RENO, NV - (NewMediaWire) - December 23, 2015 - The Company (OTC PINK: LLBO) updates the meaningful activities for the year of 2015 and looks ahead for 2016.
Year 2015 has been a very busy year for Lifeline's ("The Company") primary investment, and principal activity, Cyrcadia, Inc. ("CH"). Cyrcadia is achieving meaningful value additions as it drives through its current clinical trials at El Camino Hospital, Mountain View, CA. Cyrcadia is diligently pursuing the addition of a key clinical site at the Ohio State University's (OSU) Oncology Hospital, Columbus, Ohio, headed by Dr. William Farrar. Information regarding the pace and conduct of clinical trials is released by Cyrcadia at its board and management team's discretion though the website, www.clinicaltrials.gov. Cyrcadia reports that it is currently screening patients at El Camino and reports to the Lifeline Biotechnologies Board have been positive. The addition of OSU, which is forecast to come on stream early in the first quarter of 2016, is expected to accelerate the pace of trials as the patient population and volume is far more significant.
There has been a great deal of interest generated from other clinical sites including that of the Canary Research Foundation Center at Stanford University. These opportunities are in early stage and will not preclude any activities at the main validation study sites of El Camino Hospital and OSU. However, the interest and validation of these opportunities and pursuits greatly expand on the value of the efforts of Cyrcadia's endeavors, but do not preclude pace or time to market.
Cyrcadia expects to be filing notification for 510(k) clearance in the first half of 2016. A filing does not guarantee clearance, but it will be a significant stride toward allowance for both CE marking and 510(k) clearance with a goal of both domestic and international marketing.
In addition to clinical validation and pre-marketing efforts, Cyrcadia has been nominated for a significant Edison Award™, joining the ranks of previous winners including 3M, Disney, Craftsman, Johnson Controls, Dyson, and Logitech. The Edison Award is a competitive award program that highlights the strong marketing value of an unbiased third party endorsement. The value of an Edison Award™ is powerful in terms of its ability to boost recognition and market visibility.
These major strides over the past year tie together the Company's ability to drive through the significant developmental and regulatory efforts required to bring this important lifesaving technology to market. Year 2016 expectations are: the clinical trials will be completed, the regulatory filings will be submitted pursuing clearance through FDA 510(k) and CE mark authoritative bodies. The Company and Cyrcadia have, in joint, begun exploring prospective additive strategies that can accelerate increased value and liquidity. Those shall be reported upon given validity.
About Lifeline Biotechnologies, Inc. In 2008, the principals of Lifeline Biotechnologies created Cyrcadia, Inc. via stock ownership and a revenue royalty based license of its patented, circadian rhythm based, pattern recognition technology. Lifeline conducted three rounds of proof of concept trials, testing over 500 patients. The initial trial was conducted at Ohio State University's oncology hospital. The principal investigator for that trial was Dr. William Farrar. The patients were also tested by the mammogram process and the results were compared. Overall, Lifeline's process was superior in identifying breast tissue abnormalities and breast cancer at earlier stages. The test results were validated by the aerospace engineers (foremost pattern recognition engineers in the world) at Nanyang Technological University "NTU"), Singapore. The principals of Lifeline and the engineers at NTU filed for and received patents on the technology. Those patents were assigned to Lifeline Biotechnologies. The patents are the basis of the license granted to Cyrcadia. The main purpose for creating Cyrcadia was to increase the value and reduce the cost of capital. This has been confirmed. At the time of Cyrcadia's formation, Lifeline's value was less than six hundred thousand dollars ($600,000). Currently, Lifeline's value is over six million dollars ($6,000,000), a tenfold increase. The current value is projected to grow with Cyrcadia's future achievements.
About Cyrcadia Health Cyrcadia, Inc., also known as Cyrcadia Health ('CH"), founded as First Warning Systems in 2008, is based in Reno, Nev. CH's product line is a device and software service that detects breast tissue abnormalities leading to health risk assessment and management including early breast cancer identification. Cyrcadia is underway in a final, limited clinical trial and a 510(k) device clearance to validate the fourth generation of the product. Cyrcadia's technology is exclusively licensed for development, manufacturing and marketing worldwide from Lifeline Biotechnologies, Inc. Cyrcadia is preparing to apply for FDA clearance and CE Mark with the intent of marketing in the European Union and Asia Pacific markets in 2016. Visit Cyrcadia Health at www.cyrcadiahealth.com.
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.