Development and qualification of Talon microIPG to treat Chronic Migraines

项目摘要/摘要 偏头痛是最常见的神经疾病，也是导致50岁以下人群残疾的第三大原因。 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。 美国有600万人患有慢性偏头痛，他们在28-32个月中偏头痛的时间超过50%，其中78% 61目前的治疗方法帮助了许多患者，而美国有近100万患者这样做 对最初的治疗没有反应或随着时间的推移停止反应；这被称为顽固性慢性偏头痛(ICM)17、18 这些耗尽了传统治疗选择并经常迫切需要缓解的ICM患者通常 更具侵入性的治疗，如枕神经刺激(ONS)的进展。ONS涉及外科植入 植入式脉冲发生器(IPG)和皮肤下提供低电平的刺激导线(电线) 对枕神经的电刺激。二十年来，ONS一直被有效地用于非处方治疗各种 头痛障碍，并成功地减少每月头痛的天数，疗效优于 “黄金标准”预防性治疗1-15，其中65%的患者报告头痛缓解效果良好或非常好 1年后。12不幸的是，ONS治疗的设备和程序不良事件的数量不可接受(~70%) 这在很大程度上是由于标签外使用的脊髓刺激(SCS)系统不是为此而设计的 申请。使用非标准化植入，方案，非标签SCS装置被植入颈部以下 导联穿过颈部到达位于头部的枕神经。 目前还不存在设计、开发和合格的植入式刺激系统 英国国家统计局。因此，在医疗设备武器库中存在对专门的ONS设备的大量未满足的需求，并且 标准化的植入技术。在这一未得到满足的需求得到解决之前，慢性偏头痛患者将继续受到 面对不充分和昂贵的治疗方案，往往需要反复手术干预和 持续的忍耐折磨。我们的长期目标是建立一个安全、可靠和有效的ONS慢性偏头痛 经过广泛的试验台测试和支持FDA批准、报销的严格临床研究证明的治疗 并最终实现商业领养。 NeoGenesis提出，ONS疗法临床和商业成功的关键是开发微型IPG 专门为植入头部后部、颈部关节上方和更靠近靶点的部位而设计的系统 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 目的：确定枕神经头部局部刺激的IPG形状因子和大小。这些关键输入 构成第二阶段工作的基本基础。我们第二阶段的总体目标是设计、开发和 Talon MicroIPG系统的资格认证。我们将通过设计和开发微型IPG来实现这一目标 枕部放置的机械包装和刺激导联，建立和测试IPG和导联，并验证 该系统通过临床前研究进行设计。

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.