Avita gets more US army funds for ReCell trial

Avita Medical (ASX:AVH) has secured additional funding from the US Department of Defense to support the FDA trial for its ReCell Spray-On-Skin in burn injuries.

The US$880,000 ($765,500) from the department and the US Armed Forces Institute for Regenerative Medicine (AFIRM) brings the total funding for the trial provided by the armed forces to US$2.63 million.

ReCell is a cell harvesting, processing and delivery technology for using the patient's own skin cells to treat wounds, burns and skin defects. The product has a number of advantages compared to traditional skin graft techniques.

The armed forces are helping to fund Avita's FDA application for ReCell in order to have the product approved for use in the US, and therefore available to US military personnel.

The initial $1.75 million grant was awarded in 2009. The army has also contracted Avita to provide ReCell technology for wounded personnel once it is approved.

The study is due to be the most comprehensive clinical trial of ReCell yet conducted. It will involve up to 106 patients with partial-thickness thermal injuries. Patients will receive both ReCell and standard-of-care graft treatment.

This trial design complicates patient selection, as it will require similarity across subjects, and individual patients will need two comparable wounds to treat.

According to Dr James H. Holmes IV, an AFIRM program director, it was this complexity that motivated the additional grant.

“The AFIRM program managers have acknowledged that this is an extremely difficult study and are backing their assessment of the importance of the ReCell technology with additional funding at a time of tight budgetary constraints,” he said.

Avita this month commenced an up to $10 million capital raising to help support US commercialisation efforts for ReCell.

But the trial may hold significance that stretches beyond whether ReCell will be approved for the US market. It may provide Avita with the clinical data needed to stimulate further adoption of the technology in the markets where it has been approved, including Australia.

Avita Medical (ASX:AVH) shares were trading 4% higher at $0.130 as of around 2:30pm on Friday.