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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
5R43NS076101-02
Application #
8304201
Study Section
Special Emphasis Panel (ZRG1-SBIB-Q (11))
Program Officer
Fertig, Stephanie
Project Start
2011-08-01
Project End
2013-05-31
Budget Start
2012-08-01
Budget End
2013-05-31
Support Year
2
Fiscal Year
2012
Total Cost
$138,872
Indirect Cost
Name
Nanonerve, Inc.
Department
Type
DUNS #
800435591
City
Berkeley
State
CA
Country
United States
Zip Code
94720