There is a need for an ?off-the-shelf? nerve guide that can support the regeneration of peripheral nerves over large gaps. While there are several nerve guides on the market, none are approved for nerve gaps > 3 cm in humans. The innovation effort proposed will enhance efforts to commercialize a biodegradable nerve guide for long gap peripheral nerve repair. The intellectual merit of this proposal involves the development of a novel conduit that controllably delivers of neurotrophic factors for ~ 60 days. The nerve guide being developed in this project has the requisite components to promote both motor and sensory nerve repair over long gaps. The PI and her team have been developing such a guide for over a decade, and this project not only addresses a clinical need, but has supported several students (from the high school level through the graduate student level), resulting in an increased understanding of drug delivery kinetics and the role of porosity on nerve regeneration.

The broader impacts are, in addition to the clinical significance, to enhance and stimulate scientific literacy in biomedical engineering at both the undergraduate and graduate levels by involvement of students in ongoing research and outreach activities, Through the I-Corps program, the team seeks to enhance their network of commercial partners and enhance their knowledge of commercialization concepts. Scientifically, the team plans to deliver a therapeutic strategy which results in increased functional recovery for large gap peripheral nerve injuries. If successfully deployed, this technology could address a serious unmet need for clinical care of diseased and damaged nerve tissue.

Project Report

During this course of the NSF I-Corp program, the PI and her team, which included a post-doctoral fellow (ie entrepreneurial lead) and an executive-in-residence (ie business mentor), participated in the I-Corp course in Ann Arbor Michigan in the summer of 2012. Our objectives were to learn about the commercialization process of our product, which is a biodegradable nerve guide. Prior NSF funding, in addition to current DOD funding, has resulted in the development of a nerve guide that has a strong potential impact on peripheral nerve repair. Previous research has allowed us to develop a reproducible, successful nerve conduit, thus decreasing the translational risk. During the course of the last several years, we have assembled a strong team of experienced researchers and surgeons from the University of Pittsburgh and collaborating institutions. The overall goal to develop an ‘off-the-shelf’ nerve guide is a long-standing goal of the team. Large animal nerve defect studies have been initiated in Dr. Marra’s laboratory at the University of Pittsburgh. This model will allow for direct clinical translation. Industry collaborations are vital to the further development of the nerve guide, providing a ‘freedom to operate. Wew will need to be able to manufacture the guides under GMP conditions. The team will continue to work with the FDA to obtainapproval. Our results were that we have several additional applications for our nerve guide, and that we will likely license our technology to a nerve guide company. Our goals were met, and we've achieved an enhanced knowledge of the business perspective of science. We have obtained an invaluable knowledge of the business side of science.

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University of Pittsburgh
United States
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