Fish-skin treatment for chronic wounds receives FDA 510(k) clearance

The FDA has given 510(k) clearance for the marketing of a proprietary fish-skin, omega-3, tissue-regeneration product for treating chronic wounds in the United States, Kerecis Limited has announced.

The product (MariGen Omega3) has been indicated for the management of wounds, including diabetic, vascular and other hard-to-heal ulcers, according to a press release. It consists of intact, decellularized fish skin sheets devoid of all cells and antigenic materials. It is produced in Iceland from North Atlantic-harvested fish.

Fish skin largely consists of the same material as human skin, plus omega-3 polyunsaturated fatty acids, according to the release.

“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,” the release stated.

“Despite a clear need, few treatments are consistently effective in accelerating wound closure in people with chronic wounds,” Gudmundur Fertram Sigurjonsson, CEO of Kerecis, said in the release. “The FDA approval represents an important milestone for Kerecis, as we now have an approved product in the largest market for biological products worldwide.”