Feasibility study of a novel noninvasive RF sensor for blood pressure measurements.

PROJECT SUMMARYABSTRACTHigh blood pressureor hypertensionis an important public health challenge because of its high prevalence and its role in increasing risk for a variety of other diseasesAccording to the American Heart Associationapproximatelyout of everyadults in the United States has hypertensionand the situation is projected to worsen with the percentage rising to approximatelyof the adult population in the nextyearsDue to the difficulty of effectively managing hypertensionexperts in cardiovascular disease have identified an unmet need to record blood pressures over the long term as a basis for cardiovascular health assessmentThere is also a need to determine the effects of external influences such as alcoholsmokingdrugsexerciseand eating on blood pressureThis contextualized information will ultimately provide insights into how behaviorsmedicinesand other drugs impact blood pressureUnfortunatelythere isn t yet a solution that can provide continuous blood pressure measurements during everyday useTodaysome people persevere with infrequent data points collected using blood pressure monitors at homeOthers go through the pain of wearing an ambulatory blood pressure monitor with a cuff that inflates and deflates throughout the day and nightBlumio is developing a revolutionary radar based blood pressure sensor for anytimeanywhere monitoringIf we succeedwe will be the first to achieve non contact continuous blood pressure monitoring and address a critical need for personalized medicine for hypertensionThe Blumio sensor can be worn next to the bodywith no need to form a tight contactor on top of clothingwhich allows for seamless blood pressure measurement without disturbing the userThe goal of this SBIR Phaseapplication is to demonstrate that Blumio s sensor can satisfy the validation criteria of the ANSI AAMI ISOstandard of a mean difference of no more thanmmHg and a standard deviation of no more thanmmHg when compared against a reference deviceand therefore be recommended for measurements in the clinical set up and for research purposesSpecific Aimwill validate Blumio against a clinical grade automated blood pressure monitor for one time measurement of blood pressureSpecific Aimwill validate Blumio against a clinical grade noninvasive continuous blood pressure monitorSuccessful completion of these aims will lay the foundation for a follow on largerandomized controlled trial that will be performed in Phaseof this projectThe aims of Phasewill be focused on establishing the Blumio device as a superior technology over existing blood pressure monitors for hypertension managementThe Phasestudy will measure the impact of Blumio s device on hypertension management with the intent of demonstrating superior effectiveness when compared to cuff based blood pressure monitorsThese studies will lay the groundwork for commercialization of our devicewhich addresses a significant unmet clinical need with a very large potential market PROJECT NARRATATIVE Approximatelyof adults in the US have high blood pressureand the situation is projected to worsen with the prevalence rising toof adults in the nextyearsBlumio is developing a revolutionary radarbased blood pressure sensor for anytimeanywhere monitoringThis device will allow for seamless blood pressure measurement without disturbing the userDue to the comfort and ease of use of the Blumiothe data collected will yield unprecedented insight into short and long term blood pressure rhythms and will open a brand new window into how we understand and manage cardiovascular health