The U.S. Food and Drug Administration approved commercial manufacturing of MACI at Vericel's new Burlington cell therapy facility, enabling commercial production to begin in the second quarter of 2026 and supporting capacity expansion and potential international commercialization.

Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for MACI® (autologous cultured chondrocytes on porcine collagen membrane) commercial manufacturing at its state-of-the-art cell therapy manufacturing facility in Burlington, Massachusetts. The approval enables Vericel to begin commercial production of MACI at its new facility in the second quarter of 2026, positioning the Company to expand capacity to meet increasing demand for its restorative cartilage repair product and potentially commercialize MACI outside of the United States.

"This FDA approval reflects a major achievement for Vericel and underscores the Company's operational and scientific expertise in complex cell therapy manufacturing," said Nick Colangelo, President and Chief Executive Officer of Vericel. "Bringing our Burlington facility online for commercial MACI production strengthens our supply chain and supports our mission to deliver innovative, high-quality therapies to patients. We look forward to building on this foundation as we continue to scale our business and create long-term value for patients and shareholders."

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COMTEX_478592392/2227/2026-05-05T17:23:36