Kerecis Omega3 is intact fish skin that is rich in naturally occurring Omega3 polyunsaturated fatty acids. When grafted onto damaged human tissue such as a burn wound or diabetic wound the material recruits the body's own cells and is ultimately converted into living tissue.

Fish skin is much more similar in structure to human skin than anti-viral-processed skin substitutes. Because there is no risk of disease transmission, fish skin is only minimally processed, retaining its similarity to human skin. This has relevance in wound closure as shown by multiple clinical trials, including a double-blind, comparative, randomized control trial (N=162) where fish skin favorably compared with mammalian skin substitutes. Fish skin is also rich in Omega3 fatty acids, which possess multiple health benefits.

Applications include reconstructing the skin in burn, chronic wounds and oral wound; for hernia repair, breast reconstruction and dura mater reconstruction. Other tissue-transplant products are based on tissues of human and porcine origin. Kerecis™ Omega3 is uniquely fish-skin-based, and offers improved economics and clinical performance, as well as reduced disease transfer risk and no cultural constraints on usage.

The fish skin originates in the pristine waters of North Atlantic Ocean off the township of Isafjordur, in northwest coast Iceland. Consequently we can track each and every batch of raw materials to ensure the quality of our products. We process the fish skin using a proprietary method that preserves the structure and lipid composition of the skin.

We have demonstrated proficiency in creating lipid-containing tissue matrices from fish skin, and shown that our material is safe, non-toxic and structurally sound. When the Kerecis™ Omega3 fish skin is inserted into or onto damaged human tissue, the fish skin is vascularized and populated by the patient's own cells, and ultimately converted into living tissue.

Kerecis Omega3 Wound has been approved by the FDA and European regulatory authorities for wound healing. The product is undergoing registration at multiple regulatory authorities around the world.

 

Figure 1 - Kerecis™ Omega3 fish skin

 

Our product development strategy is to develop medical device applications with a predicted high return on investment and a low-to-medium cost of development. We focus exclusively on tissue regeneration and maintenance utilizing our core Omega3 fish-skin technology.

 

Intellectual Property 

We have filed multiple patents protecting our core technology and have several more applications in process. Patent have been issued in several territories, including the US, and remain pending in other. Kerecis is committed to building a substantial patent portfolio protecting the company´s intellectual property so that revenue from manufacturing and licensing activities can be maximized over the invention's lifetime.

 

Technical Basis

The Kerecis™ Omega3 fish-skin contains lipids and proteins that, in a concerted manner, help the body regenerate damaged tissue.

 

Figure 2 - Kerecis™ Omega3 fish skin

 

The lipids in Kerecis™ Omega3 include sterols, fat-soluble vitamins, and phospholipids as well as polyunsaturated fatty acids (Omega3). The health benefits of polyunsaturated fatty acids have long been recognized and their positive impact on health is on sound scientific footing [1]. These favorable effects are in large part mediated by the Omega3 (n-3) fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are found in high concentration in fish oil. One reason why wounds fail to heal is the shortage of lipids that are formed in the Golgi apparatus of the keratinocytes [2].

 

Figure 3 - Currently marketed porcine transplant extra-cellular matrix (left) and Kerecis™ Omega3 fish skin (right)

 

Kerecis™ Omega3 Applied to the Wound

The acellular fish skin graft is derived from decellularized Icelandic Codfish skin. Its protein composition closely resembles that of human skin and the porous microstructure provides a scaffold for efficient ingrowth of dermal cells and capillaries. In addition, the FDA cleared graft is uniquely rich in the polyunsaturated Omega3 fatty acids EPA and DHA that are known for their anti-inflammatory properties. Furthermore significant biological activity is demonstrated [3, 4]. Kerecis™ Omega3 fish skin does not elicit an immune response since the major antigenic components present within cell membranes are removed during processing.

Other extra-cellular transplant products available today come from mammalian sources. Their use within multiple bioengineering fields has grown rapidly due to their biocompatibility; low antigenicity; high biodegradability; and good mechanical, haemostatic and cell-binding properties.

Non-mammalian-derived transplant products have so far not received much attention. Some aquatic and marine sources have been explored (including fish scales for corneal regeneration [5] and reconstituted collagen for wound treatment), but complete fish skin generally has received little attention as a suitable extra-cellular material. Fish skin does, however, possess many of the same features as mammalian skin, among them an appropriate surface chemistry and microstructures that facilitate cellular attachment, competent mechanical strength and biodegradation rate without undesirable by-products [6, 7, 8].

References 

1. Harris WS, Mozaffarian D, Lefevre M, Toner CD, Colombo J, et al. (2009) Towards Establishing Dietary Reference Intakes for Eicosapentaenoic and Docosahexaenoic Acids. J Nutr 139: 804S-819S.

2. Feingold KR (2007) Thematic Review Series: Skin Lipids. The Role of Epidermal Lipids in Cutaneous Permeability Barrier Homeostasis. J Lipid Res 48: 2531-2546.

3. Badylak SF, Freytes DO, Gilbert TW (2009) Extracellular Matrix as a Biological Scaffold Material: Structure and Function. Acta Biomater 5: 1-13.

4. Reing JE, Zhang L, Myers-Irvin J, Cordero KE, Freytes DO, et al. (2009) Degradation Products of Extracellular Matrix Affect Cell Migration and Proliferation. Tissue Eng Part A 15: 605-614.

5. Lin CC, Ritch R, Lin SM, Ni MH, Chang YC, et al. (2010) A New Fish-scale-derived Scaffold for Corneal Regeneration. Eur Cell Mater 19: 50-57.

6. Hawkes JW (1974) The Structure of Fish Skin. I. General Organization. Cell Tissue Res 149: 147-158.

7. Le Guellec D, Morvan-Dubois G, Sire JY (2004) Skin Development in Bony Fish with Particular Emphasis on Collagen Deposition in the Dermis of the Zebrafish (Danio rerio). Int J Dev Biol 48: 217-231.

8. Rakers S, Gebert M, Uppalapati S, Meyer W, Maderson P, et al. (2010) 'Fish Matters': the Relevance of Fish-skin Biology to Investigative Dermatology. Exp Dermatol 19: 313-324.

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