Commercialization Readiness for Nerve Tape: a nerve repair coaptation aid

项目总结

Project Summary This SBIR Commercialization Readiness Pilot project will prepare and achieve the commercial launch of Bio- Circuit Technologies’ Nerve Tape® device for sutureless nerve repair. Nerve injuries are common and result in paralysis, sensory loss, and chronic pain. In current repair techniques, the ends of a cut nerve are microsutured back together under high magnification by a specialized surgeon. Microsuture repair techniques are technically challenging and time intensive, and repair quality is not consistent. Nerve Tape was developed as a simple and easy-to-use alternative to microsuture repair. Nerve Tape consists of flexible columns of microscale Nitinol hooks embedded in a biologic wrap. The device easily wraps to align and hold together the two ends of a severed nerve. The microhooks are designed for safe, shallow penetration into outer connective tissue layers of the nerve, evenly distributing tension for a firm hold. Nerve Tape is easily and quickly applied, reliably and safely aligning nerve ends for high-quality repairs. To achieve initial commercialization launch of the Nerve Tape product, BioCircuit must complete several key steps. A strategic switch in the 510(k) cleared device to a new biologic material supplier requires some verification and validation testing steps to be repeated. This testing will support a new regulatory submission to gain clearance for the updated device. Prior to production of devices for clinical use, a formal design transfer process must be completed. This process includes ensuring all vendors and suppliers are certified and/or qualified, and all supplier agreements are in place. Tooling for fabricating the full range of device sizes must also be built and qualified. Manufacturing processes that were previously developed and refined must now be transferred to a certified contract manufacturer, and all production processes must to be qualified to meet product specifications. After completing the design transfer process and documenting this process in BioCircuit’s Quality Management System, production runs will build enough devices to support an initial commercial launch phase. To prepare for successful commercial launch, market research and analytics will guide plans for initial launch and subsequent growth. Clinical affairs activities will include plans for gathering evidence to support key claims and preparations for a clinical registry as part of a broader evidence strategy. A strategically limited “soft launch” will be conducted at select accounts to establish and optimize commercial procedures, obtain clinical feedback, and position Nerve Tape for market penetration following full launch. Due to its simple, efficient, and reliable usage, Nerve Tape will be an attractive tool for surgeons and could expand future treatment strategies for nerve repair.