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Automated Seizure Detection for Home Seizure Monitoring with Epilog Sensors

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1U44NS121562-01
Agency Tracking Number: U44NS121562
Amount: $1,992,939.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 105
Solicitation Number: NS18-012
Timeline
Solicitation Year: 2018
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-05-15
Award End Date (Contract End Date): 2023-04-30
Small Business Information
420 CHIPETA WAY, STE 1700
Salt Lake City, UT 84108-6500
United States
DUNS: 808401157
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 MARK LEHMKUHLE
 (734) 646-6266
 lehmkuhle@epite.com
Business Contact
 DANUTA PETELENZ
Phone: (734) 646-6266
Email: danuta.petelenz@tco.utah.edu
Research Institution
N/A
Abstract

ABSTRACT
Aura is a digital health platform that uses Epilog™, a miniature, wireless, wearable EEG sensor worn on the
scalp below hairline that can record clinical and subclinical seizures. After an initial diagnosis of epilepsy, an
epileptologist will use known information about patients’ seizures to guide the best scalp location to place the
Epilog EEG sensor (A). EEG data is continuously transferred (B) to the Aura app on a person’s smartphone (C)
using secure BluetoothTM where it communicates over WiFi (D) to the Aura cloud platform (E). Epilog EEG is
analyzed for seizures and a daily digital seizure diary is shared with epileptologists (F) and pushed back to the
Aura app (G). Epilog is recharged daily, and reusable for a year. Epilog is designed to be discreet, allowing for
continuous use in all facets of daily life.
Data are a 10 s snippet of the beginning of a focal seizure with motor impairment and intact awareness (ILAE
1A1) recorded from Epitel’s single-channel Epilog sensor placed on the left forehead. The patient was admitted
for video-EEG monitoring as standard-of-care. This seizure was verified independently by three epileptologists.
In Phase I, automated, machine learning-based seizure detection algorithms will be designed to first work in the
Aura cloud to detect seizures in Epilog EEG, including seizures a person may not consciously know they are
having (rt50% of all seizures), such as while sleeping. Aura will run these algorithms developed exclusively for
Epilog’s single-channel of EEG to provide a daily digital seizure diary.
In Phase II, the Aura system will enter clinical validation trials for FDA clearance as an EEG-based automated
home seizure detection and alerting system. Early in Phase II Aura will be commercialized as a medical
device-enabled-service business model. Out-of-pocket costs for a person living with epilepsy is an average of
$380/year. Armed with long-term, reproducible EEG, epileptologists will now have a more precise, quantitative
record of seizure counts, enabling them to adapt patient treatment more rapidly and successfully to improve
quality of life. Aura will give people living with epilepsy their lives back. Aura provides certainty where you are
and when you need it. Throughout Phase II, physiological, psychological, behavioral, and environmental factors
will be combined in the Aura app to collect 27,000 days of multi-modal data from 300 patients to create an
unprecedented dataset of features known to precipitate seizures.
These data will be used in Phase III to create a robust, wearable seizure forecasting system using artificial
intelligence that combines multi-modal seizure precipitating factors, creating an hourly seizure probability.
Aura will profoundly disrupt how epilepsy is managed and improve the quality of life of people living with epilepsy.

* Information listed above is at the time of submission. *

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