FDA Clears Fish-Skin Technology to Heal Human Wounds

Kerecis Limited announced has received FDA 510(k) clearance from the Food and Drug Administration (FDA) to market a proprietary fish-skin, Omega3, tissue-regeneration technology for the treatment of chronic wounds in the US. The technology, marketed under the name MariGen Omega3, is indicated for the management of chronic wounds, including diabetic, vascular and other hard-to-heal wounds. MariGen Omega3 is produced in Iceland from fish locally harvested in the North Atlantic waters. MariGen Omega3 products are intact, decellularized fish skin sheets, which have had all cells and antigenic materials removed. Fish skin is largely made from the same material as human skin, with the addition of Omega3 polyunsaturated fatty acids. When the product is inserted into or onto damaged human tissue, protease activity is modulated, the fish skin is vascularized and populated by the patient's own cells, and ultimately converted into living tissue.