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Screening Under REgular assessment with hemoTAG (SURE TAG)

使用 hemoTAG (SURE TAG) 定期评估进行筛查

基本信息

批准号：
10200513
负责人：
Kaustubh Kale
金额：
$ 18.97万
依托单位：
AVENTUSOFT, LLC
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-04-15 至 2021-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10200513
关键词：
Biological Blood Pressure Blood Tests Businesses Cardiac Cardiac Catheterization Procedures Cardiomyopathies Cardiovascular Diseases Clinical Clinical Research Collaborations Communities Congestive Heart Failure Continuity of Patient Care Coronary heart disease Detection Development Devices Diabetes Mellitus Diagnostic Early Diagnosis Echocardiography Etiology Event Florida Functional disorder Goals Health Fairs Heart failure Hospitalization Image Incidence Institutional Review Boards Left Left Ventricular Dysfunction Measurement Measures Medical Medical Device Methods Microvascular Dysfunction Monitor Morbidity - disease rate Multi-Institutional Clinical Trial Multi-site clinical study Myocardial Outcome Patients Performance Peripheral arterial disease Phase Prevention Public Health Randomized Clinical Trials Reporting Risk Risk Factors Severities Small Business Innovation Research Grant Stroke Technology United States Ventricular Visit Work base checkup examination clinical practice commercialization cost diabetes management diabetic economic impact evidence base glycemic control health care quality hemodynamics improved innovation insight macrovascular disease mortality novel point of care portability screening verification and validation

项目摘要

7. PROJECT SUMMARY/ABSTRACT 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.

7. 项目总结/文摘