Vericel Soars 50% On Awaited FDA Approval

Vericel Corp VCEL, a nano-cap commercial-stage biopharmaceutical company that focuses on therapies which enable the body to repair and regenerate damaged tissues and organs, soared by more than 50 percent Tuesday morning.

Vericel is currently developing MACI, a third-generation autologous chondrocyte implant and ixmyelocel-T, which is a patient-specific multicellular therapy. On Tuesday the U.S. Food and Drug Administration announced that it has approved Maci, which marks the first FRDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient's own knee.

Maci is composed of a patient's own cells, which 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.

The FDA noted the safety and efficacy of Maci was demonstrated by Vericel throughout a two-year clinical trial which consisted of 144 patients. The trial supported a long-term clinical benefit from the use of the Maci implant.

"Different cartilage defects require different treatments, so therapy must be tailored to the patient," said Celia Witten, Ph.D., M.D., deputy director of the FDA's Center for Biologics Evaluation and Research. "The introduction of Maci provides surgeons with an additional option for treatment."