AVITA Medical Inc. (NASDAQ: RCEL) announced that its RECELL GO system has received certification from Australia's Therapeutic Goods Administration and has been listed on New Zealand's Web Assisted Notification of Devices database by Medsafe, enabling commercialization in both markets.

RECELL GO is an automated system for preparing RECELL Spray-On Skin for treating burn and trauma wounds. The system combines a reusable, AC-powered RECELL Processing Device with a single-use RECELL Preparation Kit, with one kit capable of treating wounds up to 1,920 cm2.

Revolution Surgical Pty Ltd, AVITA Medical's distribution partner in Australia and New Zealand, expects to initiate commercial launch within the coming weeks, according to the company's press release statement.

The system automates what has historically been a manual preparation process in Australia. RECELL GO regulates enzyme incubation times and processing conditions to optimize cell yield and viability while reducing operator variability and training requirements.

RECELL works by using a small sample of a patient's healthy skin to prepare a suspension of skin cells that is sprayed onto wounds. Professor Fiona Wood, Director of the Burns Service of Western Australia, who originally developed the RECELL technology, said the certification represents "the evolution of a technology we developed in Australia."

Cary Vance, Interim Chief Executive Officer of AVITA Medical, stated that the regulatory approvals represent "an important step in expanding access to RECELL" and bring "greater standardization and efficiency to the preparation process."

RECELL GO is now approved for use in the United States, Europe, the United Kingdom, Australia and New Zealand. The company holds FDA approval for RECELL in treating thermal burn and trauma wounds in the U.S. market.