The Kerecis MariGen™ Omega3 Extra Cellular Matrix technology is based on the distinctive material characteristics of fish skin tissues. The source material is fish skin from fish that is 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 that the fish are healthy. Our procedure involves gentle processing of the fish skin by our proprietary methods that preserve the structure and lipid composition of the skin matrix. 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. The MariGen™ Omega3 Extra Cellular Matrix, when inserted into or onto damaged tissue, is vascularized and populated by the patient's own cells, and is ultimately converted into living tissue.

MariGen™ Omega3 Extra Cellular Matrix prototype

Pipeline

Our product development strategy is focused on developing 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 marine derived lipid and protein technology.

Kerecis product pipeline

Intellectual Property

We have filed multiple patents protecting our core technology and have several more in process. 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 inventions lifetime.

Technical Basis

The MariGen™ Omega3 Extra Cellular Matrix technology is made from fish skin and contains lipids and proteins that in a concerted manner help the body regenerate damaged tissue.

MariGen™ Omega3 Extra Cellular Matrix prototype

Our source material is fish skin that is harvested from fish 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 that the fish are healthy. Our procedure involves gentle processing of the fish skin by our proprietary methods that preserve the structure and lipid composition of the skin matrix. 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. The MariGen™ Omega3 Extra Cellular Matrix, when inserted into or onto damaged tissue, is vascularized and populated by the patient's own cells, and is ultimately converted into living tissue.

Currently marketed porcine ECM product (left) and MariGen™ Omega3 Extra Cellular Matrix (right)

The lipids in MariGen™ include sterols, fat-soluble vitamins, and phospholipids as well as polyunsaturated fatty acids. 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 omega-3 (n-3) fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) found in high concentration in fish oil. One of the reasons why wounds remain chronic and fail to heal is the shortage of lipids which are formed in the Golgi apparatus of the keratinocytes [2].

MariGen applied to the wound

MariGen™ contains intact insoluble proteins from the extracellular matrix (ECM) of the fish skin. In all animals the ECM is the extracellular part of animal tissue that provides structural support to the cells in addition to performing various other important functions. Skin ECM consists of structural proteins (primarily collagen), adhesive glycoproteins, proteoglycans, and matricellular proteins. Scaffolds composed of ECM have been shown to be rich in bifunctional molecules such as fibronectin and various types of collagen, among other structural and functional molecules. Degradation products of the ECM molecules have as well demonstrated significant biological activity themselves [3,4]. The MariGen™ Omega3 Extra Cellular Matrix scaffolds do not elicit an immune response since the major antigenic components present within cell membranes are removed during processing.

All commercially available ECM scaffolds to date derive from mammalian sources. Their use within many bioengineering fields has grown rapidly, due to their excellent biocompatibility, low antigenicity, high biodegradability and good mechanical, haemostatic and cell-binding properties. Non-mammalian derived scaffolds have so far not received much attention. A small number of aquatic and marine sources have been explored, including and fish scales for corneal regeneration [5], but fish proteins generally have received little attention as a suitable material in an ECM structure. Fish skin does, however, possess much the same features as mammalian derived ECM, 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]. Fish protein ECM from marine sources also has the added bonus of being free of potential human pathogens, and other confounding concerns, for instance religious beliefs and societal issues.

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.