SBIR Phase I: Developing a Novel, Non-Hormonal Device for Vaginal Atrophy for Breast Cancer Survivors and Post-menopausal Women

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是为患有阴道萎缩的妇女开发一种无激素治疗方案。阴道萎缩是指阴道组织变薄、干燥和缺乏弹性，阴道萎缩的女性会经历每天的阴道干燥和性交疼痛。这个SBIR项目促进了一个技术平台的早期开发，该平台将使一种新型的家庭使用、无激素的医疗设备能够治疗阴道萎缩。该项目将是第一个专门为希望避免激素疗法的妇女开发的治疗阴道萎缩的医疗设备。目前可用的治疗方案分为两类：非处方产品和激素替代疗法。非处方产品，如润滑剂和润肤霜，可以在药店买到，但相对于许多女性经历的严重症状，这些产品的功效往往有限。另一方面，激素替代疗法，如雌激素乳霜，对于选择使用它们的女性来说是有效的；然而，这类药物对很大一部分妇女（如乳腺癌幸存者和有心血管危险因素的妇女）是禁忌用药。因此，该SBIR项目对于开发一种安全的妇女替代治疗方法至关重要，并代表着显著改善其生活质量的机会。拟议的项目支持开发这种治疗阴道萎缩的医疗装置所需的技术工作，并解决乳腺癌幸存者和绝经后妇女未得到满足的主要需求。由SBIR拨款支持的研究和开发工作将克服对这种创新医疗设备成功商业化至关重要的技术障碍。该项目的三个主要目标是：1)设计理想的设备形状因素和组成材料，以与患者交互；2)确定最佳治疗设置；3)固化所需的最佳系统设计，以产生所需的治疗方案。为了实现这些目标，将完成用户访谈以及替代组织和具有代表性的阴道解剖（根据人体测量学）的计算机和台式模拟。组织样本将配备传感器来监测感兴趣的组织参数，并确定理想的治疗方案。总的来说，这项工作的目标将决定拟议的医疗器械创新的技术可行性。完成这三个目标将开发治疗方法，并为技术平台产生必要的系统需求，最终为商业化做好准备。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to develop a hormone-free treatment alternative for women suffering from vaginal atrophy. Vaginal atrophy is a condition in which the vaginal tissue is thin, dry, and inelastic, and women with vaginal atrophy experience day-to-day vaginal dryness and pain with intercourse. This SBIR project catalyzes the early stage development of a technology platform that will enable a novel home-use, hormone-free medical device to treat vaginal atrophy. This project will represent the first medical device treatment for vaginal atrophy developed specifically for women wishing to avoid hormone-based therapies. Currently available treatment options fall in two categories: over-the-counter products and hormone-replacement therapies. Over-the-counter products, like lubricants and moisturizers, are available at drugstores, but these products are often limited in their efficacy relative to the severity of symptoms many women experience. Hormone-replacement therapies on the other hand, such as estrogen creams, can be effective for women who choose to use them; however they are contraindicated for large market segments of women (e.g. breast cancer survivors and women with cardiovascular risk factors). Therefore, this SBIR project is critical to the development of a safe treatment alternative for women and represents a chance to significantly improve their quality of life.The proposed project supports the technical work required to develop this medical device treatment for vaginal atrophy and addresses a major unmet need for breast cancer survivors and post-menopausal women. The research and development work supported by this SBIR grant will overcome the technical hurdles crucial to successful commercialization of this innovative medical device. The three main objectives of this project are to 1) design the ideal device form factor and constituent materials to interface with the patient, 2) determine the optimal therapy settings, and 3) solidify the optimal system design required to generate the desired therapy profile. To achieve these objectives, user interviews as well as computer and bench simulations in surrogate tissues and representative vaginal anatomies (informed by anthropometry) will be completed. Tissue samples will be instrumented with sensors to monitor tissue parameters of interest and determine the ideal treatment profile. In aggregate, the goals of this work will determine the technical feasibility of the proposed medical device innovation. Completing these three objectives will develop the therapy and generate the necessary system requirements for the technology platform, ultimately equipping it for commercialization.