MicroMRI, Inc. Development of a cost-effective p?MRI for in vivo structural examination of bone Abstract Osteoporosis is a systemic bone disease characterized by low bone mass and abnormal bone quality. The current """"""""gold standard"""""""", dual-energy x-ray absorptiometry (DXA), cannot assess bone quality and fails to detect > 50% of persons at greatest risk of fracture. MicroMRI is refining a new approach to non-invasively assess the micro- structural aspects of bone quality, at the wrist and ankle, using high-resolution magnetic resonance imaging (?MRI). Previously, this technology was coined """"""""Virtual Bone Biopsy"""""""" by its inventor, Dr. Felix Wehrli. Our preliminary studies using coils that are """"""""add-ons"""""""" to standard full-body MRI equipment indicate that bone structure parameters we determine have the necessary properties to monitor and direct appropriate treatment at the individual patient level. Thus, the company believes that ?MRI is an important complement to DXA. While DXA remains the tool for diagnosis of osteoporosis for the foreseeable future, ?MRI will be the tool of choice to measure disease progression and assess therapy response. The prevalence of osteoporosis requires that its diagnosis and monitoring remain at the physician's office, not hospitals. Appropriately, the majority of DXAs are currently located in out-patient settings. To fully capitalize on the promise of ?MRI of bone, this technology should also be at the point-of-care in physicians' offices. In this grant, we are proposing to develop a cost-effective stand-alone MRI system for extremity measurement in the PCP setting. We have termed the proposed new technology p?MRI to remain in line with peripheral devices for studying the skeleton, using methods that expose the patient to ionizing radiation (pDXA, pQCT), . Extremity MRI scanners are already available for purchase but are either low-cost with low-resolution, or very expensive with high-resolution. In Phase I of this proposal, MicroMRI will test the feasibility of developing a technology which can produce high resolution images of similar quality as its existing ?MRI system, yet cost-effective enough to be adopted by physician groups and in private clinics. In Phase II, we will develop a prototype of the p?MRI, and perform safety and efficacy tests. We will optimize this prototype, conduct accuracy and reproducibility measurements to establish that the data obtained are identical (within acceptable, pre- specified limits) to our existing ?MRI method. Once these activities are completed, MicroMRI will use non-grant funds to complete the commercialization and product launch of the stand-alone scanner. ? ? ?
