Phase II year
2014
(last award dollars: 2016)
Phase II Amount
$1,987,208
Portable Brain Injury Biomarker Detection System with Integrated Microdialysis ProbeProject Summary: SFC Fluidics is developing a portable, fully-integrated and automated medical device forclinical monitoring of patients with severe brain injury. The instrument will allow for automateddetection of several small molecule biomarkers, glucose, glutamate, lactate, pyruvate and urea,and a protein biomarker, S100B. These biomarkers are present in the extracellular fluid in thebrain and continuous real-time monitoring of their concentration will provide important cluesabout adverse secondary insults like ischemia, hypoxia, seizure, vasospasm and more, and willhelp in critical care of patients in neuro-ICU. SFC Fluidics will use a suite of proven, patentedtechnologies to develop the proposed instrument and make it ready for FDA approval andsubsequent clinical trials in Phase III. SFC's innovative component technologies have beentested and assembled into an initial prototype, whose basic functionality has been demonstratedduring Phase I. During Phase II, SFC will systematically and iteratively improve the design andfunctionality of the existing prototype, conduct extensive side-by-side, in vitro and in vivo testingand validate performance in an established rat model. The targeted instrument will integratemany clinically relevant and useful features to significantly change the modality of critical care ofneurotrauma patients.
Thesaurus Terms: Animals;Arkansas;Back;Base;Biological Assay;Biological Markers;Brain;Brain Hypoxia-Ischemia;Brain Injuries;Calibration;Case Study;Cerebrum;Clinical;Clinical Trials;Clinically Relevant;Code;College;Computer Software;Controlled Cortical Impact;Critical Care;Design;Detection;Development;Dextran;Dextrans;Ensure;Enzyme-Linked Immunosorbent Assay;Evaluation;Extracellular Fluid;Failure (Biologic Function);Feedback;Glucose;Glutamates;Government;Graphical User Interface;Guidelines;Health;Hour;Immunoassay;Improved;In Vitro;In Vivo;Individual;Injection Of Therapeutic Agent;Injury;Innovation;Instrument;Intervention;Legal Patent;Life Cycle Stages;Medical Device;Medicine;Microdialysis;Modality;Modeling;Monitor;Nurses;Operation;Patient Monitoring;Patients;Performance;Persons;Phase;Pressure;Proteins;Protocols Documentation;Prototype;Public Health Relevance;Pump;Pyruvate;Quality Of Care;Rattus;Reagent;Recovery;Regulation;Reporting;Response;Running;Seizures;Sensor;Shock;Side;Small Molecule;Software Validation;System;Technology;Testing;Time;Traumatic Brain Injury;United States;Urea;User-Friendly;Variant;Vasospasm;Verification And Validation;Work;