Research Project
9324105
Pelvic organ prolapse (POP) is a highly prevalent condition affecting over 50% of women in the US during their lifetimes. Urinary incontinence (UI) affects an estimated 38% 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: 1) need for reimbursement / CPT codes, 2) high manufacturing cost, 3) additional clinical evidence of VTI capabilities in diagnosis and aid for choice of applied treatment, and 4) FDA clearance for clinically relevant Indication for Use. Removing these obstacles would lead to clinical acceptance and market penetration of this new technology.
