Commercial Readiness in CTS Pain Management

CTS 疼痛管理的商业准备

• 批准号: 10822612
• 负责人: Laura Dipietro
• 金额: $ 40万
• 依托单位: HIGHLAND INSTRUMENTS, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-21 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10822612
• 关键词: Address; Affect; Agreement; Authorization documentation; Brain; Businesses; Calibration; Capital; Carpal Tunnel Syndrome; Clinical; Clinical Research; Communities; Confidential Information; Coupling; Data; Development; Devices; Diabetes Mellitus; Disease; Electromagnetics; Ensure; Equity; Esthesia; Event; Feedback; Funding; Goals; High Prevalence; Industrialization; Industry; Injury; Intention; Interview; Investments; Manufacturer; Marketing; Medical; Medical Device; Methods; Modality; Neuropathy; Pain; Pain management; Patients; Perception; Pharmaceutical Preparations; Phase; Physical therapy; Population; Positioning Attribute; Preparation; Privatization; Process; Readiness; Research; Rights; Secure; Site; Small Business Innovation Research Grant; Source; Structure; Technology; Time; Tissues; Ultrasonics; Underrepresented Populations; United States; United States National Institutes of Health; Work; central pain; chronic pain; chronic pain management; chronic pain patient; chronic painful condition; clinically significant; commercialization; commercialization readiness; diabetic; disability; effective therapy; experience; human subject; improved; instrument; neural; neuroregulation; non-opioid analgesic; noninvasive brain stimulation; outreach; pain sensation; painful neuropathy; programs; symptomatology

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.

专有：本提案包含Highland Instruments的商业机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提案。不授予其他权利。这一建议和 未经Highland Instrument的许可，不得在NIH之外披露本文所含的商业秘密和其他专有或机密信息的全部或部分内容。该限制并不限制NIH使用数据中包含的信息（如果该信息是从以下来源获得的）的权利 另一个来源没有限制。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）、商业化计划和人类受试者部分。 摘要 腕管综合征（CTS）影响高达4%的美国人口，在美国的患病率更高。 劳动人口[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]没有直接解决疼痛感觉在大脑中处理的事实 [5，12 - 14]并且大多数作用于神经病变部位（即，在外周），虽然CTS患者也有一个中央 因其受伤而引起的疼痛[5，6，12 - 15]。非侵入性脑刺激（NIBS）已成功 用于治疗某些疾病状态下的CP，其中治疗引起大脑活动的变化 恢复与CP的感知/感觉相关的适应不良可塑性[16 - 19]。不过最 普通NIBS方法在治疗神经性疼痛中显示出有限的（如果有的话）功效[13，20 - 24]。高地 仪器（HI）的超声电刺激（ESStim ™）是一种改进的NIBS模式，克服了 通过结合独立控制的电磁和超声波来克服其他NIBS技术的局限性 场，以通过神经组织中的调谐机电耦合来聚焦和提升刺激电流。ESStim ™ 已证明在治疗CTS所致CP以及其他CP方面具有统计学和临床显著效果 如糖尿病引起的疾病[25 - 27]。 作为商业化准备试点（CRP）计划的一部分，HI计划扩大其执行团队， 启动金融和工业合作活动，为ESStim ™的商业化做好准备。首先，HI将 扩大其团队，聘请一位经验丰富的高管，他可以推进HI的商业化准备， ESStim ™技术。HI的新高管将立即专注于业务发展（BD）和私人 该公司已经在制定合作计划。这将侧重于CTS BD活动 包括执行战略市场分析，审查当前的监管和业务计划，并进行 伙伴关系发现研究，为HI计划的伙伴关系倡议做准备。之后，HI和它的新 行政部门将发起一项倡议，以吸引投资和/或与工业界建立伙伴关系。我们将进行 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 其中10个目标旨在成功筹集资本和/或执行合伙协议， 将HI的ESStim ™技术商业化，用于治疗CTS患者的CP。