Because no viral transfer risk exists between cold-water fish and humans, the Kerecis patented fish skin is only gently processed and retains its similarity to human skin. Compared to mammalian-based skin substitutes, fish skin offers improved economics and clinical performance and no cultural constraints on usage.
Most tissue-transplant products are based on tissues of human and porcine origin. These are not ideal substitutes because heavy processing is needed to eliminate the risk of disease transmission. This harsh, anti-viral treatment removes most of the material’s natural components, making it dissimilar to human skin.
Fish skin has been shown to be 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, preserving its structure and components. In a double-blind, comparative, randomized controlled clinical trial (N=162), fish skin favorably compared with mammalian skin substitutes.
Application include reconstructing the skin in burn, chronic wounds, and oral wounds, hernia repair, breast reconstruction, and dura mater reconstruction.
Other tissue-transplant products are based on tissues of human and porcine origin. Mammalian tissue carries the risk of disease transmission to humans that is nonexistent from the Atlantic cod to humans. The FDA has strict requirements on tissues from farm animals including viral inactivation methods involving treatment with detergents that remove lipids from the tissues and denature the native structure leaving behind only the most insoluble collagens. Products from human tissues like skin and dehydrated human amnion/chorion membrane call for extensive use of antibiotics to reduce bioburden. The acellular fish skin graft is not subject to this harsh treatment, leaving a more naturally intact product with its associated benefits.
The fish are caught in the pristine waters of North Atlantic Ocean off the township of Isafjordur, on the northwest coast of Iceland. Each and every batch of raw materials is tracked to ensure product quality. The fish skin is processed using a proprietary method that preserves its structure and lipid composition.
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.
Kerecis has demonstrated its proficiency in creating lipid-containg tissue matrices from fish skin, and it has been shown that the material is safe, non-toxic and structurally sound. The company is focused on developing medical device applications with a predicated high return on investment and a low-to-medium cost of development. Kerecis focuses exclusively on tissue regeneration and maintenance, utilizing its core Omega3 fish-skin technology.
The Kerecis Omega3 fish skin contains lipids and proteins that, in a concerted manner, help the body regenerate damaged tissue.
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 . 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 .
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, which are known for their anti-inflammatory properties. Significant biological activity has been 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. Fish skin possesses 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].
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