Avita enrols first patient for key burns trial

Avita Medical (ASX:AVH) has commenced recruitment for a key phase III trial of its ReCell skin graft technology for the treatment of burn injuries.

The first patient for the FDA-approved trial has been enrolled. The trial will aim to recruit 30 subjects.

Each patient will act as his or her own control, with a portion of the burn injury randomly allocated to receive skin grafting and a similar portion selected to receive ReCell in combination with meshed skin grafting.

Treatment will then be evaluated by donor site to treatment area expansion ratios and the incidence of complete closure eight weeks after treatment.

Avita expects ReCell to show a comparable incidence of complete closure but a superior expansion of donor skin.

Positive results would help pave the way for FDA approval to market ReCell for burns in the US and help support commercialisation efforts in other markets including the UK.

Avita Medical separately revealed its ReCell sales in its approved markets - Australia, Europe and China - grew 32% year-on-year during the second quarter.

Year-to-date ReCell sales improved 29%, but due to a 15% decline in respiratory product sales, total group sales declined 2% year-on-year.

Net operating cash outflows for the second quarter decreased by 52% thanks to the receipt of a $1.4 million R&D tax credit.

During the quarter, UK regulatory agency NICE released positive guidance covering the use of ReCell to treat skin loss, scarring and depigmentation following a burn injury. Avita said a positive outcome in the US trial would generate data to assist NICE’s evaluation process for the treatment.

Avita Medical (ASX:AVH) shares were trading unchanged at $0.086 as of around 2 pm on Friday