Celularity CEO Comments on Centers for Medicare & Medicaid Services' Withdrawal of Skin Substitute Local Coverage Determinations
FLORHAM PARK, N.J., Dec. 26, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (NASDAQ:CELU) ("Celularity"), a regenerative and cellular medicine company addressing age-related and degenerative diseases, today released comments by Robert J. Hariri, M.D., Ph.D., CEO and Chairman, on the Centers for Medicare & Medicaid Services' (CMS) recent withdrawal of skin substitute Local Coverage Determinations (LCDs) that were set to go into effect on January 1, 2026.
On December 24, 2025, CMS announced that effective immediately, A/B Medicare Administrative Contractors (MACs) were withdrawing the LCDs for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers scheduled to become effective on January 1, 2026. The LCDs, adopted under an earlier Medicare 2026 Skin Substitute Update, set which skin substitute products would be eligible for Medicare coverage beginning in 2026. While Celularity's Biovance® and Biovance 3L remained eligible for Medicare coverage under the now-withdrawn LCDs, Medicare coverage was eliminated for 158 skin substitute products sold by other companies. Unaffected by CMS' recent action is its new payment policy that effective January 1, 2026, all skin substitute applications furnished in physician office settings and hospital outpatient department settings will be paid at a flat rate of $127.28 per square centimeter.
Commenting on the recent change, Dr. Hariri said, "We have amassed substantial real-world evidence, or RWE, from multiple studies showing how our Biovance® Human Amniotic Membrane Allograft works in actual clinical practice for wound healing, demonstrating its effectiveness in diverse, real-life diverse patient populations patients with chronic wounds. RWE from large observational studies published in the peer-reviewed journal WOUNDS and elsewhere show Biovance® effectively treats chronic wounds, even in patients with multiple health issues. Other RWE shows reduced steroid use in about half of patients treated with Biovance®, which evidence indicates helps decrease pro-inflammatory factors and increase anti-inflammatory ones, guiding the body's natural healing."
Dr. Hariri noted that CMS' 2026 Medicare payment policy setting skin substitute reimbursement at a flat $127.28 per square centimeter remains in effect despite it withdrawing the LCDs. "Biovance® has been supported by a highly efficient, proven scalable manufacturing process since its commercial launch in April 2014, which today allows us to operate comfortably under the new Medicare reimbursement for skin substitute products," he said. "Our sustained investment in advanced infrastructure includes a world-class GMP/GTP manufacturing facility located in Florham Park, New Jersey, where today we manufacture a range of commercial advanced biomaterial products and investigational cell therapy products, including both Celularity branded products and contract manufactured products for third parties. Consistent with our emphasis on real-world evidence gained from actual clinical use of our products, we have integrated an ‘Industry 5.0' approach into our manufacturing operations, introducing digitization and AI and building adaptable and robust value chains and production systems," Dr. Hariri said.
About Celularity
Celularity Inc. (NASDAQ:CELU) is a regenerative and aging-related cellular medicine company developing, manufacturing, and commercializing advanced biomaterial products and allogeneic and autologous cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placenta's unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies that target fundamental aging mechanisms like cellular senescence, age-related chronic inflammation, and tissue degeneration. For more information about Celularity and its cutting-edge regenerative medicine solutions, please visit www.celularity.com.
Forward Looking Statements
Certain statements in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding: (i) Celularity's ability to execute its strategic priorities, including leveraging its placental-derived platform and aligning its operations and organizational focus with those priorities; (ii) Celularity's plans to emphasize applications related to longevity and age-related disease; and (iii) the anticipated impact and benefits of the financing transactions on Celularity's business and strategic flexibility. All statements other than statements of historical facts are "forward-looking statements," including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "believe," "can," "could," "continue," "expect," "improving," "may," "observed," "potential," "promise," "should," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Celularity's current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including those risk factors set forth under the caption "Risk Factors" in Celularity's annual report on Form 10-K and Form 10-K/A for the year ended December 31, 2024, filed with the Securities and Exchange Commission (SEC) on May 8, 2025 and May 21, 2025, respectively, and other filings with the SEC. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity's current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity's views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
Carlos Ramirez
Senior Vice President, Celularity Inc.
