Administrative Supplement to Promote Diversity in Research and Development Small Businesses-SBIR (Rodrigo Jordao)

7.项目摘要/摘要 该SBIR快速通道项目将开发一种创新的非侵入式云连接设备，用于 血流动力学引导治疗改善心力衰竭(HF)患者的预后 中心临床试验，以支持FDA 510(K)批准。标准的远程监测干预包括 客观监测血压、体重、心电图或节律条供复查时， 在180日内因任何原因再次入院或因任何原因死亡的人数显示减少 招生。侵入性设备已经证明，动态肺动脉压(PAPs) 血流动力学测量可以更有效地进行心衰治疗，从而减少住院次数。因此， 考虑到心力衰竭住院的临床和经济影响，以及鉴于侵入性治疗的风险和成本 监测需要无创、负担得起、准确、绝对和可操作的血流动力学 可以在临床和家庭中监测心力衰竭患者的测量方法。提供一种有效的方法 用于早期发现充血和指导治疗干预，以避免住院。一种设备的能力 使心力衰竭患者的管理贯穿于从急诊科到住院的连续护理。 患者，到门诊，到家庭，都将具有巨大的价值。朝着这一目标努力 管理方面，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血流动力学。Aventusoft已完成多项 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II的活动将集中在更大的多中心临床研究，加强HEMOTAG技术 血流动力学引导治疗改善心力衰竭患者的预后，减少心力衰竭住院时间， 通过远程监测和及时干预，提高死亡率、发病率和改善护理质量。结果 在FDA 510(K)的使用适应症中，用于HEMOTAG指导的心衰患者的治疗。非金属材料的发展 侵入性、准确性和易于使用的解决方案，可以提供可操作的目标测量，而不需要 需要超声心动图成像或右心导管术，不仅对心衰有很大的潜力 管理，但也有许多其他原因。Aventusoft的HEMOTAG提供了补充或 替代目前测量肺动脉压力所需的昂贵设备。这个 HEMOTAG设备可以通过以下方式实现可靠、准确、绝对、可操作和易于使用的应用 医疗保健专业人员和患者在家中，用于及早发现因以下原因导致的充血恶化 液体超载。它克服了成本、规模、可获得性和技术人员可获得性的限制 现有设备的要求。HEMOTAG的验证和确认将在该阶段完成 其次是在佛罗里达州和全国范围内商业化，基于商业伙伴关系和临床 为帮助创造商业上成功的产品而建立的合作。

7. PROJECT SUMMARY/ABSTRACT This SBIR Fast-Track project will develop an innovative non-invasive cloud connected device for hemodynamic-guided therapy to improve outcomes in Heart Failure (HF) patients, validated through a multi- center clinical trial to support FDA 510(k) clearance. The standard telemonitoring interventions involving objective monitoring of blood pressure, weight, electrocardiograms, or rhythm strips for review, have not demonstrated reduction with respect to readmission for any reason or death of any cause within 180 days after enrollment. Invasive devices have demonstrated that ambulatory pulmonary artery pressures (PAPs) hemodynamic measurement allow more effective HF management leading to fewer hospitalizations. Thus, given the clinical and economic impact of HF hospitalizations, and in view of the risk and cost of invasive monitoring there is a need for non-invasive, affordable, accurate, absolute and actionable hemodynamic measurement methods that can monitor HF patients in the clinic and at home. Providing an effective method for early detection of congestion and guided therapy intervention to avoid hospitalization. The ability of a device to allow the management of HF patient across the continuity of care from the emergency department, to in- patient, to out-patient clinic, and to the home, would be of tremendous value. Towards this goal of HF management, Aventusoft has developed a novel non-invasive medical device (HEMOTAG) enabling specific measurements of hemodynamics, 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 therapy to improve outcomes in heart failure patients, reducing HF hospitalization, mortality, morbidity, and improving quality of care through remote monitoring and timely intervention. Resulting in FDA 510(k) indications of use, for HEMOTAG guided treatment for HF patients. The development of a non- invasive, accurate and easy-to-use solution that can provide actionable targets measurements without requiring an echocardiogram imaging or right heart catheterization, will have great potential not only for HF management but for many other etiologies as well. Aventusoft’s HEMOTAG provides a complement or replacement for expensive devices currently required for measuring the pulmonary artery pressures. The HEMOTAG device can enable reliable, accurate, absolute, actionable and easy-to-use application by healthcare professionals and by patients at home, for the early detection of congestive exacerbations due to fluid overload. It overcomes the limitations of cost, size, accessibility and availability of skilled personnel requirements of existing devices. 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.