BIOCREDE INC. — Department of Health and Human Services SBIR Phase II: 300

Description

PROJECT SUMMARYABSTRACT In Phase IBiocrede developed a wirelessFrflexibleand aFrdual lumencatheternitric oxideNOreleasingin vivo tested without heparin injectionscontinuous lactate sensor that can wirelessly monitor intravenousIVblood lactate levels to alert caregivers in the ICU when lactate levels riseElevated blood lactate levels are associated with major morbidity and mortality in critically ill patients recovering from organ transplantation or traumaand in pediatric patients with congenital heart diseaseCHDundergoing cardiac surgery with cardiopulmonary bypassCPBOur sensorsBiocrede IPprovisional patents USand USpossess NO releasing technologyLicensed from the University of Michiganthat prevents thrombosis fordays that otherwise renders IV sensors inoperable inaccurate within minutes in nonheparinized or inadequately heparinized patientsThis novel device can be used to discriminate between infants at high and low risk of morbidity and mortality after CHD surgeryand allow care providers to intervene earlier to prevent adverse outcomesKey features of the non tethered sensor includeproven thrombosis protection tested forhours in pigsNO releases fordaysfold reduction of live bacteria counts on surface with NO for andgtdayssafest scores on ISO GLP leachingimplantationand cell toxicity testscontinuous lactate readout ability fordays everysecondsandability to discern increasing lactate levels withinmin without requiring a blood sample compared to current blood gas instrumentsThe pediatric interventional cardiology market is estimated at $MM bywith a CAGR ofthe blood and electrolyte testing market was $B inwith a CAGR of$MM byand the global sepsis therapeutics market is estimated to be $B bywith a CAGR ofIn Phase II we propose toManufactureperform quality controland setup the design history files and device master records for the full development and manufacture of devices following ISOFDA requirementimplant lactate sensing dual lumen central venous cathetersCVCin femoral vein for continuous measurement of endogenous lactic acid production in rabbit model of cardiopulmonary bypass and cardioplegic arrestnto determine best lactate increase rate detection timesandfinalize GLP biocompatibility studiesestablish IRB and file first submission to FDA to perform an acute clinical study of lactate sensors in infants with CHD undergoing CPB at the University of Michigan C SMott Childrenandapos s Hospital Congenital Heart CenterJCharpieCo DirectorBiocredeUS ownedmanufactures the sensors and assembles these into OEM ed FDA approved CVCs NARRATIVE Blood lactate levels and lactate rate of change are valuable parameters to measure during resuscitation of critically ill patients with organ failure and sepsisand in infants with congenital heart disease undergoing heart surgery with cardiopulmonary bypassRising blood lactate levels are indicative of tissue hypoperfusion or poor oxygenationand a shift from aerobic to anaerobic cellular respirationThese pathophysiologic changes often precede circulatory failureand correlate with major morbidity and mortality in the intensive care unitA point of care device that can continuously quantitate blood lactate levels in real time will better predict impending circulatory failure than current benchtop blood analyzers that may providehour discrete measurements