FDA Approves Expansion of AVITA Medical IDE Program for Skin Regeneration Device

Regenerative Medicine Company AVITA Medical received the FDA’s approval to increase the number of patients by 20 who can receive treatment with its skin regeneration medical device under the agency’s Compassionate Use Investigational Device Exemption program. 

This is the fifth expansion the agency has approved for this program, bringing the total number of patients who may be treated with the RECELL Autologous Cell Harvesting Device to 88. 

The company said it filed a PMA application for the device in September 2017 and expects the review to be completed during Q2 or Q3.