AEIOU Scientific, LLC. (AEIOU) aims to develop and commercialize Ohio University's (OHIO's) patent-pending Cortical Bone Mechanics Technology (CBMT) as a non-invasive medical device for improving the diagnosis and monitoring of osteoporosis and other bone diseases. Osteoporosis and low bone mass affect 54 million Americans and 325 million people worldwide. In women, the resulting fragility fractures cause pain, disability and a higher death rate than heart disease, stroke and breast cancer combined. The associated annual medical expenses will reach $25 billion in the US and ?35 billion in Europe by 2025. While osteoporosis is characterized by a decline in bone strength leading to an increased risk of fracture, no commercially available medical device measures bone strength. Instead, physicians decide who to treat to prevent fragility fractures based on bone mineral density (BMD) measured by dual energy X-ray absorptiometry (DXA), or based on clinical risk factors assessed by FRAX (a World Health Organization questionnaire). Unfortunately, repeated and consistent prospective studies have found that neither of these methods predicts fractures well. Bone stiffness accurately predicts bone strength, but the current method for measuring bone stiffness, Quasistatic Mechanical Testing (QMT), can only be performed on excised bones. OHIO's novel CBMT enables, for the first time, noninvasive measurements of bone stiffness that are indistinguishable from QMT measurements (R2 = 0.99). AEIOU's long term goal is to develop a commercial medical device based on this technology. High demand for a CBMT-based medical device has been confirmed through interviews of 188 potential customers in the 2016 iCorps@Ohio program. In Phase I of this SBIR project, we will conduct human factors engineering studies in Aim 1 to guide the design, fabrication and validation of a CBMT medical device in Aim 2.
In Aim 3, we will conduct a controlled experiment to confirm that CBMT can detect effects of changes in bone protein on bone mechanics that are unique and independent of BMD. In Phase II of this SBIR project, AEIOU and clinical collaborators will conduct studies of patients with age-related and secondary osteoporosis and low bone mass to study the effectiveness of CBMT for predicting fragility fractures and for monitoring disease progression and treatment, and to document adverse events associated with the use of CBMT in these populations.