USA flag logo/image

An Official Website of the United States Government

DEVELOPMENT OF SUTURELESS AMNIOTIC MEMBRANE GRAFT

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
65575
Program Year/Program:
2006 / SBIR
Agency Tracking Number:
EY014768
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
TISSUETECH, INC.
7000 SW 97 AVENUE SUITE 212 MIAMI, FL -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2006
Title: DEVELOPMENT OF SUTURELESS AMNIOTIC MEMBRANE GRAFT
Agency: HHS
Contract: 2R44EY014768-02A1
Award Amount: $730,591.00
 

Abstract:

DESCRIPTION (provided by applicant): Due to the Principal Investigator's pioneering work over the past decade, amniotic membrane transplantation (AMT) for ocular surface reconstruction was approved by the FDA in 2001 and reimbursed by Medicare in 2004 as a standard surgical procedure. A number of studies have shown that AMT is effective in facilitating epithelial wound healing and reducing stromal inflammation, scarring and unwanted new blood vessel formation. Using the Principal Investigator's proprietary method, Bio-Tissue, a subsidiary of TissueTech, Inc., has distributed more than 10,000 human amniotic membrane products (trademark name: "AmnioGraft(tm)") to more than 1,200 ophthalmic surgeons worldwide since 1997. Nevertheless, the AmnioGraft(tm) transplantation procedure requires the use of sutures and surgery in an operating room. Under past SBIR Phase I grant support, we developed a "suture-less" AmnioGraft(tm), currently trademarked as Prokera(tm) (formerly called AmnioLens) as a first step toward achieving our ultimate objective of performing AMT without sutures to reduce the medical cost and facilitate the ease of patient care, especially for those patients suffering from severe ocular surface destruction such as Stevens Johnson syndrome and chemical burns. Now that Prokera(tm) has received FDA's 510(k) approval as a Class II device (Dec 2003), we would like to accomplish the following three tasks in this Phase II SBIR application. Aim 1: To automate the manufacturing process for FDA-approved Prokera(tm) to meet the projected increase of clinical uses. Aim 2: To explore the future clinical applicability of FDA-approved Prokera(tm) to promote corneal nerve regeneration in neurotrophic corneas caused by diseases and surgeries before epithelial breakdown takes place. Aim 3: To develop and complete pre-clinical testing of "ProKera-S", a second generation of softskirt ProKera(tm) that provides more comfort to patients receiving excimer laser-assisted corneal refractive surgeries. Taken together, we may further promote our business development by expanding the market potential using Prokera(tm) for suture-less AMT.

Principal Investigator:

Scheffer C. Tseng
3052741299
stseng@ocularsurface.com

Business Contact:

Amy Tseng
3054124430
ATSENG@BIOTISSUE.COM
Small Business Information at Submission:

TISSUETECH, INC.
7000 SW 97 AVENUE SUITE 212 MIAMI, FL 33173

EIN/Tax ID: 651116071
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No