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

用于颅颌面外科系统的生物可吸收镁 (Mg) 植入物的商业化准备计划 (CRP)

• 批准号: 10266126
• 负责人: Stephen LeBeau
• 金额: $ 58.09万
• 依托单位: NANOMAG, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-06-15 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10266126
• 关键词: Acute; Address; Alloys; Back; Biological; Blood; Canis familiaris; Chemistry; Code; Collaborations; Consult; Corrosion; Data; Development; Device Approval; Devices; Engineering; Ensure; Excision; Feedback; Fracture; Funding; Grant; Implant; Individual; Inflammatory; Investigation; Laboratories; Learning; Magnesium; Mandible; Manufacturer Name; Mechanics; Medical Device; Medicine; Metals; Michigan; Modeling; Nanostructures; Operative Surgical Procedures; Organ; Orthopedics; Osteotomy; Pain; Patients; Performance; Phase; Physicians; Polymers; Procedures; Process; Readiness; Regulatory Pathway; Research; Research Contracts; Risk; Safety; Sampling; Sterilization; Surgeon; System; Testing; Time; Titanium; Trauma; United States National Institutes of Health; Universities; Urine; Validation; Weight-Bearing state; absorption; biomaterial compatibility; bone; bone healing; commercialization; cost; craniomaxillofacial; design; distraction; ductile; experience; healing; in vivo; infection rate; mechanical properties; method development; novel; operation; pre-clinical; preclinical efficacy; preclinical study; preclinical trial; programs; provider adoption; reconstruction; research and development; response; sample fixation; systemic toxicity

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.

NIH 19-333 -项目摘要 nanoMAG发明了一种生物可吸收的镁金属合金BioMg ®250，用于颅颌面 创伤和重建固定（1，2，3）。这种新颖的专利合金旨在消除 二次取出手术的成本和疼痛，20%的现有可吸收和 不可吸收植入物。BioMg 250的生物相容性化学和新型纳米结构提供了 应用于自攻螺钉和承重CMF固定系统，这对于 生物可吸收聚合物。 在NIH资助R44 DE 024919 -0351的支持下，nanoMAG已经完成了为期78周的BioMg 76只犬的下颌骨固定研究，其中骨愈合更快，力学性能更好。 与钛对照品相当。使用愈合数据、性能观察和吸收率 根据本研究的数据，硬件设计用于更小、更简单的BioMg面中部固定 系统，这将是拟议项目的主题。项目计划包括将来自 下颌骨和面中部研究，以获得FDA试验用器械豁免（IDE）批准。 为了获得IDE批准，本项目中的关键研究计划活动来自广泛的 与FDA的对话是： a.使用BioMg 250热机械进行螺钉和接骨板机械和吸附设计 处理开发以最大限度地提高性能 B.下颌骨临床前的完整器官、血液和尿液分析，以支持全身毒性 C.通过完全吸收进行的新CMF面中部安全性和有效性临床前试验 D.新型面中部吸收剂临床前试验的吸收机制分析 e.通过器械包装和灭菌发展供应链 F.台式吸收/腐蚀试验方法开发和验证 至于商业化计划，该项目将利用下颌骨研究来支持设计， 为BioMg面中部固定系统获得FDA IDE批准而开展的开发活动。该计划是 由经验丰富的企业家管理团队领导，并得到a）学术领袖的支持， 匹兹堡大学、密歇根大学的骨科医学和工程， 密歇根州立大学，B）GLP实验室的合同研究组织，c）个人，两者 内部和外部，具有医疗器械批准经验。CMF设备制造商将监督 并通过咨询和提供商业设备作为对照样品来支持该项目。