The product, Maci, is the first FDA-approved implant to use healthy cartilage tissue from a patient’s own knee to grow cells on the scaffold. Since the product’s approval in December 2016, surgeon uptake has helped to fuel the company’s continued growth, president & CEO Nick Colangelo told Drug Delivery Business News.
Revenue for Vericel’s cartilage repair franchise jumped 44% in the second quarter, compared to the same period last year, Colangelo said – and he doesn’t see the growth slowing down anytime soon.
“We expect this momentum to continue, particularly in light of the fact that we currently have a relatively low penetration rate into the patient population of Maci,” he said.
Maci was designed to help patients ages 18 to 55 with cartilage defects return to an active lifestyle. Vericel plans to conduct a pediatric study for the drug-device product, Colangelo said, and they hope to launch that post-approval commitment next year.
The company has three products in its portfolio – Maci, Epicel and Ixmyelocel-T – and they all make use of a patient’s own cells.
For people with cartilage defects, Vericel uses the cells that produce cartilage and expand and seed them onto a collagen membrane. The membrane is in turn implanted back into the patient’s knee. The entire process can be completed in three weeks, Colangelo said.
Epicel, the company’s product for burn wounds, uses a small biopsy of a patient’s healthy skin. Vericel isolates the patient’s keratinocytes and expands them, creating a skin graft that can serve as a permanent replacement for skin that has been badly burned.
The company is also developing a product, Ixmyelocel-T, for patients with advanced heart failure.
With two products on the market and one under development, Vericel is no stranger to the manufacturing and commercializing of autologous cell therapies. Colangelo said that although it has taken a long time to bring these types of products to the market, there are sure to be more cell therapies on the way.
“Like many new technologies, and often times people look back at antibodies, it’s a bit of a long path but once you kind of reach the crescendo, they became an important therapeutic option for patients,” he said. “It takes a while to develop technologies and go through the clinical development process, demonstrating results. But I do think we are at sort of a watershed moment.
“I think we are going to see a coming wave of these technologies moving through the regulatory process.”
Colangelo pointed towards the provisions written into the 21st Century Cures Act that put the focus on regenerative medicines like the ones developed by Vericel. The company’s Ixmyelocel-T product won fast track designation from the FDA and also the regenerative medicine advanced therapy designation, creating the opportunity for a potentially accelerated approval pathway for the heart failure product.
“I think that reflects both Congress and the agency’s interest in these cell and gene therapies, or regenerative medicines. It’s an accelerated program to foster development and approval of regenerative medicine products intended to treat these serious diseases and conditions,” Colangelo said.
“I do think the regulatory pathways, certainly now, are more amenable to bringing these products to market sooner.”