SBIR Phase II: A novel peripheral nerve matrix platform for severe acute peripheral nerve injuries

这一小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力将改善创伤性或姑息性周围神经损伤(PNI)患者的临床结果。在美国，有2000万人患有PNIS，在年轻人中发病率很高，每年给社会造成的总经济损失超过1500亿美元。在美国，急性PNIS每年的外科手术超过50万例，经常导致永久性残疾。该项目开发了一种具有解决多种类型PNI的潜力的平台技术。这一小型企业创新研究(SBIR)第一阶段项目将创造一种用于修复神经间隙损伤的新型神经移植物/导管和神经帽。该项目的目标是提出一种解决方案，以改善神经功能结果，同时仍能减少修复过程中的紧张。它提供了一种组织样的基质，使排列的神经从游离的神经末梢生长出来。该技术源自脱细胞的猪神经组织，并保留了天然的结构和功能蛋白质，为神经修复和再生提供了理想的环境。该项目进行体内研究、灭菌演示和冷冻干燥。供应链安全、包装开发和工具将为商业启动做准备。该奖项反映了NSF的法定使命，并已通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact /commercial potential of this Small Business Innovation Research (SBIR) Phase I project will enhance clinical outcomes for patients with a traumatic or palliative peripheral nerve injury (PNI). In the U.S., 20 million people suffer from PNIs, with a high prevalence among young individuals and a total economic cost to society in excess of $150 billion per year. Acute PNIs account for more than 500,000 annual surgical procedures in the U.S and frequently result in permanent disability. This project develops a platform technology with the potential to address many types of PNI.This Small Business Innovation Research (SBIR) Phase I project will create a novel nerve graft/conduit for nerve gap injury repair and a nerve cap. The project goal is to advance a solution to improve the nerve functional outcome while still reducing the tension across the repair. It provides a tissue-like matrix that allows aligned nerve growth out of the free nerve ending. The technology is derived from decellularized porcine nerve tissue and maintains native structural and functional proteins, providing an ideal environment for nerve repair and regeneration. This project conducts in-vivo studies, sterilization demonstrations, and lyophilization. Supply chain security, packaging development, and tooling will be developed in preparation for commercial launch.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.