Celularity Responds to CMS Withdrawal of Skin Substitute Policies
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 26 2025
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Source: Newsfilter
- Policy Impact: On December 24, 2025, CMS withdrew the Local Coverage Determinations (LCDs) for skin substitutes set to take effect on January 1, 2026, which while maintaining Medicare coverage for Celularity's Biovance®, eliminates coverage for 158 other products, potentially reshaping market dynamics.
- Stable Payment Policy: Despite the withdrawal of the LCDs, CMS's new payment policy will still take effect on January 1, 2026, establishing a reimbursement rate of $127.28 per square centimeter for all skin substitute applications, providing a stable revenue foundation for Celularity's offerings.
- Clinical Evidence Support: CEO Hariri emphasized that Biovance® has demonstrated effectiveness in treating chronic wounds across diverse patient populations, supported by substantial real-world evidence, which enhances its competitive positioning in the market.
- Manufacturing Capability Enhancement: Since its commercial launch in April 2014, Celularity has developed a highly efficient and scalable manufacturing process, integrating an 'Industry 5.0' approach to enhance flexibility and digitization in production systems, ensuring operational viability under the new Medicare reimbursement framework.
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About CELU
Celularity Inc. is a regenerative and cellular medicine company. The Company is developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Its therapeutic programs target aging-related diseases, including degenerative diseases, cancer, and immune disorders, using mesenchymal-like adherent stromal cells, T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells. It develops, manufactures and commercializes advanced biomaterial products derived from structural tissue components of the postpartum placental tissues, including the umbilical cord. Its advanced biomaterials include Celularity Tendon Wrap, FUSE Bone Void Filler and Celularity Placental Matrix. Its advanced biomaterial products include Biovance, Biovance 3L, CentaFlex, Interfyl and Rebound products.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Celularity's Biovance Products to Maintain Medicare Coverage Post LCD Withdrawal
- Medicare Coverage Continuation: Celularity's Biovance and Biovance 3L products will continue to be eligible for Medicare coverage following the CMS withdrawal of skin substitute LCDs effective January 1, 2026, ensuring competitive positioning and product accessibility in the market.
- Stable Payment Structure: CMS will implement a flat payment rate of $127.28 per square centimeter for all skin substitute applications, providing Celularity with a sustainable revenue stream that enhances its financial stability.
- Manufacturing Capability Enhancement: Celularity's GMP/GTP-certified facility in New Jersey not only produces commercial biomaterials but also employs advanced digitized and AI-driven Industry 5.0 manufacturing systems, improving production efficiency and supply chain resilience.
- Market Performance Review: Over the past year, CELU's stock price fluctuated between $1.00 and $4.35, with the latest closing price at $1.34, reflecting a 1.52% increase from the previous trading day, indicating market confidence in the company's outlook.
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Celularity Withdraws Skin Substitute LCDs; Biovance® Remains Medicare Eligible
- Policy Impact: On December 24, 2025, CMS withdrew the Local Coverage Determinations (LCDs) for skin substitutes set to take effect on January 1, 2026, which, while allowing Celularity's Biovance® to remain Medicare eligible, eliminated coverage for 158 other products, potentially reshaping market competition.
- Medicare Payment Policy: Despite the withdrawal of the LCDs, CMS's new payment policy will reimburse skin substitutes at a flat rate of $127.28 per square centimeter, providing Celularity with a stable revenue foundation that ensures its ongoing competitiveness in the market.
- Clinical Evidence Support: Celularity has amassed substantial real-world evidence demonstrating Biovance®'s effectiveness in treating chronic wounds across diverse patient populations, particularly those with multiple health issues, highlighting its unique value proposition in the market.
- Manufacturing Capability Enhancement: Since its commercial launch in April 2014, Biovance® has leveraged a highly efficient, scalable manufacturing process, integrating an 'Industry 5.0' approach that incorporates digitization and AI, thereby enhancing the adaptability and resilience of its production systems, further solidifying its market position.
Continue Reading