Vaginal Tactile Imager for Pelvic Floor Biomechanical Assessment

Pelvic organ prolapse POP is a highly prevalent condition affecting over of women in the US during their lifetimes Urinary incontinence UI affects an estimated of women Both POP and UI are more common in women than in men and their prevalence is increased with age Some loss of utero vaginal support occurs in most adult women however the true etiology of prolapse and differences seen among individuals are not entirely understood Changes in the elasticity of the vaginal walls connective support tissues and muscle function are thought to be significant factors in the development of the diseased conditions There is a strong need in pelvic floor structure and functional imaging to be integrated into mainstream diagnostics in obstetrics gynecology and urogynecology This integration will facilitate communications between different specialties and has the potential to greatly improve the multidisciplinary management of complex pelvic floor disorders In the Phases I IIB of this project we developed an innovative approach and the device Vaginal Tactile Imager VTI completed clinical studies received an FDA approval for the core technology and established manufacturing and distribution partnership with Advanced Tactile Imaging www tactile imaging com These were the critical steps that significantly reduced number of project risk factors However crossing the Valley of Death to make this innovative device commercially successful requires additional support in technical assistance as well as in later stage research and development We identified and proposed how to overcome four critical barriers to commercial success need for reimbursement CPT codes high manufacturing cost additional clinical evidence of VTI capabilities in diagnosis and aid for choice of applied treatment and FDA clearance for clinically relevant Indication for Use Removing these obstacles would lead to clinical acceptance and market penetration of this new technology Pelvic organ prolapse urinary incontinence and other pelvic diseased conditions affect over of women in the US during their lifetimes Prevalence of these conditions is increased with age Some loss of utero vaginal support occurs in most adult women however the true etiology of prolapse and differences seen among individuals are not entirely understood It impairs the quality of life and results in over surgical procedures annually in the US The goal of this project is to develop Vaginal Tactile Imager VTI for real time elasticity imaging quantitative characterization of pelvic floor support structures and muscle function The VTI has the potential to predict risk of developing diseased conditions aid in diagnosis monitoring and individually optimized treatment