SFC FLUIDICS, INC. — Department of Health and Human Services SBIR Phase II: 102

Description

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 S B 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 SFCandapos 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 PUBLIC HEALTH RELEVANCE An estimated million traumatic brain injury TBI cases are reported every year in the United States with of these being severe enough to require invasive monitoring There is an urgent need for development of a bedside microdialysis system with in built analyzer which will help in rapid and continuous monitoring of the state of health of a patient with severe TBI Early and timely monitoring of the progress of injury of TBI victims will help attending practitioners take immediate remedial actions and improve the quality of care to the patient while greatly mitigating long term complications