Shares of Vericel Corp (NASDAQ:VCEL) are soaring nealy 67% as of 8:30 a.m. EDT today after the biopharmaceutical company announced that the FDA has approved MACI (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.

“The treatment of articular cartilage defects in the knee is challenging because articular cartilage in adults has minimal capacity to repair itself,” said David Recker, MD, chief medical officer of Vericel.  “While orthopedic surgeons have long understood that autologous chondrocyte implantation can regenerate cartilage tissue, the previous surgical procedure was technically complex and time consuming, and the indicated patient population was limited.  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.  With the introduction of MACI, orthopedic surgeons will have a simplified treatment option available for a broader patient population supported by solid clinical evidence.”

The approval of MACI is based on the SUMMIT study (Superiority of MACI implant versus Microfracture Treatment in patients with symptomatic articular cartilage defects in the knee), a two-year prospective, multicenter, randomized, open-label, parallel-group study which demonstrated a statistically significantly (p=0.001) greater improvement in KOOS pain and function (SRA) scores in the MACI group compared to the microfracture group at two years.  Patients from the two-year SUMMIT study had the option to enroll in a three-year follow-up study (extension study).  A majority of the patients who completed the SUMMIT study also participated in the extension study.  Overall efficacy data support a long-term clinical benefit from the use of MACI in patients with cartilage defects of the knee.

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.

“Bringing an important new therapy to orthopedic surgeons and patients is a significant milestone for Vericel, and I would like to thank the FDA for working closely with us to make MACI available for these patients,” said Nick Colangelo, president and CEO of Vericel. “We believe that the introduction of MACI, along with investments to expand our commercial organization and implement new patient support programs, positions Vericel to generate significant growth in 2017 and beyond.” (Original Source)

On the ratings front, Vericel has been the subject of a number of recent research reports. In a report issued on November 10, Ladenburg analyst Kevin Degeeter reiterated a Buy rating on VCEL, with a price target of $11.60, which implies an upside of 346% from current levels. Separately, on the same day, Needham’s Chad Messer reiterated a Buy rating on the stock and has a price target of $9.00.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Kevin Degeeter and Chad Messer have a yearly average return of 16.0% and 1.7% respectively. Degeeter has a success rate of 57% and is ranked #400 out of 4285 analysts, while Messer has a success rate of 43% and is ranked #1694.

Vericel Corp. engages in the development of patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions. It markets two cell therapy products in the United States of America, Carticel (autologous cultured chondrocytes), an autologous chondrocyte implant for the treatment of cartilage defects in the knee and Epicel (cultured epidermal autografts), a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns.