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December 17, 2012 Volume One

The leader in ocular surface tissue therapiesBIO-TISSUE, founded in 1997, is the industry leader in regenerative tissue engineering fueled by its desire to provide the highest quality tissue product and the highest level of patient care.

AmnioGraft® and PROKERA® are cryopreserved amniotic membrane grafts processed using the CRYOTEK™ Method to ensure that the tissue is able to

deliver anti-inflammatory, anti-angiogenic, anti-scarring, and wound healing actions.

Bio-Tissue serves as an operating entity engaged in the procurement, processing, storage and distribution of cryopreserved human amniotic membrane (AmnioGraft® and PROKERA®) for transplantation and research uses. In addition, Bio-Tissue has retained patent rights to process, preserve, and distribute cryopreserved human amniotic membrane for ocular surface reconstruction.

Bio-Tissue is registered with the US Food and Drug Administration (FDA) as:

A Tissue Bank (recover, screen, test, package, process, label, store and distribute tissue)

A Medical Device Manufacturer and Specification Developer

Bio-Tissue adheres to the FDA's tissue and medical device guidelines. Bio-Tissue is also licensed to operate as a tissue bank by the Department of Health in the State of New York and California.

AmnioGraft® is the ideal graft for surgical use.Based on a highly innovative and dynamic platform technology, Bio-Tissue’s talented research team

developed its primary product, AmnioGraft®: the only tissue graft designated by the FDA as homologous for promoting ophthalmic wound

healing while suppressing scarring and inflammation. Harnessing amniotic membrane’s mechanisms of action, the Bio-Tissue Method allows AmnioGraft® to retain the natural properties of amniotic membrane without the risk of rejection.

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AmnioGraftAmnioGraft® is the amniotic membrane allograft of choice for ophthalmologists around the world because of its unique ability to repair and

heal wounds. AmnioGraft® serves as a tissue replacement and delivers the amniotic membrane’s unique wound repair and wound healing actions that improve surgical outcomes by preventing scarring,

reducing inflammation, reducing the formation of abnormal blood vessels, and minimizing patient pain.

In addition to its wound repair and wound healing actions, AmnioGraft® also reduces surgical times because it does not require rehydration, it is easy to handle and suture and conserves the patient’s tissue for other use.

AmnioGraft® Handling:

AmnioGraft® is supplied in an easy to use dual peel pouch. Use sterile smooth forceps or gloves to remove the inner pouch containing the tissue. The clear inner pouch may be introduced to the sterile field. Using sterile scissors, cut below the sealed line of the inner pouch and remove AmnioGraft® using smooth sterile forceps. Once retrieved from the sterile, clear inner pouch, AmnioGraft® can be easily removed from its carrier paper using a dry surgical sponge or 0.12 forceps.

The tissue is ready for transplantation immediately after removing it from the carrier paper

without the need for rehydration. Bio-Tissue’s unique cryopreservation method retains the tissue’s natural tensile strength which makes this naturally strong tissue easy to handle and suture.

AmnioGraft® is always manufactured with the stromal side of the tissue attached to the carrier paper. It is easy to determine the orientation of AmnioGraft® after it has been removed from its carrier paper using a dry surgical sponge. The dry sponge will stick to the stromal side, but it will not stick to the basement membrane side.

Indications for use:AmnioGraft® improves surgical outcomes for a variety of eye surgeries including:

Pterygium, Conjuntivochalasis, Corneal defects, High-risk trabeculectomies, Leaking glaucoma blebs, Chemical burns, Stevens-Johnson Syndrome, Strabismus and many other procedures.

Storage:AmnioGraft® is shipped in a temperature controlled container and can be kept in the box until the expiration date and time on the outer container. Once removed from the shipping container, AmnioGraft® can be easily stored in standard refrigeration or freezer devices.

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OverviewPROKERA® is class II medical device composed of CryoTek™ amniotic membrane in a thermoplastic ring set. PROKERA® is a unique, active, treatment option for ocular surface and corneal wound healing due to its anti-inflammatory and anti-scarring properties.

PROKERA® leverages cryopreserved amniotic membrane for regenerative healing

Key features:

Innovative-PROKERA® delivers the unique healing properties of cryopreserved amniotic membrane in a convenient, sutureless, thermoplastic ring set.

Active wound healing-Key components responsible for tissue regeneration are retained using the CryoTek™ processing method

Intuitive-PROKERA® is designed to conform snugly to the ocular surface and can be inserted in the office.

Specifications-16-mm diameter ring.

For more detailed information and purchasing options click here: