This application represents a competing renewal request for a Phase II STTR project, in which we constructed an ultra-fast gradient system for magnetic resonance imaging. Operation of the novel system is based upon the principle that the nervous system is relatively insensitive to very short exposures to changing magnetic fields. As a result, we are showing in clinical trials that magnetic slew rates (i.e., changes in gradients per time) can be 1,000 times faster than are currently available in clinical MRI scanners, and deliver magnetic gradients 10 times higher, without painful stimulation. The purpose of this competing renewal is to take the technology to the level of FDA approval. Based on well-established principles of MRI physics, it stands to reason that the increased gradient strength and shorter pulse sequences permitted by the new technology will have multiple meaningful benefits to users of clinical and research systems, including overall decreased acquisition time, reduction in acoustic noise, and elimination of artifacts due to subject motion. The multidisciplinary team assembled for this project includes MRI physicists, pediatric and general radiologists, and neuroscientists, experts in pulsed power technology, medical capital equipment entrepreneurs, and committed technical representatives of potential strategic partners active in this field. The team has worked well together over the past five years to achieve significant achievements, and has collaborated in the past to launch four medical products with the aid of the NIH SBIR program. Milestones to be accomplished in this project include adaptation of the system to a 7-Tesla animal MRI scanner and a clinical 3-Tesla system, visualization of post-mortem human tissues and moving vertebrate animals, FDA-mandated human trials of nervous stimulation and acoustic noise, and high- resolution tractography and functional MRI of the human brain in vivo. From a commercial point of view, configuring the product as a replacement upgrade to existing MRI systems has been a very successful financial strategy for several companies, one of which has committed to assisting us in this effort. Potential benefits to the country include health-care cost reduction (as a result of reduced scan-times per patient), increased scientific knowledge and diagnostic confidence as we examine smaller features of the nervous system, export potential of advanced medical products, and improved patient comfort (as we reduce acoustic noise and the need for sedation of pediatric and adult subjects).
Potential benefits to the country include health-care cost reduction (as a result of reduced scan- times per patient), increased scientific knowledge and diagnostic confidence as we examine smaller features of the nervous system, export potential of advanced medical products, and improved patient comfort (as we reduce acoustic noise and the need for sedation of pediatric and adult subjects).