PreMD Initiates FDA Review Process and Provides Corporate Update
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 21CFR part 10.75(c). As announced on Jan. 15, the company received anon-substantially equivalent (NSE) letter from the FDA regarding the 510(k)submission for an expanded regulatory claim on its point-of-care (POC) skincholesterol test. PreMD continues to believe that its skin cholesterol testmerits 510(k) clearance. "We have acted as quickly as possible in initiatingthe process and will continue to evaluate the best strategies to help achieveFDA clearance," said Brent Norton, president and chief executive officer ofPreMD. PreMD is working with AstraZeneca Pharmaceuticals, which has licensedthe test for marketing and distribution in the United States, to fully explorethe 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 actionsto maximize company value. These actions include a workforce reduction ofapproximately 33% and other general and administrative expense decreases. Thekey members of PreMD are concentrating their efforts on the FDA review andassessing strategic alternatives to maximize shareholder value. PreMD willcontinue to realign its organization and optimize the company's cost structureand cash resources. PreMD continues to advance the development programs forother product candidates in its oncology pipeline, which remain unaffected bythe FDA decision.
PreMD also recently appointed Ronald Henriksen as Chair of the AuditCommittee. Mr. Henriksen has been a director of PreMD since 2004 and is thechief investment officer of Twilight Ventures.
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 include a line of non-invasive skincholesterol tests. PreMD's other skin cholesterol products include PREVU(x)LT, a test designed for use in the life insurance industry. 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 PreMD, please visit www.premdinc.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 successful development or marketing of the Company's products, thecompetitiveness of the Company's products if successfully commercialized, thelack of operating profit and availability of funds and resources to pursue R&Dprojects, the successful and timely completion of clinical studies, productliability, reliance on third-party manufacturers, the ability of the Companyto take advantage of business opportunities, uncertainties related to theregulatory 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 bechallenged, invalidated or circumvented by our competitors and there can be noguarantee of our ability to obtain or maintain patent protection for ourproducts or product candidates.
Investors should consult the Company's quarterly an
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