REMI Platform for Remote EEG Monitoring

摘要 远程脑电监测的REMI平台 雷米脑电筛查平台。运行在医疗平板电脑上的Remi应用程序引导工作人员通过 放置四个安眠药传感器。Epilog通过蓝牙将脑电传输到应用程序，然后应用程序将 数据到运行PerSyst EEG审查软件的云服务器。癫痫专家登录PerSyst Mobile 在PerSyst中，远程查看Epilog EEG，将其作为10个通道的“纵向-横向”蒙太奇。 问题：显然需要离散的、可穿戴的EEG，可以由非EEG专业人员部署 在紧急情况下，特别是在缺乏脑电服务的社区和乡村医院。快速神经 当患者面临治疗不足的风险时，脑电图筛查是至关重要的，如果他们有 未发现的亚临床或非惊厥发作，如果脑电正常则过度治疗，如果脑电正常则延迟治疗 他们被送往三级医院进行诊断。 可穿戴解决方案 埃皮特尔开发了一种名为Epiog的无线 一种可传输的可穿戴式脑电传感器 EEG到记录、显示和回顾 名为REMI(远程脑电)的平台 监控)。通过R43/R44开发， Remi同步四个癫痫传感器 由医院急诊科放置 (ED)工作人员在病人到达后几分钟内 谁是癫痫的嫌疑人，在最初 治疗。REMI使用一体式导电和粘合剂安全地传输数据催眠传感器 到其云服务器，PerSyst®软件将传感器贴在发际线以下的头皮上。 实时处理脑电 癫痫专家使用Pesyst Mobile进行远程审查。作为R44的最后一个里程碑，埃皮特尔清除了REMI 与FDA(K203827)合作的平台，用作急诊室和重症监护室紧急护理的远程脑电筛查工具 护理单元，特别针对无法获得神经科或脑电波检查的社区和乡村医院。 REMI使癫痫专家能够在医院更准确、更快地远程指导时间敏感的治疗 缺乏神经学或提供紧急脑电服务的能力的人。 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FDA后的开发活动，旨在进行翻译。 1.通过多中心、前瞻性、盲法、随机临床试验展示临床实用性 在儿童和成人中 2.健康经济学和成果研究 3.知识产权战略援助 4.制造优化 5.入市技术支持 这种CRP对EPitel的价值是临床实用性、卫生经济学模型、市场准入和 制造优化。通过此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，让REMI平台对风险资本投资具有吸引力。

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.