Development of Cortical Bone Mechanics Technology for Enhancing the Diagnosis of Osteoporosis

Osteodx Inc., Athens OH

Investigators

Linked publications & trials

Abstract

PROJECT SUMMARY This administrative supplement will fund development of regulatory plans in support of the commercialization of OsteoDx’s Cortical Bone Mechanics Technology (CBMT) that is being developed and validated by parent grant NIA R44AG058312. The parent grant is developing and validating the clinical utility of our 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. The primary scope of work of the parent grant are studies that demonstrates the accuracy (aim 1) and clinical precision (aim 2) of the final design production version of the medical device, and advances safety and regulatory compliance (aim 3). The company’s Phase IIB grant award did not include specific funding and aims for several pressing product development needs that ultimately would help OsteoDx making better technical decisions, minimizing technical risks, and facilitate the developing and commercialization of our CBMT product (e.g., intellectual property protections). As such, we are requesting this supplemental funding via the SBIR Technical and Business Assistance (TABA) program. Specifically, OsteoDX is submitting this request to provide support for 1) intellectual property protections, 2) market research and validation, and 3) assistance with product sales.