This SBIR Phase II project will develop a novel mobile framework to measure left ventricular ejection fraction as a marker for systolic dysfunction using automated non-invasive analysis of cardiac signals. Heart disease is the leading cause of death for men and women accounting for more than one-third (33.6%) of all U.S. deaths. In 2011, total costs associated with cardiovascular disease in the U.S. were estimated to be $320 billion, making it the costliest health problem facing the nation. In addition, it occurs disproportionately among minority and health disparity populations. For example, heart failure related deaths are 37% higher among African- Americans than among whites. Decreased ejection fraction is a marker of left ventricular systolic dysfunction, the most common type of heart failure. Overall cardiac health can be significantly improved by proper triage at the primary care level by determination of the ejection fraction without requiring a 2-D echo-cardiogram. It will provide health care professionals with point-of-care technology to guide diagnostic, monitoring, and therapeutic efforts. Portable device capability makes it even more accessible and readily available without high costs. As the technology being developed does not require skilled operators or specially trained physicians, it will allow healthcare providers to measure ejection fraction within their normal medical training. Through the course of the two-year Phase I work we have developed a revolutionary medical device that enables measurement of ejection fraction using the cardiac sound signals measured at the chest wall. The scope of the science proposed in this Phase II project is to complete development of the diagnostic framework using our specially engineered sensor system combined with the novel algorithm technology to be accessed via a smartphone or tablet for a portable and cost-effective solution. Resource-poor communities across the globe lack access to quality healthcare arising from shortages in medical expertise and poor availability of expensive medical diagnostic devices. In recent years, mobile phones have become increasingly advanced and ubiquitous. The mobile framework developed through this project is a tremendous opportunity to provide low-cost diagnostics to under-served populations. The benefit of this pioneering work is the development of a low-cost and portable solution that can be used to diagnose systolic dysfunction, and thus enable improved screening during routine annual checkups, doctor visits, at community medical screenings, classes, and health fairs leading to healthier communities. It will make measuring ejection fraction as routine as measuring blood pressure. In Phase II, we will continue validation of the device through user-trials and seek FDA 510(k) clearance for commercialization. Followed by commercialization in the Florida and Mississippi region, based on the partnerships and joint collaborations established to help create a commercially successful product.
Overall this project provides direct relevance to public health by facilitating new insights through the development of a novel mobile framework to be used in current clinical practice for non-invasive direct assessment of the ejection fraction. The novel biologically-inspired device will significantly impact the current known methods for detection, monitoring, prevention and treatment of systolic dysfunction, and support evidence-based clinical practice. The project will help reduce health disparities in the area of heart disease, assist in providing preventive cardiac care, assist in improving access to care, assist in early diagnosis of the risk of heart diseases and it will significantly impact the current known methods, technologies, treatments, and address critical barriers to progress in the field.