CAMBRIDGE, MA, USA I January 04, 2016 I Vericel Corporation (NASDAQ:VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for MACI™ (matrix applied characterized autologous cultured chondrocytes), the company’s investigational autologous cellular product intended for the treatment of symptomatic cartilage defects of the knee in adult patients.

“The BLA submission for MACI represents an important step toward our goal of providing a new treatment option for the repair of symptomatic cartilage defects of the knee in adult patients,” said David Recker, MD, chief medical officer of Vericel. “We look forward to continuing to work closely with the FDA during the BLA filing and review process for MACI in the United States.”

About MACI

MACI (matrix applied characterized autologous cultured chondrocytes) is a third-generation autologous chondrocyte implant (ACI) product intended for the treatment of symptomatic cartilage defects in the knee in adult patients. MACI is an autologous implant consisting of autologous cultured chondrocytes seeded onto a resorbable Type I/III collagen membrane. Autologous cultured chondrocytes are human-derived cells which are obtained from the patient’s own cartilage for the manufacture of MACI.

MACI is an investigational product that was studied in the pivotal Phase 3 clinical trial SUMMIT (“Superiority of MACI Implant to Microfracture Treatment”) and the three-year SUMMIT Extension trial. SUMMIT was a two year, prospective, multicenter, randomized, open-label, parallel-group clinical trial designed to evaluate the safety and efficacy of MACI to reduce pain and improve function compared with arthroscopic microfracture in the treatment of patients (n = 144) with symptomatic Outerbridge Grade III or IV focal cartilage defects. The SUMMIT Extension trial evaluated the safety of both treatments for an additional three years.

About Vericel Corporation

Vericel Corporation (formerly Aastrom Biosciences, Inc.) is a leader in developing patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions. The company markets two autologous cell therapy products in the U.S.: 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 comprising greater than or equal to 30% of total body surface area. Vericel is also developing MACI™, a third-generation autologous chondrocyte implant for the treatment of cartilage defects in the knee, and ixmyelocel-T, a patient-specific multicellular therapy for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy. For more information, please visit the company’s website at www.vcel.com.

SOURCE: Vericel