LLBO Lifeline Biotech Inc (CE)

Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) announced today that the Company has completed an independent market survey. Additionally management has updated the Quality System as required by the FDA.

In efforts to execute a commercialization strategy for the First Warning System™, Management reported the Company has completed a market survey, conducted by an independent market research firm. The survey included a description of the First Warning System’s technology and process focused as a potential assistance in the early detection of breast tissue abnormalities. The survey included over 30 physicians, more than 150 potential users and three managed care payers. The results of the survey were very optimistic and confirmed Company Management’s expectation that the First Warning System, with its features and benefits, holds a significant market potential.

Further, Lifeline’s FDA consulting firm has completed their Gap Analysis and external audit of FWS’ FDA and ISO required Quality System. Results of the analysis lead the Company to implement a new Quality System according to the Code of Federal Regulations Title 21 (21 CFR 820) and ISO 13485 which will allow the First Warning System to eventually be marketed in the United States and the EU. These measures were also undertaken to allow the Company to pursue FDA filing, as well as obtain a CE mark for internal marketing clearances.

Management has made an initial request for proposal from a qualified, experienced and highly recommended CRO (Clinical Research Organization). The CRO will assist in the development of the pending and final clinical trials. Once received, their proposal is expected to provide an indication of the scope, time and cost of the clinical trial. The clinical trial will have to be successfully completed prior to the preparation and submission of an FDA market clearance request. Management’s best estimate at this time is that the First Warning System is most probably at least 18 to 24 months from FDA clearance.

Jim Holmes, Lifeline’s CEO, said, “Our efforts continue to reestablish DTC’s (Depository Trust Corporation) services to the Company. We have provided all information requested by our attorneys and are hopeful DTC will soon reestablish 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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