Regenerative medicine firm Avita Medical has secured approval from the US Food and Drug Administration (FDA) for its Recell autologous cell harvesting device to treat severe thermal burns.
The FDA has approved the company’s premarket approval (PMA) application to commercialize Recell autologous cell harvesting device for the treatment of severe thermal burns in patients aged18 years and older.
Avita’s system will use small portion of patient’s own skin to prepare spray-on skin cells at the point of care within 30 minutes, enabling to provide new approach to treat thermal burns.
The approval was based on two randomized and controlled clinical trials, which showed that treatment of acute burn wounds with the Recell system needed substantially less donor skin than required with conventional split-thickness autografts to close burn wounds.
The first controlled study compared treatment with the Recell system against treatment with conventional split-thickness autografts in patients with deep partial-thickness (second-degree) burn injuries.
Avita’s second trail assessed treatment of deep full-thickness (third-degree) burns with the Recell system with split-thickness autografts against treatment with standard of care.
The system can be used alone in the treatment of partial-thickness burns, as well as in combination with autografting for the treatment of full-thickness burns.
A small skin sample will be collected and immersed in the firm’s enzyme solution in the Recell system to separate the skin cells to generate spray-on skin cells.
The resultant regenerative epidermal suspension (RES) is comprised of keratinocytes, fibroblasts, and melanocytes, which will play a significant role in wound healing.
Later, the suspension will be directly sprayed onto the prepared burn wound, offering a broad and even distribution of live cells across the entire wound bed.
Avita Medical CEO Michael Perry said: “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.”