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FDA Given 510(K) Clearance for Marketing of Iceland-Based Kerecis' Proprietary Fish-Skin

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Core Tip: The US Food and Drug Administration (FDA) has given 510(k) clearance for the marketing of Iceland-based Kerecis' proprietary fish-skin, omega-3, tissue-regeneration product for treat

The US Food and Drug Administration (FDA) has given 510(k) clearance for the marketing of Iceland-based Kerecis' proprietary fish-skin, omega-3, tissue-regeneration product for treating chronic wounds in the US.

The product known as MariGen Omega3 has been indicated for the management of wounds, such as diabetic, vascular and other hard-to-heal wounds.

MariGen Omega3 consists of intact, decellularized fish skin sheets devoid of all cells and antigenic materials and is produced in Iceland from North Atlantic-harvested fish.

In the US about six million people per annum suffer from problem wounds caused by diabetes, circulatory problems and other conditions, with 1.1 to 1.8 million new cases added each year.

The company said that delayed wound healing can lead to infection, amputation and even death.

Fish skin largely includes of the same material as human skin, plus omega-3 polyunsaturated fatty acids.

When MariGen Omega3 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.

Kerecis president, chairman and CEO Gudmundur Fertram Sigurjonsson said, "Despite a clear need, few treatments are consistently effective in accelerating wound closure in people with chronic wounds."

Kerecis produces a novel, patent-pending, tissue-regeneration material derived from fish skin to speed up the healing of wounds and tissue reconstruction. 

 
 
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