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.
Overall this project provides direct relevance to public health by facilitating new insights through the development of a cloud connected hemodynamic-guided HF management centered around the ?HEMOTAG? transducer accompanied by an app on a personal smartphone. Resulting in FDA 510(k) cleared device with indications of use, for HEMOTAG guided treatment for HF patients. The novel device will significantly impact the current known methods for detection, monitoring, prevention and treatment of heart failure, and support evidence-based clinical practice. The device that will have great potential in reducing mortality, morbidity, and improving quality of care through remote monitoring and timely intervention.