Vericel Submits BLA to FDA for MACI for Treatment of Knee Cartilage Defects

By Julie A. Vetalice

Vericel submitted a Biologics License Application to FDA for MACI™ matrix applied characterized autologous cultured chondrocytes, an investigational product intended to treat adult symptomatic cartilage defects of the knee.

Source: Vericel Corporation

The submission comes just slightly after Vericel's previous estimate to submit the MACI BLA by the end of 2015. The product was studied in a pivotal Phase III clinical trial called SUMMIT (Superiority of MACI Implant to Microfracture Treatment) and a 3-year extension trial, results of which indicated that the treatment was clinically and statistically significantly better than microfracture, with similar structural repair tissue and safety.

Product Labels: Orthobiologic Soft Tissue Repair

Tags: Regulatory