# A device to prevent Sudden Unexpected Death in Epilepsy (SUDEP)

> **NIH NIH R43** · SOTERYA, INC. · 2021 · $502,561

## Abstract

Project Summary/Abstract
Sudden Unexpected Death in Epilepsy (SUDEP) is the leading cause of death in epilepsy children and
otherwise healthy adult epilepsy patients, with a cumulative lifetime risk of ~8%. About 70% of SUDEP occurs
during sleep, and nearly 90% are found in the prone (face-down) position. SUDEP can likely be prevented by
the simple intervention of repositioning and stimulating the patient after a convulsive seizure. Such intervention
must be performed quickly and autonomously within a critical 3-minute window after a convulsion. Soterya,
Inc., founded with the mission to develop technologies to decrease the risk of SUDEP, addresses this critical
unmet medical need with an innovative smart mattress, the KORUS. Soterya has demonstrated feasibility by
developing a functional alpha prototype consisting of an array of expandable cells and a shapeable surface
that safely and rapidly repositions human subjects. There are currently no products that detects the prone
position and physically repositions a patient into a recovery (sideways) position. The goal of this Phase I SBIR
is to develop and validate two key technologies required to successfully develop a fully functional autonomous
prototype: 1) advanced expandable cell with the size, weight, safety features, and noise management suitable
for a human clinical trial, while maintaining our benchmark of generating enough lift at a required velocity with a
1000 lb/cell capacity; 2) embedded sensor system for rapid detection of body position change, and detection of
the prone position. Soterya will optimize sensor manufacturing capabilities and software tools for body
positioning visualization and data processing, and develop software for integrating these tools into a single
sensory network system. Human feasibility testing will be performed through our academic partners at the
epilepsy and sleep medicine service of the Brigham and Women’s Hospital. A total of 10 normative control
subjects will be recruited to test the device efficacy in repositioning, awake testing to assess detection of body
position changes, and overnight testing for detecting spontaneous body position changes during sleep.
Milestones for this study will be 1) safely repositioning subjects from a prone to a recovery position within 30
seconds; 2) detecting body position changes into a prone position with 95% accuracy. The completion of this
project will position Soterya for the development of a fully functional prototype. A subsequent Phase 2 study
will pair the KORUS with a commercial seizure detection device for a clinical trial in the hospital epilepsy
monitoring unit, with the ultimate goal of developing a fully embedded seizure detection and management
system. The development of KORUS as a medical device for the night-time management of convulsive
seizures will achieve a 50-75% risk reduction of night-time SUDEP.

## Key facts

- **NIH application ID:** 10323597
- **Project number:** 1R43NS120394-01A1
- **Recipient organization:** SOTERYA, INC.
- **Principal Investigator:** Jong Woo Lee
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $502,561
- **Award type:** 1
- **Project period:** 2021-09-21 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10323597

## Citation

> US National Institutes of Health, RePORTER application 10323597, A device to prevent Sudden Unexpected Death in Epilepsy (SUDEP) (1R43NS120394-01A1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10323597. Licensed CC0.

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