CLINICAL SENSORS, INC. — Department of Health and Human Services STTR Phase II: NIAID

Description

PROJECT SUMMARY Clinical Sensors has developed a manufacturable prototype microfluidic sensor for measuring nitric oxide in whole bloodThis STTR Phase II project aims to complete several key aims necessary to commercialize this deviceincluding a clinical study where NO levels will be evaluated clinically in sepsisSepsis is the leading cause of death in non cardiac intensive care unitsICUsEach yearsepsis affectsmillion peoplecausingdeaths and healthcare costs over $billionThe incidence and cost burden of sepsis are steadily increasingBroadly definedsepsis has been understood as a pathophysiological state in response to systemic infection by bacterial and or fungal pathogens in bloodThe definition of sepsis is continually evolving as new research emerges about this disease and clinicians seek to better manage patient careHoweverthe treatment paradigm remains consistentprompt detection and action are critical for reducing sepsis associated morbidity and mortality and reducing the costs associated with sepsis careCurrentlysepsis and its associated syndromeslack specific clinicalimaginglaboratoryor biochemical markers with which to confirm their presenceNitric oxideNOis endogenously produced in the host response to infectionis a causative agent in sepsis induced organ dysfunctionand has been proposed as a potential biomarker for sepsisUntil recentlyno tools have existed to measure NO directly in complex matrices such as bloodWe have developed a first inclass microfluidic sensor that enables measurement of NO in whole bloodWith this toolwe have demonstrated that NO levels increase rapidly in preclinical models of sepsisIn Phase Iwe developed a prototype sensordemonstrated its unprecedented analytical performance in bloodand confirmed its ability to monitor pathophysiologic NO levels in a pre clinical modelFor Phase IIwe have assembled a team of scientistsengineersand clinical researchers to complete key steps on the critical path to receiving an Investigational Device ExemptionIDEand ultimately commercialize this device