Bi-layered Diametrically Patterned Nanofibrous Dural Substitutes for Enhanced Dur

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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. Xenogenic collagen matrices have significant disadvantages including low mechanical strength, low suturability, 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 I project will assess the biological performance of the diametrically patterned nanofibrous dural substitute and compare against two leading commercial products in an acute canine duraplasty model. Successful completion of Phase I milestones will enable biocompatibility, stability and long-term in vivo implantation studies in Phase II. Upon achievement of Phase II milestones, NanoNerve will file an FDA IDE application for human clinical testing. PUBLIC HEALTH RELEVANCE: Over 225,000 neurosurgical procedures are performed annually that require grafting of the dura mater to prevent fluid leakage, infection and neural tissue damage. Currently available dural substitutes have major limitations including incomplete dural repair, low mechanical strength and high leakage rate complications. This phase I study will enable development of a strong, versatile and diametrically patterned nanofibrous dural substitute for rapid and effective dura mater regeneration.