The ReCell device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the company said.
“We are thrilled that the FDA is allowing us to continue to serve severely burned patients through the Compassionate Use program. This also allows us to further build our collaborations with U.S. surgeons as we develop best practices for treatment of burn injuries in front of our planned launch of ReCell next year,” clinical development senior VP Andrew Quick said in a prepared statement.
The federal watchdog has expanded the number of patients treatable under the compassionate use protocol up to 68, the Cambridge, U.K.-based company said, and also increased the number of hospitals which are cleared to deploy the device from 15 to 18.
“We are pleased to receive this compassionate use expansion, which we think underscores both the necessity of our product for treating life-threatening burns, and the growing interest within the U.S. burns community. We look forward to submitting for premarket approval (PMA) of ReCell in coming weeks with the goal of launching the product, if approved, into the broader burns market in 2018,” Avita CEO Adam Kelliher said in a press release.
The company said that, to date, its ReCell device has been used in 49 compassionate use cases so far. Avita Medical is seeking pre-market approval from the FDA for the device, with submission slated for mid-2017 with an anticipated approval during Q2 2018.
Last September, Avita Medical said it inked a distribution deal with Iran-based Teb Sanaat Lotus and its Iranian partner company Zikad International Aesthetics Supplier. As part of the deal, a dedicated clinic using Avita’s regenerative medical devices will open in Tehran, the company said.
The initial focus of the center will be on aesthetics, including repigmentation and scar reconstruction. The company said Zikad plans to expand into treatments for burns and chronic wounds in the coming months.