Innovation for the earlydetection, diagnosis, and quantification of diabetic cardiomyopathy.

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7. PROJECT SUMMARY/ABSTRACT This SBIR Phase I project will develop an innovative medical device useful for rapid automated characterization of myocardial performance in diabetes patients. Left ventricular systolic and diastolic myocardial impairment is the most common manifestation; and the systolic function is monitored with left ventricular ejection fraction measurement and the diastolic function is monitored with left ventricular filling pressure. These two measurements are available after reading and analyzing the echocardiographic examinations. The reported incidence of systolic dysfunction is approximately 2% and diastolic dysfunction is approximately 30% in diabetes patients without known heart disease. Even though the development of cardiovascular disease is the most common complication of type 1 diabetes, echocardiography is not routinely performed in patients with type 1 diabetes. Thus, the cardiologist and patients care provider need to collaborate to identify new non-invasive techniques to detect cardiac dysfunction at an early and potentially reversible stage, before the onset of the clinical signs and symptoms. The ability to use a device in any patient care setting by any healthcare professional, without the special requirement of an echocardiogram, would be of significant value. Towards this goal of early identification of cardiac dysfunction, AventuSoft is developing a novel portable medical device (HemoTag) to provide measurement of systolic function using heart sounds. Through this SBIR project, we will develop technology to include the rapid and automated measurement of diastolic function without requiring an echocardiogram. During this Phase I SBIR, the AventuSoft team will complete validation studies with diabetes patients to demonstrate a major clinical advancement by enabling the automated characterization of myocardial performance using HemoTag. At a fraction of the size and cost of current products, HemoTag can enable reliable, accurate and easy-to-use application by healthcare professionals, for the measurement of myocardial systolic and diastolic performance. It overcomes the limitations of cost, size and skilled personnel requirements of existing echocardiography devices. Phase II activities will focus on larger multi-center clinical studies, enhancing the technology for early detection, verification and validation testing requirements necessary for the FDA 510(k) premarket notification, and on productizing the system for commercial use. The benefit of this pioneering work is the development of a low- cost and portable device that will have great potential for early detection, diagnosis, and quantification of cardiovascular disease and cardiomyopathy complications in diabetes. HemoTag can help address the significant problems of patient safety though advancements in imaging equipment, make it more accessible and readily available as the technology does not require skilled specially trained operators.