Celularity CEO Comments on Centers for Medicare & Medicaid Services’ Withdrawal of Skin Substitute Local Coverage Determinations

Rhea-AI Summary

Celularity (NASDAQ: CELU) commented on CMS’s December 24, 2025 withdrawal of skin substitute Local Coverage Determinations (LCDs) that had been due to take effect January 1, 2026.

CMS withdrew the LCDs while leaving in place a new Medicare payment rate of $127.28 per square centimeter for skin substitute applications effective January 1, 2026. The withdrawn LCDs would have kept Celularity’s Biovance and Biovance 3L eligible; CMS’s action removed Medicare coverage for 158 other skin substitute products. CEO Dr. Robert J. Hariri highlighted real-world evidence (including reduced steroid use in about half of treated patients) and cited Celularity’s scalable GMP/GTP manufacturing in Florham Park, NJ as compatible with the new reimbursement.

Positive

• Biovance and Biovance 3L retained Medicare eligibility under the withdrawn LCDs
• Medicare payment set at $127.28 per square centimeter effective Jan 1, 2026
• Elimination of 158 competitor products could reduce competitive pressure
• Company reports reduced steroid use in ~50% of patients treated with Biovance

Negative

• LCD withdrawal creates short-term coverage uncertainty for skin substitute classification

Key Figures

Medicare flat rate $127.28 per sq cm Skin substitute applications from January 1, 2026

Products losing coverage 158 products Skin substitute products from other companies under withdrawn LCDs

LCD effective date January 1, 2026 Original effective date for withdrawn coverage determinations

Policy effective date January 1, 2026 Start of new flat-rate Medicare payment policy

Commercial launch April 2014 Commercial launch of Biovance manufacturing platform

Market Reality Check

$1.32 Last Close

Volume Volume 15,331 is 0.22x the 20-day average of 68,703, indicating subdued trading ahead of this update. low

Technical Shares at $1.32 are trading below the 200-day MA of $2.13 and about 69.66% under the 52-week high.

Peers on Argus

CELU gained 2.33% with mixed peer moves: ABVC up 1.3%, APLT up 3.31%, while INKT fell 3.33% and others were flat, suggesting a more company-specific backdrop than a broad biotech move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 22	Financing close	Negative	-2.3%	Closed loan and convertible note financing with warrants to fund operations.
Dec 18	Financing term sheet	Negative	-3.9%	Entered binding term sheets for debt and convertible note financing with warrants.
Oct 30	Strategic partnership	Positive	-2.1%	Partnered with DefEYE, becoming exclusive contract manufacturer for ophthalmic biologics.
Oct 14	Phase 2 results	Positive	+11.3%	Published Phase 2 data showing PDA-002 improved DFU healing and safety outcomes.
Sep 03	Quarterly filing	Negative	+0.0%	Filed delayed 10-Qs, regained compliance but highlighted losses and going-concern risk.

Pattern Detected

Recent financing and regulatory filings often saw flat-to-negative reactions, while positive clinical data triggered the strongest upside move.

Recent Company History

Over the last six months, Celularity has balanced financial restructuring with clinical and commercial progress. On Sep 3, 2025, it reported Q1–Q2 10-Q filings and restored Nasdaq compliance while retiring over $41.6M of debt, but also disclosed going-concern risks. An Oct 14, 2025 Phase 2 DFU study showed efficacy for PDA-002 and drew the largest positive reaction. More recently, in December 2025, Celularity secured up to $12.0M in financings via loans, convertibles and warrants. Today’s CMS-related reimbursement update ties directly to the wound-care side of this story.

Market Pulse Summary

This announcement centers on CMS withdrawing certain skin substitute coverage determinations while maintaining a flat Medicare payment rate of $127.28 per square centimeter from January 1, 2026. Celularity emphasizes that Biovance products remained eligible under the prior LCDs and highlights real-world evidence and a long-established manufacturing platform. In light of earlier financings and going-concern disclosures, investors may watch how this reimbursement framework affects wound-care volumes, margins, and the company’s ability to leverage its GMP/GTP facility.

Key Terms

real-world evidence medical

"We have amassed substantial real-world evidence, or RWE, from multiple studies"

Real-world evidence is information gathered from everyday sources like patient records, insurance claims, or everyday experiences, rather than controlled experiments or clinical trials. It helps investors understand how products or policies perform in real life, providing a more complete picture of their effectiveness and value beyond official tests. This type of evidence can influence decision-making by offering insights based on actual, everyday outcomes.

AI-generated analysis. Not financial advice.

While Celularity’s Biovance® and Biovance 3L products remained eligible for Medicare coverage under the now-withdrawn LCDs, Celularity CEO Dr. Robert J. Hariri welcomed the recent action taken under the leadership of CMS Administrator Dr. Mehmet Oz

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.

Carlos.ramirez@celularity.com

FAQ

What did CMS announce on December 24, 2025 affecting Celularity (CELU)?

CMS announced withdrawal of skin substitute LCDs scheduled for Jan 1, 2026 while keeping a flat Medicare payment of $127.28 per square centimeter.

Will Celularity’s Biovance remain eligible for Medicare after CMS’s Dec 24, 2025 action?

Yes; Biovance and Biovance 3L remained eligible under the now-withdrawn LCDs, per the company comments.

How many skin substitute products lost Medicare coverage due to the LCD withdrawal?

CMS’s action eliminated Medicare coverage for 158 skin substitute products sold by other companies.

How does the new Medicare payment policy affect Celularity’s reimbursement starting Jan 1, 2026?

The payment policy sets reimbursement at $127.28 per square centimeter for skin substitute applications in office and outpatient settings.

What clinical evidence did Celularity cite about Biovance in the Dec 26, 2025 comments?

The company cited real-world evidence, including published observational studies and reduced steroid use in about half of patients treated with Biovance.

Does Celularity have manufacturing capacity to operate under the new Medicare reimbursement?

The company stated it operates a GMP/GTP manufacturing facility in Florham Park, NJ, and described its process as scalable and compatible with the new reimbursement.