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INTRACORNEAL LENS FOR THE CORRECTION OF HYPEROPIA

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
60190
Program Year/Program:
2002 / SBIR
Agency Tracking Number:
EY013031
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
ANAMED, INC.
ANAMED, INC. 7700 IRVINE CENTER DR, STE 800 IRVINE, CA 92610
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2002
Title: INTRACORNEAL LENS FOR THE CORRECTION OF HYPEROPIA
Agency: HHS
Contract: 2R44EY013031-02
Award Amount: $1,444,100.00
 

Abstract:

DESCRIPTION (provided by applicant): Anamed has developed PermaVisionr intracorneal implants for the correction of refractive errors, specifically, hyperopia from +1D to +6D. These implants are made from a selected proprietary Nutraporer micro-porous hydrogel that allows transport of fluid and nutrients satisfying the needs of the human cornea. There is no permanent solution for hyperopia today. Implantation is done using a procedure to be called Sutureless Synthetic Keratophakia (SSKTM). This involves lamellar dissection to generate a flap (like in LASIK surgery), placing the lens on the stromal bed and closing the flap without sutures. Rehabilitation is quick. The power of the lens is predefined and pre-tested during manufacturing so the surgeon can accurately correct the power in one sitting. The procedure is reversible and adjustable. Improper power correction/lens placement can easily be corrected by re-lifting the flap and replacing/repositioning the lens. During Phase II we propose to develop final lens design(s), manufacture clinical supplies, conduct a Phase I clinical trial under an approved USFDA-IDE, develop commercial packaging and sterilization process, determine shelf life and photo-stability, select a marking material/method to confirm proper lens placement/orientation which was found difficult during the one year GLP swine study (completed), develop commercial manufacturing process(es), and perform validations.

Principal Investigator:

Alok Nigam
9497072740
ALOKN@ANAMEDINC.COM

Business Contact:

Alok Nigam
7147532845
ALOKN@ANAMEDINC.COM
Small Business Information at Submission:

ANAMED, INC.
ANAMED, INC. 7700 IRVINE CENTER DR, STE 800 IRVINE, CA 92610

EIN/Tax ID: 330692792
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No