Commercial Readiness in CTS Pain Management

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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.