Lifeline Biotechnologies, Inc. Prepares an FDA Filing
27 Mayo 2009 - 7:30AM
Business Wire
Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) today
announced that management is preparing for a filing with the FDA
for the Company�s First Warning System�, a capable process designed
to assist in the early detection of breast cancer.
Jim Holmes, CEO of Lifeline, said that its �subsidiary, First
Warning Systems, Inc., is focused on preparing a preliminary filing
with the FDA. The FDA�s response to this initial filing could take
several months to receive. We expect the FDA�s response to give us
guidance for the subsequent filing required in order to obtain
marketing clearance for this proprietary process.�
Lifeline Biotechnologies has in the past year filed for a patent
on the recent technological advancements of the First Warning
System�, which 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 a well known
fact that mammograms are missing an estimated 20% to 30% of the
breast cancers.
Holmes noted that �Brass Bulls, an investor relations firm
previously assisting the Company, will no longer be used as their
consulting agreement has expired. The Company�s website has been
updated and our direct phone number has been included thereon.�
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.
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