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Magnetic Urethral Occlusive Device

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
71544
Program Year/Program:
2004 / SBIR
Agency Tracking Number:
DK066941
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
GT UROLOGICAL, LLC
1313 5TH ST SE MINNEAPOLIS, MN -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2004
Title: Magnetic Urethral Occlusive Device
Agency: HHS
Contract: 1R43DK066941-01A2
Award Amount: $210,200.00
 

Abstract:

DESCRIPTION (provided by applicant): The purpose of this Phase I Proposal is to demonstrate the utility of magnetic attraction technology for a simple, easy to use, urethral occlusive device for men with urinary incontinence following impaired sphincter function. Recent advances in magnetic materials have made it possible to fabricate lightweight, yet strong enough, magnets that can exert sufficient forces over the distances anticipated in typical urethral anatomies. The proposed configuration of this device consists of two components: 1) an implanted magnetic material positioned between the corpora cavernosa and urethra, and 2) an external magnet that is geometrically matched with the implanted component and attached to the surface of the penis in such a way as to be optimally aligned with it. The research will proceed in several phases: 1) a bench technique to allow characterization of the magnet strength and behavior in relation to a penile analog, 2) human cadaveric range finding experimentation to identify anatomical sizing, positioning and surgical constraints as well as magnetic strengths required for urethral occlusion, 3) a tooling phase to produce the external penile retention mechanism and prototype fabrication, 4) an iterative human cadaveric study to evaluate the tooled retention mechanism and implant component and 5) chronic animal implants to evaluate the effects of prolonged tissue compression, urine leakage pressure thresholds, encapsulation and reaction to the implanted component. Successful demonstration of a safe and effective occlusive force levels will encourage a Phase II continuation study with devices prepared for humans. Successful human use of this technology will provide a significant competitive advantage over existing implantable devices and external penile compressive devices for male urinary incontinence, a market that currently exceeds $50 million annual sales, and could significantly reduce the multi-billion dollar cost of managing patients with absorbency products.

Principal Investigator:

Gerald W. Timm
6123793578
timmx007@tc.umn.edu

Business Contact:


6122698757
Small Business Information at Submission:

NOVATEK MEDICAL, LLC
NOVATEK MEDICAL, LLC 1313 5TH ST SE MINNEAPOLIS, MN 55414

EIN/Tax ID: 200270361
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No