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.