# Improving Repair of Female Congenital and Reproductive Anomalies

> **NIH NIH R44** · BIOTEX, INC. · 2020 · $814,001

## Abstract

Project Summary
The overall goal of this SBIR proposal is to develop a novel vaginal stent for use in pediatric and adult
populations. There are many girls and women born with congenital gynecologic abnormalities requiring
surgical reconstruction of their vaginal cavities. There are also women who have very shortened or scarred
vaginas after pelvic surgery or radiation treatment for cancer. Vaginal stents can be used after neo-vagina
creation to prevent scarring and re-stenosis. There are no currently available vaginal stents that meet the
anatomic needs of pediatric and adolescent girls or women who are post treatment for gynecologic cancers.
As such, there is a high rate of post-surgical complications such as vaginal tissue scaring and vaginal
stenosis. We propose to create new vaginal stents with improved fit, ease of use, unique deployment and
retrieval mechanisms, and enhanced comfort for a pediatric population and for those women with shortened
vaginas.
Biotex has completed a SBIR Phase I project where we created novel stents and deployment mechanisms,
completed benchtop performance testing, and evaluated multiple design configurations during in vivo animal
studies with promising results. The objectives of our Phase II proposal is to build on this work by creating
updated custom prototypes based on prior pre-clinical work and physician input, test designs in normal
volunteer subjects, lock down a final design and complete required validations for FDA 510(k) filing, and test
the stents in the intended population of adolescents undergoing vaginal reconstructive surgery, and women
after radiation treatment for gynecologic cancers. We believe this new vaginal stent will reduce post-surgical
morbidity, early discontinuation of stent use postoperatively, reduce health care costs, and improve clinical
outcomes for girls and women across North America.

## Key facts

- **NIH application ID:** 10023187
- **Project number:** 5R44HD092156-03
- **Recipient organization:** BIOTEX, INC.
- **Principal Investigator:** Ashok Gowda
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $814,001
- **Award type:** 5
- **Project period:** 2017-09-20 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10023187

## Citation

> US National Institutes of Health, RePORTER application 10023187, Improving Repair of Female Congenital and Reproductive Anomalies (5R44HD092156-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10023187. Licensed CC0.

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