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Kerecis: How Fish Skin is Changing Tissue Regeneration

Gudmundur Fertram Sigurjonsson, Founder, President and CEO

In Reykjavik, Iceland, Fertram Sigurjonsson worked his way through college at a fish-processing factory and on fishing boats. Who knew that this humble beginning would lead him to pioneer and patent the global use of fish-skin grafts for surgical, wound and burn applications?

Kerecis, the company Fertram founded, quietly entered the U.S. market in 2016 with a wound-treatment product and has since expanded its portfolio to include fish-skin products for burns and surgical applications. When grafted onto damaged human tissue, these products recruit the body’s own cells to regenerate tissue.

The Kerecis Omega3 products are intact fish skin that is very similar to human skin, making it ideal for tissue regeneration and grafting. Because there is no risk of a viral-disease transfer from Atlantic cod to humans, the fish skin needs only mild processing for medical use and maintains its natural three-dimensional structure, mechanical properties, native organization and chemical complexity (including Omega3). These key features enable the body to safely, effectively and naturally build healthy, vibrant tissue.

The Four Hallmarks of Tissue Building

Kerecis has the only products on the market that combine all four hallmarks of tissue building.

Three-dimensional structure: Unlike products grown two-dimensionally in a lab, intact fish skin has the full depth of the skin, from epidermis through all layers of the dermis. The fish skin is homologous to human skin in structure and pore size. Because it is ten times as porous as amnion-chorion products, the natural three-dimensional structure of the fish skin encourages significantly more cell ingrowth.

Mechanical properties: Most mammalian tissue-regeneration products require harsh chemical washing to deactivate viruses. During this process, cross-linking often occurs, which alters the natural structures of these products and changes their mechanical properties. This slows cellular ingrowth. Because cold-water cod does not transmit viruses to humans, the Kerecis fish skin needs only gentle processing, avoiding cross-linking and maintaining the skin’s natural mechanical properties. This promotes rapid cellular ingrowth.

Native organization: Optimally, the tissue is built using like-for-like tissue. For example, if heart tissue is being built, native heart tissue should be used as a source material. The Kerecis products are sourced directly from fish skin, providing the native organization of epidermis and dermis for regenerating human skin. Many products on the market are sourced from different tissues such as placenta, bladder or foreskin.

Chemical complexity: Fish skin has the same chemical composition as human skin. Its natural proteins and lipids (which are found in both fish skin and human skin) and its Omega3 fatty acids are retained during processing. In contrast, processed mammalian tissue contains only collagen. Also, fish skin provides a natural bacterial barrier. A study conducted by the Office of Naval Research (ONR) found that Kerecis products are much more resistant to staphylococcus infections than competing products.

The results from Kerecis Omega3-rich fish-skin products speak for themselves. The body typically incorporates the product within 7 to10 days, filling tissue deficits and creating healthy, viable tissue. “Surgeons and wound-care doctors are constantly amazed at how Kerecis helps even their most challenging cases heal,” said Fertram Sigurjonsson. “Often, they use Kerecis for the first time when nothing else has worked. Usually, within 10 days, they are surprised at how well the patient has progressed.”

The Kerecis Omega3 products have other advantages as well. They provide a natural microbial barrier.

Surgeons and wound care center doctors are constantly amazed at how Kerecis helps even their most complicated cases heal

They are non-allergenic, and there are no cultural or religious barriers to usage. The Kerecis products can be stored at room temperature for up to three years. Preparation is simple; the products only need to be rehydrated in saline water. The fish skin’s large, thick sheets are easy to use, mesh-like human skin, and are strong enough to support sutures and staples.

Wound Treatment and Surgical Applications

The Kerecis Omega3 product lines are patented, FDA 510k approved medical devices. These products are used to treat even the most complex cases.

The flagship product, Kerecis Omega3 Wound, is especially designed for transplantation into damaged tissue such as surgical, traumatic or chronic wounds. After debridement of the wound, Kerecis Omega3 Wound is used to manage the tissue-regeneration process and provide a bacterial barrier for the open wound. The product is especially useful for deeper tissue defects where the fish-skin graft provides a thick structure for cell ingrowth.

In surgical procedures such as post-Mohs surgery, trans-metatarsal amputations and wound dehiscence, Kerecis Omega3 Wound has shown extraordinary results. It also demonstrates unprecedented mechanical properties making it easy to mesh, cut, staple, suture and directly bolster onto the wound bed. Kerecis Omega3 Wound is rapidly becoming a powerful standard tool for podiatric, plastic, vascular and trauma surgeons dealing with complex procedures and cases (e.g., limb salvage, full-thickness wounds, abrasions, lacerations and skin tears).
The superior clinical and economical performance of Kerecis Omega3 Wound has been demonstrated in two non-industry-funded, double-blind, randomized clinical trials [2,11] and in numerous other clinical studies[7,8,12-17].

Kerecis Omega3 Burn is a unique solution for burn victims. Because its proteins and fatty acids are similar to human skin, Kerecis Omega3 Burn is typically incorporated into the body quickly, while providing a much-needed bacterial barrier to protect the wound bed. The healing process is faster with the Kerecis products than with competitive products, so patients can be ready for additional tissue building and/or move directly to split-thickness skin grafting in record time.
Kerecis has had several large clinical studies and is building up the scientific basis for its technology. Two studies focusing on diabetic wounds are underway now, one in the U.S. with 50 patients, and the other in France with 200 patients. Kerecis is also pursuing a burn study in the U.S.

“We will continue our research to demonstrate the efficacy of our products. We have the technology to prevent amputations, and our healing fish-skin products can help people regardless of their culture, race, or income,” states Fertram.

The Odd-fish in the Pond

Kerecis is the only company in the world supplying fish skin for these types of medical procedures. Founded in 2013, Kerecis has seen exponential growth and has almost 150 employees today.

The company stands out because of the efficacy of its products and its commitment to the environment. The fish skin comes from wild Atlantic cod, caught from a sustainable fish stock in pristine Icelandic waters. Originally a discarded byproduct of the fishing industry, the fish skin is processed using a proprietary method, which runs entirely on renewable energy.

The company’s value proposition has attracted prominent investors. The third largest shareholder is Laurene Powell Jobs of the Emerson Collective. “Our goal is to grow the company and become the trusted partner of surgeons, health care centres and patients. We are very fortunate that our stakeholders share that vision,” says Fertram.

Kerecis primarily markets the products to hospitals, private clinics and wound care centres. The company has a direct sales force of 50 people and plans to double that number in 2020. Kerecis plans to release products complementary with the existing product line. While the company sells in several markets such as Switzerland, Germany, Iceland, Sweden, and Taiwan, Kerecis focuses on the U.S. market.

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Company
Kerecis

Headquarters
Isafjordur, Iceland

Management
Gudmundur Fertram Sigurjonsson, Founder, President and CEO

Description
Develops and produces fish-skin, skin-substitute products that support the body’s ability to regenerate tissues. The products are used to treat wounds and burns.