Axion Biosystems, Inc. — Department of Health and Human Services SBIR Phase II: 101

Description

Project Summary We will finalize development of a microhook based device for quick and consistently effective repair of nerve injuriesThismicrohook nerve tapeconsists of an array of microscale hooksdistributed across a fineflexible meshwork and embedded in a biologic backingThis device will be used during nerve repair surgeries in place of microsutures to wrap around and bind the approximated ends of a severed nerveor the ends of a nerve graftThe short microhooks penetrate only into the outerconnective tissue layers of the nerveforming an effective mechanical attachment and distributing tension evenly across the deviceMicrohook nerve tape can be applied easily and lowers surgery time and complexity as compared to the current clinical standard of microsuture repairThe ease and intuitiveness of microhook nerve tape application will enable consistent high quality repairs to optimize recovery after nerve injuriesIn Phase Iwe refined the device design to produce a set of prototypes consisting of a stainless steel based microhook mesh laminated within a biologic layer of porcine small intestinal mucosaSISIn biomechanical testingnerves were held together by the device with strength comparable to that of microsuture repairsIn in vivo rabbit testingthe device was well tolerated by the surrounding tissueand nerves that were cut and repaired with microhook nerve tape regenerated comparably vsmicrosuture repaired nervesWe subsequently developed an enhanced Nitinolbased version of the device more suitable to clinical translationand we demonstrated the superior performance of this device in biomechanical testingIn Phase II we will finalize the design of the microhook nerve tape device with Nitinol based microhooksand we will develop efficient manufacturing and production methodsWe will conduct extensive validation testing of safety and efficacy in comprehensive rabbit studies and apply for FDAkclearanceThe final commercialization ready product will be an FDAapproved nerve repair device that can be stored on the shelf for use during nerve repair proceduresMicrohook nerve tape will reduce the technical demands and time costs of nerve repairwhile improving repair consistency and overall quality Project Narrative We are developing a microhook based nerve tape device for wrapping around and holding together the two ends of a cut nerveThe distributed array of microscopic hooks strongly affixes to the outside of the nerve without penetrating into the delicate interiorMicrohook nerve tape s simple design and ease of use enables rapid implantation and consistently high repair quality to enhance functional recovery from potentially debilitating nerve injuries