Hyperpolarized gas MRI offers unprecedented pulmonary functional diagnostic capability. Pharmaceutical companies require sensitive diagnostic end points to determine the efficacy of COPD therapies they have under development and accelerate their progress through FDA approval and into the marketplace. Individual sufferers of COPD could benefit from improved diagnosis and treatment. The US healthcare budget could benefit if the $35B spent on the 30 million Americans suffering from COPD could be directed towards effective treatments through accurate assessments. The primary obstacle to progress has been the availability of high quality hyperpolarization technology and services for both technical and legal reasons. We see a clear path to overcoming those obstacles. We propose to assemble a world-leading 3He polarizer using the low-cost spin-exchange optical pumping technique. New optical pumping technologies, many developed by us only recently and others to be developed in this proposal, will allow production of 55% polarization at 100 bar-liters per day and as high as 70% polarization at one-third that rate. This phase of the project includes submission of the product gas as an Investigational New Drug (IND) to the US FDA. A subsequent phase will include refinement and duplication of the prototype, utilization of the prototype to partner with clinical and pharmaceutical research centers for human trials, and submission of a New Drug Application (NDA) to the FDA. FDA safe harbor laws protect drug development as a non-infringing activity. ? ? ?
