The U.S. FDA granted premarket approval to Avita Medical Inc.’s Recell system for a wide range of full-thickness skin defects, potentially quintupling the company’s market opportunity. Recell is a cell harvesting device that produces and delivers a regenerative cell suspension using a small sample of the patient’s own skin. The Spray-On Skin cells, previously approved for use in severe burns, stimulate healing and repigmentation. “This is a landmark approval representing an inflection point for Avita Medical,” said Avita 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.”
Avita Medical Ltd.’s Recell system won FDA breakthrough device designations in soft tissue repair and vitiligo. Melbourne-headquartered Avita, a regenerative medicine company developed the Recell system, a technology platform that enables point-of-care autologous skin restoration.
Regenerative medicine company Avita Medical Ltd. reported that topline results were mixed for its pivotal trial evaluating the safety and effectiveness of its Recell system combined with meshed autograft for reducing donor skin harvesting in soft tissue reconstructions.
PERTH, Australia – Melbourne-headquartered regenerative medicine company Avita Medical Ltd. raised AU$120 million (US$81 million) in an institutional placement that will fund pipeline development of new indications for its Recell spray-on-skin treatment and expand its commercial footprint in the U.S. and Japan.
PERTH, Australia – Melbourne-headquartered regenerative medicine company Avita Medical Ltd. raised AU$120 million (US$81 million) in an institutional placement that will fund pipeline development of new indications for its Recell spray-on-skin treatment and expand its commercial footprint in the U.S. and Japan.
Melbourne, Australia-based regenerative medicine company Avita Medical Ltd. has received good news from the FDA. The company, which also has a presence in Valencia, Calif., said the agency gave its thumbs up to an investigational device exemption application for a pivotal trial (NCT04091672) evaluating the safety and effectiveness of the Recell autologous cell harvesting device in combination with meshed autografting for the treatment of acute full-thickness skin defects, such as degloving, crush wounds, abrasions, lacerations and surgical wounds.
