LLBO Lifeline Biotech Inc (CE)

Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) today reported on the results of the FDA submission of its First Warning System™, filed in July 2009.

Jim Holmes, Lifeline's CEO, said, "This past July we filed with the FDA to determine if our technology and testing of over 600 patients would meet the requirements for a 510(k). The FDA recently responded issuing a non-binding opinion as to the potential classification of the First Warning System™. The letter’s author noted that a number of classification possibilities are available for the System, including a potential 510(k).”

Subsequent to this response, management has begun a relationship with a consulting firm to help develop, design and implement a regulatory strategy and path for commercialization in the U.S. as well as a potential CE mark for international distribution. Strategy development and planning should take between one and three months to complete, including the preparation of the FDA application. Efforts for regulatory approval will commence subsequently.

Provided no additional clinical testing is required and according to our best estimate at this time, a 510(k) filing could take approximately four to six months or possibly longer for the FDA to clear our application. Once cleared by the FDA the First Warning System™ could immediately commence commercialization.

We've also received many questions concerning the prospect of a reverse split of the common stock. Even though the outstanding common stock is approximately 2.9 billion shares, and may be increased from time to time for additional required funding, we have no plans for a reverse split at this time."

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.

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