FULL THICKNESS PLACENTAL MEMBRANE ALLOGRAFT

Tissue Characteristics

•Multi-Layer graft processed using a proprietary processing technology to ensure all naturally occurring components of birth tissue remain intact through processing.

•Contains the Amnion, Chorion as well as the important Intermediate Layer (IL)/Spongy layer of the placenta.

•Amber color comes from advanced preservation of placental structures and layers.

•Intended for homologous use only. May act as a wound cover, that is a natural bandage shielding wounds from its external environment.

•Dehydrated, packaged, and terminally sterilized with a 2-year shelf life. Stored at ambient temperature.

Applications

•Wound Covering•Diabetic Foot Ulcer Covering

•Venous Stasis Ulcer Covering•Burn Covering

Tissue Processing – Placental Membrane Barrier

•The placental tissue for completeFT™ is sourced from healthy deliveries ofplacental tissue with maternal consent.

•Processed using minimally manipulated placental tissue in a full thicknesscomposition to retain the native characteristics of the placentalextracellular matrix (ECM).

•The placental tissue’s key structural components, specifically the chorionic,amniotic as well as the spongy are retained to allow the membrane itsutility to serve as a barrier.

•May adhere to the underlying wound surface as a cover protecting woundsand may help prevent formation of dead space on wounds.1,2

•May prevent infiltration and adhesion of microorganisms to wounds.1,2

1 Malhotra C, Jain AK. Human amniotic membrane transplantation: Different modalities of its use in ophthalmology. World J Transplant. 2014 Jun 24;4(2):111-21. doi: 10.5500/wjt.v4.i2.111. PMID: 25032100; PMCID: PMC4094946.

2 Gupta A, Kedige SD, Jain K. Amnion and Chorion Membranes: Potential Stem Cell Reservoir with Wide Applications in Periodontics. Int J Biomater. 2015;2015:274082. doi: 10.1155/2015/274082. Epub 2015 Dec 6. PMID: 26770199; PMCID: PMC4684856.

3 Mamede AC, Carvalho MJ, Abrantes AM, Laranjo M, Maia CJ, Botelho MF. Amniotic membrane: from structure and functions to clinical applications. Cell Tissue Res. 2012 Aug;349(2):447-58. doi: 10.1007/s00441-012-1424-6. Epub 2012 May 18. PMID: 22592624.

4 Tehrani, F, Firouzeh, A, Shabani, I, Shabani, A. A Review on Modifications of Amniotic Membrane for Biomedical Applications. Front. Bioeng. Biotechnol., 13 January 2021 Sec. Regenerative Medicine Volume 8 – 2020 https://doi.org/10.3389/fbioe.2020.606982

Disclaimer: Please consult your doctor to see if tissue allograft is right for you. No medical advice has been offered herein. None of the statements in this brochure have been evaluated by the FDA.

Amniotic tissue allografts are not intended to diagnose, treat, cure or prevent any disease.

The FDA’s Tissue Reference Group (TRG) has determined that completeFT™ appears to meet all of the criteria for regulation solely under section 361 of the Public Health Service Act and the regulations in 21 CFR part 1271 governing Human Cell, Tissue and Cellular and Tissue-Based Products (HCT/Ps).