REMI Platform for Remote EEG Monitoring

用于远程脑电图监测的 REMI 平台

• 批准号: 10383365
• 负责人: Mark J. Lehmkuhle
• 金额: $ 105.34万
• 依托单位: EPITEL, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-30 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10383365
• 关键词: Accident and Emergency department; Adhesives; Adoption; Adult; Applications Grants; Blinded; Bluetooth; Capital; Caring; Cessation of life; Child; Clinical; Clinical Trials Design; Community Hospitals; Computer software; Contracts; Costs and Benefits; Data; Development; Diagnosis; Economic Models; Electroencephalography; Emergency Situation; Emergent care; Foundations; Freedom; Goals; Health; Healthcare; Hospitals; Intellectual Property; Intensive Care Units; Investigation; Investments; Legal patent; Letters; Life; Marketing; Medical; Modeling; Monitor; Neurological emergencies; Neurologist; Neurology; Outcome; Outcomes Research; Patients; Peer Review; Phase; Physicians; Positioning Attribute; Process; Production; Randomized Clinical Trials; Randomized Controlled Trials; Readiness; Research; Resources; Risk; Running; Rural Community; Rural Hospitals; Sales; Scalp structure; Screening procedure; Secure; Seizures; Services; System; Tablets; Technology; Time; Traction; Translations; Universities; Utah; base; blind; budget impact; care costs; cloud platform; commercialization; cost; cost effective; design; health economics; improved; overtreatment; payment; pediatric emergency; prospective; remote grading; remote monitoring; screening; sensor; wireless

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.

摘要 REMI远程脑电监测平台 REMI EEG筛查平台。在医疗平板电脑上运行的REMI应用程序引导工作人员通过 四个Epilog传感器的位置。Epilog通过蓝牙将EEG传输到应用程序，然后将 将数据传输到运行Persyst EEG审查软件的云服务器。癫痫病学家登录Persyst移动的， 在Persyst中以真实的时间远程查看Epilog EEG，作为10通道“横向”导联。 显然需要一种可由非EEG专业人员部署的离散的、可穿戴的EEG 在紧急情况下，特别是在缺乏EEG服务的社区和农村医院。快速神经 EEG筛查对于患者存在治疗不足风险的情况至关重要， 未检测到的亚临床或非惊厥性癫痫发作，如果EEG正常，则过度治疗，如果 他们会被送往三级医院接受诊断。 可配戴解决方案 Epitel开发了Epilog，一种无线 可发射的可穿戴EEG传感器 记录、显示和回顾EEG REMI（Remote EEG） 监测）。通过R43/R44开发， REMI ®四个Epilog传感器 由医院急诊科放置 (ED)病人到达后几分钟内 在最初的调查之前， 治疗REMI安全地传输数据Epilog传感器使用一体式导电和粘合剂 连接到其云服务器，其中Persyst®软件“贴纸”将传感器贴在发际线以下的头皮上。 在现场处理真实的时间的EEG 癫痫病专家使用Pesyst移动的进行远程检查。作为R44的最后一个里程碑，Epitel通过了REMI FDA（K203827）平台，用作ED和重症监护室紧急护理的远程EEG筛查工具 医疗单位，特别是针对社区和农村医院，没有获得神经科或脑电图。 REMI使癫痫病学家能够在医院更准确、更快地远程指导时间敏感的治疗 缺乏神经病学或提供紧急脑电图服务的能力。 商业化准备试点（CRP）通过FDA获得市场许可只是第一个 迈向商业化。我们已经确定了5个专为翻译而设计的FDA后开发活动。 1.通过多中心、前瞻性、设盲、随机临床试验证明临床效用 儿童和成人 2.卫生经济学和结局研究 3.知识产权战略援助 4.制造优化 5.进入市场技术援助 该CRP对Epitel的价值是临床效用、卫生经济学建模、市场准入和 制造优化通过该CRP提供的技术援助将降低我们的技术风险， 在完全商业化之前，使REMI平台对风险资本投资具有吸引力。