AVITA Medical Announces FDA Approval of RECELL for Treatment of Full-Thickness Skin Defects

VALENCIA, Calif. and MELBOURNE, Australia, June 07, 2023 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, today announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for the use of its RECELL System to treat full-thickness skin defects.

“This is a landmark approval representing an inflection point for AVITA Medical,” said Jim Corbett, AVITA Medical Chief Executive Officer. “The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings.”

The expanded indication represents a broad label of full-thickness skin defects, such as wound injuries after traumatic avulsion (e.g., degloving), surgical excision (e.g., necrotizing soft tissue infection), or resection (e.g., skin cancer), thereby dramatically expanding the company’s market opportunity at least five times.

“We had a high level of confidence in the FDA’s approval timeline of RECELL for the treatment of skin defects,” continued Mr. Corbett. “In anticipation of the expanded indication, we more than doubled our field sales organization in the first few months of the year. Our sales team is now ready, trained, and fully prepared for the commercial launch, which will commence July 1, 2023. On behalf of AVITA Medical, I’d like to express my utmost appreciation to the many patients and healthcare providers who partnered with us to help bring our innovative technology to more patients across the U.S.”

The RECELL System was first approved in the U.S. for the treatment of severe burns in 2018. The system is an autologous cell harvesting device that prepares, produces, and delivers a regenerative cell suspension, Spray-On Skin Cells, using a small amount of a patient’s own skin. The Spray-On Skin Cells contain a combination of single living cells that stimulate healing and repigmentation throughout the wound bed.

Currently, skin grafting is the standard of care for full-thickness skin defects, including post-trauma and post-surgical skin reconstruction. However, skin grafting requires the harvesting of donor skin, resulting in an additional wound to the patient. Significant pain, delayed healing, risk of infection, the need for multiple procedures, discoloration, and scarring are associated with donor site wounds. Based on results from the company’s pivotal trial for soft tissue repair and reconstruction, RECELL demonstrated statistically non-inferior healing rates with statistically significant donor sparing, meaning less skin from the patient is required to repair and close the wound without compromising the healing outcomes relative to convention autografting.