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.

Public Health Relevance

An estimated 1.7 million traumatic brain injury (TBI) cases are reported every year in the United States with 15% 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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44NS076167-02A1
Application #
8645220
Study Section
Special Emphasis Panel (ZRG1-ETTN-A (10))
Program Officer
Fertig, Stephanie
Project Start
2011-07-15
Project End
2016-06-30
Budget Start
2014-01-01
Budget End
2014-12-31
Support Year
2
Fiscal Year
2014
Total Cost
$517,402
Indirect Cost
Name
Sfc Fluidics, LLC
Department
Type
DUNS #
125518428
City
Fayetteville
State
AR
Country
United States
Zip Code
72701