Last month, Vericel reported record second quarter revenues – the fifth consecutive time they have topped previous numbers. The Cambridge Massachusetts-based cell therapy company has two products on the market: Epicel to help burn patients and MACI (autologous cultured chondrocytes on porcine collagen membranes) to replace damaged knee cartilage.
MACI appears to be an emerging winner for the company, giving surgeons a new tool to repair cartilage injuries and possibly forestall more serious conditions.
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“The issue with cartilage is that it doesn’t have any intrinsic healing properties,” said Vericel President and CEO Nick Colangelo in a phone interview. “Once you have a cartilage injury that’s left untreated, it leads to pain and dysfunction and ultimately osteoarthritis.”
Vericel, acquired an earlier version of the therapy, called Carticel, from Sanofi in 2014. It was an unloved remnant from Genzyme’s biosurgery unit that worked reasonably well but was difficult to implant.
“It was a technically demanding procedure, requiring a full open knee surgery,” said Colangelo.
Carticel was a good idea that didn’t go far enough. Each patient’s cartilage was removed and the chondrocytes (the cells that produce cartilage) isolated and expanded. These cells were eventually put in solution and sent back to the surgeon, who had to microsuture a watertight compartment to inject them. The procedure worked, but was never proven superior to microfracture surgery.
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Vericel solved these problems by implanting the expanded chondrocytes on a collagen membrane, which can then be shaped to fit the lesion. Fibrin glue secures the transplant.
The first therapy of its kind in the U.S., MACI received FDA approval in late 2016. More recently, five-year data from the SUMMIT trial showed MACI is generally more effective than microfracture for lesions larger than three square centimeters.
“It showed, for the first time, that MACI was better than microfracture in terms of pain relief, clinical outcomes, patient satisfaction and function, though it couldn’t show it was better on MR imaging,” said Darryl D’Lima, director of Orthopedic Research at the Shiley Center for Orthopaedic Research and Education and professor of Molecular Medicine at Scripps Research, in a phone interview.
D’Lima has no affiliation with Vericel.
“MACI is probably better for larger lesions. Microfracture may be better for smaller ones,” he said.
Vericel has taken full advantage of being first to market and is excited by early results. Criminal defense attorney Leah Kisner was fleeing a bomb threat at a Riverside County, California, courthouse in 2010 when she badly tweaked her right knee. A botched ACL surgery exacerbated cartilage damage, generating two large lesions. In 2017, she received MACI surgery.
“They did cortisone, Orthovisc, microfracture, resurfacing,” said Kisner in a phone interview. “The only thing that worked was MACI.”
At $40,000, MACI is expensive, but insurance companies have stepped up, covering most Americans for the procedure. Vericel has trained more the 700 surgeons and hopes to expand the number of patients receiving the therapy, though not everyone is eligible.
“People with severe osteoarthritis probably aren’t good candidates,” said Colangelo, “there’s just too much inflammation. The people we treat tend to be young, active weekend warrior types who want to forestall knee replacements.”
Photo: Srisakorn, Getty Images
