Commercialization Readiness for Nerve Tape: a nerve repair coaptation aid

神经胶带的商业化准备：神经修复接合辅助工具

• 批准号: 10698977
• 负责人: Isaac Perry Clements
• 金额: $ 188.7万
• 依托单位: BIOCIRCUIT TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-22 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10698977
• 关键词: Adoption; Agreement; Axon; Back; Binding; Biocompatible Materials; Biological; Biological Factors; Cadaver; Certification; Cessation of life; Cicatrix; Clinical; Communication; Complex; Connective Tissue; Contracts; Devices; Ensure; Environment; Equipment; Exhibits; Fascicle; Feedback; Future; Goals; Growth; Growth Factor; Infiltration; Interview; Legal patent; Manufacturer; Market Research; Marketing; Microsurgery; Motivation; Nerve; Nerve Endings; Nerve Transfer; Operative Surgical Procedures; Outcome; Paralysed; Patients; Penetration; Peripheral Nerves; Persons; Phase; Pilot Projects; Positioning Attribute; Preparation; Procedures; Process; Production; Prognosis; Publishing; Qualifying; Readiness; Registries; Regulation; Reporting; Safety; Savings; Sensory; Shapes; Site; Small Business Innovation Research Grant; Specific qualifier value; Speed; Step Tests; Sterilization; Surgeon; Surgical sutures; Suture Techniques; System; Techniques; Technology; Testing; Thinness; Time; Tissues; Update; Validation; Vendor; axon regeneration; chronic pain; commercial launch; commercialization; commercialization readiness; design; experience; flexibility; manufacture; manufacturing process; manufacturing run; nerve injury; nerve repair; nitinol; outreach; pre-clinical; regeneration potential; regenerative; repaired; simulation; tool; treatment strategy; usability; verification and validation

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.

项目概要 该 SBIR 商业化准备试点项目将准备并实现 Bio- Circuit Technologies 的 Nerve Tape® 设备用于无缝线神经修复。 在目前的修复技术中，神经损伤很常见，会导致瘫痪、感觉丧失和慢性疼痛。 专业外科医生在高放大倍数下将切断的神经末端重新缝合在一起。 微缝合修复技术技术难度大、耗时长，且修复质量不稳定。 神经胶带是作为微缝合修复的简单易用的替代品而开发的。 嵌入生物包裹物中的微型镍钛合金钩的柔性柱可以轻松包裹以对齐和对齐。 微钩将切断的神经的两端固定在一起，以便安全、浅地刺入。 神经外结缔组织层，均匀分布张力，轻松牢固地固定神经胶带。 快速应用、可靠且安全地对齐神经末梢，以实现高质量修复。 为了实现 Nerve Tape 产品的初步商业化推出，BioCircuit 必须完成几个关键 将 510(k) 批准的设备战略转换为新的生物材料供应商需要进行一些验证。 重复的验证测试步骤将支持新的监管提交。 在生产用于临床的设备之前，需要进行正式的设计转移流程。 必须完成此过程，包括所有供应商和供应商均经过认证和/或合格，并确保 所有供应商协议都已到位，并且还必须构建和制造用于制造全系列设备尺寸的工具。 以前开发和改进的制造工艺现在必须转移到合格的。 经过认证的合同制造商，所有生产过程都必须合格，符合产品规格。 完成设计转移流程并在 BioCircuit 的质量管理中记录该流程后 系统、生产运行将构建足够的设备来支持初始商业发布阶段。 为了成功进行商业发布，市场研究和分析将指导初始发布计划和 临床事务活动将包括收集证据以支持关键主张和的计划。 作为更广泛的证据战略的一部分，临床登记的准备工作将是战略上有限的“软启动”。 在选定的账户进行，以建立和优化商业程序，获取临床反馈，以及 由于其简单、高效、可靠的使用方式，神经胶带在全面推出后将获得市场渗透。 神经胶带对于外科医生来说将是一种有吸引力的工具，并且可以扩展未来神经修复的治疗策略。