FDA Clears Fish-Skin Technology to Heal Human Wounds
New treatment option for the millions suffering from chronic wounds
Reykjavik / Isafjordur, November 7, 2013 – Kerecis Limited announced today that a 510(k) clearance has been received 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 United States.
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.
Each year about 6 million Americans suffer from problem wounds caused by diabetes, circulatory problems and other conditions, with 1.1 to 1.8 million new cases added each year. Delayed wound healing can lead to infection, amputation, and even death.
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.
“Despite a clear need, few treatments are consistently effective in accelerating wound closure in people with chronic wounds,” said Gudmundur Fertram Sigurjonsson, CEO, president and chairman 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.”