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

• 批准号: 8831142
• 负责人: Stephen LeBeau
• 金额: $ 22.47万
• 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 2016-12-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8831142
• 关键词: Absorbable Implants; Advocate; Alloys; Animals; Biocompatible Materials; Clinical; Data; Dental Implants; Development; Devices; Documentation; Engineering; Equilibrium; Evaluation; Excision; Exhibits; FDA approved; Face; Family suidae; Fracture; Funding; Goals; Harvest; Head; Histology; Implant; Industry; Infection; Jaw; Laboratory Procedures; Legal patent; Magnesium; Mandible; Mandibular Fractures; Manufacturer Name; Marketing; Mastication; Mechanics; Medical Device; Medicine; Metals; Methodology; Mission; Modeling; National Institute of Dental and Craniofacial Research; Nerve; Operative Surgical Procedures; Orthopedics; Osteomyelitis; Outcome; Pain; Patients; Phase; Pilot Projects; Plastics; Polymers; Procedures; Process; Property; Protocols documentation; Public Health; Research; Risk; Safety; Sales; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Specific qualifier value; Specimen; Speed; Stainless Steel; Sterilization; Stress; Structure; System; Technology; Test Result; Testing; Time; Tissues; Titania; Titanium; Weight-Bearing state; base; biomaterial compatibility; bone; commercialization; cost; craniofacial; craniofacial repair; craniomaxillofacial; design; implantable device; in vitro testing; in vivo; innovation; manufacturing process; microCT; next generation; operation; pre-clinical; preclinical study; programs; public health relevance; reconstruction; restoration; sample fixation; scale up

DESCRIPTION (provided by applicant): Introduction - nanoMAG LLC, an engineered biomaterials manufacturer, is developing and commercializing next generation, magnesium (Mg) biocompatible materials with applications in craniofacial and orthopaedic medicine. The overall goal of this SBIR Fast Track project is to develop a bioabsorbable Mg implant for mechanical fixation in craniofacial surgical procedures. This will include confirming function and biocompability, followed by large animal studies required both by FDA and OEM device manufacturers to advance the commercialization of these devices. Significance - Commercial bioabsorbable polymer alloys exist; but they are not strong enough for load bearing and rigid fixation applications (they are FDA approved for only non-load bearing applications). Non- bioabsorbable titanium (Ti) and stainless steel are also used in craniofacial procedures; but complications can occur that necessitate a secondary surgery to remove the devices. Surgical removal is advocated in 60% of cases involving young patients (1). Removal of Ti implants can be extremely difficult, threatened by screw- head fracture, nerve damage, infection and bone refracture (1,2,3,4,5,6). There is a critical need for stronger bioabsorbable materials for craniofacial devices. Long Term Goal and Relevance to NIDCR mission - BioMg(R) 250 will enable rigid craniofacial fixations while obviating the pain, cost, stress and infection risk of secondary operations. The Product - nanoMAG's products are bone fixation devices (plates, screws, tubing) produced from bioabsorbable Mg based alloy, BioMg 250, for use in craniofacial devices. Phase I Hypothesis and Specific Aims - An experimental methodology and protocol for functional evaluation of BioMg 250 can be developed based on a pilot animal study. A mandible fracture model pilot animal study in swine will demonstrate the feasibility of the technology, providing fully documented protocol and procedures developed for General Laboratory Procedure (GLP) animal studies to be carried out in Phase II. Phase II Hypothesis and Specific Aims - GLP Large animal craniofacial implant studies in conjunction with biocompatibility testing will demonstrate the efficacy and safety of bioabsorbable BioMg 250 implants for load bearing devices. Expected outcomes - carefully executed and fully documented pre-clinical large animal studies to support submission of data to FDA regulatory examiners as well as to OEM strategic partners. .

描述（由申请人提供）：简介 - nanoMAG LLC 是一家工程生物材料制造商，正在开发和商业化下一代镁 (Mg) 生物相容性材料，应用于颅面和骨科医学。该 SBIR 快速通道项目的总体目标是开发一种生物可吸收镁植入物，用于颅面外科手术中的机械固定。这将包括确认功能和生物相容性，然后进行 FDA 和 OEM 设备制造商要求的大型动物研究，以推进这些设备的商业化。意义——商业化的生物可吸收聚合物合金已经存在；但它们对于承重和刚性固定应用而言强度不够（它们仅获得 FDA 批准用于非承重应用）。不可生物吸收的钛 (Ti) 和不锈钢也用于颅面手术；但可能会出现并发症，需要进行二次手术来移除装置。 60% 的年轻患者主张手术切除 (1)。钛种植体的移除可能极其困难，可能会受到螺钉头骨折、神经损伤、感染和骨折的威胁 (1,2,3,4,5,6)。颅面装置迫切需要更强的生物可吸收材料。长期目标以及与 NIDCR 使命的相关性 - BioMg(R) 250 将实现刚性颅面固定，同时消除二次手术的疼痛、成本、压力和感染风险。产品 - nanoMAG 的产品是由生物可吸收镁基合金 BioMg 250 制成的骨固定装置（板、螺钉、管材），用于颅面装置。 第一阶段假设和具体目标 - 可以根据试点动物研究开发用于 BioMg 250 功能评估的实验方法和方案。猪下颌骨骨折模型试点动物研究将证明该技术的可行性，提供为第二阶段进行的通用实验室程序（GLP）动物研究开发的完整记录的方案和程序。 II 期假设和具体目标 - GLP 大型动物颅面植入物研究与生物相容性测试相结合，将证明用于承载装置的生物可吸收 BioMg 250 植入物的功效和安全性。预期结果 - 精心执行并完整记录的临床前大型动物研究，以支持向 FDA 监管审查员以及 OEM 战略合作伙伴提交数据。 。