Avita Medical Submits IDE Supplement with the U.S. FDA for The Treatment of Vitiligo

  • Jun 02, 2020 AEST
  • Team Kalkine

Avita Medical Ltd (ASX:AVH) has submitted an Investigational Device Exemption (IDE) supplement with the U.S. Food and Drug Administration (FDA) for the commencement of a key clinical trial to examine the RECELL® System for the cure of vitiligo.

The data from the pivotal trial would form the starting point of the FDA submission for consideration to increase use of the RECELL® System for repigmentation of depigmented lesions linked with stable vitiligo. Simultaneously, the company is conducting a complementary and more scientifically oriented feasibility study.

On a global scale, the RECELL® System is authorized for other skin applications, comprising vitiligo.

 

 


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