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 reduce pain and discomfort associated with insertion and removal, enable autonomous use, and address many unmet needs of current pessaries on the market. During Phase II, Reia will modify and optimize its pessary to meet mechanical and manufacturing requirements, perform critical path testing in preparation for approval by a local IRB for clinical use, and conduct early feasibility and feasibility clinical trials. Reia will achieve these aims by designing for and prototyping in realistic manufacturing techniques for production at scale, performing benchtop mechanical testing to quantify function and wear properties over a full lifecycle, and performing biocompatibility studies and microbiological testing. We will then conduct a single-visit early feasibility clinical trial with 15 patients to assess performance and function of Reia?s pessary, followed by a multi-visit feasibility clinical trial with 50 patients to evaluate the effectiveness, safety, comfort, and function of Reia?s pessary in day-to- day use. 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 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 design for clinical use and manufacture to bring to market the first-ever pessary specifically designed to address women?s needs.
The purpose of this proposal is to optimize and prepare to commercialize a novel, collapsible vaginal pessary for the non-surgical treatment of pelvic organ prolapse (POP), a condition which symptomatically affects 3.6 million women in the United States. Recent medical studies suggest that surgical treatments for POP are less effective than once believed, and current pessaries in common use are limited by a rigid and fixed design which can make them uncomfortable as well as difficult or impossible for patients to remove and insert independently. Consequently, there is an imperative to develop non- surgical treatment alternatives for women who suffer with POP which are easy to use, accepted, effective, comfortable, and cause minimal complications.
