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Research, Scholarly Activity and Innovation Section

The Sensor Evaluation of Neurologic Status in Emergencies (SENSE) Device (Sense Diagnostics LLC; Cincinnati, OH): An Emergency Medicine Led Technology Development Story

Opeolu Adeoye, MD MS FACEP FAHA
George J. Shaw, MD PhD


SENSE is a non-invasive radiofrequency (RF) sensor developed at the University of Cincinnati (UC) that detects and monitors intracranial hemorrhage (ICH). The idea for SENSE originated in a collaborative discussion between Drs. Opeolu Adeoye (Emergency Medicine and Neurocritical Care), Joseph Clark (Basic Scientist), Matthew Flaherty (Vascular Neurology) and George Shaw (Emergency Medicine and PhD Physicist). The clinical need we identified was in the bedside monitoring of patients with ICH for expansion of that ICH. The current standard of care remains frequent neurological exams, which are reliably done in the intensive care unit (ICU) setting but border on inhumane after 2-3 days of exams every hour; and, are variably done in the emergency department (ED) or hospital floor where the ebbs and flows of clinical care may necessitate deferring the scheduled checks. As such, the shortfall of the current standard of care is that patients have to suffer a deterioration of clinical exam before we begin to investigate whether they have suffered ICH expansion, the extent of that expansion, and what treatment options may be available. SENSE seeks to serve as a “brain alarm” that will alert clinicians early to ongoing ICH expansion. 

SENSEIn vitro studies in Dr. Shaw’s lab and in vivo animal laboratory studies with collaborators at UC have been completed,1,2 establishing proof of concept. We subsequently formed a startup company with the support and guidance of the UC Technology Accelerator Program and we have licensed the technology from the university. We have been able to obtain funding from the State of Ohio and the National Science Foundation as we continue to refine the technology. The current configuration of the device is shown in the Figure. We will conduct a first in human study this winter and hope to use lessons learned in that study to inform planning of a larger definitive study in the coming couple of years.

Overall, we have been fortunate to harness our disparate training, expertise and collaborators as emergency physician scientists to pursue development of a potentially commercializable device. Our experience with grant writing and basic science research has been instrumental to moving the technology along. Dr. Joseph Korfhagen was a student in Dr. Sha’s lab and is now the Research Director for the company. The support from the university and introduction to local entrepreneurs has also been critical for sustaining the development effort. Our Chief Executive Officer, Mr. Daniel Kincaid has led our fundraising efforts as we attempt to navigate the “valley of death” between university-based research and early stage investment from entrepreneurs. Our experience has been challenging yet rewarding. It remains unknown whether we will in fact be able to commercialize the device but we hope lessons learned will inform future activity if not for us, at least for the next generation of emergency physician scientists who may translate scientific ideas and discoveries into new technologies designed to enhance emergency clinical care.

References

  1. Korfhagen JJ, Kandadai MA, Clark JF, Adeoye O, Shaw GJ. A prototype device for non-invasive continuous monitoring of intracerebral hemorrhage. J Neurosci Methods. 2013;213(1):132-137.
  2. Kandadai MA, Korfhagen JJ, Beiler S, et al. In vivo testing of a non-invasive prototype device for the continuous monitoring of intracerebral hemorrhage. J Neurosci Methods. 2014;235:117-122.



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