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

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.