any obligation to update any forward-looking statements contained inthis press release as a result of new information, future events or otherwise.
SOURCE PreMD Inc.