SBIR Phase I: Next Generation Electrical Impedance Myography for Neuromuscular Disease Assessment

这个小型企业创新研究(SBIR)第一阶段项目将开发一种准确、非侵入性和具有成本效益的系统，用于诊断和评估神经肌肉疾病的严重程度。在美国，数以百万计的人患有神经肌肉疾病，从肌营养不良症和肌萎缩侧索硬化症等全身性疾病到腰椎神经根病等局限性疾病。可治疗的神经肌肉疾病需要对有效治疗进行持续评估，这就需要准确的诊断工具。在治疗有限的疾病中，临床研究试验需要改进评估疾病严重性和对实验性治疗的反应的方法。该项目的总体目标是开发一种新的用于诊断和监测神经肌肉疾病的电阻抗肌图(EIM)系统。该设备基于生物阻抗分析的原理，但它将包含特定的创新，与现有系统相比，这些创新将显著提高其精度和频率范围。研究目标包括建立一个原型系统，验证其准确性，并在人体受试者身上测试其重复性。预计该系统将迅速提供关于疾病状况的准确信息，改善这些疾病患者的治疗。该项目的更广泛的影响/商业潜力包括：1)通过提供快速、容易、可重现和敏感的诊断方法，大幅推进个别患者的护理；2)通过减少受试者和缩短研究周期，简化研究主要导致肌肉无力和功能障碍(包括肌萎缩侧索硬化症、肌营养不良症等)的疾病的临床试验；3)降低疾病管理的成本；以及4)通过非侵入性、无痛且只需要有限的合作，大大提高对受这些疾病影响的儿童的临床护理。拟议的EIM系统有可能超过目前诊断工具的使用，潜在市场超过1亿美元。该系统计划最初针对在药物发现研究中可以从中受益的制药公司。然后，该系统将直接出售给专门治疗这些疾病患者的医生。

This Small Business Innovation Research (SBIR) Phase I project will develop an accurate, noninvasive, and cost-effective system for diagnosing and evaluating the severity of neuromuscular diseases. Millions of people in the US suffer from neuromuscular disorders, from generalized diseases like muscular dystrophy and amyotrophic lateral sclerosis to localized conditions including lumbosacral radiculopathy. Treatable neuromuscular disorders require ongoing evaluation for effective management, necessitating accurate diagnostic tools. In disorders where treatments are limited, clinical research trials demand improved methods for assessing disease severity and response to experimental treatment. The overall goal of this project is to develop a novel Electrical Impedance Myography (EIM) system for diagnosing and monitoring neuromuscular diseases. The device is based in the principles of bioimpedance analysis, but it will contain specific innovations that will dramatically improve its accuracy and frequency range relative to existing systems. The research objectives include building a prototype system, verifying its accuracy, and testing its repeatability on human subjects. It is anticipated that the system will quickly provide accurate information about disease condition, improving the treatment of patients with these diseases.The broader impact/commercial potential of this project includes: 1) substantially advancing individual patient care by providing a quick, easy, reproducible and sensitive diagnostic; 2) streamlining clinical trials studying diseases primarily resulting in muscle weakness and dysfunction (including amyotrophic lateral sclerosis, muscular dystrophy, and others) by requiring fewer subjects and shorter periods of study; 3) reducing the cost of disease management; and 4) greatly advancing clinical care of children affected by these disorders by being non-invasive, painless, and requiring only limited cooperation. The proposed EIM system has the potential to exceed the usage of current diagnostic tools, with a potential market exceeding $100 million. The system is planned to initially target pharmaceutical companies that can benefit from it in drug discovery research. The system will then be sold directly to physicians who specialize in the care of those who suffer from these disorders.