Non-invasive cloud connected device for hemodynamic-guided therapy toimprove outcomes for heart failure patients

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 FailureHFpatientsvalidated through a multicenter clinical trial to support FDAkclearanceThe standard telemonitoring interventions involving objective monitoring of blood pressureweightelectrocardiogramsor rhythm strips for reviewhave not demonstrated reduction with respect to readmission for any reason or death of any cause withindays after enrollmentInvasive devices have demonstrated that ambulatory pulmonary artery pressuresPAPshemodynamic measurement allow more effective HF management leading to fewer hospitalizationsThusgiven the clinical and economic impact of HF hospitalizationsand in view of the risk and cost of invasive monitoring there is a need for non invasiveaffordableaccurateabsolute and actionable hemodynamic measurement methods that can monitor HF patients in the clinic and at homeProviding an effective method for early detection of congestion and guided therapy intervention to avoid hospitalizationThe ability of a device to allow the management of HF patient across the continuity of care from the emergency departmentto inpatientto out patient clinicand to the homewould be of tremendous valueTowards this goal of HF managementAventusoft has developed a novel non invasive medical deviceHEMOTAGenabling specific measurements of hemodynamicsanywhereanytime by anyoneAventusoft has completed multiple Institutional Review Board approved clinical studies to demonstrate the major clinical advancementPhase I and II activities will focus on larger multi center clinical studiesenhancing the HEMOTAG technology for hemodynamic guided therapy to improve outcomes in heart failure patientsreducing HF hospitalizationmortalitymorbidityand improving quality of care through remote monitoring and timely interventionResulting in FDAkindications of usefor HEMOTAG guided treatment for HF patientsThe development of a noninvasiveaccurate and easy to use solution that can provide actionable targets measurements without requiring an echocardiogram imaging or right heart catheterizationwill have great potential not only for HF management but for many other etiologies as wellAventusoft s HEMOTAG provides a complement or replacement for expensive devices currently required for measuring the pulmonary artery pressuresThe HEMOTAG device can enable reliableaccurateabsoluteactionable and easy to use application by healthcare professionals and by patients at homefor the early detection of congestive exacerbations due to fluid overloadIt overcomes the limitations of costsizeaccessibility and availability of skilled personnel requirements of existing devicesHEMOTAG verification and validation would be completed during the Phase IIFollowed by commercialization in Florida and nationwidebased on the business partnerships and clinical collaborations established to help create a commercially successful productPROJECT NARRATIVE 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 theHEMOTAGtransducer accompanied by an app on a personal smartphoneResulting in FDAkcleared device with indications of usefor HEMOTAG guided treatment for HF patientsThe novel device will significantly impact the current known methods for detectionmonitoringprevention and treatment of heart failureand support evidence based clinical practiceThe device that will have great potential in reducing mortalitymorbidityand improving quality of care through remote monitoring and timely intervention