Development and validation of a novel non-invasive device for measuring the mechanical properties of cortical bone

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ABSTRACT → Note: AEIOU Scientific, LLC is currently in the process of converting to a C-Corp under the name of OsteoDx. This Phase 2 SBIR grant application proposes to continue development and commercialization of OsteoDx’s Cortical Bone Mechanics Technology™ (CBMT), a novel osteoporosis related diagnostic device that non-invasively measures the mechanical properties of cortical bone and provides direct information about bone strength and quality that is not accessible by other diagnostic modalities. Phase 1 successfully illustrated commercial feasibility and demonstrated that CBMT can accurately and efficiently estimate ulna bone bending strength (R2=0.99). We also generated strong evidence that CBMT provides information about cortical bone that is unique and independent of bone mineral density (BMD), which suggests CBMT may yield clinically significant information about osteoporotic fracture potential. Osteoporosis is a common, chronic medical condition causing progressive weakening of bones, eventually leading to nontraumatic or fragility fractures. These fractures are painful and, in many cases, cause prolonged or life-long disability, and dramatically increases mortality rates up to 8x within 3 months post fracture. Numerous treatments with varying mechanisms of action exist for osteoporosis and, if given to high risk individuals, could dramatically reduce the risk of fracture. However, current osteoporosis treatment decisions are heavily driven by X-ray based measurements of BMD and risk surveys. Unfortunately, these tools lack sufficient discriminatory sensitivity and accuracy to identify many individuals at high risk of experiencing a fragility fracture. There is a large unmet need to better diagnose patients who are at risk of fracture so that physicians can accurately identify individuals who would benefit from osteoporosis medications and to better monitor the effectiveness of treatment. OsteoDx CBMT technology has the potential to meet these needs. OsteoDx’s market research, interviews with key opinion leaders, and an initial meeting with the FDA identified the most important and immediate commercialization milestones necessary for FDA approval and market adoption, and resulted in the development of two Specific Aims: Aim 1) Complete device design to meet specific clinical needs, and Aim 2) Conduct a clinical study assessing CBMT’s fracture discrimination capability. To achieve the aims of this proposal and the other commercialization objectives of OsteoDx, the company has assembled a team with broad experience and relevant expertise. The team includes senior individuals with mechanical design, biomedical engineering, aging and fracture risk assessment expertise, and a CEO and Board of Directors with successful medical device commercialization experience. The team also has extensive experience conducting clinical studies.