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

促进小型企业研发多样性的行政补充-SBIR (Rodrigo Jordao)

• 批准号: 10403370
• 负责人: Kaustubh Kale
• 金额: $ 13.41万
• 依托单位: AVENTUSOFT, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10403370
• 关键词: Administrative Supplement; Blood Pressure Monitors; Businesses; Cardiac Catheterization Procedures; Cellular Phone; Cessation of life; Clinic; Clinical; Clinical Research; Collaborations; Complement; Congestive; Continuity of Patient Care; Development; Devices; Early Diagnosis; Echocardiography; Electrocardiogram; Emergency Care; Enrollment; Etiology; Florida; Fluid overload; Goals; Health Professional; Heart failure; Home; Hospitalization; Human Resources; Image; Institutional Review Boards; Intervention; Measurement; Measures; Medical Device; Methods; Monitor; Morbidity - disease rate; Multi-Institutional Clinical Trial; Multi-site clinical study; Outpatients; Patients; Phase; Prevention; Public Health; Pulmonary artery structure; Quality of Care; Risk; Small Business Innovation Research Grant; Technology; Therapeutic Intervention; Time; Transducers; Weight; base; clinical practice; commercialization; cost; detection method; economic impact; evidence base; hemodynamics; hospital readmission; improved; improved outcome; innovation; insight; mortality; novel; pressure; remote monitoring; research and development; telemonitoring; verification and validation

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.

7.项目总结/摘要 这个SBIR快速通道项目将开发一种创新的非侵入式云连接设备， 血液动力学引导治疗改善心力衰竭（HF）患者的结局，通过多项 中心临床试验，以支持FDA 510（k）批准。标准的远程监护干预措施包括 客观监测血压、体重、心电图或心律条以供审查， 在治疗后180天内，因任何原因再次入院或因任何原因死亡的情况有所减少 招生有创器械已经证明，动态肺动脉压（PAP） 血液动力学测量允许更有效HF管理，导致更少的住院。因此，在本发明中， 考虑到HF住院治疗的临床和经济影响，以及侵入性治疗的风险和成本， 监测需要无创、可负担、准确、绝对和可操作的血流动力学 可以在诊所和家中监测HF患者的测量方法。提供有效的方法 用于早期检测充血和指导治疗干预以避免住院。设备的能力 允许HF患者的管理跨越从急诊科到 病人，门诊诊所和家庭，将具有巨大的价值。为了实现HF的目标， Aventusoft开发了一种新型的非侵入性医疗设备（HEMOTAG）， 任何人随时随地都可以测量血液动力学。Aventusoft已经完成了多个 机构审查委员会批准了临床研究，以证明主要的临床进展。一期 和II活动将侧重于大型多中心临床研究，增强HEMOTAG技术， 血流动力学引导治疗可改善心力衰竭患者的结局，减少HF住院， 通过远程监测和及时干预，降低死亡率、发病率并提高护理质量。所得 在FDA 510（k）适应症中，用于HF患者的HEMOTAG引导治疗。一个非- 侵入式、准确且易于使用的解决方案，可提供可操作的目标测量， 需要超声心动图成像或右心导管插入术，不仅对HF有很大的潜力， 管理，但也有许多其他病因。Aventusoft的HEMOTAG提供了一种补充或 替代目前测量肺动脉压力所需的昂贵装置。的 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在家的患者，用于早期检测由于充血性疾病而导致的充血性恶化 液体超载。它克服了成本、规模、可获得性和熟练人员可用性的限制 现有设备的要求。HEMOTAG验证和确认将在本阶段完成 二.其次是商业化在佛罗里达和全国范围内，基于商业伙伴关系和临床 建立合作，以帮助创造商业上成功的产品。