This SBIR Fast-Track project will develop a novel non-invasive device for left ventricular dysfunction assessment to improve heart failure outcomes in patients with diabetes, validated through a multi-center clinical trial to support FDA 510(k) clearance. According to national diabetes report, 33 million people in United States suffered from diabetes. Abundant evidence shows diabetes is major independent risk factor for several cardiovascular disorders including coronary heart disease, stroke, peripheral arterial disease, cardiomyopathy, and congestive heart failure (HF). Large, randomized clinical trials for screening and revascularization of stable macrovascular disease in diabetics, have failed to demonstrate a significant reduction in cardiac events and HF episodes. Studies have demonstrated that early detection of left ventricular dysfunction and prevention of microvascular complications through glycemic control in diabetes patients is a critical mechanism for reducing the incidence and severity of left ventricular dysfunction and HF. Thus, given the clinical and economic impact of diabetes and HF, and in view of the risk and cost of invasive monitoring there is a need for non-invasive, affordable, accurate, absolute and actionable method that can provide point-of-care left ventricular dysfunction assessment and facilitate optimized management of diabetes patients across the continuity of care. Towards this goal, Aventusoft has developed a novel non-invasive medical device (HEMOTAG) enabling specific measurements of left ventricular dysfunction, anywhere, anytime by anyone. Aventusoft has completed multiple Institutional Review Board approved clinical studies to demonstrate the major clinical advancement. Phase I and II activities will focus on larger multi-center clinical studies, enhancing the HEMOTAG technology for hemodynamic guided assessment and management to reduce rates of left ventricular systolic dysfunction, diastolic dysfunction, and improve HF outcomes in diabetes patients, reducing HF hospitalization, mortality, and morbidity. Resulting in FDA 510(k) indications of use, for HEMOTAG guided treatment for diabetes patients. The development of a non-invasive, accurate and easy-to-use solution to provide actionable targets measurements without requiring blood tests, echocardiogram imaging or right heart catheterization, will have great potential not only for HF management in diabetes but for many other etiologies as well. Communities across the globe lack access to quality healthcare arising from shortages in medical expertise and availability of medical diagnostic devices. The benefit of this pioneering work is the development of a low-cost and portable solution that 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 left ventricular dysfunction as routine as measuring blood pressure. HEMOTAG verification and validation would be completed during the Phase II. Followed by commercialization in Florida and nationwide, based on the business partnerships and clinical collaborations established to help create a commercially successful product.
Public Health Relevance Statement: 8. PROJECT NARRATIVE Overall this project provides direct relevance to public health by facilitating new insights through the development of an innovative medical device useful for rapid automated characterization of myocardial performance in diabetes patients. The novel biologically-inspired device will significantly impact the current known methods for detection, monitoring, prevention and treatment of systolic and diastolic dysfunction, and support evidence-based clinical practice. The device will have great potential in the early diagnosis of left ventricular dysfunction for many other etiologies as well.
Project Terms: Algorithms; Arrhythmia; base; Biological; Blood Pressure; Blood Tests; Businesses; Cardiac; Cardiac Catheterization Procedures; Cardiology; Cardiomyopathies; Cardiovascular Diseases; Cardiovascular system; checkup examination; Clinic; Clinical; clinical practice; Clinical Research; Clinical Trials; Collaborations; commercialization; Communities; Congestive Heart Failure; Continuity of Patient Care; Control Groups; Coronary heart disease; cost; Data; Detection; Development; Devices; diabetes management; Diabetes Mellitus; diabetic; diabetic patient; Diagnosis; Diagnostic; Diastolic heart failure; Early Diagnosis; Echocardiography; economic impact; EFRAC; Endocrine; Endocrinologist; Endocrinology; Etiology; Evaluation; Event; evidence base; FDA approved; Florida; follow-up; Functional disorder; glycemic control; Goals; Gold; group intervention; health care quality; Health Fairs; Health Professional; Heart Atrium; Heart failure; heart function; hemodynamics; Hospitalization; Image; improved; Incidence; indexing; innovation; insight; Institutional Review Boards; Lead; Left; Left Ventricular Dysfunction; Left Ventricular Mass; macrovascular disease; Measurement; Measures; Medical; Medical Device; meetings; Methods; Microvascular Dysfunction; Monitor; Morbidity - disease rate; mortality; Multi-Institutional Clinical Trial; Multi-site clinical study; Myocardial; Newly Diagnosed; novel; Outcome; Participant; Pathway interactions; Patient Representative; Patients; Performance; Peripheral arterial disease; Pharmacotherapy; Phase; point of care; portability; pressure; Prevalence; Prevention; Primary Care Physician; Primary Health Care; primary outcome; prospective; Public Health; Pulmonary artery structure; Randomized; Randomized Clinical Trials; recruit; Reporting; Risk; Risk Factors; screening; secondary outcome; Services; Severities; Single-Blind Study; Site; Small Business Innovation Research Grant; Specialist; standard of care; Stroke; Structure; Technology; Testing; United States; Validation; Ventricular; Ventricular Dysfunction; Ventricular End-Diastolic Volumes; verification and validation; vibration; Visit; Work
