Avita Medical Ltd (Avita Medical) has been awarded $1.45 million (AUD2 million) from the US Armed Forces Institute of Regenerative Medicine (AFIRM) to accelerate approval of the company’s ReCell Autologous Cell Harvesting device in the US market. The intent of all parties is to make the product available to soldiers and the civilian population in an accelerated timeframe.
AFIRM has a special interest in using the most advanced regenerative medicine for its wounded soldiers and recognises Avita’s innovative treatment for burns and other skin injuries has the benefits of using the patient’s own skin to yield improved and accelerated healing rates, reduced scar formation and reintroduction of pigmentation into the skin.
Avita was awarded the grant following a highly competitive approval process. Avita competed against project submissions from over 25 other companies and universities.
The award of the AFIRM grant may also accelerate the US FDA approval process for ReCell—an important milestone in Avita’s commercialisation of ReCell.
The AFIRM program, established in April 2008, is dedicated to bringing ‘transformational technologies’ in regenerative medicine to wounded soldiers by developing clinical therapies and advanced treatment options.
The award will provide funding for a 100-patient, multi-centre trial of ReCell. Up to 10 US investigational sites will participate; the study site selection process will begin in the coming weeks. The study will yield direct clinical comparison with the current standard of care in treating burn wounds.
As a major goal of AFIRM is to expedite and accelerate FDA clearance of the product, a subset of the 100 patients in the AFIRM study will be included in the US FDA trial. Updates to the FDA trials will be released in separate announcements.
Avita Medical chief executive officer Dr William Dolphin said the grant from the US Armed Forces, which closely follows the funding of a medico-economic study by the French Ministry of Health, is another compelling endorsement of ReCell.
“ReCell has been chosen from a field of excellent projects. There is significant potential for this technology,” said Dr Dolphin.
“The selection process was based on the identification of high impact, highly innovative technologies with the greatest likelihood of delivering clinical benefit. ReCell is a disruptive technology which we believe will redefine the clinical treatment of burns, scar remodeling and other skin defects and injuries. The underlying technology has enormous application in the field of regenerative medicine and tissue engineering.
“We continue to receive extremely encouraging feedback on the ReCell product and are seeing positive indications of acceptance from leading clinicians and increasing sales,” he said.
In addition to developing clinical treatments, AFIRM will serve as a training facility to develop experts in treating trauma using regenerative medicine, likely to positively impact the uptake of ReCell as a new standard of care for burns and wounds treatment in the future.
“I am overjoyed!” said Professor Fiona Wood, developer of the ReCell technology and non- executive director of Avita Medical. “The awarding of the AFIRM grant indicates the degree of interest and confidence in the ReCell technology. The ability to reduce the time to healing with limited donor sites is critical in burn wound care. With the support of the AFIRM grant the potential of ReCell can be realised.”
Dr James Holmes, Assistant Professor of Surgery at Wake Forest University School of Medicine and the Director of the Wake Forest University Baptist Medical Burn Center in North Carolina, USA, said ReCell had the potential to revolutionise the clinical treatment of burns, wounds and trauma due to illness or injury.
“We believe that this study represents an exceptional and truly viable opportunity to rapidly advance burn care for our wounded military personnel by gaining FDA approval of ReCell, and at the same time generating Level 1/Class 1/ Class A clinical burn data. We’re all excited to be participating in this important study,” said Dr Holmes.