The purpose of this Phase II SBIR proposal is to optimize the design of the Tape Mechanical Occlusive Device (TMOD) in a 10 patient Phase II Clinical Trial in men with stress urinary incontinence. The feasibility for using this device in a safe and effective manner in humans was demonstrated by bench testing, cadaveric sizing, positioning and occlusion measurements and in animal implants in the Phase I SBIR study. The proposed human study will afford the opportunity to each of the 10 subjects to evaluate and report on efficacy and ease of use. At the conclusion of this Phase II Clinical Trial we anticipate entering into a Phase III Clinical Trial to gain sufficient experience with the TMOD design to submit a Pre- Market Approval Application to the Food and Drug Administration to permit full commercialization of this device. The team assembled to conduct this trial has extensive experience with the development and commercialization of urologic implants. The team and consultants believe that this technology offers significant competitive advantages over existing implantable devices for managing male urinary incontinence, a market that currently exceeds $50 million in annual sales and could also help reduce the multi-billion dollar cost of managing patients with absorbency products.
The Tape Mechanical Occlusive Device (TMOD) is intended to provide relief to an estimated 6 million US men suffering from stress and mixed urinary incontinence. The TMOD is intended to provide functional and surgical advantages over current technologies used for the treatment of stress and mixed urinary incontinence.
| Malaeb, Bahaa S; Elliott, Sean P; Lee, Joseph et al. (2011) Novel artificial urinary sphincter in the canine model: the tape mechanical occlusive device. Urology 77:211-6 |
