Bioabsorbable Magnesium (Mg) Implants for Craniomaxillofacial Surgical Systems

描述（由申请人提供）：引言- 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。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器械制造商要求的大型动物研究，以推进这些器械的商业化。重要性-存在商业生物可吸收聚合物合金;但它们对于承重和刚性固定应用不够坚固（FDA仅批准其用于非承重应用）。非生物可吸收钛（Ti）和不锈钢也用于颅面手术;但可能发生并发症，需要二次手术取出器械。60%的年轻患者主张手术切除（1）。钛植入物的取出非常困难，可能会受到螺钉头断裂、神经损伤、感染和骨再骨折的威胁（1、2、3、4、5、6）。迫切需要用于颅面装置的更强的生物可吸收材料。长期目标和与NIDCR使命的相关性- BioMg（R）250将实现刚性颅面固定，同时避免二次手术的疼痛、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制成的骨固定器械（接骨板、螺钉、管材），用于颅面器械。 第一阶段假设和具体目标-可以基于初步动物研究开发用于BioMg 250功能评价的实验方法和方案。在猪中进行的下颌骨骨折模型中试动物研究将证明该技术的可行性，为II期开展的一般实验室程序（GLP）动物研究提供完整记录的方案和程序。II期假设和特定目标- GLP大型动物颅面植入物研究结合生物相容性试验将证明生物可吸收BioMg 250植入物用于承重器械的有效性和安全性。预期结果-仔细执行并完整记录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。.

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. .