A Naloxone Parachute: Novel Wearable Dual-Sensor Regional Oximeter to Detect Opioid-Induced Hypoxia and Enable Emergent Naloxone Rescue

纳洛酮降落伞:新型可穿戴双传感器区域血氧计,用于检测阿片类药物引起的缺氧并实现紧急纳洛酮救援

基本信息

  • 批准号:
    10612485
  • 负责人:
  • 金额:
    $ 96.4万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2022
  • 资助国家:
    美国
  • 起止时间:
    2022-05-01 至 2025-04-30
  • 项目状态:
    未结题

项目摘要

SBIR PHASE II - ABSTRACT Ayuda Medical has the vision that no-one should die from a treatable medical emergency. Opioid overdoses (OODs) are treatable with basic CardioPulmonary Resuscitation (CPR), but they claimed over 250 lives each day in the US in 2020. Patients most at risk for OOD are people in treatment for Opioid Use Disorder (OUD) or High Impact Chronic Pain (HICP). The current standard of care to OOD is bystander response (medical or nonmedical), but the bystander needs to know that an OOD is occurring. We present a wearable medical diagnostic device to detect OOD and bridge the gap to bystander intervention. Our device, Parachute ARMband, will be worn continuously, and will monitor physiologic parameters that indicate OOD, then will use an on-device escalating tonal alarm to summon bystanders, as well as on- device speaker to verbally identify the urgency to get medical help. No wireless connectivity is required for these functions. The ARMband will also send a Bluetooth alert to an adjunct Mobile Medical Application (MMA) on the User’s phone, that can reach designated contacts, previously chosen by the device user. This function requires mobile device connectivity, and that the MMA be downloaded prior to the medical event. Company has completed a Phase I SBIR, sponsored by National Institute of Drug Abuse (NIDA), that showed the upper arm is a viable location for wearable oximeters, main components of novel device. The addition of Phase I Innovation Corps enabled company to validate Minimal Viable Product (MVP) key features, including escalating alarm and wireless alert. Together our Phase I learnings allowed Principle Investigator (PI) to submit a Breakthrough Device Designation (BDD) request to the FDA. This proposed Phase II application will show feasibility of our novel device components to detect gas- induced hypoxia, compared to arterial blood gas (Aim 1); sensitivity of device to detect intravenous remifentanil “OOD” and begin alarm algorithm (Aim 2); and ability of device communications to send a real-time wireless alert (Aim 3). These three aims support device safety and effectiveness. In Aim 4, Human Factors and Instructions for Use (IFU) are specifically tested in our target population, persons with a history of OUD or OOD. Aim 5 likewise tests the device in our target population, but also adds our target use environment; it will test device’s wearability via 48hr and and two-to-four week take home studies. Together all five Aims, along with non-clinical testing of device design and alarms, will support seeking Class II marketing via a De Novo submission, with the device indicated for People Who Use Opioids (PWUOs) including HICP, and people with a history of OUD that are at risk for OOD. To date there is no FDA approved device to monitor for OOD. We offer a continuous monitor because stressors and triggers to opioid use can be unexpected. The De Novo submission will include data from studies designed for our target clinical scenario (acute opioid ingestion/ administration), and target use environment (ambulatory, at-home). Ayuda Medical plans to have several discussions with the United States Food and Drug Administration (FDA), throughout device development and Phase II. BDD was submitted in Q3, 2021, and company plans to submit a Q-sub clarifying our milestones to approval in Q4, 2021. We plan to use early gas hypoxia studies (Aim 1A) to apply for Investigational Device Exemption (IDE), and then perform clinical studies with opioid- specific protocols (Aims 2 and 3). This includes feasibility (Q4, 2022) and pivotal (Q4, 2023) studies sponsored by Phase II. Continuous interactions with FDA will align company milestones with FDA objectives. Commercialization strategy includes seeking federal Medicaid coverage in tandem with FDA approval, as part of a dual-panel (FDA-CMS) pre-marketing review. Company plans to market the ARMband directly within the OUD market, and co-market the device with a strategic partner within the HICP market. We also intend to conduct community-based pilot studies in collaboration with NIDA and the Substance Abuse and Mental Health Services Administration (SAMHSA), to validate device system in specific to the OUD/HICP populations in target environment, and to support formulary inclusion by State Medicaid. State Medicaid coverage assures that the device is affordable and accessible by Community Health Centers (CHCs), that treat the majority of the low-income populations for both chronic and acute illnesses, including OUD and OOD. Establishing a viable commercial path via state Medicaid and CHCs, that can then be expanded into 50 states, is an attractive proposal to partnerships and potential exit companies in the OUD market. Phase I validated device need and feasibility of our development approach. Phase II will provide the appropriate clinical and non-clinical testing to support a De Novo submission to the FDA. Company is fully dedicated to the approval and commercialization of the Parachute ARMband OOD diagnostic device, and to making it available to all at-risk groups, aiming to expand the protection against accidental opioid overdose.
SBIR第二阶段-摘要 Ayuda医疗公司的愿景是,没有人应该死于可治疗的医疗紧急情况。阿片 过量(OOD)可以用基本的心肺复苏(CPR)治疗,但他们声称超过250 2020年美国的每一天OOD风险最高的患者是接受阿片类药物治疗的患者 高冲击性慢性疼痛(High Impact Chronic Pain,HICP)目前OOD的标准治疗是旁观者治疗 反应(医疗或非医疗),但旁观者需要知道OOD正在发生。我们提出了一个 可穿戴医疗诊断设备,以检测OOD并弥合与旁观者干预的差距。 我们的设备Parachute ARMband将连续佩戴,并监测生理参数 指示OOD,然后将使用设备上的升级音调警报来召集旁观者,以及- 设备扬声器,以口头识别紧急情况,以获得医疗帮助。无需无线连接, 这些功能。ARMband还将向附属移动的医疗应用程序发送蓝牙警报 (MMA)在用户的电话上,可以联系到设备用户先前选择的指定联系人。这 功能需要移动终端连接,并且在医疗事件之前下载MMA。 公司已经完成了由国家药物滥用研究所(NIDA)赞助的第一阶段SBIR, 表明上臂是一个可行的位置可穿戴血氧仪,新设备的主要组成部分。的 第一阶段创新团队的加入使公司能够验证最小可行产品(MVP)的关键功能, 包括升级警报和无线警报。我们在第一阶段的学习让首席研究员 (PI)向FDA提交突破性器械认定(BDD)申请。 该拟议的第二阶段应用将显示我们的新型设备组件检测气体的可行性, 诱导缺氧,与动脉血气相比(Aim 1);器械检测静脉瑞芬太尼的灵敏度 “OOD”和开始报警算法(Aim 2);以及器械通信发送实时无线 alert(目标3)。这三个目标支持器械的安全性和有效性。目标4:人为因素和 使用说明书(IFU)在我们的目标人群中进行了专门测试,目标人群是有OUD病史的人,或 值日官Aim 5同样在我们的目标人群中测试该设备,但也增加了我们的目标使用环境;它将 通过48小时和两到四周的带回家研究测试设备的可穿戴性。 所有五个目标,沿着设备设计和报警的非临床测试,将支持寻求 通过De Novo提交的II类上市,器械适用于阿片类药物使用者(PWUO) 包括HICP和有OOD病史的人,这些人有OOD的风险。到目前为止,FDA还没有批准 监控OOD的设备。我们提供持续监测,因为阿片类药物使用的压力源和触发因素可能会 出乎意料。De Novo提交资料将包括为我们的目标临床场景设计的研究数据 (急性阿片类药物摄入/给药)和目标使用环境(门诊,在家)。 Ayuda Medical计划与美国食品和药物管理局进行多次讨论 (FDA)在整个器械开发和第II阶段。BDD于2021年第三季度提交,公司计划 提交一份Q-sub,澄清我们的里程碑,以在2021年第四季度获得批准。我们计划利用早期的气体缺氧研究 (Aim 1A)申请试验用器械豁免(IDE),然后进行阿片类药物的临床研究- 具体议定书(目标2和3)。这包括可行性(2022年第4季度)和关键性(2023年第4季度)研究 由第二阶段赞助。与FDA的持续互动将使公司里程碑与FDA目标保持一致。 商业化战略包括在FDA批准的同时寻求联邦医疗补助覆盖, 作为双面板(FDA-CMS)上市前审查的一部分。公司计划直接销售ARM Band 在OUD市场中,与HICP市场中的战略合作伙伴共同销售该设备。我们也 打算与NIDA和药物滥用问题研究所合作,开展以社区为基础的试点研究, 心理健康服务管理局(SAMHSA),针对OUD/HICP确认器械系统 目标环境中的人群,并支持州医疗补助计划的处方集。州医疗补助 覆盖范围确保该设备能够负担得起且可由治疗该疾病的社区卫生中心(CHC)使用 大多数低收入人群患有慢性和急性疾病,包括OUD和OOD。 通过州医疗补助和社区卫生服务建立一条可行的商业道路,然后可以扩展到50个州, 对于OUD市场中的合作伙伴和潜在退出公司来说,这是一个有吸引力的建议。 第一阶段验证了我们开发方法的设备需求和可行性。第二阶段将提供 适当的临床和非临床试验,以支持向FDA提交的重新分类申请。公司完全 致力于降落伞臂带OOD诊断设备的批准和商业化,并 向所有风险群体提供,旨在扩大对意外阿片类药物过量的保护。

项目成果

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Desislava Zlatanova Hite其他文献

Desislava Zlatanova Hite的其他文献

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{{ truncateString('Desislava Zlatanova Hite', 18)}}的其他基金

A Naloxone Parachute: Novel Wearable Dual-Sensor Regional Oximeter to Detect Opioid-Induced Hypoxia and Enable Emergent Naloxone Rescue
纳洛酮降落伞:新型可穿戴双传感器区域血氧计,用于检测阿片类药物引起的缺氧并实现紧急纳洛酮救援
  • 批准号:
    10339144
  • 财政年份:
    2021
  • 资助金额:
    $ 96.4万
  • 项目类别:

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