SBIR-STTR Award

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.

Public Health Relevance Statement:
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.

Project Terms:
Address; Adolescent; Adult; Aftercare; Agreement; Anatomic Models; Anatomy; Animal Model; Animals; base; Biomechanics; Cancer Patient; cancer therapy; Childhood; Cicatrix; Clinical; Clinical Research; college; Coupling; design; Devices; Economic Inflation; Engineering; Family suidae; Female; Female Adolescents; Fingers; Geometry; girls; Goals; Gynecologic; Gynecology; healing; Health Care Costs; Hour; Image Analysis; improved; In Situ; in vivo; Injury; irritation; Left; Legal patent; Length; Magnetism; Malignant Female Reproductive System Neoplasm; Medical Device; Medicine; Morbidity - disease rate; Movement; Necrosis; North America; novel; Numeric Rating Scale; operation; Operative Surgical Procedures; Outcome; Parents; Patients; Pediatric Hospitals; Pelvis; Performance; Phase; Physicians; Population; Positioning Attribute; Postoperative Complications; Postoperative Period; Preparation; pressure; prevent; Problem Solving; Process; Property; prototype; Radiation; Radiation therapy; reconstruction; Recovery; repaired; reproductive; restenosis; Retrieval; Small Business Innovation Research Grant; Stenosis; Stents; Sterility; Surgical complication; Testing; Texas; Time; time use; Tissues; Traction; United States; Vagina; Woman; young woman

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.

Public Health Relevance Statement:
Project Narrative The goal of this Phase II SBIR project is to continue development of 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 pelvic surgery and for women who have undergone pelvic surgery or radiation due to gynecologic cancer treatment. We will build on work done in Phase I to arrive a a market ready device the conclusion of this Phase II project.

Project Terms:
Address; Adolescent; adolescent patient; Adult; Aftercare; Age; Anatomic Models; Anatomy; Animal Model; Animals; base; biomaterial compatibility; Caliber; Cancer Patient; cancer therapy; Childhood; Cicatrix; Clinical; Clinical Trials; cohort; college; commercialization; Comorbidity; compliance behavior; Custom; Databases; design; Development; Devices; Engineering; ergonomics; Family suidae; Female; Female Adolescents; follow-up; girls; Goals; Gynecologic; Gynecology; Health Care Costs; healthy volunteer; improved; in vivo; Institution; instrument; Length; Maintenance; Malignant Female Reproductive System Neoplasm; Medical; Medical center; Medicine; Morbidity - disease rate; North America; novel; Operative Surgical Procedures; Outcome; Patients; Pediatric Hospitals; Pelvis; Performance; performance tests; Phase; Physicians; Population; Postoperative Period; pre-clinical; prevent; product development; Production; Protocols documentation; prototype; Radiation; Radiation therapy; reconstruction; Reconstructive Surgical Procedures; repaired; reproductive; restenosis; Retrieval; Sampling; Small Business Innovation Research Grant; Stenosis; Stents; Sterilization; success; surgery outcome; Surgical complication; System; Testing; Texas; Tissues; tool; Update; usability; Vagina; Validation; verification and validation; volunteer; Woman; Work; young woman