Commercialization Readiness for Nerve Tape: a nerve repair coaptation aid

项目摘要 该SBIR商业化准备试点项目将准备并实现Bio- Circuit Technologies的Nerve Tape®设备用于免缝合神经修复。 神经损伤是常见的，并导致瘫痪，感觉丧失和慢性疼痛。在目前的修复技术中， 被切断的神经的末端由专业外科医生在高放大率下显微缝合在一起。 显微缝合修复技术在技术上具有挑战性，并且需要大量时间，修复质量不一致。 Nerve Tape是一种简单易用的微缝合修复替代品。Nerve Tape包括 嵌入生物包裹中的微型镍钛合金钩的柔性柱。该装置易于缠绕以对齐， 将切断的神经的两端连接在一起微型钩设计用于安全、浅刺入 外层结缔组织层的神经，均匀分布紧张的坚定举行。神经胶带很容易， 快速、可靠、安全地对齐神经末端，实现高质量修复。 为了实现Nerve Tape产品的初步商业化，BioCircuit必须完成几个关键步骤， 步将510（k）批准器械战略性转换为新的生物材料供应商需要进行一些验证 并重复验证测试步骤。该测试将支持新的监管申报，以获得 更新设备的许可。在生产用于临床的器械之前，正式的设计转移过程 必须完成。该流程包括确保所有供应商和供应商均经过认证和/或合格，并且 所有供应商协议均已就绪。还必须制造用于制造各种尺寸器件的工具， 合格以前开发和改进的制造工艺现在必须转移到 认证的合同制造商，所有生产过程必须符合产品规格。 完成设计转移过程并在BioCircuit的质量管理中记录该过程后 系统，生产运行将建立足够的设备，以支持最初的商业发射阶段。准备 为了成功的商业发射，市场研究和分析将指导初始发射计划， 随后的增长。临床事务活动将包括收集证据以支持关键声明的计划， 作为更广泛的证据策略的一部分，准备临床注册。战略上有限的“软发射”将 在选定的客户中进行，以建立和优化商业程序，获得临床反馈，以及 定位神经胶带的市场渗透后，全面推出。由于其简单、高效和可靠的使用， Nerve Tape将成为外科医生的一种有吸引力的工具，并可能扩展未来的神经修复治疗策略。

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.