Two of 18 CMS-Covered Skin Substitute Products are Medical-Fish-Skin Grafts from Kerecis

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ARLINGTON, Va. & REYKJAVIK, Iceland--(BUSINESS WIRE)--Dec 16, 2025--

Kerecis, the company pioneering the use of sustainably sourced fish-skin in cellular therapy and tissue regeneration , welcomes the Centers for Medicare & Medicaid Services’ (CMS) announcement of final Local Coverage Determinations (LCDs) for skin substitutes, effective January 1 st, 2026.

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GraftGuide Meshed: Photo provided by Kerecis

In final guidance issued December 15, 2025, CMS confirmed sweeping updates of LCDs for skin substitutes used to treat diabetic foot and venous leg ulcers. The updated LCDs, adopted by all the seven Medicare Administrative Contractors, significantly narrow Medicare coverage to 18 evidence-based products nationwide, marking a major shift from prior policies that covered 340 products.

Importantly, two of the 18 covered products, MariGen ® and Shield ®, are Kerecis medical fish-skin grafts, highlights the strength of Kerecis’ clinical evidence and long-standing commitment to outcomes-driven wound care.

The 18 covered products will be reimbursed at a standardized rate of $127/cm², as previously announced by CMS on October 31, 2025. This unified payment approach is designed to reduce variability across sites of care, eliminate pricing-driven treatment decisions, and allow clinicians to focus on selecting the most appropriate therapy for each patient.

Notably, CMS indicates that seven of the 18 covered products, including MariGen ®, are currently priced at or below the standardized $127/cm² rate, reinforcing CMS’s emphasis on predictable, efficient reimbursement aligned with clinical value.

“These final LCDs remove long-standing uncertainty around payment and coverage for skin substitutes,” said Fertram Sigurjonsson, Coloplast EVP of Wound & Tissue Repair and founder and CEO of Kerecis . “Being two of only 18 covered products nationwide reflects the strength of our clinical evidence and makes Kerecis an easy partner for providers. Offering predictable access, consistent reimbursement, and clinically efficient solutions that deliver reliable outcomes.”

In addition to the list of the 18 covered products, CMS has introduced two other categories, a discretionary MAC product category and non-covered product category. The discretionary MAC product category contains 154 products that will remain eligible for payment at the MACs’ discretion on a case-by-case patient basis, subject to detailed documentation of the medical necessity of prescribing those products rather than one of the 18 products in the covered category. Products in this category will be reimbursed at the same standardized rate of $127/cm² during a 12 month status quo period. At the end of the 12 month period the MACs will conduct a formal evidence review of the products in the discretionary category and consider if some of them should be moved to the list of covered products, with a revised LCD expected in early 2027. A new Kerecis product, MariGen ® Pacto, is included in the 12-month discretionary category. This placement aligns with expectations for a product supported by ongoing and planned clinical studies. Kerecis will continue to generate high-quality clinical evidence over the coming year in preparation for a future commercial launch, the timing of which has not yet been announced.

The standardized $127/cm² reimbursement rate, combined with aligned national LCDs and site-of-service neutrality under the CY 2026 OPPS and PFS rules, creates a more predictable environment for clinicians and healthcare systems. Providers can now plan wound care pathways with greater confidence, reduced administrative burden, and fewer reimbursement-driven constraints.

• Fact Sheet - Upcoming Update to the Final LCDs for Certain Skin Substitutes
• Calendar Year (CY) 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F) | CMS
• Calendar Year (CY) 2026 Medicare Hospital Outpatient Prospective Payment (CMS-1834-FC) | CMS

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 ®, SurgiClose ®, GraftGuide ®, MariGen ®, Shield™, MariCell ®, MariGraft™, MariTex™ and MariSurgi™ 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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SOURCE: Kerecis

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PUB: 12/16/2025 03:05 PM/DISC: 12/16/2025 03:05 PM

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