Iceland-based Kerecis has obtained 510(k) approval from the US Food and Drug Administration (FDA) to market its fish-skin, Omega3, tissue-regeneration technology for the treatment of chronic wounds in the US.
The company will market the tissue-regeneration technology under the name MariGen Omega3.
Produced in Iceland from fish locally harvested in the North Atlantic waters, MariGen Omega3 is intended for the management of chronic wounds, including diabetic, vascular and other hard-to-heal wounds.
MariGen Omega3 products are intact, decellularized fish skin sheets that have had all cells and antigenic materials removed.
With the addition of Omega3 polyunsaturated fatty acids, fish skin is largely made from the same material as human skin.
Protease activity will be modulated when the product is inserted into or onto damaged human tissue and then the fish skin is vascularized and populated by the patient’s own cells, and finally converts into living tissue.
Kerecis president, chairman and CEO Gudmundur Fertram Sigurjonsson noted despite a clear need, few treatments are consistently effective in accelerating wound closure in people with chronic wounds.
"The FDA approval represents an important milestone for Kerecis, as we now have an approved product in the largest market for biological products worldwide," Sigurjonsson added.
When compared to existing human- and porcine-derived products, the Kerecis material offers advantages including improved manufacturing economics and a lower risk of disease transfer.
Patents are pending for the Kerecis material in multiple countries across the globe.