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: 10079889
• 负责人: Stephen LeBeau
• 金额: $ 226.08万
• 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/10079889
• 关键词: Acute; Address; Adoption; 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; 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镁金属合金 BioMg ®250，用于颅颌面手术 创伤和重建固定 (1,2,3)。这种新颖且专有的合金旨在避免 20% 现有可吸收和可吸收的患者需要二次切除手术的费用和痛苦 不可吸收的植入物。 BioMg 250 的生物相容性化学和新颖的纳米结构提供 在自攻螺钉和承重 CMF 固定系统中的应用，这是不可能的 可生物吸收的聚合物。 在 NIH 拨款 R44DE024919-0351 的支持下，nanoMAG 经过 78 周完成了 BioMg 76 只犬齿的下颌骨固定研究，骨愈合更快，机械性能更好 与钛合金控制器相当。使用愈合数据、性能观察和吸收率 根据这项研究的数据，硬件正在设计用于更小、更简单的 BioMg 中面部固定 该系统将成为拟议项目的主题。该项目计划包括结合来自 下颌骨和中面部研究以获得 FDA 研究设备豁免 (IDE) 批准。 为了获得 IDE 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： 一个。采用 BioMg 250 热机械的螺杆和板机械和吸收设计 加工开发以最大限度地提高性能 b.下颌骨临床前完整的器官、血液和尿液分析以支持全身毒性 c.新CMF中面安全性和有效性通过完全吸收进行临床前试验 d.新型中面部临床前试验的吸收机制分析 e.通过设备包装和灭菌开发供应链 f.台式吸收/腐蚀测试方法开发和验证 至于商业化计划，该项目将利用下颌骨研究来支持设计和 BioMg 中面固定系统获得 FDA IDE 批准的开发活动。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专业，以及 密歇根州立大学，b) 具有 GLP 实验室的合同研究组织，c) 个人，两者 内外部，具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业设备作为控制样本来支持该项目。