AVITA Medical’s Investigational Device Exemption (IDE) Application Approved by US FDA for Clinical Feasibility Study Evaluating RECELL System for Vitiligo.

 

 

 

 

  • Regenerative medicine company, AVITA Medical Limited (ASX: AVH) received US FDA Investigational Device Exemption (IDE) Application approval for conducting a feasibility study evaluating the safety and effectiveness of its RECELL® Autologous Cell Harvesting Device (RECELL® System) used for repigmentation of depigmented lesions associated with stable vitiligo.
  • The company is expecting to initiate the study in first half of financial year 2020.
  • Avita Medical would conduct a pilot study with ten patients with vitiligo lesions that have been stable for minimum one year by collaborating with leading medical centres.
  • This study is based on previous peer-reviewed, published efficacy results confirming the possibility of RECELL as a cure for repigmentation with stable vitiligo.

 

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