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

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力是一种治疗女性压力性尿失禁（SUI）的新型手术植入装置。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4000万女性患有压力性尿失禁。目前尚无药物解决方案，基于网状的中尿道吊索（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，市场上所有的SUI修复产品都是聚丙烯网基的，没有替代品。该项目旨在解决这一差距的选择与无网，无吊带，门诊经阴道修复装置为女性尿失禁。这项小企业创新研究（SBIR）二期项目旨在开发和验证一种新的经阴道手术技术，用于治疗压力性尿失禁。该项目推进了SBIR第一阶段项目的研究成果，该项目展示了功能概念验证的生物力学可行性。该二期项目旨在以适合人类使用的方式进一步推进手术程序和系统。技术活动的范围包括设计优化、机械测试和验证、外科手术程序验证、生物相容性测试和一系列台式、尸体和动物研究的组织学表征。为了最终获得美国监管机构的批准，这些活动的范围将根据临床前模型中证明慢性植入安全性和有效性所需的实践进行。该奖项反映了美国国家科学基金会的法定使命，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。

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.