The proposed project will use bone-specific design criteria to synthesize bone substitute materials using benign materials and mild processing conditions. The project team has developed a bone substitute material for use in orthopedic and craniomaxillofacial bone defects. This bone substitute product is designed to possess injectability, biocompatibility, biodegradability, osteoconductivity, and osteoinductivity properties as well as structural and mechanical integrity. This bone substitute product is sufficiently flexible to fill cavities with different geometries with closer packing compared to fixed-shape substitutes. This bone substitute product can be injected to the bone defects using minimally invasive procedures. Minimally invasive surgery tremendously reduces healthcare costs. Bone substitute products with all the above properties do not currently exist in the market. The proposed bone substitute product has the potential to reduce the need to harvest healthy bone (autografts) from the patient to use for bone repairs.
If successful, this project could have significant scientific impact on craniomaxillofacial, orthopaedic, and regenerative medicine. The bone-specific design criteria and mild processing techniques for bone substitute materials increase scientific knowledge for the bone regeneration field. The global bone graft substitute market was valued at $1.9 billion in 2010 and is forecast to reach $3.3 billion in 2017. The increasing population of elderly people is a major driving force for the market. Recent data indicate that a fracture requiring hospitalization costs an average of $27,000 and results in an average of 27 days of missed work. These costs can reduce drastically using minimal invasive procedures with innovative bone substitute materials instead of using traditional bone grafts which need longer hospitalization and rehabilitation times.
The team actively participated in the NSF I-corps educational program activities. The focus of these activities was how to engage with industry, customers, and competitors, and how to translate research innovations into products and processes that benefit to society. The team participated in the two NSF I-Corps workshops held in Washington DC in January and March 2013. In addition to these two workshops, there were five online course meetings between January and March 2013. The NSF I-Corps award allowed us to explore the preliminary business model around our osteograft. As a result of I-Corps activities, we studied commercial potential, market analysis, partnerships, competitive customers, patent search, regulations, and commercialization plan around our OsteoGraft product. In addition, we completed in vivo animal studies using a defect in rat femur model at 6 and 12 weeks. We investigated preliminary biocompatibility, toxicity, biodegradation, and bone formation using this OsteoGraft in a rat femur model. We found that the developed OsteoGraft supports bone growth and did not show any toxicity during the implanted period. Entrepreneurial lead's Ph.D. dissertation in Biomedical Engineering was completed in 2014 with partially support from this grant. Two conference presentations, one invention disclosure, and a manuscript were partially supported from this grant.
