Cyrcadia Health Expands Breast Cancer Screening Trial to The Ohio State University

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Stefanie Spielman Comprehensive Breast Center to Enroll Patients in Study

We are targeting both the 70 percent of the population that undergo biopsies on non-cancerous tissue resulting from mammographic referral and mass screening of patients with dense breasts

Cyrcadia Health is pleased to announced the expansion 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 and mass screening of patients with dense breasts,” said Rob Royea, president of Cyrcadia Health. “Patients with dense breast tissue have a higher propensity for cancer. Furthermore, mammography is challenged by detecting cancer in dense breast tissue as the tissue itself can mask cancer cells and lesions.”

One in eight women in the U.S. are diagnosed with breast cancer annually, and approximately 500,000 women die worldwide from the disease each year, many due to lack of early detection. Cyrcadia’s wearable, smart phone-enabled iTBraTM technology, uses a comfortable data collection device placed under a bra to collect from two to twelve hours of breast cell data (dynamic cell chaos). Circadian rhythm-based temperature variances of cell cycles are then measured through a Cyrcadia-patented process to identify abnormalities at the earliest stages of cellular change over time.

The results collected from the technology are transferred through a smart device to a global cancer library, where advanced analytical analysis occurs. The results then are communicated back to the patient and physician.

“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 our study to The Ohio State University is truly exciting, as The Ohio State University was the point of origin for the initial 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 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 biomarker identification for breast cancer. The ability to correlate the Cyrcadia findings with those biomarkers, which are early indicators of breast cancer cell infusion, are invaluable and could lead to earlier therapy intervention in the progression of breast cancer.

“We are looking forward to participating in the Cyrcadia study,” said Dr. Farrar. “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.”

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 Cyrcadia, Inc.
Cyrcadia, Inc., also known as Cyrcadia Health, was founded as First Warning Systems in 2008, is based in Reno, Nev. 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 underway in a final, limited clinical trial and a 510k device classification to validate the product. Cyrcadia technology is exclusively licensed for development, manufacturing and marketing worldwide from Lifeline Biotechnologies, Inc (OTC Market: 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. Furthermore, Cisco Systems, Inc. has financially supported the making of a documentary by Ironbound Films about the evolution of Cyrcadia technology, called “Detected Movie” to be released . Please visit http://www.DetectedMovie.com and Cyrcadia Health at http://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 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.

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