SBIR Phase I: Development of a Peripheral Nerve Matrix Conduit to Enable Nerve Regeneration

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project involves the advancement of biomaterials development for nerve repair. Each year in the U.S. alone, surgeons perform around 550,000 procedures to repair peripheral nerves affected by traumatic or iatrogenic nerve injury, which are associated with an economic burden due to loss in employee productivity in excess of $150B per year. Peripheral Nerve Injury (PNI) can severely impact the quality of life, productivity, and interpersonal relationships of injured patients. Existing materials are primarily indicated for use as passive support or to prevent complications (e.g., mechanical instability, neuroma, or donor site morbidity associated with autograft). None of these products has shown clinical improvement in functional outcomes. As such, any technology or method that can accelerate or improve nerve repair is of significant interest as it can improve quality of life for those with nerve injuries and reduce the economic burden associated with long term disability for those with nerve injuries. This SBIR Phase I project proposes to undertake the initial development and testing of a porcine tissue-based nerve conduit. The objective of this proposal is to fabricate conduits that have suitable mechanical, structural, and biological properties to provide an ideal environment for nerve repair and regeneration in nerve gap injuries. The proposed work includes the development and in vitro characterization of the conduit, as well as in vivo testing in a small animal model of nerve gap repair. The animal study will compare the functional outcomes obtained with the proposed conduits with those obtained with commercially available conduits and autografts. Pilot studies have suggested that the proposed conduits have the potential to promote key early events in the nerve regeneration process leading to the formation of functional nerve tissue. The expected outcome is that the proposed conduits will be superior to existing nerve guides and allografts, enabling improvements in nerve repair and providing improvements in the clinical care of affected patients. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.