The AVITA Medical Inc (ASX: AVH) share price is up more than 14% after getting some positive news from the US FDA.
AVITA is a regenerative medicine business that is developing and commercialising a “technology platform” that enables point-of-care autologous skin restoration for multiple unmet needs.
US FDA announcement
AVITA announced that the US Food and Drug Administration (FDA) has approved expanded use of the RECELL System in combination with meshed autografting for the treatment of all sizes and acute full-thickness thermal burn wounds for both pediatric and adult patients.
Specifically, RECELL is now indicated to treat full-thickness thermal burns in patients 1-month of age and older. This has removed the prior limitation of use in patients younger than 18 years of age. In addition, the indication now includes treatment for full-thickness thermal burns that extend beyond 50% total body surface area (TBSA).
AVITA pointed out that, unfortunately, nearly a quarter of the burn cases in the United States occur in children under the age of 16 years old. One of the main goals within the burn community is to avoid multiple surgical grafting procedures. RECELL significantly reduced the mean number of pediatric grafting procedures compared to the National Burn Repository.
Management comments
AVITA CEO Dr Mike Perry said: “We are pleased that the RECELL System, with both its clinical and health economic benefits, can now more broadly support surgeons in treating full-thickness burns of all sizes, including treatment of patients over 1-month age.
“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.”
Summary thoughts on the AVITA share price
AVITA has fallen a lot since February 2021. But this is good news and it’s no surprise that the share price is rising in reaction. I’m not sure if it’s a buy, as I don’t know enough about the business or the market opportunity. But it’s encouraging to see that more patients can get help.
