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

这项小型企业技术转移计划（STTR）第一阶段项目的更广泛影响/商业潜力是推进一种新的妇女健康设备，以解决压力性尿失禁（SUI）。据估计，到80岁时，女性尿失禁手术的终生风险为20%，到2050年，估计有4130万女性患有尿失禁。相关市场在2018年的估计价值为16亿美元，预计到2026年将达到23亿美元。所建议的设备解决了这一需求并改善了临床结果。这个小型企业技术转移计划（STTR）第一阶段项目旨在通过开发第一个可行的原型和基于设备每个组件（即弹性带、组织锚和骨锚）和设备整体的机械测试（强度、刚度和耐久性）迭代设备设计元素，来证明非网状手术设备的机械可行性。技术目标包括使用计算模拟来评估材料刚度和优化放置，准备和测试材料，并确保组装设备的强度和寿命。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 Technology Transfer Program (STTR) Phase I project is to advance a new women's health device to address stress urinary incontinence (SUI). The estimated lifetime risk of urinary incontinence surgery in women is 20% by age 80, with 41.3 million women estimated to suffer from urinary incontinence by 2050. The associated market had an estimated value of $1.6 billion in 2018, with projections to reach $2.3 billion by 2026. The proposed device addresses this need and improves clinical outcomes. This Small Business Technology Transfer Program (STTR) Phase I project aims to demonstrate the mechanical feasibility of a non-mesh surgical device by developing the first viable prototype and iterating elements of the device design based on mechanical tests (strength, stiffness, and durability) of each of the device’s components (i.e., the elastic band, the tissue anchor, and the bone anchor) and the device as a whole. The technical objectives include using computational simulations to assess the material stiffness and optimize placement, preparing and testing materials, and ensuring strength and longevity of the assembled device.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.