I-Corps: Treating Bone Trauma Using a Biodegradable Bone Fixation Device

这个i-Corps项目的更广泛的影响/商业潜力是通过患者特定的可生物降解骨固定装置改善骨创伤治疗结果。目前治疗骨创伤患者的方法依赖于永久性和僵硬的骨固定装置的使用，这些装置具有很大的风险，增加了患者的痛苦和总的手术成本。新的可生物降解(非永久性)设备具有优越的设计和性能，如果被采用，可能会解决这些问题，并导致重大的临床突破。在美国或全球市场上，还没有发现其他具有类似优势的技术。到2020年底，全球目标颅颌面部固定市场的价值预计将达到15亿美元。此外，预计到2020年，仅北美地区可生物降解骨移植材料的市场规模就将超过6.9亿美元。这个i-Corps项目专注于开发非永久性骨固定装置，该装置由一种正在申请专利的可生物降解的镁基合金制成，其性能采用新的后期制造工艺。根据初步的体外研究，这些装置有望既足够强大，足以承受负载，然后失去强度，并在骨愈合后完全吸收。据推测，该团队的固定装置将向愈合的骨骼传递足够的压应力，以促进持续的骨重建。通过一系列体外研究，成功地实现了初步的概念验证。此外，该合金在加工前后的生物相容性得到了保证。非永久性固定装置的成功开发预计将减少术后并发症，减少总体住院时间和成本，并消除第二次手术移除植入物的需要。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is the improvement of bone trauma treatment outcomes through patient-specific biodegradable bone fixation devices. Current modalities of treating patients with bone trauma rely on the use of permanent and stiff bone fixation devices that carry substantial risks and increase the suffering of patients and the total operation cost. The new biodegradable (nonpermanent) devices have superior design and properties that, if adopted, may address these problems and result in a significant clinical breakthrough. No other technology with advantages similar to these has been identified in the US or the global market. The global targeted craniomaxillofacial fixation market is estimated to reach a value of USD $1,500 million by the end of 2020. In addition, the market size of biodegradable bone graft materials in North America only is expected to exceed $690 million by 2020. This I-Corps project is focused on the development of nonpermanent bone fixation devices made of a patent-pending biodegradable magnesium-based alloy with properties achieved using novel post-fabrication processes. Based on preliminary in-vitro studies, these devices are expected to be both strong enough to bear loads then lose strength and fully resorb following bone healing. It is hypothesized that the team's fixation devices will transfer enough compressive stresses to the healing bone to facilitate continuous bone remodeling. A preliminary proof-of-concept through a series of in vitro studies was successfully achieved. In addition, the biocompatibility of the alloy before and after the post-fabrication processes was assured. The success in developing nonpermanent fixation devices is expected to result in reduced post-surgery complications, reduced overall hospital stays and costs, and elimination of the need for a second surgery for implant removal.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.