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：本提案包括 Highland Instruments 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) 使用，其唯一目的是评估本 SBIR 提案，不授予本提案任何其他权利。 未经 Highland Instrument 许可，不得将本文中包含的商业秘密和其他专有或机密信息全部或部分披露给 NIH。此限制并不限制 NIH 使用从数据中获得的信息的权利。 该图例适用于整个提案，包括但不限于该提案的摘要、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。 抽象的 腕管综合症 (CTS) 影响着多达 4% 的美国人口，其中在美国的患病率更高 慢性疼痛（CP）是工作人群最常见且最难治疗的并发症之一。 CTS [2-6] 目前的疗法 [2-11] 并未直接解决疼痛感觉在大脑中进行处理的事实。 [5, 12-14] 尽管 CTS 患者也有中枢神经病变，但大多数作用于神经病变部位（即外周） 非侵入性脑刺激 (NIBS) 已成功缓解因受伤引起的疼痛 [5, 6, 12-15]。 用于治疗某些疾病状态下的脑瘫，治疗会引起大脑活动的变化 恢复与 CP 感知/感觉相关的适应不良可塑性 [16-19]。 常见的 NIBS 方法在治疗神经性疼痛方面的疗效即使有，也是有限的 [13, 20-24]。 Instruments 的 (HI) 电声刺激 (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 通过神经组织中的调谐机电耦合来聚焦和增强刺激电流。 已证明在治疗 CTS 引起的 CP 以及其他 CP 方面具有显着的临床效果 诸如源自糖尿病的疾病[25-27]。 作为商业化准备试点 (CRP) 计划的一部分，HI 计划扩大其管理团队并 首先，HI 将启动金融和工业合作活动，为 ESStim™ 的商业化做好准备。 扩大团队规模，聘请经验丰富的高管，以推进 HI 的商业化准备工作 HI 的 ESStim™ 技术的新高管将立即专注于业务开发 (BD) 和私人业务。 公司已经在制定合作计划，重点是 CTS BD 活动。 包括进行战略市场分析、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 计划的合作伙伴计划做准备。此后，HI 及其新的合作伙伴计划。 高管将发起一项吸引投资和/或与行业合作的举措。 系统地接触潜在的行业和投资者目标（至少 30 个）。 其中 10 个目标旨在成功筹集资金和/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。