NONINVASIX, INC. — Department of Health and Human Services STTR Phase I: NICHD

Description

AbstractIn newborn infants intermittent total hemoglobin concentrationTHbmeasurement represents an essential diagnostic testHoweverblood sampling in neonates results in iatrogenic anemiais a painful experience for infantsand is a tedious procedure for health care personnelBlood sampling forTHbmeasurements represents a high proportion of painful procedures required in infantsyet heel sticksthe most common type of blood sampling in infantsproduce blood samples that poorly correlate with blood drawn by venipunctureAt presentthere is no noninvasive technology for accurateTHbmeasurementsThe only commercially available noninvasive device forTHbmeasurementMasimo s Rainbow Pulse CO Oximetercorrelates poorlyRwith invasive measurements and is inaccurateNoninvasix recently demonstrated in neonates that optoacoustic technology permits easyaccuratedirectand noninvasiveTHbmeasurement by detecting and analyzing signals from the superior sagittal sinusa large central cerebral vein located immediately beneath the skullHaving established the proof of concept for optoacousticTHbmonitoring in neonatesthis Phase I application proposes to refine that technique as a major step toward commercialization of a device for intermittent measurementsIn this Phase I projectwhich is based on a laboratory laser diode optoacoustic prototypeNoninvasix will collaborate with the University of Texas Medical Branchwhich co owns NoninvasixThe research team will iteratively design and build a clinical prototype neonatal interface and a user interface and test them in post delivery neonates by progressing through the following specific aimsThe goal of Specific Aimis to develop a clinical prototype probeincluding headgearand a graphical user interfaceGUIfor the noninvasive optoacoustic measurement device that will accurately measureTHbin neonates when used by one unassisted caregiverThis Aim will consist of a three to four cycle iterative processin which a team of bioengineersnursesand clinicians will iteratively design and test the probe design in neonatesthen revise and retest the design based on that experienceThe goal of Specific Aimis to evaluate the accuracy of noninvasiveTHbmeasurements inneonatesThe research team will noninvasively measureTHbwith the optoacoustic system and evaluate agreement of the measurements with venipuncture samples measured using a clinical hemoximetergold standardNarrative In newborns hemoglobin concentrationTHbmeasurement is an essential diagnostic testbut it requires blood sampling that results in iatrogenic anemiais a painful experience for infantsand is a tedious procedure for health care personnelAt presentthere is no noninvasive technology for accurateTHbmeasurementsIn this project we will develop a probe that permits that measurement and will test it in neonates