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

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.