SOURCE: Lifeline Biotechnologies

Lifeline Biotechnologies

April 01, 2016 08:00 ET

Lifeline Biotechnologies Announces a Cyrcadia Milestone and 2016 Expectations

RENO, NV--(Marketwired - Apr 1, 2016) - Lifeline Biotechnologies, Inc. ("The Company") (OTC PINK: LLBO), in conjunction with its affiliate Cyrcadia, Inc. (" Cyrcadia"), is pleased to announce the achievement of a major milestone in Cyrcadia's regulatory and business development path. Cyrcadia Health announced the extension of its clinical trial for early breast cancer detection to The Stefanie Spielman Comprehensive Breast Center at The Ohio State University, in Columbus, Ohio. The trial, which began in 2015 at El Camino Hospital, in Mountain View, California, will continue at both locations to reach enrollment of 173 patients focused on breast cancer health screening.

"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."

"The expansion of the study to The Ohio State University is truly exciting, as The Ohio State University was the point of origin for the original 500 patient study conducted with our previous FDA cleared device," said Royea. "Dr. William Farrar, Professor, Division of Surgical Oncology, Department of Surgery, and Medical Director of the Stefanie Spielman Comprehensive Breast Center was one of our original researchers. His confidence to include the Cyrcadia study at one of the nation's highest rated cancer hospitals is a significant complement to our early clinical trial progress. As we evaluate and potentially add new sites to the study, we will post final results of the study on clinicaltrials.gov once we have reached clearance by the FDA or final trial enrollment."

Current studies are partially supported financially by the Canary Foundation, the only foundation in the world which, over the past 10 years, has focused solely on early cancer detection. Cyrcadia and the Canary Foundation will be collaborating on early biomarkers identification for breast cancer. The ability to correlate the Cyrcadia findings with those biomarkers, which are early indicators of breast cancer, are invaluable and could lead to earlier therapy intervention in the progression of breast cancer. These opportunities are in early stage and will not preclude any activities at the main validation study sites of El Camino Hospital and OSU.

"We are looking forward participating in the Cyrcadia study. Early indications from the original predicate device from Cyrcadia showed promise that the monitor may be useful for screening those women with difficult mammographic interpretation (dense breast tissue)," said Dr. Farrar. "We look forward to further testing these new wearable devices to validate Cyrcadia's use as an adjunctive screening solution to reduce unnecessary biopsies and to determine its abilities to further define cancer in patients with dense tissue."

Cyrcadia expects to file its notification for 510(k) clearance with the FDA parallel with the current 173 patient trial. Such a filing does not guarantee clearance, but it will be a significant step toward clearance for both CE marking and 510(k) clearance with a goal of both domestic and international marketing.

This on-time achievement adds value and validates the Cyrcadia's ability to get through the developmental and regulatory efforts required to bring this important lifesaving technology to market. Year 2016 expectations are that the clinical trials will be completed, the regulatory filings will be achieved which is intended to lead to clearance by the FDA of the 510(k) application and CE Mark authoritative body. Additionally, the Company and Cyrcadia have begun exploring prospective alternative strategies that could accelerate increased value and liquidity.

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. 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 three million dollars ($3,800,000), a six fold increase. The current value is projected to grow with Cyrcadia's future achievements.

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.

About The Stefanie Spielman Comprehensive Breast Center at The Ohio State University:

The Stefanie Spielman Comprehensive Breast Center is part of The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. It is the first of its kind in the Midwest to offer the full continuum of breast cancer care - from prevention and screening through detection, diagnosis, treatment, and survivorship - in one world class facility. The Stefanie Spielman Comprehensive Breast Center is home to a transdisciplinary, multimodality team of nationally renowned breast cancer experts, all singularly focused on preventing, detecting, treating, and curing breast cancer. In this unique environment, breast cancer researchers and clinicians work closely together to deliver the latest innovations to every patient. The Stefanie Spielman Comprehensive Breast Center is designated a Breast Imaging Center of Excellence by the American College of Radiology and is accredited by the American College of Surgeons National Accreditation Program for Breast Centers.

About Canary Foundation:
Canary Foundation is a non-profit organization dedicated to the goal of identifying cancer early through a simple blood test, and then isolating it with imaging. Canary Foundation is based in Palo Alto, California and was founded by Don Listwin in 2004. The program areas of the foundation are early detection for ovarian, prostate, breast, lung, and pancreatic cancer. 

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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