Commercialization Readiness for Nerve Tape: a nerve repair coaptation aid

项目摘要 本次SBIR商业化准备试点项目将准备并实现Bio-List的商业化启动。 电路技术公司的神经Tape®设备，用于无缝合神经修复。 神经损伤很常见，会导致瘫痪、感觉丧失和慢性疼痛。在当前的修复技术中， 切断的神经的末端在专业外科医生的高倍放大下被显微缝合在一起。 显微缝合修复技术具有技术难度大、耗时长、修复质量参差不齐等特点。 神经胶带被开发为一种简单易用的替代微缝合修复的方法。神经磁带由以下部分组成 嵌入在生物包裹中的微米级镍钛合金钩的柔性柱。该设备易于包装，以对齐和 把被切断的神经的两端合在一起。微钩设计用于安全、浅层穿透 神经的外部结缔组织层，均匀地分配张力以牢牢握住。神经胶带很容易和 快速、可靠、安全地对齐神经末梢，获得高质量的修复。 要实现神经胶带产品的初步商业化推出，生物电路必须完成几个关键 台阶。510(K)许可设备向新生物材料供应商的战略性转换需要一些验证 以及要重复的验证测试步骤。这项测试将支持新的监管提交以获得 更新设备的许可。在生产临床使用的设备之前，要经过正式的设计转移过程 必须完成。这一过程包括确保所有供应商和供应商都经过认证和/或合格，以及 所有供应商协议都已到位。还必须制造用于制造各种尺寸的设备的工具，并且 合格。以前开发和改进的制造工艺现在必须转移到 经认证的合同制造商，所有生产过程都必须符合产品规格。 在完成设计移交过程并将该过程记录在生物电路的质量管理中之后 系统，生产运行将制造足够的设备，以支持最初的商业发布阶段。做好准备 对于成功的商业投放，市场研究和分析将指导初始投放计划和 随后的增长。临床事务活动将包括收集证据以支持关键主张的计划和 作为更广泛证据战略的一部分，为临床登记做准备。一次战略上有限的“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，以便在全面推出后进行市场渗透。由于其简单、高效和可靠的使用， 神经胶带对外科医生来说将是一个有吸引力的工具，并可能扩大未来神经修复的治疗策略。

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.