Avita Earns Investigational Device Exemption for Cell Harvester

The FDA approved Avita Medical’s investigational device exemption (IDE) application to conduct a clinical feasibility study for treatment of vitiligo, a disease that causes patients to lose skin color.

Avita’s RECELL system, an autologous cell harvesting device for treating stable vitiligo, is designed to restore pigment in depigmented areas caused by the disease. Stable vitiligo is defined as having no new lesions and no progression of existing lesions for at least two years.

The feasibility study is expected to be conducted in the second half of 2020, after which the company said it will likely begin a pivotal clinical trial.