This PFI: AIR Technology Translation project focuses on translating a biomimetic collagen-based bone grafting scaffold for enhanced bone defect repair and new bone regeneration. Currently, more than 1.3 million bone-repair procedures are performed annually in the USA, and a large proportion of them are for large defect repair. The project will result in a prototype of the scaffold production as well as initiation of the FDA documentation process of the biomimetic scaffold. The biomimetic scaffold will directly address the problems of most currently existing bone grafting materials on the market, including poor osteoconductivity, poor mechanical properties, and dissimilar degradation rates to natural bone regenerating rates. It has demonstrated enhanced bone forming capability when compared to a leading product in this market space. The new bone substitute material will greatly benefit patients who suffer from bone defects caused by accidents or diseases, and are in need of orthopedic surgery. Commercialization of this product will greatly improve quality of life for patients, shorten rehabilitation time, and substantially lower medical costs associated with hospitalization and health care.
The biomimetic scaffold has the following unique features which make it a competitive product in the bone grafting market: (1) Tunable micro- and macro-structure suitable for enhanced vascularization, osteoprogenitor cells migration, and new bone formation; (2) Mild fabrication conditions (room temperature and neutral pH) and simple fabrication process, which makes the scale-up manufacturing step easy to achieve at a low cost; (3) Superior mechanical properties, providing the necessary mechanical strength for initial surgical handling and mechanical support prior to new bone formation; (4) Excellent osteoconductivity compared to both a commonly used equiaxed scaffold and a commercial scaffold, which will significantly reduce patients' rehabilitation time; (5) Degradation rate matching the ingrowth rate of new bone, leading to perfect defect repair by natural bone that is superior to any artificial bone substitute materials on the market.
This project addresses the following technology gaps as it translates from research discovery toward commercial application. It will center on issues related to the biomimetic scaffold scale-up and prototype, such as inhomogeneity and irreproducibility of large pieces of scaffold. To address these problems, heat flow analyses will be conducted and a tight control system will be established, which will further advance understanding of the interrelationship between scaffold structure/property and processing parameters in scaffold scale-up and prototyping.
The project will be led by a materials scientist, guided by two entrepreneurs for commercialization, and advised by an orthopedic surgeon to provide the team the end-user perspective. In addition, it will result in the training of a number of graduate and undergraduate students in areas of biomaterial scale-up, product prototyping, FDA documentation and product commercialization, while exposing them to a multidisciplinary working environment.
