Recent policy inclusions across leading U.S. insurers expand access to intact fish‑skin grafts and reinforce their role in treating complex wounds at scale
ARLINGTON, Va. & REYKJAVIK, Iceland–(BUSINESS WIRE)–#kerecis–Kerecis, the company pioneering the use of sustainably sourced fish‑skin grafts in cellular therapy and tissue regeneration, today announced a significant expansion in U.S. insurance coverage, adding more than 40 million covered lives through recent policy updates across multiple large national and regional insurers, as well as state Medicaid programs.
The expansion marks a meaningful step in the mainstream adoption of fish-skin grafts, with Kerecis now included in policy frameworks informed by the Blue Cross Blue Shield Association (BCBSA), a national umbrella organization representing more than 30 independent health plans. Several affiliated plans have already begun adopting updated policies, with additional plans expected to follow over the coming months as reimbursement pathways continue to align with evolving clinical practice. Kerecis now ranks in the top-two widest covered skin substitute for diabetic foot ulcers (DFUs).
“We are seeing a clear shift in how payors evaluate biologic solutions,” said Fertram Sigurjonsson, Founder, CEO, and Inventor at Kerecis and Coloplast Executive Vice President. “Coverage decisions are increasingly grounded in clinical outcomes, practical applicability, and the ability to reduce downstream burden on the healthcare system. That is where fish‑skin grafts are resonating.”
Kerecis’ intact fish‑skin grafts are designed to preserve the natural structure of the tissue, supporting cellular ingrowth and tissue regeneration. Unlike heavily processed or synthetic materials, fish skin maintains structural and biochemical components that enable efficient wound‑bed preparation and reliable progression toward closure.
“Securing these policy inclusions is a direct reflection of our targeted clinical trial strategy and the undeniable biological advantages of intact fish skin,” said Gunnar Johannsson, MD, Senior Vice President and Medical Director at Kerecis. “Major payors demand definitive evidence that a biologic solution reliably advances tissue regeneration. Our data establishing efficacy in the most severe ulcers sets a new clinical benchmark, and that clear differentiation is driving these coverage decisions.”
“Coverage determines whether innovation is actually used,” Sigurjonsson added. “What we are seeing now is access catching up with clinical experience. That is when adoption accelerates.”
The expansion of commercial coverage carries heightened strategic importance as enrollment in Medicare Advantage plans continues to rise nationwide, now accounting for more than half of the total Medicare population. Because Medicare Advantage plans frequently align their clinical coverage criteria with their parent organization’s commercial medical policies, Kerecis’ new commercial inclusions significantly multiply actual patient access across both private and government-sponsored segments.
In parallel, Kerecis has also in recent months seen expanded access through Medicaid programs across multiple states, including Illinois, Kentucky, Missouri, Delaware, West Virginia, Connecticut, South Carolina, and Michigan, broadening availability of fish-skin grafts to nearly all state Medicaid plans.
Kerecis is now one of a limited number of biologic graft solutions included in these policies, reflecting increased payor confidence in both the clinical performance and practical value of intact fish skin in tissue regeneration.
Kerecis has not only met the clinical evidence standards of other products but has established a new benchmark for advanced wound care. Recent clinical data demonstrates the efficacy of intact fish-skin grafts in treating the most severe DFUs, specifically those with exposed bone and tendon. The Odinn randomized controlled trial, focused on complex DFUs with exposed structures, found that 44% of wounds treated with intact fish-skin grafts healed at 16 weeks compared to 26.4% with the standard of care. By providing definitive, high-quality evidence that the biologic solution heals severe wounds with exposed bone, joint, or tendon faster than the standard of care, Kerecis has delivered the critical differentiation insurers require to add a new product to their covered lists.
This milestone further strengthens Kerecis’ position in the U.S. and reflects a broader trend toward evidence‑driven reimbursement for biologic solutions that combine clinical outcomes with operational simplicity.
About Kerecis
Kerecis, founded by Fertram Sigurjonsson, develops intact fish-tissue derived products for cellular therapy, tissue regeneration, and protection. When grafted onto damaged human tissue or implanted, the patented material supports the body’s own processes to heal and regenerate. Because no viral or prion transfer risk exists between Atlantic cod and humans, Kerecis products are only gently processed and retain their similarity to human tissue. The gentle processing preserves the material’s original three-dimensional structure, maintaining its inherent natural strength, complexity, and molecules (such as fatty acids). Clinical studies show that Kerecis products heal wounds faster than competitors. Kerecis is the only global manufacturer of medical devices containing intact fish-tissue and is the fastest growing company in the U.S. xenograft biologics skin market. Products include SurgiBind®/SuriClose®, GraftGuide®, MariGen®, and Shield™, MariCell®, MariGraft™, MariSurgi™ that address various medical complications. Committed to the UN Sustainable Development Goals, Kerecis uses sustainably sourced Icelandic fish processed with renewable energy. Kerecis is a part of Coloplast, a leading supplier of intimate healthcare products. For more information about Kerecis and its clinical research, visit www.kerecis.com.
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