FDA Approves Vericel's Maci Knee Implants, Shares Skyrocket

(RTTNews) - Vericel Corp. (VCEL) said Wednesday that the U.S. Food and Drug Administration or FDA has approved Maci for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Shares of Vericel are surging more than 55 percent following the news.

Maci thus becomes 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.

Articular cartilage is a highly organized avascular tissue. Its primary function is to enable the smooth articulation of joint surfaces, and to cushion compressive, tensile and shearing forces. But as it is avascular, it has little capacity to repair itself or regenerate.

Cartilage defects in the knee can result from an injury, straining the knee beyond its normal motion, or can be caused by overuse, muscle weakness, and general wear and tear.

David Recker, chief medical officer of Cambridge, Massachusetts-based Vericel said, "MACI is the first product to show a statistically significantly greater improvement in KOOS pain and function scores compared to microfracture, a commonly performed alternative surgical treatment for cartilage repair, in a well-controlled Phase 3 clinical study."

Maci is composed of autologous cells, or a patient's own cells, that are expanded and placed onto a bio-resorbable porcine-derived collagen membrane that is implanted over the area where the defective or damaged tissue was removed. Administration should be performed by a surgeon specifically trained in the use of Maci.

The approval of Maci is based on the SUMMIT study, a Phase 3 two-year multicentre clinical trial that enrolled 144 patients. The study was designed to demonstrate reduced pain and improved function in comparison to microfracture, an alternative surgical procedure for cartilage repair.

The study demonstrated a statistically significant improvement in the KOOS (Knee injury and Osteoarthritis Outcome Score) pain and function scores in the Maci group, compared to the microfracture group at two years.

A majority of the patients who completed the SUMMIT study also participated in a three year follow-up study. Vericel noted that overall efficacy data supports a long-term clinical benefit from the use of Maci in patients with cartilage defects of the knee.