Avita Medical wins FDA PMA for Recell severe burn treatment device

Avita Medical (ASX:AVH) said today that it won FDA premarket approval for its Recell autologous cell harvesting device, now cleared for use in treating severe thermal burns in patients 18 and older, and that it plans to launch the device in the fourth quarter. The Recell autologous cell harvesting 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 Valencia, Calif.-based company said. “Patients are at the center of everything we do at Avita Medical, and we are pleased to be able to provide an innovative solution for the treatment of severe burn injuries. Today’s approval of the Recell system marks an important milestone for us and provides a new way to treat burns for the thousands of patients with significant unmet medical needs. We are grateful to those patients who participated in clinical trials of the Recell system and to the clinical trial investigator teams whose dedication and scientific rigor made this approval possible. We also greatly appreciate our collaboration with [Biomedical Advanced Research and Development Authority] and the support that they have provided to us throughout the development of the Recell System,” CEO Dr. Michael Perry said in a press release. Approval of the system came based off the results of two randomized, controlled clinical trials comparing treatment with the Recell system against standard of care. Results from the first pi...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regenerative Medicine Regulatory/Compliance avitamedical Source Type: news