# Non-surgical treatment option for pelvic organ prolapse

> **NIH NIH R44** · REIA, LLC · 2021 · $891,138

## 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 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.

## Key facts

- **NIH application ID:** 10145052
- **Project number:** 5R44HD097809-03
- **Recipient organization:** REIA, LLC
- **Principal Investigator:** Paul Hanissian
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $891,138
- **Award type:** 5
- **Project period:** 2018-09-25 → 2023-05-03

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10145052

## Citation

> US National Institutes of Health, RePORTER application 10145052, Non-surgical treatment option for pelvic organ prolapse (5R44HD097809-03). Retrieved via AI Analytics 2026-06-10 from https://api.ai-analytics.org/grant/nih/10145052. Licensed CC0.

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