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Vericel Announces FDA Approval and Commercial Availability of MACI Arthro
First Restorative Biologic Cartilage Repair Product Approved for Arthroscopic Administration Targets the Largest Segment of MACI’s $3 Billion Addressable
About this update from Vericel Corporation
[{"type":"text","content":"First Restorative Biologic Cartilage Repair Product Approved for Arthroscopic Administration Targets the Largest Segment of MACI’s $3 Billion Addressable Market CAMBRIDGE, Mass., Aug. 26, 2024 (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 approved a supplemental Biologics License Application (sBLA) expanding the MACI® (autologous cultured chondrocytes on porcine collagen membrane) label to include arthroscopic delivery of MACI to repair symptomatic single or multiple full-thickness cartilage defects of the knee up to 4 cm2 in size. MACI ArthroTM provides a less invasive technique compared to the current approach, allowing surgeons to evaluate and prepare the defect site as well as deliver the MACI implant through small incisions using custom-designed MACI Arthro instruments. “The approval of MACI Arthro represents another significant milestone in our strategy to provide innovative solutions for patients suffering from pain and dysfunction caused by cartilage defects in the knee,” said Nick Colangelo, President and CEO of Vericel. “MACI Arthro provides orthopedic surgeons and their patients with a less invasive option for MACI administration, which we believe has the potential to significantly increase penetration into the largest segment of the MACI addressable market and will support sustained top-tier revenue growth for the Company in the years ahead.” MACI is the first FDA-approved cellularized scaffold product that applies tissue engineering processes to grow cells on scaffolds using healthy cartilage tissue from the patient's own knee. MACI is the only restorative biologic cartilage repair product approved for arthroscopic administration. MACI Arthro incorporates the advantages of an arthroscopic approach with the long-term durability and established clinical results of MACI. The custom MACI Arthro instruments are designed to treat the most common defects in the MACI addressable market, which are 2-4cm2 defects on the femoral condyles, representing approximately 20,000 patients per year or one-third of the $3 billion addressable market for MACI. In conjunction with the launch of MACI Arthro, Vericel is expanding its target surgeon base from 5,000 to 7,000 to inclu...