CarePATCH™
by


STERILE DUAL LAYER AMNIOTIC MEMBRANE ALLOGRAFT
Characteristics
•carePATCH™ is a dehydrated tissue product stored at ambient temperature with a 2 Year Shelf Life.
• carePATCH™ retains amniotic membrane’s natural structure and relevant characteristics including epithelium and basement membrane layers.
•carePATCH™ acts as a wound cover, that is a natural bandage shielding wounds from its external environment.
Amniotic Tissue as a Barrier
• Amniotic membrane adheres closely to its underlying surface as a cover protecting wounds and may help prevent formation of dead space on wound.2, 3
•Amniotic membrane’s barrier function may help prevent infiltration and adhesion of microorganisms to wounds.2, 3
Applications
carePATCH™ is intended only for homologous use as a barrier that protects wounds from the surrounding environment during the wound healing process.1 This includes non-healing wounds and surgically created wounds.
• Wound Covering
• Diabetic Foot Ulcer Covering
• Venous Stasis Ulcer Covering
• Burn Covering
Manufacturing
• The amniotic membrane for carePATCH™ is sourced from healthy deliveries of placental tissue with material consent.
• carePATCH™ is produced using minimally manipulated amniotic membrane in a dual layer composition.
• Through minimally manipulated methods carePATCH™ retains amniotic membrane’s original relevant characteristics relating to its utility to serve as a barrier, specifically its physical integrity, tensile strength, and elasticity.
• carePATCH™ retains the amniotic membrane’s key structural components related to its utility to serve as a barrier, specifically:
– Epithelium Layer – Basement Membrane
• carePATCH™ is dehydrated, packaged, and terminally sterilized with a 2 year shelf life.
1 Velnar T, Bailey T, Smrkolj V. The wound healing process: an overview of the cellular and molecular mechanisms. J Int Med Res. 2009 Sep-Oct;37(5):1528-42. doi: 10.1177/147323000903700531. PMID: 19930861.
2 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.
3 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.
4 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.
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 carePATCH™ 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).
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