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Vericel Announces FDA Approval of New State-of-the-Art Advanced Therapy Manufacturing Facility

Company Achieves Significant Regulatory and Operational Milestone

Substantially Increases Manufacturing Capacity to Support Long-Term Growth

Enables Potential MACI Commercialization Outside of the U.S.

CAMBRIDGE, Mass., March 04, 2026 (GLOBE NEWSWIRE) -- 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.”

About Vericel Corporation
Vericel is a leading provider of advanced therapies for the sports medicine and severe burn care markets. The Company combines innovations in biology with medical technologies, resulting in a highly differentiated portfolio of innovative cell therapies and specialty biologics that repair injuries and restore lives. Vericel markets three products in the United States. MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area. Vericel also holds an exclusive license for North American rights to NexoBrid® (anacaulase-bcdb), a biological orphan product containing proteolytic enzymes, which is indicated for eschar removal in adults and pediatric patients with deep partial-thickness and/or full-thickness thermal burns. For more information, please visit www.vcel.com.

Epicel and MACI are registered trademarks of Vericel Corporation. NexoBrid is a registered trademark of MediWound Ltd. and is used under license to Vericel Corporation. © 2026 Vericel Corporation. All rights reserved.

Forward Looking Statements
This press release contains forward-looking statements. Forward-looking statements are subject to risks and uncertainties such as those described in Vericel’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Investor Contact:

Eric Burns
ir@vcel.com
+1 (734) 418-4411


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