This Small Business Innovation Research (SBIR) Phase I project relies on a novel and surprising physiological phenomenon recently published by the company and its academic collaborators: That magnetic gradient fields used in MRI can be dramatically increased without causing unpleasant nerve stimulation, if the rise- and fall-times of the gradient pulse are kept below 10 microseconds. This physiological principle can be used to advantage in dental MRI, where the magnetization decay in bone is so short that conventional MRI pulse sequences are of limited use, and where high gradients can yield improved spatial resolution with reduced artifacts from metallic materials (e.g., orthodontics). The small field-of-view required for dental MRI suggests that it will be possible to develop of a low-cost system (i.e., <$20,000) that will compete effectively with conventional x-ray based technologies. Introduction of this device will reduce the cumulative x-ray dose delivered to the American population, which has been shown to contribute to increase the incidence of certain cancers. Phase I of the project will consist of construction of a prototype system, with comparable diagnostic performance to x-ray-based dental imaging, evaluated on cadaveric human teeth.
The broader impact/commercial potential of this project will be multi-fold: It will help reverse the trend of constructing ever-larger diagnostic imaging devices, which contributes to high overall health care costs in the USA. The increase in cost of imaging systems is driven by several factors: (1) It is more profitable for the few companies who sell capital medical equipment to sell an expensive system than a low-cost system, and (2) radiologists, who represent the traditional customer for the vendors of MRI systems, are trained on systems that can examine all parts of the human body. The company proposes a contrarian approach, in which a cost-effective device serves the needs of cost-sensitive specialists (i.e., dentists). The company?s staff has extensive experience in marketing organ-specific systems, having sold breast imaging devices that reduced the need for expensive MRI studies. The significant marketing advantage of reduced pediatric exposure ionizing radiation will accelerate penetration into the $30 billion global dental marketplace. Finally, the ultra-fast pulse sequences to be developed in this project are likely to be helpful in other scientific investigations of solid-state phenomena, such as electron paramagnetic resonance imaging.
Intellectual Merit: The project represents the first clinical application of ultra-fast MRI technology. Signals from dental-bound water are too fast for conventional MRI, but were a good fit to the microsecond time-scales utilized in this project. In Phase I of the project, technical milestones achieved included the collection of cross-sectional dental images in seconds, spatial resolution of better than 50-microns, and clear depiction of internal dental structures. Broader/Commercial Impact: Published evidence is accumulating that correlate childhood exposure to dental radiation with the eventual development of head tumors. Coupled with existing strong regulatory pressures to reduce ionizing radiation from medical procedures of all kinds, we believe that the time is ripe for a cost-effective and efficacious alternative to dental x-rays. The improved soft-tissue imaging ability of dental MRI promises to increase diagnostic confidence and thus potentially reduce the need for root canal and other invasive procedures. In the Phase I portion of the project, proof-of-principle was established for a low-profile cost-effective dental MRI system. Commercial benefits of the project include reversal of the "bigger is better" mentality of the radiological market that has led to ever-increasing MRI static field strengths and concomitant higher purchase and operating costs. Elimination of the regulatory burden (e.g., radiation badges, state licensing) associated with the use of x-ray equipment (typically several thousand dollars per year) will reduce a hidden cost that is currently passed on to consumers. Low power usage will enable battery operation, better serving the dental needs of the growing middle class in developing countries (an attractive export market). Summary: The goal of the Phase I effort was the demonstration of proof-of-principle for a low-profile cost-effective dental MRI system. Technical achievements and market projections were used to raise funding from two non-Federal sources for further development of the project, which will be further supplemented if Phase II Federal funding is awarded.
