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 -项目总结