Screening Under REgular assessment with hemoTAG (SURE TAG)

7.项目总结/摘要 该SBIR快速通道项目将开发一种新型的非侵入性左心室功能障碍器械 评估改善糖尿病患者的心力衰竭结局，通过多中心验证 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 国家患有糖尿病。大量证据表明，糖尿病是几个主要的独立危险因素 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）。筛选和血运重建稳定的大规模随机临床试验 糖尿病患者的大血管疾病，未能证明心脏事件的显著减少， HF发作。研究表明，早期发现左心室功能障碍并预防 糖尿病患者中通过血糖控制的微血管并发症是减少糖尿病患者中 左心室功能障碍和HF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HF，并且鉴于侵入性监测的风险和成本，需要非侵入性， 一种经济实惠、准确、绝对和可行的方法，可提供即时左心室功能障碍 评估和促进糖尿病患者在护理连续性方面的优化管理。朝向 为了实现这一目标，Aventusoft开发了一种新型的非侵入性医疗设备（HEMOTAG）， 左心室功能障碍的测量，任何地方，任何人。Aventusoft已完成 多个机构审查委员会批准的临床研究，以证明主要的临床进展。 I期和II期活动将侧重于大型多中心临床研究，以增强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障碍的发生率， 舒张功能障碍，改善糖尿病患者的HF结局，降低HF住院率、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 患者开发非侵入性、准确且易于使用的解决方案，以提供可操作的目标 不需要血液检查、超声心动图成像或右心导管插入术的测量将具有 不仅在糖尿病HF管理方面，而且在许多其他病因方面也具有巨大的潜力。社区 地球仪缺乏高质量的医疗保健，这是由于医疗专业知识和可用性短缺造成的 医疗诊断设备。这项开创性工作的好处是开发了一种低成本， 便携式解决方案，可在常规年度检查、医生访视和社区检查期间改善筛查 医疗检查、课程和健康博览会，从而建立更健康的社区。它将使测量左 心室功能障碍就像测量血压一样常规。HEMOTAG验证和确认将 在第二阶段完成。其次是商业化在佛罗里达和全国范围内，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.