CAMBRIDGE, Mass. — March 4, 2026 — Leads & Copy — Vericel Corporation (NASDAQ:VCEL) 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 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. This positions the company to expand capacity to meet increasing demand for its restorative cartilage repair product and potentially commercialize MACI outside of the United States.
According to Nick Colangelo, President and Chief Executive Officer of Vericel, this FDA approval reflects a major achievement for Vericel and underscores the company’s operational and scientific expertise in complex cell therapy manufacturing. Colangelo added that bringing the Burlington facility online for commercial MACI production strengthens the supply chain and supports their mission to deliver innovative, high-quality therapies to patients.
Vericel combines innovations in biology with medical technologies, resulting in a differentiated portfolio of innovative cell therapies and specialty biologics that repair injuries and restore lives. The company markets three products in the United States: MACI® (autologous cultured chondrocytes on porcine collagen membrane), Epicel® (cultured epidermal autografts) and NexoBrid® (anacaulase-bcdb).
MACI 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 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. NexoBrid is a biological orphan product containing proteolytic enzymes, indicated for eschar removal in adults and pediatric patients with deep partial-thickness and/or full-thickness thermal burns.
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.
Source: Vericel Corporation
