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Problem Tech Solves

Tech Brief

Heart disease is the number one killer globally – yet cardiovascular care today addresses the symptoms of heart disease and does not directly evaluate the actual disease. The current reactive approach to cardiovascular care contributes to massive waste and inefficiency within the healthcare system and it is critical that the way physicians identify and treat heart disease is changed to save lives. By waiting for heart disease symptoms, cardiovascular evaluation begins at the onset of end-stage disease. Current approaches are highly inefficient: nearly two-thirds of referrals for invasive evaluation of the heart are unnecessary and 90% of stress tests come back normal. All told, the U.S. currently spends more than $320 billion annually on cardiovascular care, and this is projected to approach $820 billion by 2030. Patients and their families pay a steep price, too, in the form of high payments through deductibles, and steep increases in health insurance premiums. Clearly, this is unsustainable. The heart care industry along with other disease states must shift the approach from treating late-stage symptoms to proactively identifying early stages of disease when we can prevent its progression more easily. The industry has the technology and data available to begin making changes to the care approach, better capturing patients at risk, and enabling personalized preventive treatment. The approach to precision patient care will improve clinical outcomes while yielding significant cost savings.

Tech Differentiators

Cleerly is the only company that allows for whole-heart quantification and characterization of actual heart disease—atherosclerosis (plaque) building up in the walls of the heart arteries—as opposed to surrogate or indirect markers of heart disease. In this respect, Cleerly is emulating the world’s most successful preventive care paradigms in medicine, which have historically been in early cancer detection. Leveraging advanced imaging enabled through non-invasive, high-resolution, low dose coronary CT scans, Cleerly directly images the amount and type of heart disease in an individualized fashion, similar to 3D mammography, colonoscopy and lung CT scans. These efforts have significantly reduced cancer mortality, and Cleerly is pioneering the transformation of heart disease using this approach towards precision prevention.


As of July 2022, Cleerly’s CONFIRM2 clinical trial registry had 11,000 patients enrolled – making it the largest cardiovascular phenotype outcomes study ever performed. CONFIRM2 is designed to evaluate associations between CCTA imaging findings and clinical presentation and their ability to predict mortality and major adverse cardiac events in patients with chronic CAD. The international registry seeks to enroll more than 100,000 patients over the next decade. In February 2022, Cleerly published the second of six studies comparing Cleerly analysis against current gold standards to plaque and coronary artery imaging – CLARIFY 2. In this study, Cleerly demonstrated its effectiveness in the identification and exclusion of high-grade stenosis against traditional core-lab interpreted quantitative coronary angiography (QCA) and invasive fractional flow reserve (FFR) methods. The findings in this study of 303 stable patients echo the recent American College of Cardiology guidelines on the use of CCTA for non-invasive heart disease evaluation. Using the patient data from CLARIFY 2, in March 2022, Cleerly published a paper in the Journal of Cardiovascular Computed Tomography, proposing a four-stage system for the disease burden of atherosclerotic plaque, the direct cause of CAD. The paper used findings from the 303 patients to stage their disease based on either the total plaque volume or percent atheroma volume (PAV), which is the proportion of arterial walls occupied by plaque. Stages are defined as normal (no plaque), mild, moderate and severe plaque.

Why Us