Lifeline Biotechnologies Reports on FDA Filing Preparation
February 02 2010 - 1:20PM
Business Wire
Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) today
reported the regulatory strategy for its First Warning System™ is
well underway and the development of an FDA submission for a 510(k)
marketing clearance is expected to be filed later this year.
Jim Holmes, Lifeline's CEO, said, "The FDA, in its recent
response, opined that the claims concerning the First Warning
System’s ability to identify prospective cancerous conditions of
the breasts, as set forth in Lifeline’s submission to the FDA in
July 2009, would require modification or a premarketing approval
process for a Class 3 device. In the development of our regulatory
strategy, we have engaged the services of an FDA consulting firm,
whose task will be to review the claims made and recommend the
appropriate modifications to said claims in order to allow our
device to comply with the 510(k) Class 1 or Class 2 medical device
guidelines. Our FDA consulting firm is also conducting a thorough
review and validation of the testing processes Lifeline utilized in
the gathering of physiological patient data obtained from over 600
patients in three different clinical trials. In addition, the FDA
consulting firm will make a thorough review of our patent pending
interpretative computer software system in order to ensure
compliance with FDA verification and validation requirements. Our
software system technology was developed by Lifeline
Biotechnologies, together with our ‘Pattern Recognition’ experts at
Nanyang Technological University, Singapore.
"Once the review has been completed we intend to move forward a
fully-compliant 510(k) submission. The submission will be based on
the regulatory strategy and could/should be filed by midyear
2010.
"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 or
other services, 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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