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

STTR 第一期：无网、无吊带的微创治疗女性压力性尿失禁

• 批准号: 2127552
• 负责人: Ghazaleh Rostami Nia
• 金额: $ 25.6万
• 依托单位: ALTYX SURGICAL, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2022-01-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2127552&HistoricalAwards=false
• 关键词: STTR; Phase; mesh; free; sling

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.

该小企业技术转让计划 (STTR) 第一阶段项目的更广泛影响/商业潜力是开发一种新的女性健康设备，以解决压力性尿失禁 (SUI) 预计女性终生尿失禁手术风险为 20%。 80 岁以上女性，预计到 2050 年将有 4130 万女性患有尿失禁。相关市场估计价值 16 亿美元2018 年，预计到 2026 年将达到 23 亿美元。拟议的设备满足了这一需求并改善了临床结果。这个小型企业技术转让计划 (STTR) 第一阶段项目旨在通过开发非网状手术设备的机械可行性。基于每个设备组件（即松紧带、组织锚定件和骨骼）的机械测试（强度、刚度和耐用性），设备设计的第一个可行原型和迭代元素锚）和整个设备的技术目标包括反映使用计算模拟来评估材料刚度和优化放置、准备和测试材料以及确保组装设备的强度和寿命。该奖项是 NSF 的法定使命，并已被视为值得通过使用基金会的智力优点和更广泛的影响审查标准进行评估来支持。