Reported by OTC Markets.
We are pleased to share current information and developments with our stakeholders and the public, February 19, 2019.
Regarding Lifelines investment in Cyrcadia, Inc. (CI), CIs largest shareholder at approximately 35%, Cyrcadia has reported the resumption of its clinical studies at El Camino Hospital (ECH) in Mountain View, CA. The resumption of the studies is the result of improvements to both the iTBra system (hardware and application interface) and improvement of the underlying predictive analytics. The objective and result of the improvements yield a system capable of acquiring patient data in a far reduced wear time, 6 hours vs. 24 hours, a low energy Bluetooth communications system, and a design of the hardware intended for ease of use comfort and transfer to manufacturing for eventual commercialization.
The design, development and commercial grade improvements have been performed by Jabil, a world leader in medical device design and engineering, under a contract with Cyrcadias licensee company, Hong Kong based, Cyrcadia Asia (CA). Cyrcadia Asia is supplying CI with product for the resumption and completion of this round of studies.
CI has recently returned from a site visit at ECH, to kick off the study resumption, reporting a very energetic and eager response from the primary investigator and referring physician at the site. Continued enrollment is expected by late March to early April 2019.
Following the enrollment at ECH, CI will then move to continuation of studies at its other clinical site, Ohio State University. Enrollment of both sites, along with the usability improvements to the CDR-100 system (potentially branded the iTBra) is expected to rapidly accelerate enrollment for completion of the study. The statistical requirement for validation of the study is 173 patients. The study has already achieved enrollment and completion of the initial 66 cases with a balance of 107 to complete. CIs expectation of accelerated enrollment is based on the reduced wear-time along with broader regional outreach at both site locations.
Additionally, CI is preparing for a potential pre-submission meeting with the FDA to ensure regulatory adherence with the intent of achieving marketing clearance. Upon FDA acceptance of the meeting, CI expects to meet with the FDA in approximately 90 days yielding clear guidance for marketing approval.
Cyrcadia is also currently designing a Pilot Program as a usability and market testing study. The strategy is to contract a number of womens health clinics throughout the US under a similar protocol to the clinical studies, placing the system in physicians hands at real-world clinics. The objectives are to gauge user feedback and refine the marketing strategy. Though the Pilot Program is being designed, it will not take place until the company has acceptance by the FDA.
The intended result of these activities is to accelerate CIs drive to possible significant value via generation of revenue by the end of 2019 or early 2020, through sales directly to physician clinics (based on information obtained from the Pilot Program), leading to a possible merger or acquisition potentially some time in 2020. It must be noted that the iTBra system has not yet been cleared by the FDA for marketing in the United States.
Safe Harbor Statement
This release includes forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995.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
We appreciate your interest and patience. This product is expected to assist in saving lives by the prospective early identification of breast tissue abnormalities, many of which could lead to cancers.
Please do not hesitate contacting me at jholmes@lbti.com.
Regards,
Jim Holmes, President
