REMI Platform for Remote EEG Monitoring

用于远程脑电图监测的 REMI 平台

• 批准号: 10548863
• 负责人: Mark J. Lehmkuhle
• 金额: $ 116.76万
• 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/10548863
• 关键词: Accident and Emergency department; Adhesives; Adoption; Adult; Applications Grants; Blinded; Bluetooth; Capital; Caring; Cessation of life; Child; Clinical; Clinical Trials Design; Communities; Community Hospitals; Computer software; Contracts; Costs and Benefits; Data; Development; Diagnosis; Economic Models; Electroencephalography; Emergency Situation; Emergent care; Exclusion; Foundations; Freedom; Goals; Good Manufacturing Process; Health; Healthcare; Hospitals; Institution; Intellectual Property; Intensive Care Units; 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, Controlled Trials; Research; Resources; Risk; Running; Rural Hospitals; Sales; Scalp structure; Screening procedure; Secure; Seizures; Services; System; Tablets; Technology; Time; Traction; Translations; Universities; Utah; blind; budget impact; care costs; cloud platform; commercialization; commercialization readiness; cost; cost effective; data exchange; design; empowerment; health economics; improved; manufacture; overtreatment; payment; pediatric emergency; prospective; randomized, clinical trials; remote grading; remote monitoring; screening; sensor; transmission process; trial planning; 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.

抽象的 用于远程脑电图监测的 REMI 平台 REMI 脑电图筛查平台。在医疗平板电脑上运行的 REMI 应用程序可指导工作人员完成 四个 Epilog 传感器的放置。 Epilog 通过蓝牙将脑电图传输到应用程序，然后应用程序转发 将数据传输到运行 Persyst EEG 检查软件的云服务器。癫痫病专家登录 Persyst Mobile 在 Persyst 中以 10 通道“纵向-横向”蒙太奇形式实时远程查看 Epilog EEG。 问题 显然需要可以由非脑电图专业人员部署的离散、可穿戴脑电图 在紧急情况下，特别是在缺乏脑电图服务的社区和乡村医院。快速神经 当患者有治疗不足的风险时，脑电图筛查至关重要。 未发现的亚临床或非惊厥性癫痫发作，如果脑电图正常则过度治疗，如果脑电图正常则延迟治疗 他们被送往三级医院进行诊断。 可穿戴解决方案 Epitel 开发了 Epilog，一种无线 能够传输的可穿戴脑电图传感器 脑电图记录、显示和回顾 称为 REMI（远程脑电图 监控）。通过R43/R44开发， REMI 同步四个 Epilog 传感器 由医院急诊科安排 (ED) 工作人员在患者到达后几分钟内 怀疑癫痫发作的人，在初次检查之前 治疗。 REMI 使用一体式导电粘合剂安全地传输数据 Epilog 传感器 到其云服务器，其中 Persyst® 软件“贴纸”将传感器粘贴到发际线以下的头皮上。 实时处理脑电图 癫痫病专家使用 Pesyst Mobile 进行远程审查。作为 R44 的最后一个里程碑，Epitel 清除了 REMI 与 FDA (K203827) 合作的平台，用作急诊科和重症监护室紧急护理的远程脑电图筛查工具 护理单位，特别针对无法进行神经内科或脑电图检查的社区和乡村医院。 REMI 使癫痫科医生能够在医院中更准确、更快速地远程指导时间敏感的治疗 缺乏神经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步 迈向商业化。我们已经确定了 5 项专为翻译而设计的 FDA 后开发活动。 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. 卫生经济学和成果研究 3. 知识产权战略协助 4. 制造优化 5. 上市技术援助 Epitel 的这个 CRP 的价值是临床效用、健康经济学模型、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 使 REMI 平台在全面商业化之前对风险投资具有吸引力。