Avita (ASX:AVH), a regenerative medicine company focused on the treatment of wounds and skin defects, has reported positive results from a clinical trial of its ReCell medical device.
According to the company, deploying a suspension of cells generated from the device onto a skin donor site can speed up healing by 30.7 per cent and deliver a superior final outcome.
The company said the findings, reported in the British Journal of Surgery, supported its growing data package around its ReCell autologous cell harvesting device.
This is the third randomised controlled trial announced in recent weeks. Last month, Avita presented data from two trials conducted at leading burns centers across the US, including successful results from its pivotal trial needed for PMA approval with the US FDA.
“We are excited about these results, as together, the data show that ReCell can be deployed both to reduce patient trauma, and to help patients heal faster,” said Avita’s CEO Mike Perry. “Our pivotal trial in the US, announced last month, showed how ReCell allowed doctors to successfully treat burns using about 30% less donor skin. Now, in China, surgeons have shown that the donor site itself can heal some 30% faster when treated with Regenerative Epithelial Suspension made using the ReCell device. Demonstration of clinical benefit for treatment of burn injuries and treatment of donor sites further substantiates the key, versatile role for ReCell in burn care.”
The Chinese investigators explored whether donor sites for skin grafts heal faster and better if ReCell is deployed alongside the main standard of care, which was a hydrocolloid dressing. Over a period of 18 months, a total of 106 patients were recruited, with 53 in either the control or ReCell-treated groups, amongst patients who presented at the hospital requiring split-thickness skin grafts.
The researchers evaluated how long it took for the epithelial layer of skin to restore on donor sites, with and without ReCell.
The reserachers reported the median time to complete re-epithelialization was 9 days in the ReCell-treated group, compared with 13 days in the control group, a 30.7 per cent difference that was a statistically significant.
“The autologous skin cell suspension is produced quickly and is available immediately for wound application,” the investigators said. “This study suggests that its use [on] skin graft donor [sites] should promote healing and improve long-term aesthetic results.”