Commercialization Readiness for Bone Filler Scaffold Device to Aid in Dental Applications and Reconstruction

项目摘要 目前用于牙种植体功能康复的骨移植技术存在局限性。 -成本高，固定稳定困难，骨再生不足，发病率高 使用自体块移植，愈合时间延长至9个月。现有合成骨 填充物不能匹配缺陷的形状和体积，即使有，也是弱吸收的，不容易和 在手术中大小和形状可快速改变，不能促进早期和增强 新生血管和骨结合；不适合于晚期重建。 目前的技术无法调整以匹配现有的骨骼结构--这是一个关键特征 以改善治疗效果。虽然种植前重建手术是常见的，但一种 由于这些限制，估计有7%的患者无法接受牙科植入物。这个 NuCress™支架在动物研究中表明，它是这些自体移植物的更好选择， 由于它的形状和形状可控，促进了骨形成和早期新生血管， 在一系列储存条件下的保质期稳定性和耐受性，以及 仅包括已获得FDA许可可在其他设备上使用或在 通关程序。在原位，支架膨胀以锁定在骨缺损处，消除了 需要特殊的工具来保护它。这些脚手架可以降低成本和 康复期，惠及数百万患者。NIDCR资助的快速跟踪SBIR结果 通过NuCressTM骨填充支架展示卓越且快速的骨再生 颅颌面部在临床前动物研究中的应用，为下一步奠定基础 商业化以造福患者。商业化不可或缺的是FDA批准了 NuCressTM支架作为牙科医疗设备(必需)和临床试验(非常可取)。 这些基本步骤需要实施和最终确定生产实践，以满足FDA的要求 制造法规(目标1)，执行生物兼容性和化学特性/风险 评估研究，以及根据FDA指南进行的动物研究，以比较 NuCressTM支架在临界大小牙槽骨中的应用 脊线缺陷模型(目标2)，从科研生产过渡到患者生产 临床治疗(目标3)，以及规划和准备未来的临床试验(目标4)。这个 拟议的团队拥有学术和临床领导者支持的专业知识和经验， 全球公认的合同研究机构和顾问成功满足FDA的要求 研究和NIDCR支持的临床研究成功。

Project Summary Current bone grafting techniques for functional rehabilitation with dental implants have limitations – high-cost, difficulties with fixation and stabilization, insufficient bone regeneration, high morbidity using autogenous block grafts and prolonged healing of up to 9 months. Existing synthetic bone fillers cannot match defect shape and volume, are weakly resorbed if at all, are not easily and quickly modifiable in size and shape during surgery, cannot promote early and enhanced neovascularization and osseointegration; and are poorly suited for advanced reconstruction. Current technologies cannot be modulated to match existing bone architecture – a critical feature for improved healing. Although pre-implant reconstructive surgeries are commonly performed, an estimated 7% of patients are unable to receive dental implants due to these limitations. The NuCress™ scaffold has shown in animal studies that it is a better alternative for these autografts, due to its controllable shape and form, enhanced bone formation and early neovascularization, shelf-life stability and tolerance over a range of storage conditions, and a composition that includes only components that have received FDA clearance for use in other devices or are in process of clearance. In situ, the scaffold swells to lock into place in the bone defect, eliminating the need for special instruments to secure it. These scaffolds could reduce costs and convalescent time, benefiting millions of patients. NIDCR-funded Fast Track SBIR results demonstrate superior and fast bone regeneration by the NuCressTM bone filler scaffold for craniomaxillofacial applications in pre-clinical animal studies, setting the stage for the next step of commercialization to benefit patients. Integral to commercialization is FDA approval for the NuCressTM scaffold as a dental medical device (required) and clinical trials (highly desirable). These essential steps require implementing and finalizing manufacturing practices to meet FDA manufacturing regulations (Aim 1), performing biocompatibility and chemical characterization/risk assessment studies, as well as animal studies per FDA guidance to compare performance of the NuCressTM scaffold to a predicate device and untreated control group in critical-sized alveolar ridge defect model (Aim 2), transition from production for research to production for patient treatment in clinics (Aim 3), and planning and preparing for clinical trials in the future (Aim 4). The proposed team has the expertise and experience backed by academic and clinical leaders, globally recognized Contract Research Organizations, and consultants successfully fulling FDA studies and NIDCR-supported clinical study successes.