HC SIMULATION LLC — Department of Health and Human Services SBIR Phase II: FDA

Description

The purpose of this proposal is to develop a validated physiological model of the human physiologyespecially the cardio renal axisfor submission to the FDA Medical Device Development Tool pilot programThe model will be used to aid in the development and regulation of medical devices designed to treat hypertensionExamples include devices for renal nerve ablationelectrical stimulation of the carotid baroreceptors and creation of an A V FistulaGiven thatof US patients with resistant hypertension onor more drugsat a price tag of $$billionthe importance of a tool that streamlines the time for designtestingand regulation of a non pharmacological device is clearThe multifactorial nature of hypertension complicates its treatmentand no device intervention is guaranteed to successfully treat each patientOur physiological model is a powerful tool for understanding the impact of interpatient variability on antihypertensive therapies and confirming the correctness of using a specific device for blood pressure controlIn Phase IIwe will demonstrate a validated and documented modelextending HumModour existing model of human physiologyto include more intracellular signaling and adaptationas well as a multileveldetailed circulationThe aims of this study includethe complete transfer of the model from a proprietary simulation environment into Modelicaa multidomain language for modeling of complex systemsdocumentation of model evidence and structure in a searchable repositoryanda verification suite to ensure that the model functions correctly This proposal will fund the developmentdocumentationand validation of a mathematical model that will aid medical device manufacturers and the FDA to streamline the current regulatory processThis model has the potential to reduce the cost and time associated with bringing new devices to market while adding another layer of protection for consumers