Lifeline Biotechnologies Updates Current Matters
RENO, NV — (Marketwired) — 06/13/16 — Lifeline Biotechnologies, Inc. (“The Company”) (OTC PINK: LLBO) updates its shareholders and provides information to the public.
Lifeline has entered into an option agreement with its affiliate, Cyrcadia, Inc. which grants certain rights to potentially acquire Lifeline’s patents. Cyrcadia is currently conducting validation clinical trials on Lifeline’s patents and other intellectual property. Upon achieving successful results, regulatory filings and clearances, Cyrcadia will pursue the market and sales of the products. Financial resources are required to support these value additions to the IP and Cyrcadia. Financial sources have indicated that providing the required funding is more likely to be secured based on Cyrcadia owning the technology. Certain preliminary conditions are perquisite to the transfer and have been mutually defined between the companies. Lifeline will review Cyrcadia’s progress and prospects of achieving its business model. Lifeline will determine, in its sole judgment, if acceptable progress has and is being made, and that adequate financing is available, upon acceptable terms, to support the requirements. Assuming a transfer of the patents would occur, Lifeline’s holdings, currently the largest single shareholder in Cyrcadia, would increase.
Cyrcadia has and will be seeking multiple resources to execute its business plan, including major companies interested in Cyrcadia’s technology and its proven early breast cancer detection process. The selected major collaborator or partner would provide multiple needs, such as finance, management, technology resources, brand identification, marketing and sales channels.
Jim Holmes, LLBO CEO, said: “Regarding the dissemination of information to Lifeline shareholders and other interested parties, according to securities law regulations, we cannot discuss information that has not previously been addressed and made public in our press releases or other regulatory filings. Concerning Cyrcadia’s ongoing clinical trials, we can only discuss information and updates as permitted by FDAA Clinical Trial Guidelines. The Company is aware that often, postings on various internet hubs and discussion boards represent direct discussions and communications with Company executives and that those posters have particular information obtained from the Company. Please be aware and cautious as these representations are unfounded and cannot be relied upon for any purpose valuing the Company’s assets or securities.”
Jim Holmes further stated, “We suspect the decline in the market price of our Common Stock is, at least in part, a result of the extended period of time, from previous estimates, for Cyrcadia’s completion of the current and ongoing clinical trials. Cyrcadia’s management anticipated a more rapid patient participation in their earlier forecasts. Regarding the pace of clinical trials as sponsored by Cyrcadia, it is a matter that is not under control of the management of the company, but a number of other forces and procedures as dictated and implemented by each clinical study site and Good Clinical Practices as given by directives through entities such as the FDA. The pace of any trial is subject to factors such as the number of available patients that meet the inclusion criteria of the study, as well as that individual’s willingness to participate in the study. Some of the roles that Cyrcadia takes in its studies are that of drafting study protocols, maintaining the legal and Good Clinical Practice structures and sponsoring the cost of the studies. Cyrcadia is otherwise a ‘hands-off’ sponsor regarding the study’s pace and outcomes. Furthermore, FDAA regulations will not permit reporting on ongoing clinical studies until completion of those studies. Further information cannot and will not be disseminated for Cyrcadia or Lifeline.” (See: Federal FDAAA 801 guidelines, Cyrcadia will release information on trial location additions, as well as clinical trial data only at time of trial completion or FDA clearance for disclosure).
Comments by Rob Royea, President of Cyrcadia and Dr. Shyamali Singhal, founder of the El Camino Hospital Cancer Center
“We are targeting both the 70 percent of the population that undergo biopsies on non-cancerous tissue resulting from mammographic referral, as well as mass screening of patients with dense breasts,” said Rob Royea, President of Cyrcadia. “Patients with dense breast tissue have a higher propensity for cancer. Furthermore, mammography is challenged by detecting cancer in dense breast tissue as it can mask cancer cells and lesions.”
“We have had a great deal of interest in this technology that may change the need for a breast biopsy,” said Dr. Shyamali Singhal, founder of the El Camino Hospital Cancer Center. “The trial at El Camino Hospital opened with strong interest from the patient population and the early results are indeed promising. We look forward to further involvement with the Cyrcadia study here at El Camino Hospital.”
About Lifeline Biotechnolgies, Inc.:
In 2008, the principals of Lifeline Biotechnologies, a Nevada corporation, based in Reno, NV, 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, of the three, 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.
About Cyrcadia, Inc.:
Cyrcadia, Inc., a Nevada corporation, also known as Cyrcadia Health, was founded as First Warning Systems in 2008, and is based in Reno, NV. The company’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. Three clinical trials with over 500 participants have achieved proof of concept and superior outcomes when compared to other diagnostic protocols. Cyrcadia is in a final, limited clinical trial and a 510(k) device classification to validate the fourth generation of its product. Cyrcadia technology is exclusively licensed for development, manufacturing and marketing worldwide from Lifeline Biotechnologies, Inc. (OTC PINK: LLBO). Cyrcadia is preparing to apply for FDA Clearance and a Euro CE Mark to market in the European Union and Asia Pacific markets, with anticipation of launching its technology to market in 2017. Cisco Systems, Inc. is financially supporting the filming of a documentary by Ironbound Films called “Detected Movie” to be released about the evolution of Cyrcadia technology. Please visit www.DetectedMovie.com and Cyrcadia Health at www.cyrcadiahealth.com. Per Federal FDAAA 801 guidelines, Cyrcadia will release information on trial location additions, as well as clinical trial data only at time of trial completion or FDA clearance for disclosure.
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.
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