Commercial Readiness in CTS Pain Management

专有：本建议书包括高地仪器的商业秘密和其他专有或机密信息，仅供美国国立卫生研究院(NIH)用于评估本SBIR建议书的目的。不授予任何其他权利。这项建议和 未经高地文书许可，不得在NIH以外的地方披露本文中包含的商业秘密和其他专有或机密信息的全部或部分。这一限制不限制NIH使用数据中包含的信息的权利，如果该信息是从 另一个不受限制的来源。本图例适用于整个提案，包括但不限于本提案的摘要、引言、具体目标、研究计划(所有组成部分)、商业化计划和人类主体部分。 摘要 腕管综合征(CTS)影响高达4%的美国人口， 工作人口[1，2]。慢性疼痛(CP)是最常见和最难治疗的并发症之一 CTS[2-6]。目前的治疗方法[2-11]并没有直接解决痛感是在大脑中处理的事实 [5，12-14]尽管CTS患者也有中枢神经病变，但大多数都发生在神经病变部位(即，周围)。 因受伤而产生的疼痛成分[5、6、12-15]。非侵入性脑刺激(NIBS)已经成功 适用于某些疾病状态的脑性瘫痪的治疗，治疗引起脑活动的变化 恢复与CP知觉/感觉相关的适应不良可塑性[16-19]。然而，最多的 常见的NIBS方法在治疗神经病理性疼痛方面显示出有限的疗效[13，20-24]。高地 仪器(HI)电声刺激(ESSTim™)是一种改进的NIBS模式，它克服了 独立控制电磁和超声波相结合的其他NIBS技术的局限性 通过神经组织中的可调谐机电耦合聚焦和增强刺激电流的电场。ESSTim™ 在治疗CTS引起的CP和其他CP方面显示出统计和临床上的显著效果 糖尿病引起的疾病[25-27]。 作为商业化准备试点(CRP)计划的一部分，HI计划扩大其高管团队并 启动金融和行业合作活动，为ESSTim™商业化做好准备。首先，HI将 扩大其团队，聘请一位经验丰富的高管，他可以推动HI和 它的ESSTim™技术。HI的新高管将立即专注于业务发展(BD)和私人 该公司已经在开发合作倡议。这将集中在CTS BD活动上 包括执行战略市场分析，审查当前的监管和业务计划，以及进行 合作伙伴发现研究，为HI计划的合作计划做准备。在此之后，HI及其新的 高管将发起一项倡议，以吸引投资和/或与业界建立伙伴关系。我们将进行一项 系统地接触潜在的行业和投资者目标(至少30个)。我们的计划是至少与 这些目标中的10个，目的是成功筹集资金和/或执行以下合作伙伴关系协议(S) 将HI的ESSTim™技术商业化，用于治疗慢性阻塞性肺疾病患者的CP。

Proprietary: This proposal includes trade secrets and other proprietary or confidential information of Highland Instruments and is being provided for use by the National Institutes of Health (NIH) for the sole purpose of evaluating this SBIR proposal. No other rights are conferred. This proposal and the trade secrets and other proprietary or confidential information contained herein shall further not be disclosed in whole or in parts, outside of NIH without Highland Instrument's permission. This restriction does not limit the NIH's right to use information contained in the data if it is obtained from another source without restriction. This legend applies to the entire proposal, including, but not limited to the Abstract, Introduction, Specific Aims, Research Plan (all components), Commercialization Plan, and Human Subject's Sections of this proposal. Abstract Carpal Tunnel Syndrome (CTS) affects up to 4% of the United States population, with higher prevalence in the working population [1, 2]. Chronic pain (CP) is one of the most common and difficult to treat complications of CTS [2-6]. Current therapies [2-11] do not directly address the fact that pain sensation is processed in the brain [5, 12-14] and most act at the neuropathy site (i.e., in the periphery), although CTS patients also have a central pain component due to their injury [5, 6, 12-15]. Non-Invasive Brain Stimulation (NIBS) has been successfully applied for the treatment of CP in some disease states, where treatment induced changes in brain activity revert maladaptive plasticity associated with the perception/sensation of CP [16-19]. However, the most common NIBS methods, have shown limited, if any, efficacy in treating neuropathic pain [13, 20-24]. Highland Instruments' (HI) Electrosonic Stimulation (ESStim™) is an improved NIBS modality that overcomes the limitations of other NIBS technologies by combining independently controlled electromagnetic and ultrasonic fields to focus and boost stimulation currents via tuned electromechanical coupling in neural tissue. ESStim™ has demonstrated statistically and clinically significant effects in treating CP due to CTS, as well as other CP conditions such as those originating from diabetes [25-27]. As part of this Commercialization Readiness Pilot (CRP) program, HI plans to expand its executive team and launch financial and industrial partnering activities to ready ESStim™ for commercialization. First, HI will expand its team, hiring an experienced executive who can advance the commercialization readiness of HI and its ESStim™ technology. HI's new executive will immediately focus on Business Development (BD) and private partnering initiatives the company already has in development. This will be focused on CTS BD activities including performing strategic market analysis, reviewing current regulatory & business plans, and conducting partnership discovery research in preparation for HI's planned Partnering Initiatives. After which, HI and its new executive will launch an initiative to attract investment and/or partnership with industry. We will conduct a systematic outreach to potential industry and investor targets (at least 30). Our plan is to engage with at least 10 of these targets with the aim of successfully raising capital and/or executing a partnership agreement(s) for commercializing HI's ESStim™ technology for treating CP in CTS patients.