Additional time allows Kerecis to contribute new clinical data to ongoing evidence review
Kerecis, the company pioneering the use of sustainably sourced fish skin and fatty acids in cellular therapy and tissue regeneration, welcomes the recent decision by the Centers for Medicare & Medicaid Services (CMS) to postpone the effective date of the proposed Local Coverage Determination (LCD) for Skin Substitute Grafts/Cellular and Tissue-Based Products. The new implementation date is January 1, 2026.
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Kerecis fish-skin MariGen Expanse 7x8 cm
Kerecis products remain fully covered under existing Medicare policies and are supported by strong clinical evidence. Kerecis intact fish-skin grafts have shown exceptional outcomes across a range of chronic and complex wounds, including those with exposed bone and tendon.
With the proposed LCDs not finalized, current MAC-specific coverage policies will remain in place through 2025. This includes broad coverage under the Novitas and FCSO LCDs for products with demonstrated clinical effectiveness. In jurisdictions without specific LCDs, the standard of “reasonable and necessary” continues to apply.
As scrutiny around skin substitute utilization increases, particularly in light of recent audit activity, providers should expect greater attention to documentation and the clinical justification for product selection. Kerecis supports CMS’s focus on evidence-based care and continues to distinguish itself through rigorous clinical research and responsible product use.
The decision to postpone follows an administrative review process associated with the transition to a new CMS administration. Kerecis views this delay as an opportunity to contribute updated clinical evidence, including findings from recent studies on venous leg ulcers, ischemic ulcers, post-Mohs wounds, and pressure ulcers.
“The postponement provides a meaningful opportunity for Kerecis to share additional clinical data, including results from the largest skin substitute randomized controlled trial on diabetic foot ulcers with exposed bone or tendon done to date,” said Fertram Sigurjonsson, Founder and CEO of Kerecis. “It also allows us to present data on our latest product innovations.”
Kerecis remains committed to collaborating with CMS and supporting policies that prioritize patient outcomes and the use of clinically validated products.
About Kerecis
Kerecis, founded by Fertram Sigurjonsson, develops fish skin and fatty acid 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 disease-transfer risk exists between cold-water fish and humans, the Kerecis fish-skin is only gently processed and retains its similarity to human tissue. The gentle processing preserves the skin’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-skin and is the fastest growing company in the U.S. biologics skin market. Products include SurgiBind®/SuriClose®, GraftGuide®, MariGen®, and Shield™ for various medical applications. 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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