- The US regulator approves the expanded use of Avita Medical's (AVH) RECELL system in combination with meshed autographs to treat burns patients
- The system uses a sample of a patient's cells to prepare Spray-On Skin Cells, in combination with autographs or alone, depending on the depth of the burn
- RECELL was first approved for patients aged 18 or above, but the Food and Drug Administration has now green-lit the treatment for those one-month and older
- The regulator has also removed a limitation in the 2018 approval, precluding use in patients with full-thickness thermal burns over more than half the body
- AVH shares are trading 10.9 per cent higher at $4.99 at 10:15 am AEST
The US regulator has approved the expanded use of Avita Medical's (AVH) RECELL system in combination with meshed autographs to treat burns patients.
The system uses a sample of a patient's cells to prepare Spray-On Skin Cells, and is able to treat a wound up to 80 times the size of the donor skin sample. The Spray-On Skin Cells can be applied directly in second-degree or partial thickness burns, or used in combination with autographs in a third-degree, or full thickness burns.
RECELL was first approved for patients aged 18 or above, but the Food and Drug Administration has now green-lit the treatment for those one month and older.
The regulator has also removed a limitation in the 2018 approval, precluding use in patients with full-thickness thermal burns over more than half the total body surface area.
"For patients with large injuries, the availability of viable skin for conventional skin grafting to treat the burn injury is often challenging to the point of becoming critical," said Nicole Kopari, Medical Director Burn Center at the University Medical Center New Orleans.
"Reducing the amount of donor skin needed for treatment with the RECELL System is beneficial for efficient healing, which can result in less pain and scarring, as well as a decrease in the overall cost of care since with fewer operations, and patients can typically go home earlier when treated with the RECELL System."
Avita Medical CEO Dr Mike Perry said the company is pleased RECELL — and the clinical and economic health benefits it offers — is more broadly available to surgeons and patients.
"Supported by a substantive body of clinical evidence and peer-review publications, the RECELL System is rapidly becoming the standard of care in burn treatment, and we are committed to pursuing and realizing the full potential of this innovative regenerative technology platform to address other clinical indications where significant unmet need exists."
According to a 2019 report by the National Burn Repository, nearly a quarter of burn cases in the US are in children under the age of 16. Data from an ongoing paediatric burns study shows that RECELL more than halves the average number of paediatric grafting procedures.
"Skin grafting, which is currently the standard of care used to treat many pediatric burns, is painful, results in an additional wound, can be disfiguring, and may result in additional complications as a child grows," said Anjay Khandelwal, MD, FACS, FICS, Akron Children’s Hospital Burn Center.
"There has been a high unmet need for alternative treatments for pediatric burns, so I am pleased that the RECELL System, with its proven efficacy to accelerate the burn healing process with less donor skin requirements, is now available as an FDA-approved treatment option for my younger burn patients."
The revised FDA indication has also prompted a new phase of the paediatric study with the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services.
"BARDA and AVITA Medical have decided to stop recruitment for the ongoing pediatric burn study and follow currently enrolled patients for 12 months in alignment with the study protocol," said Dr Perry.
AVH shares were trading 10.9 per cent higher at $4.99 at 10:15 am AEST.