Vericel Announces FDA Clearance and Commercial Availability of MACI Arthro Page 1

CAMBRIDGE, Mass., Aug. 26, 2024 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn 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 administration of MACI to repair symptomatic single or multiple full-thickness cartilage defects of the knee up to 4 cm.² in size. MACI Arthro^TM offers a less invasive technique compared to current approaches, allowing surgeons to evaluate and prepare the defect site and place the MACI implant through small incisions using specially designed MACI Arthro instruments.

“The approval of MACI Arthro represents another important 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 offers orthopedic surgeons and their patients 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 support the company’s continued revenue growth in the years ahead.”

MACI is the first FDA-cleared cellularized scaffold product that uses tissue engineering processes to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee. MACI is the only biologic cartilage repair product approved for arthroscopic delivery. MACI Arthro combines the benefits of an arthroscopic approach with the long-term durability and established clinical outcomes of MACI. The custom MACI Arthro instruments are designed to treat the most common defects in the MACI addressable market, which are 2-4 cm² femoral condyle defects, representing approximately 20,000 patients annually 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 include surgeons who perform high-volume cartilage repair surgeries, primarily via arthroscopic procedures.