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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.

周围神经损伤（PNI）发生在所有创伤病例的3%和战斗损伤的30%，极端情况，每年损失500万个工作日，费用150美元临床护理的标准是从神经干细胞中进行自体神经移植。病人的腿。NeuroSpan Bridge是一种独特的仿生多通道支架，在整个结构中保持线性，从而加速和引导再生轴突精确地到达切断神经远端的目标。它已经过广泛的测试在长达3 cm的间隙中，并在短间隙动物中证明了优于现有器械模型，并在长间隙动物模型中优于自体神经移植物。该项目将投入制定一项计划，完成临床前研究，向FDA提交IDE申请，进行可行性临床研究，然后进行510（k）申请。该项目将带来周围神经损伤、轴突再生、神经病学、神经外科和生物工程开发一个实用的，具有成本效益的，一致的，跨国相关的用于治疗周围神经损伤的医疗装置。