|Vericel Jumps 13% On Plans to Submit Biologics License Application|
|By Josh Gee|
|Wednesday, 10 June 2015 14:55|
Vericel Corp. (NASDAQ:VCEL) confirms plans to submit Biologics License Application to FDA by 2015 end for treating Cartilage Defects in the Knee
Leading developer of cellular therapies for treating diseases, Vericel Corporation, has confirmed that it has had discussion with U.S. Food and Drug Administration (FDA) and would be submitting Biologics License Application (BLA) to them by 2015 end for treatment of focal chondral cartilage defects in the knee.
David Recker, MD, chief medical officer of Vericel, opined that the firm has had fruitful discussions with FDA on regulatory pathway for submitting MACI BLA in the United States. Recker added that the submission shows Vericel's commitment of delivering innovative therapies with serious cartilage injuries in patients.
MACI (matrix-applied characterized autologous cultured chondrocytes) is third-generation autologous chondrocyte implantation (ACI) product which treats cartilage defects in knee.
It was first tissue-engineered product approved by European Commission.
The important Phase 3 clinical trial that supports MACI registration in Europe shows hugely important and clinically meaningful improvement in co-primary endpoint of pain as well as function for patients treating with MACI implant vis-a-vis microfracture at two years.
Vericel Corporation (Vericel), formerly Aastrom Biosciences, Inc. develops patient-specific expanded cellular therapies for use in the treatment of patients with diseases and conditions. Vericel markets two autologous cell therapy products in the United States: 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 greater than or equal to 30% of total body surface area (TBSA) .
Shares of VCEL are up 13% to $3.52.