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 pivotal trial indicated that the Recell system required 97.5% less skin to be harvested as compared to the standard of care and resulted in definitive wound closure comparable to the standard of care.
Results from a second pivotal trial compared deep, full-thickness burns combined with split-thickness autografts against standard of care treatments, and showed that the Recell system required 32% less skin than the standard of care. Results also indicated definitive closure comparable to standard of care treatment, and that at eight weeks post treatment, 92% of burn sites achieved complete healing versus 85% for the sites treated with the standard of care.
“I have participated as an investigator in the two pivotal clinical trials of the Recell system as well as the Compassionate Use and Continued Access programs. Based on my personal experience treating patients with the Recell system, and the strength of the entire body of clinical evidence supporting this innovative technology, today’s approval will improve the treatment of burn patients,” Dr. William Hickerson of Memphis, Tenn.’s Firefighter Burn Center said in a press release.
Development of the system was supported by the BARDA, Avita said, with the company receiving approximately $50 million to support regulatory clearance and trials of the device, including trials exploring use in a pediatric population.
“While severe thermal burns happen every day, in a national security emergency an overwhelming number of people may need burn care quickly. Medical providers need easy-to-use treatments on hand to save more lives. Our goal is not only to support product development but also to integrate those products into routine care to build preparedness,” BARDA director Rick Bright said in a prepared statement.
Avita said that it has recruited a sales and marketing team alongside market research in preparation of its US market launch, and that with FDA approval, it will finalize packaging and promotional materials in support of that launch.
Last month, Avita Medical said that it successfully finished multiple production runs for its Recell device at its newly-acquired manufacturing facility in Ventura, California.