Transferring Laboratory Precision to the Field

Based on Dr. Smith’s decades of experience in sensory research, we knew that the precision devices for measuring olfactory function, though common in the laboratory, would not work for field research in humans.  

Our first challenge was to develop an apparatus and method that would overcome the limitations of laboratory olfactometers and give us the capability to test our hypotheses that olfactory measures are predictors of neurologic disease and injury.

US Patent: 10682087 (June 16, 2020)

US Patent: 11478183 (October 25, 2022)

This patent covers a system and methodology to deliver an automated, standardized assessment and analysis of a human olfactory system's odor detection ability as an indicator or predictor of cognitive impairment (e.g., related to mTBI) or change in cognitive health (e.g., Alzheimer’s or Parkinson’s Diseases). 

This automated system is suitable for use in all age groups of humans and provides quantitative detection and analysis of a subject's olfactory system’s detection ability compared with a relevant demographic population.

Based on tests with our early prototypes and Dr. Smith’s continued research, we refined the system and increased the sophistication of our device to account for the fact that all sensory systems are dependent on stimulation level relative to threshold.  At the time, the few commercially available olfactory tests presented stimulation at one, or a few absolute levels, irrespective of a test subject’s actual sensitivity to that stimulus, resulting in skewed or inaccurate assessments. 

This continued research and innovation lead to the development of a second-generation device and the Olfaxis Index of olfactory function based on precise measurement of odor threshold, identification, discrimination, and adaptation. We completed the fully portable device (shown at left) and covered in the following patent. 

US Patent: 1186310 (May 21, 2024)

This patent covers methods, devices and systems estimating a subject’s odor threshold, then presenting test stimuli at a determined level above a patient's threshold, resulting in more repeatable, reliable sensitivity estimates.  With this new capability, we enlisted Dr. Andreas Keil, a leading international expert on electrophysiological and imaging studies of the brain, to help develop EEG measures of olfactory CNS function; we theorized that the odorant stimulus delivered by the Olfaxis 2.0 device would trigger neural responding in the brain that could be recorded and analyzed for their potential to categorize the extent of neuropathology related to mTBI and repeated subclinical blows to the head.

     We presented our research to US Army Special Operations Command and were given access to test the Olfaxis System on special operations soldiers. That experience, and the subsequent analysis of the data, provided the basis for the following patent application.

Patent Pending

WO 2019/173588 A1 (September 12, 2019)

This patent covers a system for presenting an odorant, auditory, or somatosensory stimulus to a subject to illicit a brain response that can be measured using quantitative EEG. These electrophysiologic measures provide valuable biomarkers of neurologic dysfunction.

Using the data and lessons learned from the Special Operations data collection trial, we refined the analytic tools and continued data collection to assess their efficacy. Through multiple experiments with various machine learning tools such as Support Vector Machine algorithms for classification of the data. The results from these trials enabled us to develop the Olfaxis Composite Index of key biomarkers that produce an accurate classification of brain functional status.  Concurrently, we developed partnerships with equipment manufacturers to provide commercial-off-the-shelf components that would simplify the data collection process, improve data quality and simplify test administration. Further testing with this system has demonstrated high sensitivity and specificity for classifying mTBI. 

Patent Pending

WO 2021/034591 A1 (February 25, 2021)

This patent covers a system and methods to generate the Olfaxis Composite Index comprised of sensory evoked and cortical measures of neurologic function, use AI tools for analysis of the composite index, and train those tools to deliver a precise classification of neurologic function based on comparison to a normative (demographically appropriate) baseline or to the subject’s previous measure. In the case of suspected brain injury, the system and AI is trained to deliver an mTBI classification to support triage decisions at the point of injury.