Avita Medical (ASX: AVH) has gained FDA approval for a new continued access protocol for its ReCell autologous cell harvesting device, which simplifies a previously approved protocol for treating burn injuries.
This essentially allows doctors to access the ReCell device while the premarket application is pending FDA approvals.
ReCell works by taking a sample of a patient’s normal skin. The sample is processed using ReCell to generate a spray suspension [regenerative epithelial suspension (RES)] of healthy skin cells.
Once the RES is created, it is sprayed directly onto the wound. The wound is then dressed and healing can begin, with the entire process carried out within a 30-minute time-frame.
According to Avita Medical, ReCell’s RES “offers distinct advantages over conventional grafting methods alone.”
Advantages include its usability for large burn areas, less donor skin harvesting required, reduced hospital stay, improved healing and less scarring, which, in turn, leads to a diminished need for reconstructive procedures and scar management. The regenerated skin is also deemed “superior” in appearance to wounds treated with skin graft alone.
Under the previous access protocol, a randomised comparison was required between two distinct burn injury areas, with one to be treated using conventional skin grafts and the other using RES.
Avita Medical’s new FDA approval allows use of RES on burn injuries without randomised comparison to a conventional graft.
“Based on what we have seen this product do, confirmed by the recent positive analysis of the study results, consenting a patient to have an area of their burn injury treated without ReCell purely for purposes of comparison causes concern from a medical perspective,” Wake Forest Baptist Medical Centre’s Burn Centre medical director Dr James Holmes IV said.
“The new continued access protocol without a comparison, allows us to continue use of ReCell with more focus on what’s best for the patient,” Dr Holmes added.
Avita Medical’s senior vice president of clinical development said the updated continued access protocol enables the company to better-understand the integration of ReCell into the US burn surgeons’ armamentarium, while helping burn victims and providing a learning platform for burn care teams.
The pre-market approval application was submitted on 28 September 2017 and is currently under FDA review.
Avita Medical’s stock rose more than 10% in early morning trade.