Research Project
8788450
DESCRIPTION (provided by applicant): Portable Brain Injury Biomarker Detection System with Integrated Microdialysis Probe Project Summary: SFC Fluidics is developing a portable, fully-integrated and automated medical device for clinical monitoring of patients with severe brain injury. The instrument will allow for automated detection 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 the brain and continuous real-time monitoring of their concentration will provide important clues about adverse secondary insults like ischemia, hypoxia, seizure, vasospasm and more, and will help in critical care of patients in neuro-ICU. SFC Fluidics will use a suite of proven, patented technologies to develop the proposed instrument and make it ready for FDA approval and subsequent clinical trials in Phase III. SFC's innovative component technologies have been tested and assembled into an initial prototype, whose basic functionality has been demonstrated during Phase I. During Phase II, SFC will systematically and iteratively improve the design and functionality of the existing prototype, conduct extensive side-by-side, in vitro and in vivo testing and validate performance in an established rat model. The targeted instrument will integrate many clinically relevant and useful features to significantly change the modality of critical care of neurotrauma patients.
