Avita Medical Inc. (ASX: AVH) has received a big shot in the arm following an extension of US Food and Drug Administration approvals for the company's treatment of acute burns wounds.
The medtech company, which is also listed in the US (NASDAQ: RCEL), has announced the FDA approved the expanded use of its RECELL System in combination with meshed autografting for the treatment of all sizes of acute full-thickness thermal burn wounds for both paediatric and adult patients.
This allows RECELL to be used in patients as young as one year old, lifting the previous restrictions of the treatment on patients younger than 18 years. The ruling bolsters Avita's market in the US where nearly a quarter of burn cases affect children under 16.
RECELL, which was developed by Perth surgeon Fiona Woods and used to treat victims of the Bali bombings in 2002, is now also approved by the FDA to treat full-thickness thermal burns that cover more than 50 per cent of the total body surface area.
Avita's shares surged more than 17 per cent in early trade following the company's announcement.
CEO Dr Mike Perry says the new FDA approvals are a major step in supporting surgeons in treating full-thickness burns, commonly known as third-degree burns, of all sizes.
"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 realising the full potential of this innovative regenerative technology platform to address other clinical indications where significant unmet need exists," he says.
The approvals granted to RECELL, a technology that significantly reduces the mean number of paediatric grafting procedures, was granted following new clinical data provided by the company. The system is garnering support among the medical community.
"Skin grafting, which is currently the standard of care used to treat many paediatric burns, is painful, results in an additional wound, can be disfiguring, and may result in additional complications as a child grows," says Anjay Khandelwal, of the Akron Children's Hospital Burn Center in Ohio.
"There has been a high unmet need for alternative treatments for paediatric 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."
Avita's RECELL System was originally approved by the FDA in 2018. The system allows surgeons to collect a sample of cells from a patient's skin to create a suspension of Spray-On Skin Cells used to regenerate an outer layer of healthy skin.
The process can create enough Spray-On Skin Cells to treat a wound up to 80 times the size of the donor skin sample.
Avita saw revenue for RECELL surge 161 per cent to $US14.26 million ($18.4 million) in FY20. In its most recent report, the company reported that RECELL revenue jumped 126 per cent in the third quarter of FY21 to US$8.8 million ($11.35 million).Never miss a news update, subscribe here. Follow us on LinkedIn, Instagram and Twitter.
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