HISTORY OF LIFELINE BIOTECHNOLOGIES, INC. ("Lifeline, LBTI or The Company")
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.