Mountain View, CA, July 7, 2015 - Cyrcadia Health, Inc. announces it is entering a clinical trial for its wearable early detection of breast cancer device and is enrolling the first trial participants at El Camino Hospital, in Mountain View, California. Utilizing its previous FDA cleared device as a predicate, Cyrcadia Health is combining the company’s fourth generation, wearable device technology, made by Flextronics, and Salesforce database software to track results.
“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 Health. “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.”
Following successful completion of the clinical trials, Cyrcadia intends to produce a wearable, smart phone enabled technology, called the iTBraTM, which will utilize 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 patented process to identify abnormalities at the earliest stages of cellular change, the results of which are transferred through a smart device to a global cancer library, where advanced analytical analysis occurs, and results are communicated back to the patient and physician.
“El Camino Hospital is pleased to be involved in Cyrcadia Health’s research study to evaluate this potential new technology,” said Katherine Sutherland, MD, co-investigator for the iTBra trial at El Camino Hospital. “Participation in this trial is another way we continue our effort to bolster early breast cancer detection.”
Dr. Katherine Sutherland and Dr. Imtiaz Qureshi will lead El Camino Hospital’s work to enroll more than 170 trial participants. Cyrcadia Health’s study is expected to enroll approximately 250 at three sites across the U.S.
One in eight women in the U.S. alone are diagnosed with breast cancer annually and approximately 39,000 die from the disease each year, many due to lack of early detection. Previous trials comprised of 500 participants, using Cyrcadia Health’s non-compressive, non-irradiative technology, demonstrated significant promise in addressing the dense breast tissue population by using machine-learning predictive algorithms. With a higher propensity for cancer and limitations of current imaging standards, such as mammography, Cyrcadia Health’s screening technology could provide a much earlier alert to the state of cancer for this difficult to image population.
About El Camino Hospital
El Camino Hospital is an acute-care, 443-bed, nonprofit and locally governed organization with campuses in Mountain View and Los Gatos, Calif. In addition to sleep care, key medical specialties include cancer, men's health, mental health, neuroscience, orthopedic and spine, senior health, urology, and the first Women's Hospital in Northern California. The hospital is recognized as a national leader in the use of health information technology and wireless communications, and has been awarded the Gold Seal of Approval from The Joint Commission as a Primary Stroke Center as well as back-to-back ANCC Magnet Recognitions for Nursing Care.
About Cyrcadia Health, Inc.
Cyrcadia Health, Inc., 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 Health is planning a final, limited clinical trial and a 510k device classification to validate the fourth generation of the product. Cyrcadia Health technology is exclusively licensed for development, manufacturing and marketing worldwide from Lifeline Biotechnologies, Inc. (OTC Market: LLBO). The company is preparing to apply for a Euro CE Mark to market in the European Union and Asia Pacific markets, with FDA applications following for the US market.