Lifeline Biotechnologies, acquired Chronodynamics in 1994. Chronodynamics, prior to the acquisition, had developed the early breast cancer detection technology, First Warning System, including FDA 510(k) clearance for the patient data collection device. The technology was developed as an early cancer screening tool performing non-invasive tissue analysis through algorithm based neural nets (pattern recognition), trained on known breast cancer data. The process detects cell change at the molecular level. The process involves a patient wearing a halter monitor type device, with eight sensors applied to each breast. Each sensor records tissue temperature changes over 12-24 hours, taking periodic readings. The data acquired is sent to First Warning’s Analytics Software under strict HIPAA standards, where the patient data is analyzed by proprietary/patented software. A report as to the condition of the breast tissue is then provided to the patient’s physician for his/her follow up and determination if treatment is required. There is no radiation or compression in the process and it is noninvasive.
In early development, Chronodynamics had completed two rounds of testing involving approximately 350 women. The first proof-of-concept trials were conducted at The Ohio State University’s Oncology Hospital. The next round of study was conducted at Green Memorial Hospital, Dayton, Ohio. The Green Memorial Principal Investigator was Dr. Ronald Fletcher. Dr. Fletcher was head of oncology at Green Memorial and former head of the Health Department for the State of Ohio. The last round of patient testing with 188 subjects was conducted at Clem Plam Breast Clinic, La Plata, Argentina under the direction of Dr. Marten Laguens, a noted Argentinian Pathologist at the University of La Plata. The System proved to have similar accuracy to mammography across all tissue types. In addition, the system found tissue abnormalities, where the biopsy proved the state of cancer, in patients with smaller tumors than normally visible with mammography, and with those difficult to image or "dense breasted" populations that mammography was simply unable to ascertain.
Management then engaged groups of aerospace and computer engineers from Nanyang Technological University (NTU) and Ngee Ann Polytechnic University (NAP) respectively, both in Singapore, to review the patient data and validate the results. The request made of these pattern recognition and algorithm experts was to improve and expand the neural nets and their capabilities to identify cancers. Following NTU’s validation, the principals of Lifeline and the engineers at NTU and NAP filed for three US software patents. The patents were granted in 2012. The patents were assigned by the five inventors to Lifeline Biotechnologies.
Upon validation of the technology, Lifeline formed an affiliate, First Warning Systems, Inc. (now Cyrcadia Health) in 2008 to obtain a better valuation of the technology and reduce the cost of capital and dilution. A license, in exchange for shares and a revenue royalty of FWS, was entered into conveying rights for further development of the technology and the worldwide marketing rights.
CURRENT STATUS AND FORWARD EXPECTATIONS
Cyrcadia has conducted several rounds of funding, providing the financial resources for upgrading the Lifeline technology and preparing for product deployment in early 2015. There is an FDA regulatory clearance for the software integration with the hardware (device) via a 510(k) required for US market entry as well as a CE Mark required for market entry outside the US. Emergo, Cyrcadia's regulatory consulting firm has opined the CE Mark should be obtainable based on current data and testing results.
Regarding the DTC “Chill” and the thin trading of Lifeline’s stock (OTC: LLBO), Lifeline has brought its disclosure information current on OTC Market (otcmarkets.com), removing the trading stop sign. Lifeline and many other companies were ensnared by the conduct of a few unscrupulous traders who participated in the transactions of shares of those companies. Through diligence and effort, Lifeline has proven no culpability in those activities and the DTC "Chill" has sinced been lifted. LLBO is now free and clear to trade through most all borkers.
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About Lifeline Biotechnologies:
Lifeline Biotechnologies, Inc. (OTC Market: LLBO) founded in 1994 is based in Reno, NV. LLBO has invested over $10M in a device and process for early detection of breast tissue abnormalities some of which are cancerous or pre-cancer. Three “Proof of Concept” clinical trials of over 500 women have been completed and three patents (one hardware, two software) have been awarded.
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