TORONTO, June 13 /PRNewswire-FirstCall/ - Predictive medicine company PreMD Inc. today announced that the Company has had further meetings with the U.S. Food and Drug Administration (FDA) in an effort to resolve the outstanding issues associated with obtaining broader regulatory clearance for its non-invasive skin cholesterol test. Over the next 60 days PreMD and the FDA will work together to try to obtain consensus on certain conclusions from the existing clinical data in order to develop appropriate labeling for the product.
“The FDA has provided constructive comments and assistance in defining the most appropriate strategy for clearance, and we look forward to a productive outcome at the end of the 60 days,” said Brent Norton, president and CEO of PreMD.
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 skin cholesterol 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 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.
CONTACT: Ron Hosking, Vice-President, Finance, Tel: (416) 222-3449, Email:
rhosking@premdinc.com; Michelle Rabba, Manager, Corporate Communications,
Tel: (416) 222-3449 ext. 25, Email: mrabba@premdinc.com
