A history of firsts

More than a timeline—it’s a history of firsts.

1995

  • Carticel is manufactured and commercialized, becoming the first and only cell-based therapy for cartilage repair.
  • First patient is treated with Carticel in the US.
  • Viability assay implemented.

1996

  • Carticel biologics license application (BLA) is filed.

1997

  • Carticel receives approval in accordance with new FDA cell therapy guidance.
  • It is the first FDA-approved biologics license application for cell therapy.
  • Carticel is the only autologous cultured chondrocyte product available in the US (and still to this day).

2004

  • First rapid automated sterility test for lot release of a biologic.

2009

  • The Study of the Treatment of Articular Repair (STAR), the first Good Clinical Practice (GCP), prospective, longitudinal, multi-center Phase 4 clinical study in the US for cartilage repair, is published in the American Journal of Sports Medicine.

2010

  • Identity assay FDA-approved and implemented as part of the final release criteria for each patient lot.