Tape Mechanical Occlusive Device (TMOD)

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44DK076397-02
Agency Tracking Number: DK076397
Amount: $940,866.00
Phase: Phase II
Program: SBIR
Awards Year: 2008
Solicitation Year: 2008
Solicitation Topic Code: N/A
Solicitation Number: PHS2007-2
Small Business Information
1313 5th Street SE, MINNEAPOLIS, MN, -
DUNS: 143572159
HUBZone Owned: Y
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Principal Investigator
 (612) 379-3578
Business Contact
Phone: (612) 379-3578
Email: gtimm@gturo.com
Research Institution
DESCRIPTION (provided by applicant): 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 us ing 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 e ach 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 A pproval 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 consult ants 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 d ollar cost of managing patients with absorbency products. PUBLIC HEALTH RELEVANCE: The Tape Mechanical Occlusive Device (TMOD) is intended to provide relief to an estimated 6 million US men suffering from stress and mixed urinary incontinen ce. The TMOD is intended to provide functional and surgical advantages over current technologies used for the treatment of stress and mixed urinary incontinence.

* Information listed above is at the time of submission. *

Agency Micro-sites

SBA logo
Department of Agriculture logo
Department of Commerce logo
Department of Defense logo
Department of Education logo
Department of Energy logo
Department of Health and Human Services logo
Department of Homeland Security logo
Department of Transportation logo
Environmental Protection Agency logo
National Aeronautics and Space Administration logo
National Science Foundation logo
US Flag An Official Website of the United States Government