Cyrcadia, Inc. Prepares for iTBra™ Product Launch and Expands Strategic Operations to Asia

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 into regulated countries in the near term.

CI’s proprietary early breast cancer monitoring technology 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 CI’s artificial intelligence (AI) lab, are automatically communicated to the patient, her physician and insurance company. Powered by this machine-learning process, the greater the population served by the CI AI technology, the more accurate the results become for future patients.

Cyrcadia’s 80%+ accuracy also compares very favorably to mammography which has a published accuracy of less than 50% for the densest of breast tissue. Tissue density, which leads to a higher propensity for cancer, affects 40% of the western population and up to 70% of the Asian population.

To ensure a successful launch in the Asia market, CI’s former CI CEO, Rob Royea has now assume the role of CEO for CA. CI’s co-founder, Matt Benardis, who has been serving in an operational role for CI, has assumed the role of CEO of CI, and initially will focus on the U.S. market with the launch by CI of the iTBra technology and products in the U.S., which CI expects to commence in the near term.

“One of our objectives has been to launch Cyrcadia’s early breast cancer monitoring technology in Asia, where breast cancer is accelerating at twice the pace of the rest of the world,” said Rob Royea, CEO CA. “With a much higher breast density population, virtually no nationalized screening initiatives, and the average age for breast cancer incident rate being approximately 20 years earlier than for those women in Europe and the U.S., a wearable technology such as Cyrcadia’s is addressing a clear and urgent need in Asia. There is great interest by several global insurance providers to partner with Cyrcadia Health in delivering our wearable monitoring to Asia expected by late 2017.”

“The License and Collaboration Agreement between CI and CA brings advantages for both parties,” said Royea. “The opportunity for early market entry and funding from the Asian operations brings additional funding into CI to exercise its option, under an Intellectual Property Asset Option Agreement with the technology’s developer to acquire directly certain patents which previously had been licensed to CI. Those patents are in the process of transferring to CI to be fully owned by CI, and they are licensed to CA under the License and Collaboration Agreement. Furthermore, the License and Collaboration Agreement allows for CI and CA to cooperate on global expansion of the intellectual property portfolio.”

Under the License and Collaboration Agreement, CI and CA have also established a joint venture, Cyrcadia Data Services, Ltd. to fund and develop the Cyrcadia health predictive analytics core lab. This entity will ensure improved accuracy in the technology as the companies feed in large volumes of data from their respective regions.

CI’s CEO Matt Benardis, sees the new structure as a win-win for all parties. “The new partnership with Cyrcadia Asia, Ltd. provides an accelerated speed to market globally,” said Benardis. “The Cyrcadia Health brand recognition that we can achieve together in large populations, along with the significant expansion of powerful intellectual property, is intended to maximize CI shareholder value as we move to our planned market launch here in North America. The joint venture of our unified predictive analytic core lab is intended to provide the highest possible accuracy for patients and providers of our technology throughout the world.”