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

小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力是一种用于治疗女性压力性尿失禁(SUI)的新型外科植入设备。到2050年，美国近50%的女性将随着年龄的增长患有压力性尿失禁，导致超过4000万女性遭受痛苦。目前尚无药物解决方案，基于网眼的中段尿路悬吊术(MU)是主要的手术选择，尽管它们与各种长期并发症、挑战和风险有关。此外，市场上所有的SUI修复产品都是以聚丙烯网状物为基础的，没有替代品。该项目旨在通过一种无网眼、无吊带的门诊女性尿失禁经阴道修补器来解决这一缺口。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治疗压力性尿失禁的新型经阴道外科手术技术。该项目是SBIR第一阶段项目的进展，该项目证明了功能概念验证生物力学的可行性。这个第二阶段的项目旨在以一种适合人类使用的方式推进外科程序和系统。技术活动的范围包括设计优化、机械测试和验证、手术程序验证、生物兼容性测试以及一系列台式、身体和动物研究的组织学特征。活动的范围将按照在临床前模型中证明慢性植入的安全性和有效性所需的做法进行，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 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.