REMI Platform for Remote EEG Monitoring

ABSTRACT REMI Platform for Remote EEG Monitoring The REMI EEG screening platform. The REMI app running on a medical tablet guides staff through the placement of four Epilog sensors. Epilog transmits EEG through Bluetooth to the app which then relays the data to a cloud server running Persyst EEG reviewing software. An epileptologist logs on to Persyst Mobile to remotely review Epilog EEG in real time as a 10-channel “longitudinal-transverse” montage in Persyst. PROBLEM There is a clear need for discrete, wearable EEG that can be deployed by non-EEG professionals in an emergent setting, especially in community and rural hospitals that lack an EEG service. Rapid neuro screening with EEG is critical for situations when patients are at risk of under-treatment if they are having undetected subclinical or non-convulsive seizures, over-treatment if EEG is normal, and delayed treatment if they are transported to a tertiary hospital for diagnosis. WEARABLE SOLUTION Epitel has developed Epilog, a wireless wearable EEG sensor capable of transmitting EEG to a recording, display, and review platform called REMI (Remote EEG Monitoring). Developed through R43/R44, REMI synchronizes four Epilog sensors placed by hospital Emergency Department (ED) staff within minutes of patient arrival who are suspect of seizures, prior to initial treatment. REMI securely transmits the data Epilog sensors use a one-piece conductive and adhesive to its cloud server where Persyst® software ‘sticker’ that attaches the sensor to the scalp below hairline. processes the EEG in the real time for live remote review by an epileptologist using Pesyst Mobile. As the final milestone in R44, Epitel cleared the REMI platform with FDA (K203827) for use as a remote EEG screening tool for emergent care in EDs and intensive care units, specifically targeting community and rural hospitals that do not have access to neurology or EEG. REMI enables epileptologists to remotely direct time-sensitive treatment more accurately and faster in hospitals that lack neurology or the capability to provide emergency EEG services. COMMERCIALIZATION READINESS PILOT (CRP) Gaining market clearance through FDA is simply the first step toward commercialization. We have identified 5 post-FDA development activities designed for translation. 1. Demonstrate Clinical Utility through a multi-center, prospective, blinded, randomized clinical trial in children and adults 2. Health Economics and Outcomes Research 3. Intellectual Property Strategy assistance 4. Manufacturing Optimization 5. Go-to-Market Technical Assistance The value of this CRP for Epitel is evidence for clinical utility, health economics modeling, market access, and manufacturing optimization. The technical assistance provided through this CRP will de-risk our technology to make the REMI platform attractive to venture capital investment prior to full commercialization.