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A NEW ARTIFICIAL CORNEAL PROSTHESIS (KPRO)

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
60184
Program Year/Program:
2002 / SBIR
Agency Tracking Number:
EY014079
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
TAMCENAN CORPORATION
TAMCENAN CORPORATION 1703 S MINNESOTA AVE SIOUX FALLS, SD 57105
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2002
Title: A NEW ARTIFICIAL CORNEAL PROSTHESIS (KPRO)
Agency: HHS
Contract: 1R43EY014079-01
Award Amount: $97,841.00
 

Abstract:

DESCRIPTION (provided by applicant): About 4 to 8 thousand people yearly in the U.S. suffer blinding corneal disease not amenable to conventional keratoplasty. The improved keratoprosthesis (KPro) may restore functional vision for these people, and is the basis for a significant demand supporting commercialization. This Phase I project involves developing an improved thinner KPro of PMMA that, with a significant innovative process, can be more securely fixated to a donor cornea for use as a standard graft. The measurable goals are: 1) developing a KPro production methodology to produce powers within +0.5D accuracy; 2) demonstration of the fusion of front and back flanges with a narrow gap of 0.5-0.7mm with strength of 50 Newtons; 3) an independent laboratory determination of bioburden and ethylene oxide sterilization validation, and toxicology testing. Reaching these endpoints will permit processing directly to a Clinical Trial in Phase II project under FDA Guidance Document for Keratoprostheses. Tamcenan Corporation, and the Principle Investigator have experience in developing and securing regulatory clearence and comericalization of ophthalmic implants. Engineering & Ophthalmic Services has experience in devising manufacturing protocols for contact lenses and Kpros. Geneva Laboratories, Inc. is a full service certified testing laboratory that follows accepted protocols for required tests. PROPOSED COMMERCIAL APPLICATION: The estimated 4 to 8 thousand patients in the U.S. yearly that cannot be adequately served by standard keratoplasty or existing KPros form a significant market for commercialization of a product that costs between $500.00 and $1000.00. The participation of Eye Banks in this project will aid distribution and increase rewards for those participating.

Principal Investigator:

Thomas C. White
6053347715
TWHITE@USD.EDU

Business Contact:

Thomas White
6053340113
Small Business Information at Submission:

TAMCENAN CORPORATION
TAMCENAN CORPORATION 1703 S MINNESOTA AVE SIOUX FALLS, SD 57105

EIN/Tax ID: 460401719
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No