The unique patent-pending MariGen Omega3 fish-skin acellular dermal matrix transplantation technology from Kerecis uses complete acellular fish skin for tissue regeneration by transplantation. Applications include reconstructing the skin in chronic wounds, for hernia repair, breast reconstruction and dura reconstruction. Other tissue-transplant products are based on tissues of human and porcine origin. MariGen 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 in the MariGen Omega3 acellular dermal matrix products is from cod farmed in the pristine North Atlantic Ocean off the northwest coast of 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 MariGen 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.

 

Figure 1 - MariGen 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 MariGen Omega3 fish-skin contains lipids and proteins that, in a concerted manner, help the body regenerate damaged tissue.

 

Figure 2 - MariGen™ Omega3 fish skin

 

The lipids in MariGen 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 MariGen Omega3 fish skin (right)

 

MariGen Omega3 Applied to the Wound

 

MariGen Omega3 fish skin mainly consists of the natural insoluble proteins of the skin referred to as the acellular dermal matrix (ADM) or extra cellular matrix (ECM)) of the skin. In addition to performing other important functions, the extra-cellular matrix provides structural support to the cells in animals.

 

Acellular dermal matrix is rich with bifunctional molecules such as fibronectin and various types of collagen, among other structural and functional molecules. Degradation products of the extra-cellular matrix molecules have also demonstrated significant biological activity [3, 4]. MariGen 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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