Lifeline Biotechnologies Updates FDA and DTC Status

Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) announced today that the Company has received its FDA consulting firm’s analysis and requirements for the preparation of an FDA medical device submission.

Jim Holmes, Lifeline’s CEO, said, “Our FDA consulting firm has completed their review of the First Warning System™. We have spent most of 2010 reviewing, with two different FDA consulting firms, the historical development of the First Warning System’s™ hardware, software, and the testing process (approximately 500 women tested in three different venues). Their opinion has indicated an additional limited clinical trial (less than 100 women) is most likely required to further validate and verify the development process and the results of the prior testing. The last round of testing we conducted is now several years old and those trials were conducted with the second generation First Warning System™ hardware. The development of new technologies and state-of-the-art materials necessitates the re-engineering of the First Warning System™ data acquisition hardware as we start to develop our go-to-market device. Since the last trials took place, our software engineers have been diligently re-developing the interpretive software of the FWS known as CAPP (Computer Assisted Physiological Profile). It is now time to conclude the development of the system and prepare the comprehensive market ready device and system for FDA approval.

“Additionally, we have contacted several CROs (independent Clinical Research Organizations), one of which will be selected to conduct the prospective limited clinical trial. Subsequent to the conclusion of the successful limited clinical trial our FDA consulting firm will assist us in the final preparation of a Class II 510(k) medical device submission to the FDA. Upon clearance by the FDA, our First Warning System™ is expected to be ready for commercialization. The First Warning System™ is a process designed, engineered and patient tested, to assist in the identification of breast tissue abnormalities, some of which may be pre-cancers or cancer. Concerning the question of timing to market ready, the best estimate we can suggest at this time could be 15 to 18 months.”

Holmes went on to say, “I know I am repeating, but it is worth noting, though the trading volume and stock price, as quoted in the public market, has declined as a result of the DTC situation, the intrinsic value of Lifeline’s First Warning System™ has not declined. In fact, several significant achievements in 2010 have increased the intrinsic value. Additionally, we continue to attempt to resolve the DTC situation and re-establish clearing services.”

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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