FDA grants premarket approval to Recell for burn treatments

The FDA granted premarket approval to Recell, a spray-on-skin agent, to treat burns in patients aged older than 18 years, its manufacturer announced.

Recell (Avita) uses a small amount of a patient’s own skin to prepare Spray-On Skin Cells at the point of care in about 30 minutes. The agent can be used by itself to treat partial-thickness burns or in combination with autografting for the treatment of full-thickness burns and can be used to treat a wound up to 80 times the size of the donor skin sample. This is equivalent to a skin sample approximately the size of a credit card being used to treat a wound that covers a patient’s entire back, according to Avita.

The company stated that FDA granted approval based on two trials. One trial showed Recell required 97.5% less donor skin than the amount harvested to treat burn sites using standard of care, leading to a statistically significant reduction in patient-reported pain, increased patient satisfaction and improved donor scar outcomes. The second trial showed 32% less donor skin needed to treat burn sites vs. the usual standard of care. Eight weeks post-treatment, 92% of the burn sites treated with Recell achieved complete healing compared with 85% of the sites treated with the standard of care.

“Today’s approval of the Recell System is a significant advancement in how we treat patients with burns,” James H. Holmes IV, MD, FACS, of Wake Forest Baptist Medical Center, said in the release.

“Dramatically reducing the amount of donor skin needed to treat second- and third-degree burns has important implications for pain, scarring and costs of care, while still providing comparable healing to the current standard of care. Additionally, the potential reduction in mortality is extremely promising,” Holmes added.

Recell should be available in the U.S. in fourth quarter 2018, Avita said.

Disclosure: Healio Family Medicine was unable to determine Holmes’ relevant financial disclosures.