Line extension and expanded preclinical evidence for Nerve Tape, a sutureless nerve repair coaptation device

Project Summary BioCircuit Technologies’ Nerve Tape® is a biologic wrap with integrated microhooks for sutureless repair of injured nerves. This SBIR Phase IIB project comprises activities critical for promoting adoption of Nerve Tape upon commercial launch. 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. The device 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 consistent, high-quality repairs. To promote adoption of Nerve Tape upon commercial launch, the proposed work will 1) extend the size range of the device for greater market capture and 2) gather key preclinical data to guide surgeon perception and support key marketing claims. To address commonly injured nerves such as small digital, facial, and branched motor nerves, the Nerve Tape size range will be expanded to include 1-2mm nerve diameters. Addition of the new size requires design optimization and subsequent verification and validation testing to support regulatory clearance of the smaller sized device. Separately, performance data in specific scenarios will be collected to proactively dispel perceived clinician concerns that might hinder adoption. Specifically, Nerve Tape’s performance will be demonstrated in areas of flexion (using a rabbit knee flexion model) and in long-term implant scenarios (using a 9-mo. pig model). Finally, we will gather evidence of Nerve Tape’s superior efficiency and repair quality consistency. These advantages will be demonstrated through a rabbit transected nerve repair study comparing surgical time and regeneration outcomes achieved by surgeons of varied microsurgery experience using Nerve Tape or conventional microsuture-based repair. The steps proposed in this project will position Nerve Tape for maximal market penetration after commercial launch, enabling widespread adoption as a nerve repair device that reduces surgical time and complexity for consistent, high-quality repairs and improved recovery outcomes.