- AVITA Medical (AVH) reports positive top line results for its RECELL trial in patients with soft-tissue injuries
- The company released results from its randomised, controlled trial which evaluated the effectiveness of the RECELL system when combined with meshed autograft for soft tissue reconstruction in patients with injuries such as degloving or flesh-eating disease
- AVITA says the study showed statistically superior donor sparing and comparable healing rates for the RECELL treatment of soft tissue injuries
- The company now plans to submit a pre-market approval submission for this new indication to the US FDA by the end of 2022
- AVITA Medical is down 11.9 per cent, trading at $2 at 10:40 am AEST
AVITA Medical (AVH) has reported positive top line results for its RECELL trial in patients with soft-tissue injuries.
The company today announced results from its randomised, controlled trial which evaluated the effectiveness of the RECELL system when combined with meshed autograft for soft tissue reconstruction.
AVITA’s RECELL can remove the issues typically associated with skin grafting, such as creating an additional wound to harvest donor skin. The RECELL device enables healthcare professionals to spray-on skin cells using a small sample of the patient’s own skin to create an autologous suspension. The RES Regenerative Epidermal Suspension is then sprayed onto the areas of the patient requiring treatment to regenerate natural healthy epidermis.
Patients were required to display injuries such as degloving or peeled back skin injuries, road rash, surgical wounds, and flesh-eating disease to be included in the trial. Subjects then received RECELL used in combination with widely-meshed skin grafting, and the control treatment of conventional skin grafting.
While the healing endpoint in the study did not reach pre-specified statistical non-inferiority, observed values for healing with RECELL were the same or slightly better than control.
CEO Dr Mike Perry said the study showed statistically superior donor sparing and comparable healing rates for RECELL treatment of soft tissue injuries.
“The RECELL System has been used to effectively treat serious burn injuries and we anticipate that the RECELL System will be well-positioned to treat patients with soft-tissue injuries, pending FDA review and approval.”
“Soft-tissue injuries can be challenging to treat and I am very pleased with the outcomes using RECELL – especially the use of less donor skin when treating a variety of injuries,” Assistant Professor of Surgery TCU and Division Chief of Plastic Surgery at John Peter Smith Hospital, Dr Steven E Mapula said.
“Following FDA approval, I look forward to utilising RECELL broadly to help patients with a wide variety of soft-tissue injuries.”
The company said it plans to submit pre-market approval submission for this new indication to the US FDA by the end of 2022.
AVITA Medical was down 11.9 per cent, trading at $2 at 10:40 am AEST.