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VCEL (4.22) Huge news... CAMBRIDGE, Mass., Dec. 14, 2016 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leading developer of expanded autologous cell therapies for the treatment of patients with serious diseases and conditions, today announced that the U.S. Food and Drug Administration (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."

Conference Call Information

Today's conference call will be available live at 9:00am (EST) in the Investors section of the Vericel website at http://investors.vcel.com/events.cfm. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary. To participate in the live call by telephone, please call [phone] and reference Vericel Corporation investor call. If calling from outside the U.S., please use the international phone number [phone]. If you are unable to participate in the live call, the webcast will be available until December 13, 2017. A replay of the call will also be available until 12:00pm (EDT) on December 18, 2016 by calling [phone], or from outside the U.S. [phone]. The conference ID is 39558058.

http://www.nasdaq.com/press-release/fda-approves-maci-for-the-treatment-of-symptomatic-cartilage-defects-of-the-knee-in-adults-20161214-00189