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

摘要 描述。我们的FastTrack SBIR计划开发了HD64-一种高分辨率的脊髓刺激疗法 为患有慢性神经病理性疼痛和阿片类药物的患者提供更多、更具特异性的疼痛缓解 依赖。在美国，超过2500万人遭受躯干和四肢无力的疼痛，55%的人依赖于 阿片类药物来减轻他们的痛苦。在过去十年中，阿片类药物滥用夺走了20多万人的生命，并导致 生活质量、工作能力和精神健康的毁灭性下降。脊髓刺激 (SCS)已经为60%的慢性肢体疼痛患者提供了疼痛缓解，并在更多的患者中完全取消了阿片类药物的使用 而不是50%。尽管有这些优势，SCS在治疗孤立的膝盖、脚、腹股沟或下腹部疼痛方面取得了有限的成功。 背。脊髓的外侧定位纤维(例如。背根进入区和背角)代表更多 选择性神经靶向机会然而，目前可植入的板式外科导联过于僵硬和笨重，无法接触到 这些纤维没有明显的瘫痪或神经根受压的风险。 HD64提供了一个覆盖整个脊柱宽度的60个刺激触点的超薄保形毯子 电源线。主动引线HD64技术在手术引线中嵌入了一个微小的电子芯片，使 与目前的技术相比，治疗触点不需要增加导线的数量。总而言之，这些 功能改进了治疗并简化了手术工作流程。 第二阶段：在第二阶段，我们开发了HD64主动铅技术。我们已经获得了FDA的批准 使用活性HD64活性电极、AL-EPG可穿戴设备进行早期可行性研究和人体可行性研究 刺激器和iPad编程器平板(n=10例，n=23个治疗组，n=2个波形)。我们还开发了 植入式脉冲发生器样机并开始进行机械和电气设计验证测试 并在大型动物中进行慢性安全性研究，以演示功能性能，为最终设备提供信息。 阶段2商业化准备：此商业化准备计划旨在 开展活动以扩展我们第二阶段SBIR的业务发展。这项CRP提案将加速 通过聘请专注于业务发展的副总裁来实现HD64治疗系统的商业化 商业化活动。正如我们所获得的，这种商业化的重要性和时机是重要的 FDA IDE批准并启动术中研究。具体地说，我们将寻找并聘用一名具有以下特点的候选人 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 许可计划。

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.