Regenerative medicine company AVITA Medical (ASX:AVH) has announced that the US FDA has approved its premarket approval (PMA) supplement for the use of the RECELL System to treat full-thickness skin defects.
“This is a landmark approval representing an inflection point for AVITA Medical,” said CEO Jim Corbett.
“The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings.”
The company said the expanded indication represents a broad label of full-thickness skin defects, such as wound injuries after traumatic avulsion, surgical excision, or resection, 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 US.”
The RECELL System was first approved in the US 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.