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)
基本信息
- 批准号:10266126
- 负责人:
- 金额:$ 58.09万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AcuteAddressAlloysBackBiologicalBloodCanis familiarisChemistryCodeCollaborationsConsultCorrosionDataDevelopmentDevice ApprovalDevicesEngineeringEnsureExcisionFeedbackFractureFundingGrantImplantIndividualInflammatoryInvestigationLaboratoriesLearningMagnesiumMandibleManufacturer NameMechanicsMedical DeviceMedicineMetalsMichiganModelingNanostructuresOperative Surgical ProceduresOrganOrthopedicsOsteotomyPainPatientsPerformancePhasePhysiciansPolymersProceduresProcessReadinessRegulatory PathwayResearchResearch ContractsRiskSafetySamplingSterilizationSurgeonSystemTestingTimeTitaniumTraumaUnited States National Institutes of HealthUniversitiesUrineValidationWeight-Bearing stateabsorptionbiomaterial compatibilitybonebone healingcommercializationcostcraniomaxillofacialdesigndistractionductileexperiencehealingin vivoinfection ratemechanical propertiesmethod developmentnoveloperationpre-clinicalpreclinical efficacypreclinical studypreclinical trialprogramsprovider adoptionreconstructionresearch and developmentresponsesample fixationsystemic toxicity
项目摘要
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
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Stephen LeBeau其他文献
Stephen LeBeau的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Stephen LeBeau', 18)}}的其他基金
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 - 财政年份:2015
- 资助金额:
$ 58.09万 - 项目类别:
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 - 财政年份:2015
- 资助金额:
$ 58.09万 - 项目类别:
相似海外基金
Rational design of rapidly translatable, highly antigenic and novel recombinant immunogens to address deficiencies of current snakebite treatments
合理设计可快速翻译、高抗原性和新型重组免疫原,以解决当前蛇咬伤治疗的缺陷
- 批准号:
MR/S03398X/2 - 财政年份:2024
- 资助金额:
$ 58.09万 - 项目类别:
Fellowship
Re-thinking drug nanocrystals as highly loaded vectors to address key unmet therapeutic challenges
重新思考药物纳米晶体作为高负载载体以解决关键的未满足的治疗挑战
- 批准号:
EP/Y001486/1 - 财政年份:2024
- 资助金额:
$ 58.09万 - 项目类别:
Research Grant
CAREER: FEAST (Food Ecosystems And circularity for Sustainable Transformation) framework to address Hidden Hunger
职业:FEAST(食品生态系统和可持续转型循环)框架解决隐性饥饿
- 批准号:
2338423 - 财政年份:2024
- 资助金额:
$ 58.09万 - 项目类别:
Continuing Grant
Metrology to address ion suppression in multimodal mass spectrometry imaging with application in oncology
计量学解决多模态质谱成像中的离子抑制问题及其在肿瘤学中的应用
- 批准号:
MR/X03657X/1 - 财政年份:2024
- 资助金额:
$ 58.09万 - 项目类别:
Fellowship
CRII: SHF: A Novel Address Translation Architecture for Virtualized Clouds
CRII:SHF:一种用于虚拟化云的新型地址转换架构
- 批准号:
2348066 - 财政年份:2024
- 资助金额:
$ 58.09万 - 项目类别:
Standard Grant
The Abundance Project: Enhancing Cultural & Green Inclusion in Social Prescribing in Southwest London to Address Ethnic Inequalities in Mental Health
丰富项目:增强文化
- 批准号:
AH/Z505481/1 - 财政年份:2024
- 资助金额:
$ 58.09万 - 项目类别:
Research Grant
ERAMET - Ecosystem for rapid adoption of modelling and simulation METhods to address regulatory needs in the development of orphan and paediatric medicines
ERAMET - 快速采用建模和模拟方法的生态系统,以满足孤儿药和儿科药物开发中的监管需求
- 批准号:
10107647 - 财政年份:2024
- 资助金额:
$ 58.09万 - 项目类别:
EU-Funded
BIORETS: Convergence Research Experiences for Teachers in Synthetic and Systems Biology to Address Challenges in Food, Health, Energy, and Environment
BIORETS:合成和系统生物学教师的融合研究经验,以应对食品、健康、能源和环境方面的挑战
- 批准号:
2341402 - 财政年份:2024
- 资助金额:
$ 58.09万 - 项目类别:
Standard Grant
Ecosystem for rapid adoption of modelling and simulation METhods to address regulatory needs in the development of orphan and paediatric medicines
快速采用建模和模拟方法的生态系统,以满足孤儿药和儿科药物开发中的监管需求
- 批准号:
10106221 - 财政年份:2024
- 资助金额:
$ 58.09万 - 项目类别:
EU-Funded
Recite: Building Research by Communities to Address Inequities through Expression
背诵:社区开展研究,通过表达解决不平等问题
- 批准号:
AH/Z505341/1 - 财政年份:2024
- 资助金额:
$ 58.09万 - 项目类别:
Research Grant