The Commercialization of High-Resolution, Spinal Cord Stimulation for Non-Opioid Treatment of Neuropathic Pain

高分辨率脊髓刺激用于非阿片类药物治疗神经性疼痛的商业化

• 批准号: 10822401
• 负责人: Bryan L McLaughlin
• 金额: $ 40万
• 依托单位: MICRO-LEADS, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10822401
• 关键词: Acceleration; American; Animals; Area; Award; Back; Businesses; Capital; Chronic; Complex; Confidential Information; Contracts; Dedications; Development; Devices; Electrodes; Electronics; Employment; Ensure; Feasibility Studies; Fiber; Foot Pain; Funding; High Prevalence; Human; Implant; Inguinal region; Injectable; Intractable Pain; Knee; Lateral; Lead; Leg; Licensing; Limb structure; Lower Extremity; Manufacturer; Maps; Marketing; Mechanics; Mental Depression; Mental Health; Mission; Modeling; Morbidity - disease rate; Nerve Root Compressions; Neurostimulation procedures of spinal cord tissue; Operative Surgical Procedures; Opiate Addiction; Opioid; Overdose; Pain; Paralysed; Patients; Pelvis; Performance; Peripheral Nerves; Persons; Phase; Physiologic pulse; Positioning Attribute; Privatization; Quality of life; Resolution; Risk; Sales; Series; Small Business Innovation Research Grant; Source; Specificity; Spinal Cord; Suicide; System; Tablets; Technology; Testing; United States National Institutes of Health; Width; Work; addiction; arm; chronic neuropathic pain; chronic pain management; cognitive function; commercialization; commercialization readiness; cost; debilitating pain; design verification; dorsal horn; experience; foot; human subject; improved; interest; knee pain; neural; neuroregulation; non-opioid analgesic; opioid abuse; opioid use; pain processing; pain relief; painful neuropathy; prescription opioid; programs; prototype; safety study; safety testing; skills; spinal nerve posterior root; success; wireless

Abstract DESCRIPTION. Our FastTrack SBIR proposal has developed HD64—a high-resolution, spinal cord stimulation therapy to provide more pain relief with greater specificity for those suffering from chronic neuropathic pain and opioid dependence. Over 25 million in the U.S. suffer from debilitating pain in the trunk and extremities and 55% depend on opioids to ease their suffering. Opioid abuse has claimed the lives of over 200,000 over the past decade and has resulted in devastating reductions in quality of life, in ability to work, and in mental health for the living. Spinal cord stimulation (SCS) has provided pain relief for 60% of those with chronic extremity pain and eliminated opioid use entirely in more than 50%. Despite these advantages, SCS has had a limited success treating isolated pain of the knee, foot, groin, or low- back. The lateral positioned fibers of the spinal cord (ex. the dorsal root entry zone and dorsal horn) represent a more selective neural targeting opportunity yet current, implantable plate-type surgical leads are too rigid and bulky to access these fibers without a significant risk of paralysis or nerve root compression. HD64 provides an ultra-thin and conformal blanket of 60 stimulation contacts across the entire width of the spinal cord. Active-lead HD64 technology embeds a tiny electronic chip within the surgical lead and doubles the number of therapy contacts compared with current technology without increasing the number of lead-wires. Collectively, these features improve therapy and simplify surgical workflow. PHASE 2: In Phase 2, we have developed the HD64 active lead technology. We have obtained FDA approval to perform an Early Feasibility Study human feasibility study using the active HD64 active electrodes, AL-EPG wearable stimulator, and IPAD programmer tablet (n=10 subjects, n=23 therapy groups, n=2 waveforms). We have also developed implantable pulse generator prototypes and are beginning to perform mechanical and electrical design verification testing and chronic safety studies in large animals to demonstrate functional performance to inform the final device. PHASE 2 COMMERCIALIZATION READINESS: This Commercialization Readiness proposal seeks to perform activities to extend the business development of our Phase 2 SBIR. This CRP proposal will accelerate the commercialization of the HD64 therapy system by hiring a focused VP of Business Development who is dedicated to commercialization activities. The importance and timing of this commercialization is significant as we have obtained FDA IDE approval and launched intraoperative studies. Specifically, we will source and hire a candidate who has a mix of business, neuromodulation, and marketing/sales skills who can lead fundraising, strategic partnerships, and component licensing initiatives.

抽象的 描述 我们的 FastTrack SBIR 提案开发了 HD64——一种高分辨率脊髓刺激疗法。 为患有慢性神经性疼痛和阿片类药物的患者提供更多、更特异性的疼痛缓解 在美国，超过 2500 万人患有躯干和四肢的令人衰弱的疼痛，其中 55% 的人依赖药物。 过去十年，阿片类药物滥用已夺去了超过 200,000 人的生命，并导致了 生活质量、工作能力和心理健康受到严重影响。 (SCS) 已为 60% 的慢性四肢疼痛患者提供了缓解疼痛的方法，并在更多国家完全消除了阿片类药物的使用 尽管有这些优势，SCS 在治疗膝关节、足部、腹股沟或下肢疼痛方面取得的成功有限。 脊髓的侧向纤维（例如背根入口区和背角）代表了更多的信息。 选择性神经靶向机会，但目前的植入式板式手术引线过于坚硬且体积庞大，难以接近 这些纤维没有明显的麻痹或神经根受压风险。 HD64 提供超薄保形毯，在整个脊柱宽度上有 60 个刺激触点 Active-lead HD64 技术在手术导线内嵌入了一个微型电子芯片，并使导线数量增加了一倍。 与现有技术相比，这些治疗触点无需增加引线数量。 功能可改善治疗并简化手术流程。 第 2 阶段：在第 2 阶段，我们开发了 HD64 活性先导技术，并已获得 FDA 批准。 使用有源 HD64 有源电极、AL-EPG 可穿戴设备进行早期可行性研究 刺激器和 IPAD 编程器平板电脑（n=10 名受试者，n=23 个治疗组，n=2 个波形）。 植入式脉冲发生器原型并开始进行机械和电气设计验证测试 大型动物的长期安全性研究，以证明功能性能，为最终设备提供信息。 第二阶段商业化准备：该商业化准备提案旨在 开展活动以扩展我们第二阶段 SBIR 的业务发展。该 CRP 提案将加速 通过聘请一位专注于业务开发的副总裁来实现 HD64 治疗系统的商业化 正如我们所获得的，这种商业化的重要性和时机非常重要。 FDA IDE 批准并启动术中研究 具体来说，我们将寻找并雇用一位具有多种能力的候选人。 能够领导筹款、战略合作伙伴关系和组件的业务、神经调节和营销/销售技能 许可建议。