Ceragenin-coated pedicle screws to tackle surgical-site infections.
涂有角锥蛋白的椎弓根螺钉可解决手术部位感染。
基本信息
- 批准号:10602633
- 负责人:
- 金额:$ 25.85万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-12-02 至 2024-11-30
- 项目状态:已结题
- 来源:
- 关键词:Anti-Infective AgentsAntibiotic ProphylaxisAntibioticsBiochemistryBody WeightBone ScrewsBusinessesCaliforniaCandida albicansCellsChemistryClinicalCommunitiesComplete Blood CountDeteriorationDevelopmentDevice or Instrument DevelopmentDoseEffectivenessExcisionExtracellular MatrixFaceFailureFormulationFrequenciesFunctional disorderGenerationsGenus staphylococcusGram-Negative BacteriaHarvestHealthHealthcare SystemsHigh Pressure Liquid ChromatographyImmuneImplantImplantation procedureIn VitroInfectionInternationalInterventionLeadershipLength of StayLicensingLocal Anti-Infective AgentsMarketingMeasuresMechanical StressMedicalMedical DeviceMedical TechnologyMedicineMetalsMicrobial BiofilmsMicroscopicModelingModificationMonitorMorbidity - disease rateOperative Surgical ProceduresOrganOryctolagus cuniculusPatientsPenetrationPharmaceutical PreparationsPhasePolymersPopulationPostoperative PeriodPrincipal InvestigatorProcessProductionPropertyPseudomonas aeruginosaQuality of lifeReportingResistanceRiskSafetySalesSecond Look SurgerySmall Business Innovation Research GrantSpinalSpine surgeryStaphylococcus aureusSurfaceSurgeonSurgical ModelsSurgical Wound InfectionTissue SampleTissuesTitaniumUniversitiesValidationVertebral columnamphiphilicityantimicrobialantimicrobial peptidebiomaterial compatibilitybonedesignexperienceflexibilityfunctional outcomesfungusimplantationimprovedin vivoin vivo evaluationinfection ratelarge scale productionlumbar vertebra bone structuremedical implantmetallicitymethicillin resistant Staphylococcus aureusmicrobial colonizationmicroorganismmortalitymortality risknovelpathogenphase 1 studypolycaprolactonepre-clinicalpreventprofessorresistant strainspine bone structuresuccess
项目摘要
PROJECT SUMMARY
Surgical Site Infection (SSI) is one of the major complications of implant surgery, especially in spinal surgery,
where SSI leads to unfavorable health and functional outcomes. Antimicrobial coatings have been explored as
a way to prevent microbial colonization on the surface of pedicle screws. However, current strategies to generate
antimicrobial coatings do not show broad-spectrum antimicrobial activity; in fact, they can engender bacterial
and fungal resistance. N8 Medical proposes a pedicle screw with a novel anti-infective coating based on
ceragenins (CSAs), which mimic antimicrobial peptides (AMPs) and are able to eradicate both bacterial and
fungal populations (including resistant strains) and to prevent the formation of biofilms without engendering
resistance. The coating will be designed as a polycaprolactone (PCL) substrate loaded with CSA, a synthetic
compound mimicking naturally occurring AMPs that shows dose-dependent anti-infective activity against Gram-
positive and Gram-negative bacteria and fungi. N8 Medical’s technology will disrupt the medical devices
antimicrobial coating market by proposing a solution that has efficacy against a broad-spectrum of pathogens,
including resistant strains, prevents the formation of biofilms, and has no known resistance pools. By reducing
the SSI rate during spinal surgery, N8 Medical will 1) reduce the burden on the healthcare system, associated
with longer hospital stays and revision surgeries; 2) reduce the frequency of implant failure; and 3) improve the
quality of life (QoL) of patients undergoing spinal surgery. Being highly scalable, N8 Medical’s coating platform
has the potential to prevent surgical site infections in a wide range of clinical interventions and improve the QoL
of patients in need of any kind of indwelling medical device. N8 Medical will sell its coated pedicle screws to the
healthcare system through a combination of direct and indirect sales. The flexibility of the platform will allow the
company to consider a licensing-based business model in the long term. This SBIR Phase I project aims at
establishing the technical feasibility of N8 medical’s CSA-based coating for titanium pedicle screws, which are
used in spinal surgery. To achieve this, N8 Medical will evaluate the pedicle screws coated with CSA-loaded
PCL (different concentrations of CSA and varying percentages of PCL) for their in vitro efficacy against resistant
Staphylococcus strains. In addition, the release of CSA will be measured by HPLC and the coating durability will
be evaluated using a lumbar vertebra model. Finally, the efficacy and safety of the coating will be tested in vivo
in a rabbit spinal surgery model. The success of the Phase I project will lay the ground for Phase II activities
where N8 Medical will optimize the coating formulation and the production process, and further investigate
coating biocompatibility, efficacy, and safety.
项目摘要
手术部位感染(SSI)是植入手术的主要并发症之一,尤其是在脊柱手术中,
SSI导致不利的健康和功能结果。抗微生物涂层已经被探索为
一种防止微生物在椎弓根螺钉表面定植的方法。然而,目前的战略,
抗菌涂层不显示广谱抗菌活性;事实上,它们可以产生细菌,
和真菌抗性。N8 Medical提出了一种具有新型抗感染涂层的椎弓根螺钉,
模拟抗菌肽(AMP)的角鲨烷配基(CSA)能够根除细菌和
真菌种群(包括耐药菌株),并防止生物膜的形成而不产生
阻力涂层将被设计为载有CSA的聚己内酯(PCL)基材,CSA是一种合成的
模拟天然存在的AMP的化合物,其显示针对革兰氏菌的剂量依赖性抗感染活性,
阳性和革兰氏阴性细菌和真菌。N8 Medical的技术将颠覆医疗设备
通过提出一种对广谱病原体有效的解决方案,
包括抗性菌株,防止生物膜的形成,并且没有已知的抗性库。通过减少
脊柱手术期间的SSI率,N8医疗将1)减少医疗保健系统的负担,
延长住院时间和翻修手术; 2)降低植入物失效的频率; 3)改善
脊柱手术患者的生活质量(QoL)。N8 Medical的涂层平台具有高度可扩展性,
有可能在广泛的临床干预中预防手术部位感染并改善QoL
需要任何类型留置医疗器械的患者。N8 Medical将把其涂层椎弓根螺钉出售给
通过直接和间接销售相结合的医疗保健系统。平台的灵活性将允许
从长远来看,公司应该考虑以许可为基础的商业模式。SBIR第一阶段项目旨在
确定N8 medical的CSA涂层用于钛椎弓根螺钉的技术可行性,
用于脊柱手术。为了实现这一点,N8 Medical将评价涂有CSA负载的椎弓根螺钉
PCL(不同浓度的CSA和不同百分比的PCL)的体外抗耐药的功效,
葡萄球菌菌株。此外,CSA的释放将通过HPLC测量,并且涂层耐久性将
使用腰椎模型进行评估。最后,将对涂层的有效性和安全性进行体内试验
在兔子脊柱手术模型中。第一阶段项目的成功将为第二阶段活动奠定基础
N8 Medical将优化涂层配方和生产工艺,并进一步研究
涂层的生物相容性、有效性和安全性。
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)
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Glenn Brunner其他文献
Glenn Brunner的其他文献
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{{ truncateString('Glenn Brunner', 18)}}的其他基金
Ceragenin-based antimicrobial coating to tackle hemodialysis catheter-related infections.
基于角藻蛋白的抗菌涂层可解决血液透析导管相关感染。
- 批准号:
10602612 - 财政年份:2022
- 资助金额:
$ 25.85万 - 项目类别:
Resorbable Antimicrobial Envelope to Prevent Infection of Implanted Cardiac Devices
可吸收抗菌包膜可防止植入心脏装置感染
- 批准号:
10483836 - 财政年份:2018
- 资助金额:
$ 25.85万 - 项目类别:
Resorbable Antimicrobial Envelope to Prevent Infection of Implanted Cardiac Devices
可吸收抗菌包膜可防止植入心脏装置感染
- 批准号:
10649672 - 财政年份:2018
- 资助金额:
$ 25.85万 - 项目类别:
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