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

SBIR II期：用于治疗严重急性周围神经损伤的新型周围神经基质平台

• 批准号: 2151582
• 负责人: Lorenzo Soletti
• 金额: $ 99.62万
• 依托单位: RENERVA, LLC
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2151582&HistoricalAwards=false
• 关键词: SBIR; Phase; II; novel; peripheral

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.

这一小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力将提高创伤性或姑息性周围神经损伤（PNI）患者的临床结局。在美国，2000万人患有PNI，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1 500亿美元。急性PNI在美国每年有超过50万例外科手术，经常导致永久性残疾。该项目开发了一种平台技术，有可能解决许多类型的PNI。这个小企业创新研究（SBIR）第一阶段项目将创建一种用于神经间隙损伤修复的新型神经移植物/导管和神经帽。 该项目的目标是提出一种解决方案，以改善神经功能的结果，同时仍然减少整个修复的张力。 它提供了一种组织样基质，允许神经生长出游离神经末梢。该技术来源于脱细胞猪神经组织，并保留了天然的结构和功能蛋白，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、灭菌演示和冻干。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。