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, and in extreme cases, hang 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 rigid design, making them difficult or impossible for patients to remove and insert independently. Consequently, patients must rely on their practitioners for regular pessary maintenance appointments, which are burdensome for both patients and practitioners alike. Reia has designed an innovative collapsible pessary that will enable autonomous use, reduce pain and discomfort associated with insertion and removal, and address unmet needs of current pessaries. During Year 1 of the Phase II award, Reia has successfully optimized its pessary to meet mechanical and manufacturing requirements, commenced necessary biocompatibility studies, and conducted an early feasibility clinical trial. In Year 2, Reia will complete all verification and validation to support 510(k) clearance including a multi-visit feasibility trial to evaluate effectiveness, safety, comfort, and function of Reia’s pessary when in use. Reia’s Phase II budget included a suite of biocompatibility testing in preparation for 510(k) clearance; however, during a pre-submission meeting in November, 2019, the FDA requested that Reia expand its originally proposed biocompatibility testing to include subacute andamp; subchronic toxicity and an extractable/leachable evaluation. This originally unforeseen biocompatibility testing will be required in the 510(k) clearance application for Reia’s pessary and is an expansion of the work outlined in Reia’s Phase II application. Reia’s Phase II application outlined Reia’s plans to conduct the feasibility trial at Dartmouth-Hitchcock Clinic (Hanover, NH). However, Reia has expanded the feasibility trial to include three additional sites located in larger metropolitan areas. Expanding the trial will increase recruitment rate to alleviate delays caused by the COVID- 19 pandemic and allow Reia’s trial to be conducted with a more diverse, and thus representative, population. Reia’s founding team, advisory board, and strategic partners allow Reia access to the necessary equipment, resources, and guidance to successfully complete the Aims outlined in Reia’s Phase II application. With the addition of this supplement, Reia will be able to complete all verification and validation to support its 510(k) clearance application and bring to market the first-ever pessary specifically designed to address women’s needs.Project Narrative The purpose of this supplement is to complete necessary verification and validation of a novel, collapsible vaginal pessary for the non-surgical treatment of pelvic organ prolapse (POP), a condition that 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.