CMS Confirms Coverage of Kerecis Fish-Skin Products by Medicare
November 14, 2024
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Kerecis Fish Skin for Tissue Regeneration
Kerecis produces it’s medical device classified fish skin grafts from Atlantic cod fish skin.
Kerecis fish skin is used to support tissue regeneration in surgical, traumatic, chronic and acute wound applications, including burns.
Kerecis fish skin is the only the only approved manufacturer of fish skin-based medical devices for tissue regeneration in the world.
Kerecis medical device products are authorized for sale in the United States, Europe, South-America, Asia and several other jurisdictions. Thousands of patients are treated annually with the Kerecis technology.
Kerecis fish skin grafts are not available over the counter. Effective wound preparation, including debridement, prior to application of the medical fish skin is crucial for the healing to start. Therefore, Kerecis fish skin grafts are only to be applied by medically trained physicians.
Kerecis is a part of Coloplast A/S
Kerecis fish skin provides the ideal environment to help facilitate tissue regeneration. Oddly enough, cod skin is thought to be homologous to the human skin in two important aspects: Firstly, it appears to have a similar structure with distinct layers (i.e., dermis, epidermis, and subcutaneous tissue). Secondly, the porosity of the two types of skin are comparable; an important aspect for cellular ingrowth of human cells into the graft.
Kerecis fish skin grafts are strong and robust grafts, making them an ideal skin replacement.
The cod skin is mildly processed, which means that many of the favorable elements of the fish skin such as its 3 dimensional and biochemical structure remain largely intact. More detail on that below.
When grafted onto a bleeding wound, the human cells migrate into the Kerecis fish skin pores.
Because of the similarity between the human skin and the fish skin, the human cells penetrate the fish skin and start the formation of fibroblasts, (the connective tissue) and facilitating creation of blood vessels.
This way the human body incorporates the Kerecis fish skin, where the fish skin offers elasticity.
When grafted onto damaged human tissue, such as a burn or a wound, the fish skin recruits the body’s own cells, supporting the body’s own ability to regenerate.
It takes about 5-7 days for the body to incorporate the Kerecis fish skin, eliminating device removal and painful dressing changes.
Note that, In some cases, it may take more than one application of Kerecis fish skin to fully heal a wound.
I don’t know what I would have done or where I would be without Kerecis.
– Alana Smith
Kerecis fish skin grafts have a composition and structure that closely resembles human skin. The similar pore sizes allow human cells to easily grow into the graft and support the healing process. (See picture below).
The ideal pore size of Kerecis fish skin enables rapid ingrowth of fibroblasts (the connective tissue) and blood vessels.
Kerecis fish skin grafts are gently processed, intact cod fish skin. The cod skin naturally contains fat, protein, elastin, glycans and other skin elements that are essential building blocks for wound management. The gentle processing of the fish skin means that the skin retains all of these useful elements that help the healing process but at the same time ensuring that the structure of the skin stays intact.
There is no known risk of viral disease transfer from cod to humans.
Given the low viral transfer risk the manufacturing process can be very mild and no harsh chemicals, alcohol or detergents are required to process the fish skins. Such cleaning chemicals would also remove many of the favorable substances in the fish skin and disrupt its natural structure and porosity.
There are no known religious or cultural barriers associated with usage of fish skin. As such, it is considered to be helpful for diverse communities.
The Atlantic cod used for Kerecis fish skin grafts, lives wild in the cold sea around Iceland. The reason Kerecis does not use farmed fish is that these are often given antibiotics and there is a risk of these remaining in the skin, unless they undergo harsh processing.
The fish skin used to be thrown away as waste but now Kerecis uses it to create a valuable medical device.
If every wound in the U.S. would be healed with skin from the Atlantic cod only 0,04% of the Icelandic cod stock would be needed. Furthermore no cod is caught simply for its skin. Kerecis sources the skin only from cod that has been sustainable fished for certified food producers.
The state of the pristine ocean around Iceland is very well monitored, and each fish can be traced to the exact location of where it was caught. This means that if any deviation from the quality standards of the fish stock is detected in any location around Iceland it can be traced all the way back to a single fish.
Kerecis creates a broad range of product variations. These products are available in different shapes and sizes, and some are fenestrated, meshed, or even fragmented for use in irregular wound surfaces. The variety reflects the multiple applicability of the product for supporting tissue regeneration management of traumatic, chronic and acute wounds, including burns.
The biggest thing for me is knowing that I am going to have a life back on stage again.
– Frank Torres
As a child the Kerecis founder and CEO Fertram Sigurjonsson, worked in a fish factory at a de-skinning machine for cod in Ísafjörður, (“Easafjorthur”) a small fishing village in North West of Iceland. Later, he went on to work for a prosthetic company, where he learned about the seriousness of amputations. There, he was assigned the task of trying to heal wounds that resulted from the constant friction between the artificial limb and the residual limb.
Having tested various skin replacements, he tried human skin. To his surprise, the human skin felt similar in texture and strength to the skin he used to handle as a kid at the de-skinning machine.
Fertram then successfully applied for a research grant to investigate the similarities between human skin to cod skin. The similarities turned out to be striking.
Following his entrepreneurial insight/spirit, he left the job at the prosthetics firm to found Kerecis, and set up a small research lab in Isafjordur.
This research lab developed into a full blown biotech manufacturing facility. To this day, Kerecis produces all of its renown medical fish skin products in Isafjordur and now employs more than 600 people globally.
The name Kerecis is inspired by the words “keratin” (a principal constituent of the top layer of the skin) and “genesis” (which means formation).
To become the world leader in tissue regeneration by sustainably harnessing nature’s own remedies.
To extend life by supporting the body’s own ability to regenerate.
Without Kerecis, he would probably not be alive today.
– Sigurlín, wife of patient Pétur Oddsson
The cod fish skin used for this medical device used to be food industry waste and thrown away.
Now, Kerecis turns it into a valuable skin graft to heal wounds and improve lives all over the world.
Not a single fish is caught only for the production of the fish skin grafts.
Kerecis manufactures in the small fishing village of Ísafjörður in the Westfjords of Iceland.
Our source, the Icelandic fisheries, operate in pristine arctic waters and are highly regulated and sustainably managed and certified.
There is full traceability of each catch through to the Kerecis product, starting at the exact location where the fish was caught.
Kerecis’s entire biotech production facility runs on green energy; a combination of geothermal and hydro power to be exact.
All fish skins are washed, cleaned, and rinsed with mountain spring water.
No harsh chemicals are used to create the medical fish skins, leaving minimal chemical waste from the operation.
Designed exclusively for patients, this App is the go-to source during their healing journey.
Learn how Kerecis can help you at each stage of the healing process.
Check the App for useful week-by-week information which may assist you during recovery.
You are going from an invalid to pretty much back to normal.
– Robert Bellschmied
Do you have an experience with Kerecis products as a patient or a caregiver? Tell us your story! If you need any further information on our products or services, please contact us here. Please abide HIPAA rules and do not share any sensitive information on medical history or condition.
I am healed from the top of my head to the bottom of my foot. We are on the road again!
– Chester Kitt
The product and its variations are not available in all countries and may be known under different trade names. Products, product names, indications and claims vary between jurisdictions. Contact your Kerecis representative if you have questions about the availability of Kerecis products in your area.
Always make sure to check with your local health care professional and read the actual printed package information prior to use. Information on this website might not be current and might not be an accurate reflection of current product labeling.
This website is not intended to provide diagnosis, treatment or medical advice. Products, services, information and other content provided on this website, including information that may be provided on directly or by linking to third-party websites, are provided for informational purposes only. Information on this website should not be considered as a substitute for advice from a healthcare professional.
Consult with a physician or other healthcare professional regarding any medical or health related diagnosis or treatment options.
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