FDA Approves Kerecis’s Fish Skin Technology to Heal Wounds

Kerecis Limited (Reykjavik, Iceland) has received FDA approval for the fish skin-based MariGen Omega3  tissue-regeneration technology approved for use to treat chronic wounds due to diabetes or other circulatory problems. MariGen Omega3 products are decellularized fish skin sheets that have had cells and antigenic materials extracted. These fish skin sheets are similar to human skin, except that they contain Omega3 polyunsaturated fatty acids that are thought to promote wound healing along with other health benefits.

According to company’s press release, each year close to 6 million people in the US suffer from chronic wounds due to diabetes or other circulatory problems, and delayed healing of these wounds can lead to severe consequences such as amputation or even death. Chronic wounds unlike regular wounds do not follow the normal wound healing process of inflammation followed by proliferation followed by remodeling. In chronic wounds, the healing process stops at the inflammation stage. When the Marigen Omega3 fish skin is transplanted to a chronic wound site, it restarts the healing process of the tissue.

The fish skin serves as a scaffold for revascularization and repopulation by the patient’s cells with the natural Omega3 lipids in the fish skin helping to reduce inflammatory processes.Wound healing then resumes normally and the skin eventually converts into living tissue and remodeling ensues. The fish skin for the Marigen Omega3 is derived from cod farmed in the North Atlantic Ocean off the northwest coast of Iceland. Compared to existing porcine skin transplants, the Kerecis fish skin is promoted as having a lower risk of disease and better manufacturing economics while also overcoming cultural and religious barriers associated with swine-sourced technologies.

Press release: FDA Clears Fish-Skin Technology to Heal Human Wounds…

Product page: Chronic wound treatment with MariGen Wound…