Vericel to submit biologics license application to FDA: 4 observations

Vericel plans to submit a biologics license application to the FDA by the end of 2015 for MACI, a new biologic.

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Here are four observations:

 

1. MACI is intended for the treatment of focal chondral cartilage defects in the knee.

 

2. MACI — matrix-applied characterized autologous cultured chondrocytes — is a third-generation autologous chondrocyte implantation product.

 

3. MACI was the first tissue-engineered product approved under the advanced therapy medicinal product guidelines by the European Commission.

 

4. Vericel is a developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions.

 

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