Vericel Gains FDA Approval of MACI Arthro

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, announced that the U.S. 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 Arthro 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.
 
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 knee. It 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 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 Arthro includes custom instruments that 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. 
 
“Arthroscopic delivery of MACI represents a significant advancement in cartilage repair,” said Grant H. Garcia, MD, Orthopedic Specialists of Seattle. “The technique and specially-designed MACI Arthro instrumentation provides surgeons with a less invasive option to administer a clinically-proven treatment to patients, and may be preferable for patients given the many post-operative benefits of arthroscopic versus open surgery.”