Kerecis Intact Fish Skin Technology

From fish skin to skin substitute

Fish Skin Technology

Because no known viral transfer risk exists between North-Atlantic Cod and humans, the Kerecis patented fish skin is only gently processed and retains its similarity to human skin. Compared to mammalian-based skin substitutes. Most skin substitutes 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.

Key Benefits

Structure similar to human skin
No cultural or religious barriers to clinician/patient acceptance
Easy to use, with larger, thicker sheets
No known risk of viral disease transfer
Supports cell ingrowth and vascular ingrowth

Similarity in structure to human skin

Fish skin has been shown to be similar in structure to human skin than other skin substitutes. Because there is no known risk of viral 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.

Some skin substitutes 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. Regulatory bodies have 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 intact fish skin graft is not subject to this harsh treatment, leaving a more naturally intact product with its associated benefits.

Human Skin
Fish Skin

Caught in the pristine waters of North Atlantic Ocean

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.

Intact fish skin has been cleared by the FDA and European regulatory authorities for wound management. The product is undergoing registration at multiple regulatory authorities around the world.

Kerecis is pioneering the use of intact fish skin in the globally expanding cellular-therapy and regenerative-medicine markets. The unique products from the company’s patented technologies help protect the body’s own tissues and provide the ideal environment to help facilitate tissue regeneration.

Product Forms

Standard
Micro
Fenestrated
Expanse

The four Hallmarks of Kerecis Tissue Regeneration

Key factors for an optimal tissue replacement product are recognized to be a product that has had it’s cells removed, and a native structure that is not affected or altered by the applied treatment process, thereby retaining its overall lipid content, ECM biochemical composition, structure, and complexity. These are the 4 hallmarks of tissue regeneration:
Three dimentional structure
Intact structure provides a framework to support
tissue regeneration.
Intact molecular organization
Fish skin is homologous to human skin.
Natural Mechanical Properties
Naturally strong, handles like skin, and easy
to suture or staple.
Preserved Molecular Content
Chemical complexity of the fish skin supports cell ingrowth and
vascularization.

The Patented EnviroIntact™ Process

Preserving the capability of nature

Fresh Atlantic cod fish skins are a by-product of food processing and are collected from local fishing companies in Isafjordur. Only the best quality skins are chosen for further processing.

All mucus is removed from the skins and then descaled. Mammalian tissues pose a risk of viral transmission and so require harsh cleaning. Conversely, tissue from Atlantic cod do not pose such a risk and so may be gently cleaned, thereby preserving all the beneficial components of the tissue.

The intact fish skins undergo decellularization; removing the fish cells from the skin, without damaging or denaturing it.

The prepared skins are then dried using a freeze dry process, where all water is removed by vacuum.

After freeze drying, skins are cut using our precision carbide tipped cutter. This is also used to ensure perfect meshing of our expandable sizes, as well as allows us to produce our unique hand shaped products.

The fish skin products undergo certified sterilization in accordance with international standards.

All the products follow regulatory and statutory protocols regarding labelling and marketing. Finally, the products are boxed, packed, and shipped to customers world-wide.

Intellectual Property

Kerecis has been awarded multiple patents protecting the core technology in the U.S. and other countries, and several more applications are pending. Kerecis is committed to building a substantial patent portfolio protecting the company´s intellectual property.

Need more information?

From the town of Isafjordur in northwest Iceland, Kerecis develops, manufactures, and sells patented fish skin soft tissue regeneration products that have regulatory approval in the United States, Europe and several other jurisdictions.
Kerecis is pioneering the use of fish skin and fatty acids in the globally expanding field of cellular therapy.
Kerecis is part of Coloplast, the leading global supplier of intimate healthcare products.
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