SBIR Phase II: A mesh-free, sling-free, minimally invasive treatment for stress urinary incontinence in women

SBIR II 期：无网、无吊带的微创治疗女性压力性尿失禁

• 批准号: 2233106
• 负责人: Ghazaleh Rostami Nia
• 金额: $ 97.57万
• 依托单位: ALTYX SURGICAL, INC.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2024
• 资助国家: 美国
• 起止时间: 2024-01-01 至 2025-12-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2233106&HistoricalAwards=false
• 关键词: SBIR; Phase; II; mesh; free

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is a novel, surgically implanted device for treating female stress urinary incontinence (SUI). Nearly 50% of women in the U.S. will suffer from stress urinary incontinence with age resulting in over 40 million suffering women by 2050. No pharmacological solutions currently exist and mesh-based midurethral slings (MUS) are the mainstay surgical option, even though they are associated with various long-term complications, challenges, and risks. Furthermore, all SUI repair products on the market are polypropylene mesh-based with no alternatives available. This project aims to address this gap in options with a mesh-free, sling-free, outpatient transvaginal repair device for female urinary incontinence.This Small Business Innovation Research (SBIR) Phase II project aims to develop and validate a novel, transvaginal surgical procedural technology for treating stress urinary incontinence. This project progresses findings from the SBIR Phase I project which demonstrated functional proof-of-concept biomechanical feasibility. This Phase II project aims to further the surgical procedure and system in a manner suitable for human use. The scope of technical activities includes design optimization, mechanical testing and validation, surgical procedure validation, biocompatibility testing, and histological characterization in a series of benchtop, cadaveric, and animal studies. The scope of the activities will be conducted in accordance with practices needed to demonstrate chronic implanted safety and efficacy in pre-clinical models in order to gain eventual U.S. regulatory approval.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.

该小企业创新研究 (SBIR) 第二阶段项目的更广泛影响/商业潜力是一种新颖的手术植入设备，用于治疗女性压力性尿失禁 (SUI)。随着年龄的增长，美国近 50% 的女性将患有压力性尿失禁，到 2050 年，将有超过 4000 万女性遭受压力性尿失禁。目前尚无药物解决方案，网状尿道中段吊带 (MUS) 是主要的手术选择，尽管它们与各种长期并发症、挑战和风险相关。此外，市场上所有 SUI 修复产品均基于聚丙烯网，没有替代品。该项目旨在通过无网、无吊带、门诊经阴道修复女性尿失禁装置来解决这一选择空白。该小型企业创新研究 (SBIR) 第二阶段项目旨在开发和验证一种新型经阴道手术程序治疗压力性尿失禁的技术。该项目推进了 SBIR 第一阶段项目的研究结果，证明了功能性概念验证生物力学的可行性。该第二阶段项目旨在以适合人类使用的方式进一步推进外科手术和系统。技术活动范围包括设计优化、机械测试和验证、外科手术验证、生物相容性测试以及一系列台式、尸体和动物研究中的组织学表征。活动范围将根据在临床前模型中证明长期植入安全性和有效性所需的实践进行，以便最终获得美国监管机构的批准。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准。