Biological Wound Dressing (Epos AmnioHeal™)
The biological wound dressing produced by this company is an allograft based on dehydrated acellular amniotic membrane with the brand of “Epos AmnioHeal™”. This product is a biological dressing for covering, repairing and regenerating skin tissue after all kinds of injuries and wounds. In traditional dressings, sterile gauze or other cellulose and synthetic polymer coatings are used. These coatings only keep the wound clean and maintain moisture to help the healing process, but they do not actively enter into biological interactions with the body to accelerate and improve the quality of wound healing. On the other hand, the new generation dressings are made of biopolymer materials that have a biological effect on the skin tissue (and other tissues and cells of the body) and support them to repair and regenerate. Epos AmnioHeal™ dressing is made from amnion membrane. Amnion membrane is a thin membrane that surrounds the fetus in the mother’s womb during pregnancy. This tissue is rich in a variety of useful biological substances, including structural proteins, cytokines and growth factors, which have several properties, such as anti-inflammatory effects, angiogenic, immune system regulating, antibacterial, pain-reducing, scaffolding for skin cells to penetrate, migrate and proliferate, and healing acceleration along with its general role to create a biological barrier against infections. This membrane is disposed of as biological wastes in hospitals after child delivery. In the preparation of the Epos AmnioHeal™, this membrane is collected from hospitals with standard methods and decellularized in a special production line through specific protocols. In this process, the cells, DNA and other cellular residues are removed to prevent the graft rejection by the host immune system of the patients receiving the product, while other biologically useful substances and the porous structure of the tissue are preserved. Then the acellular membrane enters the drying process with a freeze dryer to dry it completely without destroying the biological materials and microarchitecture, which increases its stability and lifespan and ease of transportation and handling. The final product is delivered to doctors after packaging and sterilization. At the time of use, this product is moistened and softened with sterile serum and placed on the wound.The cell-free and dehydrated amnion membrane product of this company is produced in a dedicated clean room (including classes D and C) and in accordance with GMP principles, which has been visited and approved by the experts of the Medical Device Office of the Iranian FDA. Furthermore, the product, production process, packaging, clean room and sterilization were fully validated in the authorized laboratories of the FDA. In addition, relevant physical and chemical characterizations, in vitro and in vivo animal tests in accordance with the ISO 10993 standard to evaluate the biocompatibility of the product, and the stability of the product have been successfully conducted. The ISO13485 (medical equipment quality management) certificate has been obtained from an approved international certified body (CB) for the production of this product. At the moment, the company is ready to release the product to the market after the Iranian FDA final approval.
