Improving Repair of Female Congenital and Reproductive Anomalies

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 Project Narrative The goal of this Phase I SBIR project is to develop a novel vaginal stent specifically designed to address the anatomic needs of the pediatric adolescent and gynecologic cancer patients This newly designed vaginal stent will reduce early discontinuation of stent use postoperatively and improve post surgical outcomes with regards to restenosis for girls who have undergone neo vaginal creation and for women who have undergone pelvic surgery or radiation due to gynecologic cancer treatment We will develop prototype vaginal stents and test them in an established animal model for vaginal reconstruction to verify performance in preparation for clinical studies in Phase II