Development and qualification of Talon microIPG to treat Chronic Migraines

项目总结/摘要 偏头痛是最常见的神经系统疾病，也是50岁以下人群的第三大致残原因。 世界卫生组织49.在美国，每年的医疗保健和生产力损失成本约为360亿美元。 在美国有600万人是慢性偏头痛患者，他们在一个月内有超过50%的偏头痛，其中78%的人患有偏头痛。 目前的治疗方法帮助了许多患者，但在美国有近100万患者 对初始治疗无反应或随时间推移停止反应;这被称为难治性慢性偏头痛（ICM）17，18 这些ICM患者已经用尽了传统的治疗选择，通常迫切需要缓解， 进展到更具侵入性的治疗，如枕神经刺激（ONS）。ONS涉及手术植入 植入式脉冲发生器（IPG）和皮肤下的刺激导线（电线）， 对枕神经进行电刺激ONS已在标签外有效使用了20年，用于治疗各种 头痛疾病，并成功地减少每月头痛天数，疗效上级 在“金标准”预防性治疗1 -15中，65%的患者报告头痛缓解效果极佳或良好 1年后。12不幸的是，ONS治疗的器械和手术不良事件数量不可接受（约70%） 这在很大程度上可归因于标签外使用并非为此设计的脊髓刺激（SCS）系统 应用程序.使用非标准化植入方案，将标签外SCS器械植入颈部以下 导线穿过颈部到达位于头部的枕神经。 目前不存在已经被设计、开发和鉴定为可植入刺激系统的可植入刺激系统。 ONS。因此，在医疗器械库中存在对专用ONS器械的显著未满足的需求， 标准化的植入技术。在这一未满足的需求得到解决之前，慢性偏头痛患者将继续接受治疗。 面临着不充分和昂贵的治疗选择，往往需要反复手术干预， 患者继续受苦。我们的长期目标是建立一种安全、可靠和有效的ONS慢性偏头痛治疗方法 经过广泛的实验室测试和严格的临床研究证明的治疗方法， 最终实现商业化。 NeoGenesis提出，ONS治疗的临床和商业成功的关键是microIPG的开发 专门设计用于植入头后部、颈关节上方和更靠近目标的系统 刺激组织（枕神经）。在之前的第一阶段，新生成功地完成了关键的可行性研究 以确定用于枕神经的基于头部的局部刺激的IPG形状因子和尺寸。该等主要输入数据 构成了第二阶段工作的基础。我们第二阶段的总体目标是设计、开发和 Talon microIPG系统的鉴定。我们将通过设计和开发microIPG来实现这一目标 机械包装和刺激电极导线，用于枕骨放置，构建和测试IPG和电极导线，并确认 通过临床前研究进行系统设计。

Project Summary/Abstract Migraine is the most common neurological disorder and the 3rd cause of disability in people under 50, according to the World Health Organization49. The annual healthcare and lost productivity costs are approximately $36 billion in the US.31 6 million people in the US are chronic migraineurs who have migraines for more than 50% of the month 28,32 of which 78% of them are severely disabled.61 Current therapies help many sufferers, however nearly 1 million of sufferers in the US do not respond to the therapy initial or stop responding over time; this is referred to as Intractable Chronic Migraine (ICM)17,18 These ICM patients who have exhausted traditional therapeutic options and are often desperate for relief typically progress to more invasive therapies such as Occipital Nerve Stimulation (ONS). ONS involves the surgical implantation of an Implantable Pulse Generator (IPG) and stimulation leads (electrical wires) under the skin which deliver low-level electrical stimulation to the occipital nerves. ONS has been effectively used off-label for two decades to treat a variety of headache disorders and is successful in reducing the number of headache days per month with superior efficacy to that of the “gold standard” preventative treatments1-15 where 65% of patients reported excellent or good headache relief after 1 year.12 Unfortunately, ONS therapy has an unacceptable number of device and procedural adverse events (~70%) which are attributable to a large degree to the off-label use of Spinal Cord Stimulation (SCS) systems not designed for this application. Using non-standardized implantation, the protocols, the off-label SCS devices are implanted below the neck with the leads traversing the neck to the occipital nerves located in the head. There currently does not exist an implantable stimulation system that has been designed, developed and qualified for ONS. There consequently exists a significant unmet need in the medical device arsenal for a specialized ONS device and standardized implantation techniques. Until this unmet need is addressed, chronic migraine sufferers will continue to be faced with inadequate and costly treatment options that often create the need for repeated surgical interventions and continued patient suffering. Our long-term goal is to establish a safe, reliable and efficacious ONS chronic migraine treatment proven through extensive bench testing and rigorous clinical studies that support FDA approval, reimbursement and ultimately commercial adoption. NeoGenesis proposes that the key to the clinical and commercial success of ONS therapy is the development of a microIPG system specifically designed for implantation in the back of the head, above the neck joint and closer to the target stimulation tissue (occipital nerves). In the previous Phase 1, Neogenesis successfully completed critical feasibility research to determine the IPG form factor and size for a head-based local stimulation of the occipital nerves. These key inputs comprise the foundational basis for the Phase 2 efforts. Our overall objective for Phase 2 is the design, development and qualification of the Talon microIPG system. We will accomplish this objective by designing and developing the microIPG mechanical packaging and stimulation lead for occipital placement, building and testing the IPG and leads, and validating the system design via pre-clinical studies.