Vericel Wins FDA Approval For New MACI Cell Therapy Manufacturing Site

Vericel Wins FDA Approval For New MACI Cell Therapy Manufacturing Site
Vericel Wins FDA Approval For New MACI Cell Therapy Manufacturing Site
Manufacturing & Approvals | Burlington, Massachusetts

Vericel Wins FDA Approval For New Advanced Therapy Manufacturing Facility

Facility Snapshot
Company Vericel Corporation (NASDAQ: VCEL)
Location Burlington, Massachusetts
Key Product MACI (Cartilage Repair Therapy)
Production Start Second Quarter of 2026

(RTTNews)Vericel Corporation (VCEL) announced that the U.S. Food and Drug Administration (FDA) has approved commercial manufacturing of MACI (autologous cultured chondrocytes on porcine collagen membrane) 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 the growing clinical demand for MACI, its flagship 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.

What is MACI?

Autologous cultured chondrocytes on porcine collagen membrane (MACI) is a specialized treatment designed to correct cartilage defects in the knee. By utilizing the patient's own cartilage cells, the therapy aims to restore the knee's structural integrity and function.

"This FDA approval reflects a major achievement for Vericel and underscores the company's operational and scientific expertise in complex cell therapy manufacturing. 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." Nick Colangelo President and CEO, Vericel Corporation

Expanding Portfolio and Market Reach

Vericel currently markets three advanced therapies in the U.S. market: MACI for targeted cartilage repair, Epicel for severe burn 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 overall business and production capabilities.

NASDAQ: VCEL Market Performance: VCEL has traded between $29.24 and $51.93 over the past year. The stock is currently trading at $34.83, marking an upward movement of 1.28%.
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