Avita Medical Wins CE Mark for New ReCell Device

Avita Medical plans to launch its second generation ReCell burn treatment device in Europe, following CE Mark approval, the UK devicemaker announced Monday.

The new model can treat up to a 1,920 square-centimeter surface area and features a six-fold greater coverage than the first generation device — the original ReCell could treat only 320 square centimeters. The new generation is designed for burn victims requiring heavier-duty grafts, the company said.

ReCell is TGA-registered in Australia and SFDA-cleared in China. It is limited to investigational use in the U.S. while an FDA Phase III trial is underway.

Avita Medical markets wounds, scars and skin defects products. — Jason Scott