|
Jim Holmes, CEO
Lifeline Biotechnologies, Inc.
Corporate Office
1325 Airmotive Way, Suite 175
Reno, NV 89502
F 775.852.7551
Investor Relations
T 866-284-2835
E info@e-mediadirect.com
|
|
|
 |
|
Lifeline Biotechnologies, Inc. in Discussions with Firms to Begin Filing FDA 510(k) Submission for First Warning System™
RENO, Nev.--(BUSINESS WIRE)--Lifeline Biotechnologies, Inc. (Pink Sheets:LLBT) today announced that the Company has been in discussions with various firms to help with the preparation of filing the 510(k) with the U.S. Food and Drug Administration (FDA). The selected firm will help with the verification and validation guidelines, and the Company expects to announce its selection soon.
A 510(k) is a premarket submission made to the FDA to demonstrate that a device to be marketed is substantially equivalent to an existing legally marketed device in the U.S. Submitters must compare their device to one or more similar legally marketed devices and make and support their “substantial equivalency” claims. A submitter’s product may be marketed after 510(k) clearance is granted.
“We have been working on the research and development of the First Warning System™ for many years and are excited to be selecting a firm that can assist us in properly filing the 510(k) to the FDA. Once the 510(k) process has been started, we expect the acceptance to be completed as soon as possible so that First Warning System™ can be marketed to the public,” stated Jim Holmes, CEO of Lifeline Biotechnologies, Inc.
Lifeline recently announced that the Company has expanded worldwide to continue testing the First Warning System™ technology, which is designed to assist in the detection of breast cancer. In 2008, Lifeline expects to be testing patients in Singapore at a hospital associated with Nanyang Technical University, and the results will be used to further the improvement of the First Warning System™.
About Lifeline Biotechnologies, Inc.:
Lifeline Biotechnologies, Inc. is an innovative medical technology company that is focused on completing the development of the First Warning System™, which was designed to assist in the early detection of breast cancer. Of the approximately $138 billion spent on cancer each year, Lifeline could potentially save the healthcare industry up to $4.1 billion annually, assuming the following are successfully completed: the development of the First Warning System™, the completion of clinical trials and FDA pre-marketing clearance. Lifeline competes in the money markets for funds to support the continued development of its product. The cost of funds, for early stage companies like Lifeline, are 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 and regulatory and shareholder approval for anticipated actions.
Contact:
Lifeline Biotechnologies, Inc.
Investor Relations
1-886-THE APPL(E)
www.lbti.com
Source: Lifeline Biotechnologies, Inc.
| |
