Screening Under REgular assessment with hemoTAG (SURE TAG)

7.项目摘要/摘要 SBIR快速通道项目将开发一种新的非侵入性左心功能不全装置 通过多中心验证的改善糖尿病患者心力衰竭结局的评估 支持FDA 510(K)批准的临床试验。根据国家糖尿病报告，美国有3300万人 美国各州都患有糖尿病。大量证据表明，糖尿病是多种疾病的主要独立危险因素 心血管疾病包括冠心病、中风、外周动脉疾病、心肌病、 和充血性心力衰竭(HF)。筛查和血运重建STRIST的大型随机临床试验 糖尿病患者的大血管疾病，未能显示心脏事件和 短波剧集。研究表明，早期发现左心功能不全和预防 糖尿病患者通过血糖控制的微血管并发症是降低血糖的关键机制 左心功能不全和心力衰竭的发生率和严重程度。因此，考虑到临床和经济影响 糖尿病和心力衰竭，鉴于有创监测的风险和成本，有必要进行非侵入性监测， 负担得起的、准确的、绝对的和可操作的方法，可以提供护理点左心功能障碍 在整个护理过程中评估和促进糖尿病患者的优化管理。朝向 为了实现这一目标，Aventusoft开发了一种新型非侵入性医疗设备(HEMOTAG)，使特定的 随时随地由任何人测量左心功能不全。Aventusoft已完成 多机构审查委员会批准了临床研究，以证明主要的临床进步。 第一阶段和第二阶段的活动将集中于更大规模的多中心临床研究，加强HEMOTAG技术 对于血流动力学引导的评估和管理以降低左心室收缩功能不全的比率， 舒张期功能障碍，改善糖尿病患者的心衰结局，减少心衰住院时间，降低死亡率， 和发病率。导致FDA 510(K)适应症用于HEMOTAG指导的糖尿病治疗 病人。开发一种非侵入性、准确且易于使用的解决方案，以提供可操作的目标 不需要血液测试、超声心动图成像或右心导管术的测量将具有 不仅在糖尿病的心力衰竭治疗方面，而且在许多其他病因方面，都具有巨大的潜力。社区 由于缺乏医疗专业知识和可获得性，全球各地都无法获得高质量的医疗保健 医疗诊断设备。这一开创性工作的好处是开发了一种低成本和 便携式解决方案，可在社区的年度例行体检、就诊期间改进筛查 医疗筛查、课程和健康博览会，带来更健康的社区。它将使测量向左 将心功能不全作为常规测量血压。HEMOTAG验证和确认将 在第二阶段完成。随后在佛罗里达州和全国范围内商业化，基于 建立商业伙伴关系和临床合作，以帮助创造商业上成功的产品。

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.