A new technology based on fish skin can be used to heal human skin wounds. This week, Kerecis Limited announced that it received FDA 510(k) clearance for a fish skin-based tissue regeneration technology. The technology is designed for the treatment of chronic wounds.
The technology, dubbed MariGen Omega3, is designed to treatment chronic wounds caused by diabetes or vascular disorders. The Omega3 technology is produced in Iceland.
The MariGen Omega3 device comprises decellularized fish skin sheets that have had all antigenic materials and cells removed. For the most part, fish skin is very similar to human skin. The main difference between the two is the addition of omega-3 polyunsaturated fatty acids in fish skin.
When the MariGen Omega3 device is placed on damaged human tissue, protease activity in the skin in modulated. Since all antigens have been removed from the commercial product, the fish skin can be vascularized by a patient’s body. Once this happens, the Omega3 product is populated by a patient’s cells, converting the product into living tissue.
"Despite a clear need, few treatments are consistently effective in accelerating wound closure in people with chronic wounds," noted Gudmundur Fertram Sigurjonsson, CEO and president of Kerecis Limited. "The FDA approval represents an important milestone for Kerecis, as we now have an approved product in the largest market for biological products worldwide."
