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.

这项小型企业创新研究（SBIR）II期项目的更广泛的影响/商业潜力是一种新颖的手术植入的装置，用于治疗女性压力尿失禁（SUI）。在美国，近50％的妇女将遭受压力尿失禁，到2050年，导致超过4000万痛苦的妇女。目前没有药理学解决方案，基于网状的尿道吊索（MUS）也是主要的手术选择，即使它们与各种长期并发症，挑战和风险相关。此外，市场上的所有SUI维修产品都是基于聚丙烯网状的，没有其他选择。该项目旨在通过无网状，无吊带，门诊的经阴道修复装置来解决这一差距，以解决女性尿失禁。这项小型企业创新研究（SBIR）II期项目旨在开发和验证一种新颖的，经阴道的手术手术程序技术，用于治疗压力尿液尿液尿不受治疗。该项目从SBIR I期项目中进行了发现，该项目证明了概念概念的生物力学可行性。该第二阶段项目旨在以适合人类使用的方式进一步进一步进行手术程序和系统。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。该活动的范围将根据在临床前模型中证明长期植入的安全性和功效所需的实践来进行，以便获得最终的美国监管批准。该奖项反映了NSF的法定任务，并被认为是值得通过基金会的知识分子优点和更广泛影响的评估来通过评估来获得支持的。