Microfluidic Nitric Oxide Sensor

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