Commercialization Readiness Program (CRP) for Bioabsorbable Magnesium (Mg) Implants for Craniomaxillofacial Surgical Systems

NIH 19-333-项目摘要 纳米MAG公司发明了一种可生物吸收的镁金属合金BioMG®250，用于颅颌面部 创伤重建固定1例，2例，3例。这种新颖的专有合金旨在消除 二次摘除手术的费用和痛苦，20%的患者需要现有的可吸收和 不可吸收的植入物。生物镁250‘S生物相容性化学和新型纳米结构 在自攻螺钉和承重CMF固定系统中的应用，这是 生物可吸收聚合物。 在美国国立卫生研究院R44DE024919-0351的资助下，NanMAG已经在78周内完成了BioMG 76个尖牙下颌骨固定实验，骨愈合快，力学性能好 可与钛合金控制相媲美。使用治愈数据、性能观察和吸收率 来自这项研究的数据，正在为更小、更简单的BioMG中面固定设计硬件 该系统将成为拟议项目的主题。项目计划包括组合来自 下颌和面中部研究，以获得FDA调查设备豁免(IDE)批准。 为了获得IDE的批准，该项目中的关键研究计划活动来自广泛的 与FDA的对话，包括： A.采用BioMG 250热机械进行螺杆和钢板机械及吸收设计 处理开发以最大限度提高性能 对下颌骨临床前进行完整的器官、血液和尿液分析，以支持全身毒性 C.新的CMF面中部完全吸收的安全性和有效性临床前试验 新面中部临床前试验的吸收机理分析 E.通过对设备进行包装和消毒来发展供应链 F.台面吸收/腐蚀测试方法的开发和验证 至于商业化计划，该项目将利用下颌骨研究来支持设计和 导致FDA IDE批准BioMG中面固定系统的开发活动。我们的计划是 由经验丰富的企业家管理团队领导，并由a)学术领袖支持 来自匹兹堡大学、密歇根大学的整形外科医学和工程学 密歇根州立大学，b)与GLP实验室签订研究组织合同，c)个人，两者 内部和外部，有医疗器械审批经验。CMF设备制造商将监督 并通过咨询和提供商用设备作为控制样本来支持项目。

NIH 19-333 – Project Summary nanoMAG has invented a bioabsorbable magnesium metal alloy, BioMg ®250, for craniomaxillofacial trauma and reconstruction fixation (1,2,3). This novel and proprietary alloy is intended to obviate the cost and pain of secondary removal surgery, required for 20% of patients with existing absorbable and non-absorbable implants. BioMg 250’s biocompatible chemistry and novel nanostructure afford application in self-tapping screws and load-bearing CMF fixation systems, which is not possible for bioabsorbable polymers. With the support of NIH grant R44DE024919-0351, nanoMAG has completed through 78 weeks a BioMg mandible fixation study in 76 canines, in which bone healing was faster and mechanical properties were comparable to Titanium controls. Using healing data, performance observations, and absorption rate data from this study, hardware is being designed for a smaller and simpler BioMg Midface Fixation System which will be the subject of the proposed project. The project plan includes combining data from mandible and midface studies to earn FDA Investigational Device Exemption (IDE) approval. In order to obtain IDE approval, the key Research Plan activities in this project, coming from extensive dialogue with the FDA, are: a. Screw and plate mechanical and absorption design with BioMg 250 thermomechanical processing development to maximize performance b. Complete organ, blood, and urine analyses for mandible preclinical to support systemic toxicity c. New CMF midface safety and efficacy pre-clinical trial through full absorption d. Absorption mechanism analyses of the new midface pre-clinical trial e. Supply chain development through packaging and sterilization of devices f. Test method development and validation for benchtop absorption/corrosion As to the Commercialization Plan, this project will leverage the mandible study to support design and development activities leading up to FDA IDE approval of the BioMg Midface Fixation System. The plan is led by an experienced management team of entrepreneurs and backed by a) academic leaders in orthopedic medicine and engineering from University of Pittsburgh, The University of Michigan, and Michigan State University, b) Contract Research Organizations with GLP laboratories, c) individuals, both internal and external, with medical device approval experience. CMF device manufacturers will oversee and support the project with consulting and provision of commercial devices as control samples.