Vericel Announces FDA Approval and Release of MACI Arthro

Vericel Corporation, a prominent entity in the sports medicine and severe burn care markets, has achieved a significant milestone with the U.S. FDA's approval of a supplemental Biologics License Application (sBLA). This approval expands the use of MACI® (autologous cultured chondrocytes on porcine collagen membrane) to include arthroscopic administration, targeting the repair of symptomatic single or multiple full-thickness cartilage defects of the knee up to 4 cm² in size.

The newly approved MACI ArthroTM introduces a minimally invasive technique, enabling surgeons to assess and prepare the defect site as well as deliver the MACI implant through small incisions. This process is facilitated by custom-designed MACI Arthro instruments, which simplify the procedure compared to traditional methods.

Nick Colangelo, President and CEO of Vericel, emphasized the significance of this development in providing innovative solutions for patients experiencing pain and dysfunction due to cartilage defects. Colangelo highlighted that MACI Arthro offers a less invasive option for MACI administration, which could lead to increased penetration in the largest segment of the MACI addressable market, potentially driving significant revenue growth for Vericel in the future.

MACI stands out as the first FDA-approved cellularized scaffold product that utilizes tissue engineering to grow cells on scaffolds using the patient's healthy cartilage tissue. MACI remains the only restorative biologic cartilage repair product approved for arthroscopic administration. The integration of an arthroscopic approach with MACI's established clinical results and long-term durability is expected to enhance treatment outcomes.

The custom MACI Arthro instruments are tailored to address the most common defects in the MACI market, specifically 2-4 cm² defects on the femoral condyles. This category represents approximately 20,000 patients annually, accounting for one-third of MACI's $3 billion addressable market. With the launch of MACI Arthro, Vericel is expanding its target surgeon base from 5,000 to 7,000, focusing on surgeons who perform high volumes of cartilage repair surgeries, mainly through arthroscopic procedures.

Dr. Grant H. Garcia from Orthopedic Specialists of Seattle acknowledged the advancement that arthroscopic delivery of MACI represents in cartilage repair. He pointed out that the specially-designed MACI Arthro instrumentation provides a less invasive option for administering a clinically-proven treatment, which may be more favorable for patients due to the numerous post-operative benefits of arthroscopic surgery compared to open surgery.

MACI is an autologous cellular scaffold product designed to repair symptomatic single or multiple full-thickness cartilage defects of the knee, with or without bone involvement, in adults. The MACI implant comprises autologous cultured chondrocytes seeded onto a resorbable Type I/III collagen membrane. These chondrocytes are derived from the patient's own cartilage.

Vericel Corporation remains at the forefront of advanced therapies for sports medicine and severe burn care. The company's innovative cell therapies and specialty biologics repair injuries and restore lives, solidifying its leadership in this domain. Vericel markets three products in the United States: MACI, Epicel® (cultured epidermal autografts) for treating severe burns, and NexoBrid® (anacaulase-bcdb) for eschar removal in burn patients. This robust product portfolio underscores Vericel's commitment to advancing medical treatments and improving patient outcomes.