Technology
Amnion’s human placenta-based family of products focuses on quality strictly adhering compliance to Current Good Tissue Practices (cGTP).
Our products meet or exceed the Quality and donor testing expectations set by the FDA in 21 CFR 1271.
Highly controlled donor birth tissue is recovered employing the safest recovery techniques and sterile equipment to minimize bioburden contamination and procured through a nationwide network of qualified and trained recovery partners. All human tissue is procured with maternal consent during elective Cesarean delivery.
Our team will support you in building a healthier you. No matter what your practice needs are, having a team support you will keep you on the path to meeting your goals. We work together to connect you with the services you need.
Industry Support
Decades of peer-reviewed published studies showcase the safety and efficacy of Amniotic tissue. Amnion’s robust biostructures include extracellular matrix (ECM) proteins, key growth factors, cytokines, amino acids, hyaluronic acid, and cellular components critical to the healing process.
Essence Process
Amnion’s minimally manipulated human amniotic membrane allograft products are procured using our proprietary ESSENCETM tissue processing technology retaining its essential and robust protein profile.
The result is a therapeutic biostructure employed as a biological barrier for a host of clinical applications.
Amnion eliminates logistical and cost inefficiencies by facilitating the delivery of our technologies via rigorous FDA monitored quality control methods from birth to clinical site.
AmGraftTM human amniotic membrane graft is a single layer allograft delivered in a sterile double peel pouch. AmGraftTM can easily be sutured, glued or placed gently over the surgical site.
AmGraftPLUSTM represents Amnion’s latest multi-layered allograft for applications requiring a thicker barrier. The AmGraftPLUSTM is set to launch in 2023.
AmGraftTM is intended for homologous use and is available in the most popular sizes.
Scientific
Amnion, LLC
6077 Frantz Rd. Suite 205
Dublin, OH 43017
AmDiscTM Amniotic Membrane allografts
Procured, processed and configured with our focus on the surgeon and the patient
Tissue Safety: Donor Selection, Screening and Testing
AmDiscTM are recovered meeting stringent specification during donor screening and laboratory testing to reduce the risk of transmitting infectious disease.
AmDiscTM allografts are procured and processed according to standards established by the American Association of Tissue Banks (AATB) and the United State Food and Drug Administration (FDA). All tissues are recovered under full informed consent of the planned c-section donors (represented by the mothers of the newborn children) The donors have consented to transfer of the allografts to third parties. A thorough medical exam and social history of the donor is also obtained, including detailed family history. The o donor is screened for:
- Blood type and RH Factor
- HIV-1 Antibody
- HIV-2 Antibody
- HIV-NAT
- HTLV-1 Antibody
- HTLV-2 Antibody
- Syphilis Screening
- CMV
- Hepatitis Core Antibody
- Hepatitis Surface Antigen
- Hepatitis C Antibody
All tests results are reviewed prior to release of the tissue.
Only tissue from donors that have normal CBC, tests negative for serology and test negative 0r non-reactive for infectious disease and contamination are released.
Reimbursement Information:
CPT Code 65778 Amniotic Membrane placed on the ocular surface “self retaining”
Thickness: 35 microns/ Single Layer
AmDisc™
Ophthalmic grafts procured And customized for ease of use And patient outcomes.
Cutting edge technology for Eye care professionals performing State of the art ocular surface procedures.
Introducing the latest in Amniotic Disk Technology for Ocular Treatments.
Minimally manipulated AmDiscTM human amniotic membrane allografts are versatile tissue grafts custom designed for a variety of surgical and in-office ophthalmic procedures. Biocompatible human Amniotic Membrane grafts have proven to contain extra cellular matrix (ECM), growth factors, collogen, laminin, etc. and resorbs within the host body.
Single Layer AmDiscTM Amniotic Allografts are easy to handle and taylor designed for patient comfort.
Sizes Available:
AmGraft™
AmGraftTM Amniotic Allograft Membrane is a human placental-based tissue product processed using the proprietary EssenceTM Tissue Processing technology.
AmGraftTM serves as a protective covering when placed over the wound, providing the essential biostructure found in human amnion including an intact extracellular matrix (ECM), growth factors and cytokines.
AmGraftTM is custom designed for ease of use easily conforms to the wound site providing a barrier to repair, reconstruct and replace tissue.