SBIR Phase I: Manufacturing and Testing of Nanocrystalline Hydroxyapatite Orthopedic Implants

This Small Business Innovation Research (SBIR)Phase I project proposes to develop forming and sintering processes suitable for the manufacture of nanocrystalline hydroxyapatite orthopedic implants. Though hydroxyapatite's osteoconductivity has generated interest in many clinical applications, conventionally processed hydroxyapatite materials have been limited by their poor sinterability and lack of mechanical strength attributed to poor phase purity and homogeneity. Angstrom Medica, Inc. has optimized its nanostructure hydroxyapatite powders for sinterability, mechanical strength and nanocrystallinity. The nanocrystalline HAP monoliths appear to provide superior compressive and bending strengths as well as fracture toughness, and contribute to better osteoblast attachment, proliferation and mineralization. This project will conduct the early process and product development of a marketable nanocrystalline HAP orthopedic pin for small bone fixation and the testing of this pin in a cadaver bone model. In the follow on Phase II project, these nanostructured materials will be formed into more geometrically complex implants constructs and utilized in in vivo animal models commonly employed to validate orthopedic implants for FDA approval. The commercial application of this project is in the area of orthopedic implants.