STTR Phase II: Development and commercialization of a Wearable Long-term Monitor for Cardiac Arrhythmias

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The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project is far-reaching in terms of improving the quality of life and the cost/efficacy of healthcare for more than 20 Million people in the USA. We address the need for better methods for identifying and guiding the treatment of ambulatory patients with dangerous heart dysfunctions such as intermittent arrhythmias and heart failure. For example, atrial fibrillation arrhythmia afflicts nearly 8 Million patients in the USA, approximately 460,000 new patients every year, and the patient load is projected to grow to 12.1 million by 2050. The disease and its complications (stroke, congestive heart failure, seizures, death, etc.) add $26B to the nation's annual healthcare costs. Heart Failure currently afflicts nearly 5.7 Million people in the US growing to 8 Million by 2030. Their treatment and frequent hospitalization costs are already at 14B$ and will grow to 29B$ by 2030. Together with reducing the economic impacts, it would be of an enormous benefit to human health to create a device that improves the diagnosis and guides effective therapy for these patients while they remain fully ambulatory and going about their normal activities outside the expensive confines of the hospital. The proposed project has the following intellectual merits. In our Phase I STTR program we focused on developing a wearable Atrial Fibrillation monitor to assist physicians in the diagnosis of paroxysmal or episodic versions of that disorder. In Phase II we have pivoted towards the even more critical need of ambulatory monitoring of paroxysmal tachycardia and eventually heart failure patients. The current industry standard of ambulatory ECG does not provide enough sensitivity or specificity to determine if the patient has atypical or typical atrial flutter, paroxysmal supraventricular tachycardia as well as various forms of ventricular tachycardia. Accurately diagnosing and monitoring these disorders is critical to patient treatment and outcomes. Our device will be capable of ambulatory patient monitoring for any sort of arrhythmia, and we believe it can be the preferred choice for all portable monitoring if it provides in one device ECG, heart motion and breathing rate/pattern/volume. So, the overarching technical research goal of our Phase II work is to develop a full featured prototype cardiac motion sensor as described above that can be used for initial clinical tests. These features include: wearable, battery powered, signal storage, cardiac motion from radar, disposable antenna, onboard ECG, and breathing rate.