Lifeline Biotechnologies Expects FDA Consulting Firm's Report

Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) today reported expectations of its FDA consultant’s report by the middle of this month. The anticipation is based on the commitment by Lifeline’s FDA consulting firm.

Jim Holmes, Lifeline's CEO, said, “This past January we retained an FDA consulting firm to review our clinical processes and our software systems in order to ensure compliance with FDA verification and validation requirements. We have been working closely with these consultants, providing the information they have requested. The firm has concluded its study for Lifeline’s regulatory strategy and is preparing their findings in a report to be delivered shortly. This firm was retained to the review the existing product, the clinical trial records, as well as the intended use and marketing claims of our First Warning System™. The overall task of the consulting firm is to define a regulatory strategy for the First Warning System™ to obtain product commercialization.”

Doctor Louis Keith, Lifeline’s Vice President and Medical Director, said, “We are eager to receive the consultant’s report. From this study our expectation is to prepare and submit an application to the FDA for a 510(k) marketing clearance.”

Safe Harbor: This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, the ability to obtain financing, successful development of the Company's product or market acceptance of the product and regulatory and shareholder approval for anticipated actions.

Lifeline Biotech (CE) (USOTC:LLBO)
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