Celularity CEO comments on Medicare skin substitute rule withdrawal

Celularity Inc. (NASDAQ: CELU) released comments from CEO Robert J. Hariri regarding the Centers for Medicare & Medicaid Services' withdrawal of skin substitute Local Coverage Determinations that were scheduled to take effect January 1, 2026.

CMS announced December 24 that Medicare Administrative Contractors were immediately withdrawing the LCDs for skin substitute grafts and cellular products used to treat diabetic foot ulcers and venous leg ulcers. The withdrawn rules would have eliminated Medicare coverage for 158 skin substitute products from other companies while maintaining coverage for Celularity's Biovance and Biovance 3L products.

The withdrawal does not affect CMS's new payment policy setting skin substitute reimbursement at $127.28 per square centimeter for applications in physician offices and hospital outpatient departments, effective January 1, 2026.

"We have amassed substantial real-world evidence from multiple studies showing how our Biovance Human Amniotic Membrane Allograft works in actual clinical practice for wound healing," Hariri said in the company's statement. He noted the product has been commercially available since April 2014.

Hariri said Celularity can operate under the new Medicare reimbursement structure due to its manufacturing process. The company operates a manufacturing facility in Florham Park, New Jersey, where it produces biomaterial products and cell therapy products for both its own brand and third parties.

Celularity develops regenerative medicine products derived from postpartum placenta, focusing on cellular medicine for age-related and degenerative diseases. The company's statement indicated its manufacturing operations incorporate digitization and artificial intelligence technologies.

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