FDAnews Device Daily Bulletin

Avita Scores FDA EAP Designation for ReCell

Dec. 15, 2015

The FDA has granted Avita Medical’s ReCell expedited access pathway designation

ReCell enables a clinician to quickly create regenerative epithelial suspension — an autologous suspension comprising the cells and wound healing factors necessary to regenerate skin — with a small sample of the patient's skin, in approximately 30 minutes.

Avita has recruited 26 of the target 30 patients for the trial of the device that will take place at seven burn centers.

The company estimates that ReCell will receive regulatory approval in the third quarter of 2017. It is currently CE marked in Europe, TGA‐registered in Australia and CFDA‐cleared in China. — Michael Cipriano