Improving Repair of Female Congenital and Reproductive Anomalies

Period of Performance: 09/20/2017 - 03/31/2018


Phase 1 SBIR

Recipient Firm

Biotex, Inc.
Principal Investigator


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 entered into an option agreement with collaborating physicians at Texas Children?s Hospital (Baylor College of Medicine) to create the newly designed stent based on pending patents filed by our clinical collaborators. The objectives of our Phase I proposal is to build fully functional prototypes, conduct benchtop testing, and perform in vivo studies in porcine vaginal tracts to demonstrate performance of the stents. 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.