The Neurospan Bridge: A Device for Peripheral Nerve Repair

Neurospan 桥：一种用于周围神经修复的装置

基本信息

批准号：
10515280
负责人：
Yacov Koffler
金额：
$ 100万
依托单位：
AUXILIUM BIOTECHNOLOGIES INC.
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-03-15 至 2024-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10515280
关键词：
Acceleration Agreement Allografting Animal Model Autologous Autologous Transplantation Biomedical Engineering Biomimetics Biotechnology Clinic Clinical Clinical Research Clinical Trials Data Development Device or Instrument Development Devices Dimensions Distal Exhibits Facial Nerve Injuries Fascicle Functional Regeneration Hand Human Industry Infrastructure Injury Institutional Review Boards Label Leg Length Licensing Marketing Medical Care Costs Medical Device Modeling Morbidity - disease rate Muscle Nerve Neurology Neuroma Operative Surgical Procedures Outcome Patients Peripheral Nerves Peripheral nerve injury Phase Phase II Clinical Trials Process Quality of life Ramp Recovery Reporting Safety Site Source Spinal Cord Sterilization Structure Surgeon Technology Testing Therapeutic Equivalency Time Toxicology Trauma Tube Vendor Weight Work axon regeneration chronic pain clinical implementation clinical research site combat injury commercialization cost cost effective design verification follow-up improved interest limb injury manufacture manufacturing process meetings nerve autograft nerve gap nerve injury nerve repair neurosurgery participant enrollment peripheral nerve repair pre-clinical preclinical development preclinical study programs scaffold standard of care sural nerve wound

项目摘要

Peripheral Nerve Injury (PNI) occurs in 3% of all trauma cases and 30% of combat injuries to the extremities, resulting in a loss of five million working days each year and costs of $150 billion annually in the U.S. The standard of care in the clinic is a nerve autograft from the patients’ leg. The NeuroSpan Bridge is a unique, biomimetic, multi-channel scaffold that maintains linearity throughout the structure, thus accelerating and guiding regenerating axons precisely to their targets on the distal end of the transected nerve. It has been extensively tested in gaps up to 3cm-long and demonstrated superiority to existing devices in a short-gap animal model, and superiority to nerve autograft in a long-gap animal model. This project will put in place a program to finalize pre-clinical studies, submit an IDE application to the FDA and carry out a feasibility clinical study followed by 510(k) application. The proposed project brings together experts in peripheral nerve injury, axonal regeneration, neurology, neurosurgery and bioengineering to develop a practical, cost-effective, consistent, and transnationally relevant medical device for the treatment of peripheral nerve injury.

外围神经损伤（PNI）发生在3％的所有创伤病例中，30％的战斗损伤四肢每年损失500万个工作日，费用为150美元每年在美国，诊所的每年十亿次护理标准是来自病人的腿。 Neurospan桥是一座独特的，仿生的，多通道的脚手架在整个结构中保持线性性，从而加速和引导再生轴突正是在横向神经远端的靶标。它已经进行了广泛的测试在长达3厘米长的缝隙中，在短间隙动物中表现出比现有设备的优越性在长隙动物模型中，模型和对神经自体移植的优势。这个项目将投入放置一个计划来最终临床前研究，向FDA提交IDE申请并携带发出可行性临床研究，然后进行510（k）应用。拟议的项目带来周围神经损伤，轴突再生，神经病学，神经外科和生物工程以开发实用，成本效益，一致且跨国相关的生物工程治疗周围神经损伤的医疗装置。