Lifeline Biotechnologies Files First Warning System™ With the FDA

Lifeline Biotechnologies, Inc. (Pink Sheets:LLBO) today announced that it has made its initial filing of its First Warning System™ with the Food and Drug Administration.

Jim Holmes, Lifeline’s CEO said that “through its consulting firm, Lifeline has submitted the First Warning System™ process and technology to the FDA. The purpose of this filing is to obtain the FDA’s opinion requesting a classification of this device. The opinion as to the classification is expected to determine the subsequent filing and registration required to clear the First Warning System™ for marketing in the United States. The FDA’s response is expected to take several months.”

Holmes went on to say, “This is a very exciting time for us and those that are interested in this innovative, leading edge, and disruptive technology. The First Warning System is a device and process which assists in the early detection of breast cancer, designed, developed and tested with approximately 700 women. This process has the potential of changing the way breast cancer is identified. After many years and many resources applied, we’ve moved to the important point of entering the process of clearance of this device with the FDA. The next step is expected to be obtaining clearance for market entry.”

Lifeline Biotechnologies previously received two patents on its First Warning System™ hardware and has in the past year filed for a patent on the technological advancements of the First Warning System ™ software. The software has achieved the robust capability of identifying and classifying tissue abnormalities of the breast with sensitivities (ability to identify) of 95% to 100% and specificities (verify) of 87% to 90%. Currently, it is widely recognized that mammograms miss an estimated 20 to 30% of the breast cancers.

Lifeline competes in the money markets for funds to continue the development of its products as well as supporting operating and administrative expenses. The cost of funds, for companies such as Lifeline is expensive and the terms have been, and may continue to be dilutive.

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, ability to obtain financing, successful development of the Company’s product and regulatory and shareholder approval for anticipated actions.