Avita Medical (ASX:AVH) said today that the FDA approved a supplement to the company’s investigational device exemption for its ReCell autologous cell harvesting device.
The approved treatment protocol for burn injuries has been simplified, according to the company, and the number of approved investigational sites has grown from eight to 15.
Up until now, treatment using the ReCell device under the continued access protocol required a randomized comparison between two areas of burn injury – one treated with skin grafts and one treated with expanded autografts in combination with the regenerative epithelial suspension generated from the ReCell device.
The new protocol allows for patients to be treated with the expanded autograft-RES combination without the randomized 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,” Dr. James Holmes IV, medical director of the Burn Center at Wake Forest Baptist Medical Center, said in prepared remarks.
“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.”
The FDA’s investigational device exemption guidance includes a continued access provision, which allows doctors to have access to medical devices while the product’s premarket approval application is under review – as long as “there is a public need for the device” and “there is preliminary evidence that the device is likely to be effective and no significant safety concerns have been identified for the proposed indication.”
Avita Medical submitted its PMA for the ReCell device last month.
“Continued access allows Avita to further develop our understanding of the integration of ReCell into the U.S. burn surgeons’ armamentarium, while helping patients and providing a platform for learning for burn care teams,” Andy Quick, Avita’s SVP of clinical development, added.
