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Kerecis Fish Skin Grafts

The only intact fish skin graft backed by 90+ peer-reviewed studies, the landmark Odinn Trial, and coverage for nearly 200 million Americans

90+
Peer-Reviewed Studies
~200M
Americans Covered
255
Patients in Odinn Trial
0.88%
Infection Rate (114 pts)
What is Kerecis?

The Market Leader in Fish-Skin Wound Care

Kerecis pioneered the use of intact Atlantic cod fish skin as an advanced biological scaffold for wound management and tissue regeneration — now part of Coloplast, a global leader in medical devices.

Kerecis Omega3 Wound fish skin graft close-up showing natural collagen matrix texture

Intact Fish Skin — Gently Processed, Clinically Proven

Because no known viral transfer risk exists between North-Atlantic cod and humans, Kerecis fish skin is only gently processed using the proprietary EnviroIntact™ method — preserving the skin's natural three-dimensional structure, mechanical properties, molecular organization, and lipid composition. This makes Kerecis products homologous to human skin, unlike mammalian grafts that require harsh antiviral treatment that strips away beneficial components.

  • Intact acellular matrix with preserved collagen, elastin, and glycosaminoglycans
  • Rich in natural omega-3 fatty acids (EPA and DHA) that activate anti-inflammatory pathways
  • Validated IFU allowing use over exposed bone and tendon
  • FDA-cleared since 2013 with 90+ peer-reviewed publications
  • Now covered by Medicare and major commercial insurers including Anthem BCBS, Humana, and Cigna
"I don't know what I would have done or where I would be without Kerecis."
— Alana Smith, Kerecis Patient
Mechanism of Action

The Four Hallmarks of Kerecis Tissue Regeneration

Kerecis' patented fish skin is gently processed, preserving its homologous structure to human skin. These four hallmarks are recognized as optimal traits for a tissue replacement product.

Fish skin structural matrix showing intact molecular organization

Intact Molecular Organization

Fish skin is homologous to human skin, with a comparable pore structure that facilitates rapid cellular ingrowth. The gentle EnviroIntact™ process preserves the native extracellular matrix architecture — including the natural arrangement of collagen fibers, elastin, and glycosaminoglycans — creating an ideal scaffold for host cell infiltration and tissue formation.

Atlantic cod from Iceland — source of omega-3 rich fish skin

Preserved Molecular Content

Because there is no need for harsh antiviral processing, the chemical complexity of the fish skin is preserved — including omega-3 polyunsaturated fatty acids (DHA and EPA) that activate specialized pro-resolving mediator (SPM) pathways. These reduce IL-1β production from macrophages, resolving inflammation while promoting healing. Fish skin has been shown to facilitate 20x more cell ingrowth than amniotic tissue.

Kerecis fish skin graft being applied in clinical setting

Three-Dimensional Structure

The intact structure of the fish skin provides a framework to support tissue regeneration. The natural porosity enables rapid ingrowth of fibroblasts (connective tissue) and blood vessels. When grafted onto a wound, human cells migrate into the fish skin pores and start forming connective tissue and facilitating neovascularization. The body incorporates the fish skin within 5–7 days.

Kerecis manufacturing in Isafjordur, Iceland

Natural Mechanical Properties

Kerecis fish skin is naturally strong, handles like skin, and is easy to suture or staple. It provides an immediate natural microbial barrier that protects against environmental insults while the wound transitions from the inflammatory to proliferative phase. The product resists shearing forces, allowing early physiotherapy — particularly important in burn management.

Patented Manufacturing

The EnviroIntact™ Process

A proprietary 7-step method that preserves the capability of nature — gently processing Atlantic cod skin from Icelandic waters into a powerful regenerative medical device.

Harvesting

Fresh Atlantic cod fish skins are collected as a by-product of food processing from local fishing companies in Ísafjörður, Iceland. Only the best quality skins are chosen. No fish is caught solely for its skin.

Washing & De-Scaling

All mucus is removed and the skins are descaled. Because Atlantic cod poses no risk of viral transmission to humans, the cleaning process is gentle — preserving beneficial components that harsh mammalian tissue processing destroys.

Decellularization

The intact fish skins undergo decellularization — removing fish cells without damaging or denaturing the natural matrix structure, lipid content, or biochemical composition.

Lyophilization

The prepared skins are freeze-dried under vacuum, removing all water while preserving structural integrity and bioactive properties.

Precision Cutting

Skins are cut using precision carbide-tipped cutters. This also enables perfect meshing of expandable sizes and production of unique shapes like the hand-shaped Mano product for burn management.

Sterilization

Products undergo certified sterilization in accordance with international standards.

Labeling & Shipping

Products follow all regulatory and statutory protocols, then are boxed, packed, and shipped to customers worldwide. Full traceability is maintained from the exact ocean location where the fish was caught through to the finished product.

Product Lines

Kerecis Solutions for Every Wound Type

Five specialized product lines engineered for specific clinical indications and wound characteristics, available in multiple configurations.

Kerecis MariGen product being applied to wound
Chronic & Acute Wounds

Kerecis MariGen®

Flagship product for head-to-toe management of chronic and acute wounds. Intact fish skin available in various sizes for DFUs, VLUs, pressure ulcers, surgical wounds, and trauma.

Variants: Solid, Micro (fragmented for irregular geometries), Fenestrated, Expanse (pre-meshed 2:1 for wounds 100+ cm²)

Billing: HCPCS Q4158 — $127.14/cm² (2026 Medicare)

Kerecis Shield with integrated silicone contact layer
Office-Based / DFUs

Kerecis Shield®

Intact fish skin with integrated silicone contact layer, designed for physician office use. Fenestrated graft with large-pore silicone for optimal exudate management. Protects the graft from sticking to dressings and speeds up application workflow.

Variants: Standard (50mm), Adhesive (30mm, 15mm), Spiral (30mm, 80mm)

Billing: HCPCS A2019 (Shield Adhesive) — $127.14/cm² (2026 Medicare)

Kerecis GraftGuide packaging for burn wound management
Burns & Trauma

Kerecis GraftGuide®

Optimized for burn and surgical wound management. Adheres to wounds in various shapes and sizes including mobile joints, resists shearing forces for early physiotherapy, and supports restoration of skin pigmentation with minimized scarring.

Variants: Solid, Micro, Mano (hand-shaped in L/R, Medium/Large), Meshed 2:1

Application Methods: Secondary Intention, Bridging, Primary Closure (Alexander method)

Kerecis SurgiClose for surgical wounds
Surgical Wounds

Kerecis SurgiClose®

Specialized for surgical and trauma wound closure including post-Mohs wounds, donor sites, podiatric surgery, and wound dehiscence.

Variants: Standard, Silicone (4 new sizes), Micro, Meshed 2:1

Kerecis SurgiBind for soft tissue reinforcement and tendon protection
Soft Tissue & Tendon

Kerecis SurgiBind®

For soft tissue reinforcement, grafting, and tendon protection. Fish skin has been shown to facilitate 20x more cell ingrowth than amniotic tissue and promotes revascularization faster than mammalian-sourced tissue.

Variants: Solid, Fenestrated, Tendon Protect (for newly repaired tendons)

Sizes: 3x5 cm to 7x20 cm; Fenestrated up to 250 cm²

"I use SurgiBind Tendon Protect to help protect newly-repaired tendons. It gives me peace of mind that the repair will last."
— Dr. Christopher Winters, DPM
Clinical Evidence

90+ Peer-Reviewed Studies — Including the Landmark Odinn Trial

Kerecis has the most robust clinical evidence base of any fish skin graft product, including multiple randomized controlled trials demonstrating faster healing and superior outcomes.

The Odinn Trial (NEJM Evidence, 2024)

The largest randomized controlled trial ever conducted on DFUs with exposed bone or tendon. This landmark study enrolled 255 patients at 15 care centers across four countries, filling a critical void in clinical evidence for complex diabetic foot ulcer management. Published in the New England Journal of Medicine Evidence.
Dardari D, Piaggesi A, Potier L, et al. Intact Fish Skin Graft to Treat Deep Diabetic Foot Ulcers: The Odinn Trial. NEJM Evid. 2024 Oct 4. DOI: 10.1056/EVIDoa2400148

Diabetic Foot Ulcers

Dardari et al. (2025) demonstrated 41.6% complete wound closure with Kerecis MariGen at 16 weeks in diabetic foot ulcers, compared to 22.2% with standard care — an 87% improvement in healing outcomes.
Dardari et al., 2025. Diabetes & Metabolism. Complete wound closure: MariGen 41.6% vs. Standard Care 22.2% at 16 weeks
Tan & Chng (2025) reported 100% healing rate in 6 diabetic foot ulcer patients when Kerecis MariGen was combined with negative pressure wound therapy (NPWT), demonstrating synergistic treatment approaches.
Tan & Chng, 2025. Cureus. Six DFU patients achieved 100% healing using combined Kerecis + NPWT protocol

Ischemic and Complex Wounds

Lee et al. (2024) demonstrated 82% healing success in ischemic wounds treated with Kerecis compared to 45% with standard care, highlighting effectiveness in difficult-to-heal ischemic tissues.
Lee et al., 2024. Journal of Wound Care. Ischemic wound healing: Kerecis 82% vs. Standard Care 45%

Burn Wound Management

Heitzmann et al. (2025) found that Kerecis GraftGuide reduced healing time to 17 days compared to 23 days with alternative burn treatments — representing 26% faster healing.
Heitzmann et al., 2025. Burns. Kerecis-treated burns: 17 days vs. 23 days for standard burn care
Heitzmann et al. (2026) published data showing superior scar quality at 12 months post-injury in patients treated with Kerecis GraftGuide compared to Suprathel, a commonly used synthetic alternative.
Heitzmann et al., 2026. Journal of Burn Care Research. Scar quality favoring GraftGuide over Suprathel at 12-month follow-up

Safety and Biocompatibility

Ivana & Sanjaya (2025) systematically reviewed infection rates across 114 patients in 6 studies using Kerecis products — documenting only 1 infection across the entire cohort (0.88% infection rate).
Ivana & Sanjaya, 2025. European Burn Journal. Systematic review: 1 infection in 114 patients (0.88%)
Magnusson et al. (2018) demonstrated that Kerecis fish skin showed no autoimmune response in recipients and demonstrated superior biocompatibility compared to porcine-derived acellular dermal matrices.
Magnusson et al., 2018. International Journal of Lower Extremity Wounds. No autoimmune response; superior immunogenicity profile vs. porcine
View Full Evidence Library
Real-World Outcome

Case Study: Diabetic Foot Wound

A complex DFU managed with Kerecis MariGen — from sepsis to complete healing.

Treating Physician: Sang Hyub Kim, DPM

Patient: 58-year-old male with type II diabetes. Previously treated for two months for right foot sub-4th metatarsal head ulcer. Presented to the emergency room febrile and septic — wound was draining and positive for ecchymosis, edema, and erythema. Initial treatment included repeat surgical incision and drainage, 4th metatarsal head resection, and application of antibiotic beads.

Treatment Timeline

December 7, 2021

Post incision and drainage. Antibiotic beads removed and excisional debridement performed to deep, healthy granulation tissue and tendon/muscle.

December 15, 2021

MariGen Micro and MariGen Fenestrated applied (15.0 cm × 5.0 cm × 3.0 cm wound) with wound VAC therapy.

January 12, 2022 — 1-Month Follow-Up

Significant improvement in wound depth (12.5 cm × 3.5 cm × 1.5 cm). No sign of local infection. Continued weekly wound VAC changes, debridement, and 2 additional MariGen applications.

5 Months Post-Initial Application

Advanced skin flap performed.

June 13, 2022 — Final Presentation

Three weeks after skin flap and 3 total MariGen applications — surgical incision completely healed. Patient returned to normal activities.

Reimbursement & Coverage

Broad Coverage. Real-Time Eligibility.

Kerecis products are covered by Medicare, Medicaid, and major commercial insurers — with approximately 150 million Americans now eligible for private insurance coverage in addition to existing Medicare coverage.

Commercial Coverage: Anthem BCBS, Humana, and Cigna have rated Kerecis MariGen as "medically necessary" for DFUs that have not healed with standard therapy. Combined with Medicare, this means nearly 200 million Americans are now covered.
Kerecis Current™ Tool: Clinicians can instantly confirm patient eligibility through their EMR systems — no guessing, no delays. Real-time benefit verification and prior authorization support.

2026 Medicare Payment Rates

Setting CPT Code Wound Size 2026 Application Rate Product Rate (Q4158)
HOPD 15271 / 15275 < 100 cm² $755.08 $127.14/cm²
HOPD 15273 / 15277 > 100 cm² $2,107.97 $127.14/cm²
ASC 15271 < 100 cm² $404.93 $127.14/cm²
ASC 15273 / 15277 > 100 cm² $1,128.57 $127.14/cm²
Physician Office MariGen (Q4158) / Shield Adhesive (A2019) $127.14/cm²

Reimbursement Support Hotline

The Kerecis Reimbursement Hotline team works closely with providers throughout benefit verification and prior authorization.

Phone: 844-KERECIS (844-537-3247)

Email: reimbursement@kerecis.com

Competitive Advantages

Why Choose Fish Skin Over Alternatives?

Kerecis offers distinct biological, clinical, and practical advantages compared to mammalian grafts, synthetics, and human-derived tissue products.

Fish Skin vs. Mammalian & Human-Derived Grafts

  • No Viral Transfer Risk: No known viral or prion disease transfer from North-Atlantic cod to humans — eliminating the need for harsh antiviral processing that strips natural components from porcine and human tissue
  • 20x Cell Ingrowth: Fish skin graft facilitates 20x more cell ingrowth than amniotic tissue and promotes revascularization faster than mammalian-sourced tissue
  • Preserved Bioactivity: Gentle processing retains omega-3 fatty acids, natural porosity, and 3D matrix structure that harsh processing destroys in competing products
  • No Autoimmune Response: Superior biocompatibility confirmed in clinical studies (Magnusson et al., 2018) — safe for immunocompromised patients
  • No Cultural Barriers: No religious or cultural barriers to clinician/patient acceptance, unlike porcine or cadaveric products

Fish Skin vs. Synthetic Alternatives

  • Bioactive vs. Inert: Unlike synthetics, fish skin actively promotes cellular ingrowth and vascularization through native bioactive compounds
  • 26% Faster Burn Healing: Burns treated with GraftGuide heal in 17 days vs. 23 days for synthetics like Suprathel
  • Superior Scar Quality: Better long-term cosmetic outcomes at 12 months — supports restoration of skin pigmentation
  • Multi-Mechanism Action: Combines structural support, anti-inflammatory signaling via omega-3 SPM pathways, and antimicrobial protection — synthetics address only one
Clinical Indications

Comprehensive Wound Type Coverage

Kerecis products are FDA-cleared for a wide spectrum of acute and chronic wounds, including wounds with exposed bone and tendon.

Wound Category Specific Indications Recommended Product
Diabetic Foot Ulcers DFUs including those with exposed bone or tendon; wounds not healed with standard therapy Shield (office), MariGen (HOPD/ASC)
Chronic Wounds Venous leg ulcers, pressure ulcers, chronic vascular ulcers, stasis ulcers, draining wounds MariGen, MariGen Expanse (100+ cm²)
Burn Wounds Second-degree (partial-thickness) burns, full-thickness burns, including mobile joints GraftGuide (Solid, Mano, Meshed)
Surgical Wounds Post-Mohs surgery, donor sites, podiatric surgery, post-laser surgery, wound dehiscence SurgiClose, MariGen
Trauma & Acute Abrasions, lacerations, skin tears, puncture wounds SurgiClose, MariGen
Tendon & Soft Tissue Tendon protection post-repair (Achilles, etc.), soft tissue reinforcement, plastic/reconstructive surgery SurgiBind, SurgiBind Tendon Protect
Complex Wounds Ischemic wounds, exposed structures (bone/tendon), refractory wounds MariGen + adjunctive therapy
Sustainability

From Waste to Value

Kerecis transforms what was once food-industry waste into life-saving medical devices — powered entirely by clean energy in one of the most pristine environments on Earth.

Upcycled Material

Cod fish skin was previously discarded as food processing waste. Kerecis utilizes only ~0.04% of Iceland's Atlantic cod supply, and no fish is caught solely for skin production.

Pristine Source Waters

All fish are wild-caught in the regulated, sustainable Arctic waters off Ísafjörður, Iceland. Full traceability from exact catch location through to finished product.

100% Clean Energy

The entire biotech manufacturing facility runs on green geothermal and hydro power. Fish skins are washed with mountain spring water. No harsh chemicals are used.

Patient Stories

Real Patients. Real Outcomes.

Kerecis fish skin grafts have prevented thousands of amputations, improved quality of life, and potentially increased life spans.

"Without Kerecis, he would probably not be alive today."
— Sigurlín, wife of patient Pétur Oddsson
"You are going from an invalid to pretty much back to normal."
— Robert Bellschmied, Kerecis Patient
"I am healed from the top of my head to the bottom of my foot. We are on the road again!"
— Chester Kitt, Kerecis Patient
"Shield is super easy to bill using our A code... it's easy to just stick, bandage, and go! In fact, we can see a couple more patients per day because of the time it saves us!"
— Natalie, Physician Assistant in Florida

Patients can track their healing journey with the Kerecis KERS Patient App — featuring week-by-week recovery information and resources.

Frequently Asked Questions

Common Questions About Kerecis

Kerecis uses the proprietary EnviroIntact™ 7-step process on Atlantic cod fish skin from sustainable fisheries in Iceland. Because no known viral transfer risk exists between North-Atlantic cod and humans, the fish skin only needs gentle processing — unlike mammalian tissues that require harsh antiviral treatment. The 7 steps are: harvesting from certified food producers, washing and de-scaling, decellularization (removing fish cells without denaturing the matrix), lyophilization (freeze-drying), precision cutting, sterilization to international standards, and labeling/shipping. This gentle approach preserves the skin's natural 3D structure, omega-3 fatty acids, porosity, and biochemical composition — making it homologous to human skin.

No. Per the manufacturer's contraindications, Kerecis products are derived from fish sources and should not be used in patients with a known allergy to fish or sensitivity to fish products. Note that fish allergy is distinct from shellfish allergy — a shellfish allergy alone is not a contraindication. Additionally, SurgiClose Silicone and Shield products contain silicone and are not suitable for patients with silicone sensitivity. Always consult the product labeling for the full list of contraindications.

Application depends on the product and wound type. The wound must first be properly debrided with exudate controlled and bleeding managed. For GraftGuide (burns/surgical), there are three methods: Secondary Intention (accelerate full epithelialization), Bridging (prepare a healthy wound bed for a subsequent auto/allograft), and Primary Closure using the Alexander method (apply over a highly-meshed STSG). Shield products (office-based) are designed for quick application — the integrated silicone contact layer protects the fish skin graft, and the adhesive variant keeps it in place. The silicone can be removed without pulling the graft from the wound. It takes approximately 5–7 days for the body to incorporate the fish skin, eliminating painful device removal and dressing changes. Multiple applications may be needed for complete healing.

Yes — Kerecis has extensive coverage. Medicare reimburses MariGen using HCPCS code Q4158 at $127.14 per sq cm (2026 rate), and Shield Adhesive uses code A2019 at the same rate. Application is reimbursed using CPT codes 15271–15278 depending on wound size and site of service. In addition to Medicare, approximately 150 million Americans now have commercial insurance coverage through Anthem BCBS, Humana, and Cigna, which have rated Kerecis MariGen as "medically necessary" for DFUs not healed with standard therapy. Clinicians can use the Kerecis Current™ tool to instantly verify patient eligibility through their EMR. The Kerecis Reimbursement Hotline (844-KERECIS / 844-537-3247) provides benefit investigation, prior authorization support, and fee schedule information.

The Odinn Trial is the largest randomized controlled trial ever conducted on diabetic foot ulcers with exposed bone or tendon — a wound type that historically had very limited clinical evidence. The study enrolled 255 patients at 15 care centers across four countries and was published in the New England Journal of Medicine Evidence in October 2024. This landmark study filled a critical void in the evidence base for complex DFU management, demonstrating the efficacy and safety of intact fish skin graft treatment for the most challenging diabetic wounds.

Three key differences: First, because no viral transfer risk exists between cod and humans, Kerecis fish skin is gently processed — preserving the natural 3D structure, omega-3 fatty acids, and biochemical complexity that harsh processing destroys in mammalian and human tissue products. Second, fish skin facilitates 20x more cell ingrowth than amniotic tissue and promotes faster revascularization than mammalian tissue. Third, the natural omega-3 content (EPA and DHA) activates specialized pro-resolving mediator pathways that actively reduce inflammation — a biological mechanism that synthetic products completely lack. There are also no cultural or religious barriers to using fish skin, unlike porcine or cadaveric products.

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Contact Sunspot Medical Group in Las Cruces, NM to discuss Kerecis products for your patients or facility. We can assist with product samples, ordering, insurance verification, and clinical training.

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Patient Disclaimer: Kerecis fish skin grafts are prescription medical devices that should only be applied by medically trained physicians after proper wound preparation including debridement. The information on this page is for educational purposes and does not constitute medical advice. Individual outcomes depend on wound characteristics, patient factors, application technique, and comprehensive wound care management.

Contraindications: Products should not be used in patients with a known allergy to fish or sensitivity to fish products. Do not apply over infected or deteriorating wounds until the underlying cause has been resolved. SurgiClose Silicone and Shield products are not suitable for patients with silicone sensitivity. SurgiBind is not indicated for load-bearing support. Always follow product labeling for complete indications and contraindications.

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