Diametrically Patterned Dural Graft for Enhanced Dura Mater Regeneration

描述(申请人提供)：NanoNerve正在开发一种新型的直径图案纳米纤维硬脑膜替代品，用于神经外科手术后硬脑膜的快速再生。仅在美国，每年就有22.5万例神经外科手术需要修补硬脑膜，以防止渗漏、感染和神经损伤。目前可用的硬脑膜替代物包括异种胶原基质和永久性合成装置。异种胶原基质具有机械强度低、可缝合性低、成本高和疾病传播风险高等显著缺点。永久性合成装置也存在主要缺点，包括硬脑膜再生困难，植入时需要广泛缝合，以及较高的渗漏率。该项目的总体目标是FDA 510(K)批准一种高度通用的直径图案纳米纤维硬脑膜替代品并将其商业化。NanoNerve正在利用其正在申请专利的静电纺丝技术对纳米纤维进行直径图案设计，以便快速从缺陷的整个外围向中心再生硬膜组织。NanoNerve的合成生物可吸收纳米纤维硬脑膜替代品的超薄外形和高机械强度将使其成为第一个能够缝合和免缝合植入的合成硬脑膜替代品。这个第二阶段的项目将通过在Viv植入中进行生物相容性、安全性、稳定性和长期研究来继续开发直径图案的纳米纤维硬脑膜替代物。在达到第二阶段的里程碑后，NanoNerve将提交FDA的人体临床测试IDE申请，并最终提交FDA 510k的上市许可申请。

DESCRIPTION (provided by applicant): NanoNerve is developing a novel diametrically patterned nanofibrous dural substitute for rapid dura mater regeneration following neurosurgical procedures. In the US alone, 225,000 neurosurgical procedures are performed annually that require patching of the dura mater to prevent leakage, infection and neural damage. Currently available dural substitutes include xenogenic collagen matrices and permanent synthetic devices. Xenogeneic collagen matrices have significant disadvantages including low mechanical strength, low suturability, and high cost and disease transmission risks. The permanent synthetic devices also suffer from major disadvantages including resistance to dura mater regeneration, need for extensive suturing during implantation and higher leakage rates. The overall goal of the project is FDA 510(K) clearance and commercialization of a highly versatile diametrically patterned nanofibrous dural substitute. NanoNerve is utilizing its patent pending electrospinning technology to diametrically pattern nanofibers for rapidly regenerating dural tissue from the entire periphery of the defect toward the center. NanoNerve's synthetic bioresorbable nanofibrous dural substitute's ultra-thin profile and high mechanical strength will enable it to become the first synthetic dural substitute capable of sutured and suture-free implantation. This Phase II project will continue development of the diametrically patterned nanofibrous dural substitute by performing biocompatibility, safety, stability and long-term in viv implantation studies. Upon achievement of Phase II milestones, NanoNerve will file an FDA IDE application for human clinical testing and, eventually, an FDA 510k for market clearance.