Non-surgical treatment option for pelvic organ prolapse

Reia, Llc, Lyme NH

Investigators

Abstract

Project Summary / Abstract Reia is working to address a prevalent gynecological condition, pelvic organ prolapse (POP), which affects more than 50% of women over the age of 50. POP occurs when the pelvic floor connective tissue and muscles weaken, allowing the uterus or vaginal walls to descend. In extreme cases, the uterus descends through the opening of the vagina and hangs outside of the body. POP can be treated non-surgically with a medical device called a pessary which is inserted into the vaginal canal and acts as a shelf to support the descending organs. Commonly used pessaries have a fixed and rigid design, making them difficult or impossible for patients to remove and insert independently. Reia has done preliminary work with affected women and their practitioners to design an innovative collapsible pessary that will enable autonomous use and address many unmet needs of current pessaries on the market. The purpose of this Phase I SBIR is to modify and optimize Reia?s vaginal pessary design to further meet user and regulatory requirements and evaluate the technical feasibility of the design. Reia will achieve these aims by optimizing the actuation mechanism that allows for collapsibility, changing the geometry to minimize irritation, and enhancing cleanability to improve hygienics. Reia will also examine safety and efficacy via simulations and benchtop testing. Defined evaluation criteria have been established in order to measure progress and success. Reia?s founding team is comprised of a urogynecologist with 25 years of experience fitting pessaries and treating POP and three female engineers with combined experience in R&D, product development and IP advisory. Additionally, an advisory board contributes expertise in urogynecology, bringing medical devices to market, and successful completion of numerous NIH grant funded projects. Reia has strategically aligned with facilities in New Hampshire and Massachusetts to gain access to necessary equipment and resources to successfully complete this project. Reia is committed to optimizing the pessary design to bring to market the first-ever pessary specifically designed to address women?s needs.