Reno, Nev. Aug. 11, 2015 — Cyrcadia, Inc. (“Company”) announces its clinical trial listing on ClinicalTrials.gov for its wearable breast cancer early detection device at El Camino Hospital, in Mountain View, California and upcoming additional clinical study sites. ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and is the largest clinical trials database, currently holding registrations from over 130,000 trials from more than 170 countries in the world.
“We are enthused that we have initiated the El Camino Hospital trial in Mt. View, CA and have now finalized the ClinicalTrials.gov registry. We look forward to the additions of The James Cancer Hospital at The Ohio State University and the Canary Center at Stanford’s upcoming inclusion into our early breast cancer screening trials,” says Rob Royea, President of Cyrcadia, Inc.
For those interested in learning more about the Cyrcadia clinical studies, ClinicalTrials.gov is the registry to use including all details about the study and its status. It is the only location where Cyrcadia will divulge information about the studies and will update the registry from time to time. All information desired about the clinical studies can be obtained there and will not otherwise be divulged by Cyrcadia, its staff or other related parties. All details about the study including descriptions, eligibility and contacts can be obtained there. Please follow this link: ClinicalTrials.gov/Cyrcadia or go to the clinicaltrials.gov website using the identifier NCT02511301 to learn more and follow progress of the study as it is reported.
Utilizing its previous FDA cleared device as a predicate, Cyrcadia, Inc. is combining the Company’s fourth generation, wearable device technology, made by Flextronics, and the SalesForce database software, to track the clinical results. Previous trials comprised of 500 participants, using Cyrcadia’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’s screening technology could provide a much earlier alert to the state of cancer for this difficult to image population.
“We are targeting both the 70% 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, Inc. “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.”
Cyrcadia, Inc. would also like to note the addition of an information dissemination platform approach through its website and social media channels under a Social Media Disclosure that is now on the website and included in this communication. This approach allows for timely release of public information in an appropriate means and format. Please see the Social Media Disclosure at the end of this press release or visit the “Investors” tab of the Cyrcadia, Inc. website: http://cyrcadiahealth.com/investors/
To learn more, visit our website, find us on Facebook, follow us on Twitter, or view our videos on YouTube. For a physician referral, visit our website or call the El Camino Health Line at 800-216-5556.
About Cyrcadia, Inc.
Cyrcadia, Inc. (doing business as Cyrcadia Health), founded as First Warning Systems in 2008, is based in Reno, Nev. The company’s product line is a wearable 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 equal to and superior outcomes when compared to other diagnostic protocols. Cyrcadia is undergoing a final, limited clinical trial and a 510k device classification to validate the fourth generation of the product. Cyrcadia technology is exclusively licensed for development, manufacturing and marketing worldwide from Lifeline Biotechnologies, Inc. (OTC: 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. Visit Cyrcadia, Inc. at www.cyrcadiahealth.com.
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 cancer care, key medical specialties include behavioral health, heart and vascular, men’s 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.
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.
Social Media Disclosure: Investors and others should note that we announce material information to our investors using this website, press releases, public conference calls and webcasts. We also use social media to communicate with our subscribers and the public about our company, our services and other issues. It is possible that the information we post on social media could be deemed to be material information. Therefore, we encourage investors, the media, and others interested in our company to review the information we post on the U.S. social media channels listed below. This list may be updated from time to time.
CyrcadiaHealth.com
Cyrcadia Health Facebook Page
Cyrcadia Health Twitter Account
CEO Rob Royea’s Twitter Account