SBIR and STTR Success Story for
TissueTech, Inc.

(Information Posted/Updated on 09/09/2007)

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

Contact:    Topaz Kirlew, Executive VP Technical & Clinical Affairs
Phone:      305-412-0099
Fax:          305-621-5450
Web Site:

Project Title:  Development of Sutureless Amniotic Membrane Graft (AmnioLens)
Related Award(s):  1R43 EY014768-01
Technology Developed:
Prior to the introduction of this product, the benefits of cryopreserved amniotic membrane for the protection, healing and reconstruction of the eye surface required surgery. PROKERA™ was developed so that the same sight saving benefits realized in the operating room could be delivered in the outpatient clinic, hospital bed, emergency room or physician’s office without the need for sutures. PROKERA™ is a sutureless graft that provides the same therapeutic biologic actions of cryopreserved amniotic membrane in an ambulatory setting.

Key Words:  amniotic membrane, ocular surface, wound repair, wound healing, eye surgery, corneal defects, chemical burns, Stevens-Johnson Syndrome.
Uses of Technology/Products/Service:
PROKERA™ consists of a dual polycarbonate ring system used to securely clip a circular piece of cryopreserved (frozen) human amniotic membrane (AMNIOGRAFT®) in between. This ring set sits on the eye surface like a contact lens. Amniotic membrane, sometimes referred to as the miraculous tissue of Mother Nature, is the innermost layer of the placenta. The cryopreserved amniotic membrane provides natural healing actions including reduction of scarring, prevention of blood vessel formation, and reduction of inflammation while promoting the healing of the eye surface and reducing pain in the patient eye. Cryopreserved amniotic membrane 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. The polycarbonate ring set also helps maintain space in the eye socket and to prevent the eye from closing or fusing.

PROKERA™ acts as a biologic bandage as it delivers the therapeutic benefits mentioned above while providing a physical bandage for the eye surface. When used in the office setting, PROKERA™ provides crucial sight-saving acute treatment that can possibly prevent or delay a surgical procedure or save a graft failure due to high risk corneal transplant.

PROKERA™ often eliminates the need for surgery and provides sight saving benefits and the most common indications for use are:

• Eye surface defects, erosion, or ulceration

• Chemical/thermal burns (acute stage)

• Following the removal of corneal lesions, e.g., band keratopathy

• Persistent unmanageable inflammation from herpes, or inflammation due to allergies

• Stevens-Johnson syndrome (acute stage)

• In conjunction with socket or fornix reconstruction (to prevent lid/lash rubbing)

Benefit to Company:
The grant awarded by NIH enabled TissueTech, Inc. to complete the design and commercialize PROKERA™, diversifying their line of cryopreserved amniotic membrane products.

How Product Was Commercialized:
PROKERA™ was approved by the FDA in December of 2003 as a Class II medical device (510(K) Clearance) and was launched in April 2005. Medicare provided a reimbursement supply code for PROKERA™ in October 2006 which has significantly aided in product acceptance.

Other Comments Related to Company's Success Story:
Outside of the commercial gains, PROKERA™ has also resulted in many successful patient stories. We have heard stories of pediatric chemical burns cases in which patients as young as 6-months-old received sight-saving therapy because of the treatment made available by PROKERA™ in the physician’s office. We have had cases reported in which a patient’s condition was too delicate for surgical treatment and PROKERA™ was used to alleviate their ocular surface injuries in the hospital bed.

Because of the tremendous success of PROKERA™, TissueTech is developing the next generation device, supported by a SBIR Phase II grant award that will use a softer ring in lieu of the rigid PMMA used for the current generation PROKERA™ device.

Past R&D and/or Sales from this Project:   $$700,000
Estimated Future Annual R&D and/or Sales from this Project:   $$6,000,000