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The Market – There is no cure for breast cancer, only early diagnosis can result in improved outcomes for the condition. The targeted population for our wearable technology is 717 million women between the ages of 20 and 70 globally. The National Cancer Institute recommends that each woman in this age group undergo a monthly self-breast examination for early cancer detection. In reality this seldom is done leading to cancer diagnosis at a later, much less treatable stage. 440 million of these women are in India alone where one-fifth of all of the world’s breast cancer will exist by the year 2020.
In the US, there are 38,644,885 mammograms per year, but this only represents 70% of the required population as 30% of those eligible for the irradiation and compression process of mammography diagnosis chose not to, or are unable to, enter the medical system for this important screening. In Asia, the number of prospective patients that fail to enter the system for annualized screening is closer to 70%, a leading contributor for breast cancer being the number #1 cause of cancer mortality for Asian women.
On all tissue types, of those patients who are diagnosed by mammography as having the potential state of cancer, only 25.4% of all surgical biopsies are on actual cancers, and 74.6% of surgical biopsies performed as a result of mammography diagnosis are on non-cancerous tissue. This high false positive rate as a result of mammography diagnosis results in 1.6 million unnecessary surgeries at an economical cost of over $1 billion annually in the US alone. Cyrcadia’s historic clinical results reflected over 87% accuracy on detecting invasive breast cancer demonstrating promise that the device could be utilized as an adjunctive monitoring and decision tool for physicians to potentially reduce unnecessary surgeries, or enable the referral of patients to better aligned screening or detection modalities, reducing procedures and costs.
Breast tissue density has been identified as a limitation of accuracy for screening mammography the “gold standard” diagnostic tools for breast cancer screening used today. With varying degrees of density, mammography false negative results increase dramatically with tissue density, from 20% with over all tissue types, up to 50%+ with the densest of tissue types. The CYRCADIA HEALTH solution is tissue agnostic in that we detect circadian cellular change that is indicative of cancer, and do not rely on specular reflective capabilities of varying tissue densities to make our diagnosis. Our historic false negative result of 17.3% should show diagnostic accuracy improvements for all tissue types, but most critically in the dense patient population.
With Federal legislation pending and 32 states in the US having passed tissue density notification laws requiring physicians to notify patients of their density condition, its higher propensity to cancer, and the known limitations for screening mammography, a significant opportunity exists for a non-compressive, non-irradiative, tissue agnostic early breast cancer screening tool such as ours.
Cyrcadia’s Market Position – In that Cyrcadia is not relying on tissue reflectivity required with mammography and ABUS Ultrasound, but detects metabolic activity changes of normal vs. cancerous tissues, Cyrcadia’s medical researchers believe that may be an advantage in the density population, which has a higher propensity for cancer, and the current diagnostic modalities are challenged with their condition. Today 32 states have passed, and 11 additional states have pending legislation which requires the physician to advise the patient about their condition of density, and that they have a higher propensity for cancer (up to six times higher in the densest of tissue), and that the current diagnostic modalities are highly challenged with their condition (as low as 48% documented accuracy in mammography with the densest of tissue).
Finally, and most critically, Cyrcadia is addressing the Health and Human Services Affordable Care Act targeted Precision Medicine Initiative. Through personalized healthcare monitoring, Cyrcadia is sensing and catching the earliest potential progression of the cancerous disease state. Instead of only correlating to late stage imaging outcomes with clinic or hospital based mammography, Cyrcadia is partnering with the Canary Foundation, who has also supported the current trials financially, to correlate their findings with early biomarkers already identified by Canary as indications of early cancer cell development.
Although screening and detection of breast cancer has improved dramatically over the last decade in westernized cultures, the mortality globally has not improved. Clearly we are getting to the state of breast cancer far too late to have an impact. Cyrcadia’s target is through Precision Medicine, personalized healthcare, to catch the incidence of cancer cell development early in the woman’s own environment. Correlating these results directly with early biomarker activity for this clinical patient population could enable much earlier therapy of the patient’s cancerous condition.
Due to its focus on precision medical initiatives, Cyrcadia has been requested by The Stanford Medicine X program to participate in a randomized trial to demonstrate the increased value of personalized healthcare assessment, versus hospital-based treatment in a randomized population. That trial request has been expanded with Stanford University and many other markets in Asia Pacific through our partner Cyrcadia Asia. Including Japan, South Korea, India, and Australia, where mass populations of women either cannot access healthcare, or social, economic, or religious morays keep them from exposing themselves in the presence of a physician. For women in many of these countries, discovery comes far too late, and treatment is ineffective.
Cyrcadia is in the process of reviewing and possibly updating it’s 510K Class II FDA clearance in the United States, and with sufficient funding will file for CE Mark clearance outside of the United States. Given the current clinical trials listed the Cyrcadia technology as a minimal risk, and that the majority of state legislations now require density notification here in the US, we believe the FDA looks favorably on our filings, which may help expedite the normal FDA time period for domestic marketing clearance.
Cyrcadia is a privately traded company, based in Reno, Nevada. Cyrcadia has achieved three patents through Lifeline Biotechnologies (LLBO), which is a publicly traded company that owns approximately 30% of Cyrcadia.
Current design and development of Cyrcadia’s technology is done through Jabil Circuits in San Jose, CA, which is one of the largest developer/manufacturers of wearable, medical grade technology in the world. Cyrcadia’s predictive analytics were developed out of Nanyang technological University in Singapore, and are held internally at Cyrcadia, managed by the company. Over eight years of additional predictive analytic analysis have been completed with Cyrcadia’s engineering team and continue to evolve.