Avita Medical took another step closer to launching its Recell System for treatment of people suffering from severe thermal burns, following the granting of premarket approval by the U.S. Food and Drug Administration (FDA).
The Recell Autologous Cell Harvesting Device – simply called Recell System – utilizes a patient’s own skin to make Spray-On Skin Cells for treatment of a variety of skin problems, including burns. With the FDA approval, it can now be used to treat patients who are at least 18 years old and suffering from severe thermal burns.
This essentially means that the company, based in Valencia, California, can now go ahead with the marketing of the device. It has revealed plans to launch it in the fourth quarter of the year.
“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,” Chief Executive Dr. Michael Perry said in a release. “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.”
The Recell system is intended for use at the point of care by healthcare professionals. The hope is that it will offer a faster, more convenient approach to treating people with severe thermal burns.
Compared to standard treatments, this new method requires significantly less amount of donor skin to cover burn wounds. This not only ensures patients recover faster, but also can lead to considerable drop in costs.
The system can be used singly for cases of partial-thickness burns or combined with autografts for treatment of full-thickness burns.
Two randomized, controlled clinical trials were carried out before the approval of the Recell System by the FDA. These compared the new treatment to standard of care for thermal burns.
Treatment with the autologous cell harvesting device was compared to regular split-thickness autografts in people with second-degree or deep partial-thickness burns in the first trial.
It was found that 97.5 percent less donor skin was required for treatment of burn sites. And definitive wound closure was comparable to treatment of burn sites with standard of care.
In the second pivotal trial, researchers used the Recell System together with split-thickness autografts. They then compared this to standard of care treatments for full-thickness or third-degree burns. The results were comparable despite the Recell System requiring 32 percent less donor skin.
In addition, 92 percent of burn sites treated with the harvesting device achieved full healing by the eighth week after treatment. This was better than 85 percent reported with standard care.
Results from both trials have been presented at several scientific conferences, including the 50th Annual Meeting of the American Burn Association.
According to Avita Medical, the development of the system was supported by the Biomedical Advanced Research and Development Authority (BARDA).
“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,” Rick Bright, BARDA director, said in a statement. “Our goal is not only to support product development but also to integrate those products into routine care to build preparedness.”
Avita Medical announced in August that it had completed multiple production runs for the device at its Ventura, California facility. It has also set up a sales and marketing team for the planned launch in the fourth quarter.