SBIR Phase II: Dynamic Device for the Treatment of Stress Urinary Incontinence

This Small Business Innovation Research Phase II (SBIR) project will develop a novel biomedical device to better treat stress urinary incontinence (SUI). SUI is a complex disease affecting millions of Americans in a debilitating manner which significantly impacts physiological and psychological wellness. The technology being developed is an implantable device for the treatment of SUI that will, as intentioned, be the first product to offer a universal, and more effective, solution to this multi-factorial problem. Building on the Phase I successful demonstration of technical feasibility, the main Phase II objective is to further refine and evaluate the device in preparation for future human trials. If successful, the device will simply and mechanically provide a reactional dynamic therapy that more closely resembles natural physiology than any other incontinence device currently available. This process will be empowered by focused research designed to analyze and better define the exact elements underlying the pathophysiology of SUI. This research will not only lead to a broader acceptance and understanding of the complexity of SUI, in both men and women, but also enable the company to optimize its technology. This project will be undertaken by the grantee in collaboration with leading urologists, engineers, and experienced entrepreneurs of the biomedical industry. The broader/commercial impact of this project is advancement in understanding, acceptance, and treatment of urinary incontinence. Urinary incontinence is one of the most common chronic ailments; affecting over 25 million Americans and accounting for an extended yearly cost of more than $19.5 billion. Additionally, this condition is a leading contributor to the loss of self-dependency and nursing home admittance. If successful, the technology will address a critical societal need with a device that offers a cure to underserved patients rather than a palliative compromise. The implications of this technology extend beyond urinary incontinence and should create opportunities to advance patient treatment for conditions such as fecal incontinence, gastro-esophageal reflux disease, and glaucoma.