FDA Approves Arthroscopic Delivery of Vericel’s MACI for Knee Cartilage Defects

Image Credit: Adobe Stock Images/JP STUDIO LAB

The FDA has approved Vericel Corporation’s MACI for repairing cartilage defects in the knee. According to the company, MACI uses a patient’s own cells cultured on a porcine collagen membrane. This method, also known as MACI Arthro, can be administered through small incisions using custom instruments, providing a substantial improvement in full-thickness cartilage defects up to 4 cm² in size, offering a less invasive option, according to the company.¹

“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, CEO, Vericel, in a press release. “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.”

Vericel stated that 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. The MACI Arthro is expected to benefit surgeons focusing on arthroscopic procedures, covering an estimated 20,000 patients annually, equaling one-third of the addressable market for MACI. Further, the company is expected to expand its target surgeon base from 5,000 to 7,000 to include surgeons who perform high volumes of cartilage repair surgeries, predominantly through arthroscopic procedures.

Vercel warns that MACI is contraindicated in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides, products of porcine or bovine origin, severe osteoarthritis of the knee, inflammatory arthritis, inflammatory joint disease, uncorrected congenital blood coagulation disorders, patients who have undergone prior knee surgery in the past six months—excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a MACI implant—or in patients unable to cooperate with a physician-prescribed post-surgical rehabilitation program. Additionally, the MACI implant may carry a risk of transmitting infectious diseases. Currently, it is unknown how MACI affects patients with malignancy in the area of cartilage biopsy or implant. At the time of the final results, sterility test results were not available.

Common adverse events (AEs) associated with MACI include arthralgia, back pain, joint swelling, and joint effusion. Serious AEs included arthralgia, cartilage injury, meniscus injury, treatment failure, and osteoarthritis.¹

According to the Orthopedic Medical Center, cartilage defects may be degenerative, resulting from wear and tear, or traumatic, caused by an injury such as falling on the knee, jumping down, or rapidly changing directions while playing a sport. Due to a lack of nerves in cartilage, these injuries don’t always come with immediate symptoms.2 A 2022 study published in The National Library of Medicine suggested that articular cartilage injuries are present in 60% to 66% of knees undergoing arthroscopy, with 4.2% to 6.2% of all patients experiencing focul full-thickness chondral defects, and up to 36% in athletes.³

“Arthroscopic delivery of MACI represents a significant advancement in cartilage repair,” said Grant H. Garcia, MD, Orthopedic Specialists of Seattle, in the press release. “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.”

References

1. Vericel Announces FDA Approval and Commercial Availability of MACI Arthro. Vericel. August 26, 2024. Accessed August 26, 2024. https://investors.vcel.com/news-releases/news-release-details/vericel-announces-fda-approval-and-commercial-availability-maci

2. Cartilage Defects of the Knee. Orthopedic Medical Center. Accessed August 26, 2024. https://www.orthomedctr.com/cartilage-defects.php#:~:text=Cartilage%20defects%20may%20be%20degenerative,are%20no%20nerves%20in%20cartilage.

3. Global Variation in Studies of Articular Cartilage Procedures of the Knee: A Systematic Review. NIH. May 16, 2022. Accessed August 26, 2024. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9251824/