Non-surgical treatment option for pelvic organ prolapse

项目摘要/摘要 REIA正在努力解决一种流行的妇科疾病--盆腔器官脱垂(POP)，它影响更多的人 超过50%的50岁以上的女性。当盆底结缔组织和肌肉变弱时，就会发生POP， 允许子宫或阴道壁下降，在极端情况下，挂在体外。流行音乐可以是 用一种称为阴道的医疗设备进行非手术治疗，这种设备被插入阴道并起作用 作为支撑下行器官的架子。常用的连裤袜设计僵硬，所以很难穿。 或者患者不可能独立取出和插入。因此，患者必须依靠他们的 医生定期预约剖腹产，这对患者和 从业者都一样。REIA设计了一种创新的可折叠避孕套，可以自主使用，减少 与插入和取出相关的疼痛和不适，并解决目前内裤未得到满足的需求。 在第二阶段奖的第一年，Reia成功地优化了它的花盆，以满足机械和 制造要求，开始必要的生物兼容性研究，并进行早期可行性 临床试验。在第二年，Reia将完成所有验证和确认，以支持510(K)许可，包括 多次访问可行性试验，以评估Reia的避孕套在使用时的有效性、安全性、舒适性和功能。 REIA的第二阶段预算包括一套生物兼容性测试，为510(K)审批做准备；然而， 在2019年11月的一次提交前会议上，FDA要求Reia扩大其最初提议的 生物相容性测试，包括亚急性和亚慢性毒性和可提取/可浸出评估。这 Reia的510(K)许可申请中将要求进行最初未预见的生物兼容性测试 Pessary是Reia第二阶段申请中概述的工作的扩展。 REIA的第二阶段申请概述了Reia在达特茅斯-希区柯克诊所进行可行性试验的计划 (汉诺威，NH)然而，Reia已经扩大了可行性试验，将位于较大地区的另外三个地点包括在内 都会区。扩大试验将提高招聘率，以缓解COVID造成的延误- 19大流行，并允许在更具多样性和代表性的人群中进行Reia的试验。 REIA的创始团队、顾问委员会和战略合作伙伴允许Reia获得必要的设备， 资源和指导，以成功完成Reia第二阶段申请中概述的目标。与 此外，Reia将能够完成所有验证和确认，以支持其510(K) 批准申请，并将有史以来第一款专为满足女性需求而设计的避孕套推向市场。

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 & 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.