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Thursday, March 12, 2015 6:59:07 AM
Company Information
http://www.lbti.com/#!info/c4nz
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.
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.
Products (iTBra)
http://www.lbti.com/#!first-warning-system/cm7b
The iTBra™
The iTBra™ is a wearable breast tissue abnormality screening tool and database. The device, called a Circadian Biometric Recorder (CBR), takes in thermodynamic data periodically from a woman’s breasts over a given time period. This data is then fed into a proprietary analytics software system. This software utilizes bioinformatics algorithms that are self-learning, continually improving patient outcome sensitivity, specificity, and accuracy.
Investors Relations
http://www.lbti.com/#!investors/c6w
The Company’s product, the iTBra™ (formerly the First Warning System™), is in the process of preparing for a 510(k) submission to the FDA.
Recent News (pointing to Cyrcadia and iTBra)
http://www.lbti.com/#!news/c1tii
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