Replies to post #26661 on Lifeline Biotechnologies Inc (LLBO)

[confirm]

FDA Class11 (mid of article):
Cyrcadia, Inc. Prepares for iTBra™ Product Launch and Expands Strategic Operations to Asia
by admin | Apr 25, 2017 | News
Cyrcadia, Inc.(CI) announced this week a strategic expansion to accelerate operations and market launch into Asia for early breast cancer monitoring. CI has entered into a License and Cooperation Agreement Cyrcadia Asia, Ltd. (CA), a newly formed company in Hong Kong which will serve as the base for the Asia market launch of CI’s proprietary iTBraTM technology expected to commence in late 2017 or early 2018 under the global CI brand of Cyrcadia Health. Under the License and Cooperation Agreement, Cyrcadia Asia has exclusive marketing rights to the iTBra technology and products in Asia. CA will assume and fund certain further product development and other activities with respect to the iTBra technology and products for the benefit of both CI and CA. The License and Cooperation Agreement also provides for certain other financial terms between the two parties intended to enable the launch of the technology and products in Asia. CI retains exclusive marketing rights to the United States, Mexico and Canada, with the marketing strategy for the iTBra technology and products in other countries to be further discussed by the parties. Having obtained U.S. FDA 510(k) Class II approval for its iTBra technology, CI has conducted clinical trials in the U.S. with its newly developed scalable product, which demonstrates greatly improved outcomes, beyond historical product results. CI’s predictive analytic artificial intelligence (AI) based technology now demonstrates 80%+ accuracy with a two-hour wear when compared with the original trials which required 48-hour wear and achieved 74% accuracy. CI and CA expect this greatly improved performance to support the use of the 510(k) approval to launch the technology and products...


FDA Class11: (last par)
Cyrcadia, Inc. Wins Prestigious Cannes Lions Awards
by admin | Jul 25, 2017 | News
Cyrcadia, Inc. (CI) announced it has won two prestigious awards at the Cannes Lions International Festival of Creativity, a global event for the creative communications, marketing and advertising world. Held in Cannes, France and attended by over 10,000 delegates, Lion awards are considered the most coveted in the industry. The first award was a Bronze Lion in the category of Innovation, which honors ground-breaking technology and problem-solving. It specifically looks at how technology, data and ideas, when working in unison, can revolutionize lives. Cyrcadia shared the Bronze award with industry giants such as Google, Shell and Apple. The second award was a Silver Glass Lion award, recognizing ideas that could change the world and positively impact gender inequality or injustice. Cyrcadia’s ability to deliver early breast cancer health monitoring to the mass populations of women who have little or no access to quality health care was key to Cyrcadia’s award achievement. Cyrcadia is developing and marketing a device and software that monitors for biometric changes that correlate to breast cancer . Known as the iTBra, the device is based on wearable sensor patches that are placed under a woman’s own garments and worn for two hours. The sensor data results processed through Cyrcadia’s artificial intelligence (AI) lab can be automatically communicated to the patient, her physician and insurance company. Based on Cyrcadia’s monitoring device, a patient will be recommended for further investigation by a physician. The company’s technology has obtained U.S. FDA 510(k) Class II clearance. While the technology is based on historic data from a trial of 200 patients, recent validation trials on 46 patients have confirmed prior...