SBIR and STTR Success Story for
TissueTech, Inc.

(Information Posted/Updated on 03/22/2010)

TissueTech, Inc.
7000 SW 97th Avenue, Suite 212
Miami, FL  33173

Contact:    Nelson A. Vega, Reg. Compliance & Prod. Dev. Spec.
Phone:      305-412-0098
Fax:          305-412-4429
E-mail:      nvega@tissuetechinc.com
Web Site:   http://www.biotissue.com

Project Title:  Development of PROKERA® Sutureless Amniotic Membrane Graft
Related Award(s):  5R44EY014768
Technology Developed:
The use of cryopreserved amniotic membrane (AMNIOGRAFT®) to restore a healthy eye surface is a scientifically well-accepted application for treating various eye surface diseases that threaten the sight of millions of patients. Prior to the introduction of PROKERA®, the benefits of cryopreserved amniotic membrane for the protection, healing and reconstruction of the eye surface required surgery. The PROKERA® Sutureless Amniotic Membrane (AM) Graft (a Class II, FDA-cleared, ophthalmic conformer device) was developed so that the same sight saving benefits of AM transplantation could be delivered rapidly in the outpatient clinic, hospital bed, emergency room or physician’s office, and without suture-related complications.

Key Words:  Amniotic Membrane, Ocular Surface Reconstruc, Wound Repair, Wound Healing, Eye Surgery, Corneal Defects, Chemical Burns, SJS-TEN.
Uses of Technology/Products/Service:
PROKERA® consists of cryopreserved, human AM (AMNIOGRAFT®) securely clipped into a dual, polycarbonate (PC) ring system and rests on the eye surface like a contact lens, combining the spacing and anti-adhesion properties of a symblepharon ring with the corneal healing, pain reducing, anti-scarring, anti-inflammatory, and blood vessel-prevention properties of human amniotic membrane.

Recent peer-reviewed literature has documented many beneficial outcomes following the use of PROKERA® in cases ranging from corneal neovascularization (with or without limbal stem cell deficiency) and pterygium/pseudopterygium to anophthalmic orbital contraction, corneal ulceration, and severe bacterial keratitis, resulting in positive visual outcomes, ocular surface healing, reduced inflammation, and reduced haze, with minimal side effects and good patient tolerance. There has even been a case of necrotizing scleritis in ulcerative colitis, previously unresponsive to oral or topical steroids, but successfully treated with the combined use of processed pericardium and PROKERA® to reduce inflammation and stabilize visual acuity, while avoiding the possible complications of a sutured application of AM.

PROKERA® has also been shown to provide rapid delivery of AM's inherent therapeutic properties in the early stages of such devastating and sight-threatening conditions as Stevens - Johnson syndrome and Toxic Epidermal Necrolysis (SJS/TEN) and acute alkaline burns to the ocular surface. Prompt application of the PROKERA® ring set in these conditions often results in dramatic resolution of corneal defects, preservation/restoration of visual acuity, reduction of pain & inflammation, and prevention of limbal stem cell deficiency.

While the current size of the PROKERA® ring set may, in some patients, limit the reach and benefits of AM, the success of the SBIR program at TissueTech has allowed us to continue research into the development of the next generation of PROKERA®, in the hopes of further extending the promise and potential of AM’s many therapeutic benefits.

Indications & Usage: PROKERA® is intended for use in eyes in which ocular surface cells have been damaged, or underlying stroma is inflamed or scarred. PROKERA® is used in the eye to reduce inflammation, promote healing, prevent scarring, minimize pain, and diminish the formation of abnormal blood vessels on the ocular surface. PROKERA® is for single use and prescription use only. Note: PROKERA® should be used cautiously with patients with irregular elevations of the ocular surface (e.g. glaucoma drainage devices).

Benefit to Company:
Through the support of SBIR and other grants from the NIH, TissueTech, Inc. has been able to broaden and extend the therapeutic reach and market potential of its existing Amniotic Membrane (AM) product platform by contributing to the diversification of our business from a solely tissue-based strategy to one that also includes medical devices (PROKERA®) and other groundbreaking, AM-based therapeutics currently in development.

In particular, PROKERA®’s position as a niche, AM-based, medical device has given TissueTech, Inc. a strong competitive edge in the life sciences industry.

In addition to the direct commercial success and expanded TissueTech R&D pipeline, the SBIR awards have also contributed to the growth of the Company itself, despite severe nationwide employment contraction and a stagnant economy. Our expanded scientific, product development and compliance capabilities have allowed the Company to both further examine the basic and clinical properties of human amniotic membrane and to explore new markets for their application.

How Product Was Commercialized:
Launched in April of 2005, the PROKERA® sutureless AM graft is promoted through our nationwide network of direct and indirect sales representatives, and distributed to ophthalmic surgeons across the country for the treatment of patients with difficult ocular surface diseases. In addition, our company has attained reimbursement approval by Medicare and other third-party payers.

Other Comments Related to Company's Success Story:
Outside of the commercial gains, PROKERA® has also resulted in many successful patient stories. Recently, we received a heartfelt letter of gratitude from the father of a young girl who was stricken late last year with a severe case of Stevens - Johnson syndrome (SJS), a potentially-fatal, allergic drug reaction that often results in widespread skin blistering and sight-threatening ocular surface damage.

The following is an excerpt from the father’s note to us:

“This note is to send our heartfelt thank you for the wonderful ProKera Ring device that your company produces. Our seven year old daughter…was struck for the first time with a severe case of Stevens Johnson Syndrome this past November, with major ocular involvement, and we believe the ProKera device played a key role in her remarkable recovery.

She had a regular vision check today [two months post-treatment with PROKERA]…,where the chief pediatric ophthalmologist pronounced her corneas in excellent shape, and tested her vision at almost 20/20 again. Thank you, thank you, thank you for the wonderful healing technology your company brings to the market!”