FDA Approves Vericel’s MACI for Treatment of Adult Symptomatic Knee Cartilage Defects

By Julie A. Vetalice

FDA approved Vericel's MACI® (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic single or multiple full-thickness cartilage defects of the knee, with or without bone involvement, in adults.

MACI is the first FDA-approved cellularized scaffold that applies tissue engineering processes to grow cells on scaffolds using healthy autologous cartilage tissue. In Phase III clinical study, MACI demonstrated a statistically significantly greater improvement in pain and function scores vs. microfracture.

As previously announced, Vericel expects to launch MACI in 1Q17, with Dohmen Life Science providing patient support and payor contracting/product reimbursement for the product.

Sources: Vericel Corporation; ORTHOWORLD Inc.

Product Labels: Orthobiologic Soft Tissue Repair

Tags: 510(k) Clearance, Regulatory