SB1NS100235

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 "sticker" that attaches the sensor to the scalp below hairline. Processes the EEG in real time for live remote review by an epileptologist using Persyst 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.

Epitel

(1) TO SUPPORT EXTRAMURAL RESEARCH FUNDED BY THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) INCLUDING: BASIC RESEARCH THAT EXPLORES THE FUNDAMENTAL STRUCTURE AND FUNCTION OF THE BRAIN AND THE NERVOUS SYSTEM, RESEARCH TO UNDERSTAND THE CAUSES AND ORIGINS OF PATHOLOGICAL CONDITIONS OF THE NERVOUS SYSTEM WITH THE GOAL OF PREVENTING THESE DISORDERS, RESEARCH ON THE NATURAL COURSE OF NEUROLOGICAL DISORDERS, IMPROVED METHODS OF DISEASE PREVENTION, NEW METHODS OF DIAGNOSIS AND TREATMENT, DRUG DEVELOPMENT, DEVELOPMENT OF NEURAL DEVICES, CLINICAL TRIALS, AND RESEARCH TRAINING IN BASIC, TRANSLATIONAL AND CLINICAL NEUROSCIENCE. THE INSTITUTE IS THE LARGEST FUNDER OF BASIC NEUROSCIENCE IN THE US AND SUPPORTS RESEARCH ON TOPICS INCLUDING BUT NOT LIMITED TO: DEVELOPMENT OF THE NERVOUS SYSTEM, INCLUDING NEUROGENESIS AND PROGENITOR CELL BIOLOGY, SIGNAL TRANSDUCTION IN DEVELOPMENT AND PLASTICITY, AND PROGRAMMED CELL DEATH, SYNAPSE FORMATION, FUNCTION, AND PLASTICITY, LEARNING AND MEMORY, CHANNELS, TRANSPORTERS, AND PUMPS, CIRCUIT FORMATION AND MODULATION, BEHAVIORAL AND COGNITIVE NEUROSCIENCE, SENSORIMOTOR LEARNING, INTEGRATION AND EXECUTIVE FUNCTION, NEUROENDOCRINE SYSTEMS, SLEEP AND CIRCADIAN RHYTHMS, AND SENSORY AND MOTOR SYSTEMS. IN ADDITION, THE INSTITUTE SUPPORTS BASIC, TRANSLATIONAL AND CLINICAL STUDIES ON A NUMBER OF DISORDERS OF THE NERVOUS SYSTEM INCLUDING (BUT NOT LIMITED TO): STROKE, TRAUMATIC INJURY TO THE BRAIN, SPINAL CORD AND PERIPHERAL NERVOUS SYSTEM, NEURODEGENERATIVE DISORDERS, MOVEMENT DISORDERS, BRAIN TUMORS, CONVULSIVE DISORDERS, INFECTIOUS DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, IMMUNE DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, INCLUDING MULTIPLE SCLEROSIS, DISORDERS RELATED TO SLEEP, AND PAIN. PROGRAMMATIC AREAS, WHICH ARE PRIMARILY SUPPORTED BY THE DIVISION OF NEUROSCIENCE, ARE ALSO SUPPORTED BY THE DIVISION OF EXTRAMURAL ACTIVITIES, THE DIVISION OF TRANSLATIONAL RESEARCH, THE DIVISION OF CLINICAL RESEARCH, THE OFFICE OF TRAINING AND WORKFORCE DEVELOPMENT, THE OFFICE OF PROGRAMS TO ENHANCE NEUROSCIENCE WORKFORCE DEVELOPMENT, AND THE OFFICE OF INTERNATIONAL ACTIVITIES. (2) TO EXPAND AND IMPROVE THE SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. TO UTILIZE THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM, TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.853 - Extramural Research Programs in the Neurosciences and Neurological Disorders

National Institute of Neurological Disorders and Stroke (NNDS) [HHS - NIH]

Utah United States

State-Wide

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1 Clinical Trial Required) (PAR-20-130)

Amendment Since initial award the total obligations have increased 225% from $1,053,438 to $3,421,001.