Non-surgical treatment option for pelvic organ prolapse

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 pessary that is inserted into the vagina 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 developed an innovative collapsible pessary to reduce pain and discomfort associated with pessary insertion and removal. During Phase II, the pessary successfully passed all FDA required mechanical, microbiological, and biocompatibility tests. Reia has evaluated its pessary in n=50 current pessary users between its early feasibility and feasibility trials. Subjects reported increased comfort during insertion and removal when using Reia’s pessary compared to their current pessaries and their prolapse was effectively supported. During Phase IIB, Reia will (1) prepare and submit a 510(k) clearance application to the FDA. Reia will achieve this aim by professionally manufacturing and testing fitting pessaries, performing packaging, shipping, and distribution testing, and compiling the 510(k) application. Reia will (2) modify and optimize a pessary applicator, which was designed during Phase II to increase access to self-management. To achieve this aim, Reia will professionally manufacture a ß-prototype with medical grade materials, perform benchtop mechanical, biocompatibility, and cleaning validation testing, and assemble a 510(k) application. Reia will (3) conduct a clinical trial comparing success of home-management between Reia’s pessary system (pessary and applicator) and the standard of care in pessary-naïve patients. Defined evaluation criteria have been established 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 a 3-person, female executive management team with combined experience in product development, operational manufacturing and production practices, and IP advisory. Additionally, an advisory board contributes expertise in urogynecology, commercialization of medical devices, and successful completion of numerous NIH grant funded projects. Reia has strategically aligned with manufacturing facilities, testing laboratories, and regulatory consultants to gain access to necessary equipment, resources, and guidance to successfully complete this project. Reia is committed to optimizing its pessary system for clinical use and manufacture to bring to market the first-ever pessary specifically designed to address women’s needs.