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

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是为患有阴道萎缩的妇女开发一种无痛苦的治疗替代方案。阴道萎缩是指阴道组织变薄、干燥、缺乏弹性，阴道萎缩的女性在性交时会出现阴道干燥和疼痛。该SBIR项目促进了技术平台的早期开发，该技术平台将使新型家用、免维护医疗设备能够治疗阴道萎缩。该项目将代表第一个专门为希望避免基于阴道的治疗的女性开发的阴道萎缩医疗器械。目前可用的治疗方案分为两类：非处方产品和替代疗法。非处方产品，如润滑剂和保湿剂，可在药店，但这些产品往往是有限的，其疗效相对于许多妇女经历的症状的严重程度。另一方面，激素替代疗法，如雌激素霜，对选择使用它们的女性有效;然而，它们禁忌于大部分女性市场（例如乳腺癌幸存者和有心血管风险因素的女性）。因此，该SBIR项目对于开发一种安全的女性治疗替代方案至关重要，并代表了一个显著改善其生活质量的机会。该拟议项目支持开发这种用于阴道萎缩的医疗器械治疗所需的技术工作，并解决了乳腺癌幸存者和绝经后女性的主要未满足需求。SBIR资助的研发工作将克服这一创新医疗器械成功商业化的关键技术障碍。本项目的三个主要目标是：1）设计理想的器械形状因子和组成材料，以与患者连接，2）确定最佳治疗设置，3）巩固生成所需治疗曲线所需的最佳系统设计。为了实现这些目标，将完成用户访谈以及替代组织和代表性阴道解剖结构的计算机和实验室模拟（通过人体测量学获得信息）。组织样本将配备传感器，以监测感兴趣的组织参数并确定理想的治疗曲线。总体而言，本工作的目标将确定拟议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要求，最终使其具备商业化的条件。

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.