General Amniotic Membrane FAQs

Amniotic membrane is the innermost lining of the placenta. This lining serves as a natural barrier to protect the fetus from potential bacterial and viral infections. Amniotic membrane has natural biologic properties that prevent inflammation, scarring, stop the formation of blood vessels and promote wound healing.

Amniotic membrane is ideal for use in eye surgery because it has very similar biological and physical properties to the tissue on the eye surface: it does not contain blood vessels, has a similar thickness, and it is relatively transparent. When amniotic membrane is preserved using Bio-Tissue's patented processes it retains the natural biologic properties that are present in utero including cytokines and growth factors that can reduce inflammation, reduce scarring, prevent abnormal blood vessel formation, and promote wound repair and wound healing.

Keeping the amniotic membrane frozen (cryopreserved) is an important part of maintaining its natural biologic actions while inactivating the vitality of the human cells in the tissue to eliminate the possibility for rejection. The biologic functions of amniotic membrane are retained in AMNIOGRAFT® and PROKERA ® and therapeutic value is preserved using Bio-Tissue's patented processes. AMNIOGRAFT® and PROKERA ® are ready for use immediately after thawing. The storage media used for AMNIOGRAFT® and PROKERA® is in a liquid state at temperatures higher than -20°C and freezes solid if stored at -80°C.

AMNIOGRAFT® and PROKERA® are the only cryopreserved amnion grafts. Cryopreservation is the only preservation method that retains the biologic actions of the amniotic membrane in utero (anti-inflammation, anti-scarring, anti-angiogenesis, and promotion of healing) making it ideal for use in ocular surface wound repair and wound healing.

Bio-Tissue uses only placentas supplied by approved and qualified procurement agents accredited by the American Association of Tissue Banks (AATB). These placentas are consensually donated by healthy live mothers within the US (with informed consent) during elective cesarean section delivery. Donors are screened and tested for infectious diseases.

AMNIOGRAFT® and PROKERA® are stored at -80°C (-112°F) before shipping to retain its natural function and integrity. AMNIOGRAFT® and PROKERA® are shipped frozen in an insulated container. The products should arrive cool to the touch with adequate refrigeration. If the tissue is not used immediately upon receipt, the following guidelines should be followed for the storage of AMNIOGRAFT® and PROKERA®:

See Bio-Tissue's AMNIOGRAFT® and PROKERA® Product Instructions for more details.

To order, call (1-888-296-8858) or fax the completed Bio-Tissue Order Form to (305) 412-4429. A purchase order number or credit card information is needed.

It is recommended that tissue be ordered for short-term or long-term storage to avoid unexpected delivery delays. Tissue should be ordered no later than one day before the scheduled procedure to insure express delivery. If the shipment arrives after the scheduled delivery time and is no longer required, it should not be accepted. For orders within the continental US, AMNIOGRAFT® and PROKERA® are shipped for next day delivery. For international orders it is the responsibility of the recipient to gain customs and regulatory clearance.

It is advised that AMNIOGRAFT® and PROKERA® be ordered no later than 4 pm Pacific Standard Time one business day prior to the scheduled procedure to ensure on-time delivery. Standard delivery arrives by 10:30 am the next business day. However to avoid any possible shipping delays, it is advisable to allow one extra business day for shipping.

Bio-Tissue offers Saturday and earlier delivery options upon availability in your area. Call 1-888-296-8858 for delivery options available in your area.

Bio-Tissue will replace expired and unused tissue with proof of due diligence. A shipping and handling fee will be charged for the replacement. Generally, no credit or refund will be issued for the expired product. Contact Bio-Tissue at 1-888-296-8858 for more information about our replacement policy.

AMNIOGRAFT® and PROKERA® are procured and processed according to Good Tissue Practices (GTP) regulations and Good Manufacturing Practices (GMP)  regulations established by the United States Food and Drug Administration (FDA). Placental tissues are retrieved from donor mothers after elective cesarean section under full informed consent. The donor mothers are screened at delivery for infectious, malignant, neurological and auto-immune diseases and other exposures or social habits to determine the suitability for human transplantation. Donors are tested by a CLIA certified independent laboratory using FDA licensed test kits around the time of delivery and found to be serologically negative for, at minimum, the following tests:

Amniotic membrane is processed using a validated, proprietary method to produce AMNIOGRAFT® and PROKERA® . The final product is released after microbiological testing. AMNIOGRAFT® and PROKERA® are preserved in a validated and patented storage medium. No preservatives have been added.