Vericel Corporation (VCEL) announced that the U.S. FDA has approved commercial manufacturing of MACI at its new state-of-the-art cell therapy facility in Burlington, Massachusetts.
The approval allows Vericel to begin production in the second quarter of 2026, substantially increasing capacity to meet growing demand for MACI, its autologous cell therapy for cartilage repair in the knee. The company also noted that the expanded facility positions it to 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 CEO. "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."
Vericel markets three advanced therapies in the U.S: MACI for cartilage repair, Epicel for severe burnt treatment, and NexoBrid for eschar removal in burn patients. The new facility approval marks a significant regulatory and operational milestone as Vericel continues to scale its business.
VCEL has traded between $29.24 and $51.93 over the past year. The stock is currently trading at $34.83, up 1.28%.
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