ReCell Receives FDA Approval for Clinical Trial

Avita Medical has received approval from the US Food and Drug Administration (FDA) to begin its US clinical trial for ReCell Spray-On Skin, a stand-alone regenerative point-of-care device enabling surgeons to treat burns, wounds and chronic skin defects using the patient’s own cells.

The company had previously commenced US trials in 2006 under a conditional approval; due to excessively restrictive inclusion criteria patient recruitment was very low.

Additionally, the company had failed to adequately address concerns of the FDA regarding study endpoints, patient follow-up and statistical analysis of collected data. The trial was suspended by Avita in July 2008. The company has since submitted a modified study protocol.

The changes to the approved protocol include:

· Inclusion criteria allowing for an expanded wound size and body region;

· Decrease in number of patients required to 106;

· Decrease in patient follow-up period from 52 to 16 weeks;

· Change in study endpoint from “time to 100 percent epithelialization” to a binomial assessment of ‘healed vs non-healed’ at 4 week follow-up;

· Inclusion of superiority as well as non-inferiority outcomes, significantly expanding post-study marketing claims.

The study will yield a randomised, controlled, clinical comparison with the current standard of care in treating burn wounds.

The company has appointed 10 clinical sites to participate in the trials; patient enrolment is anticipated to commence in early 2010.

Part of the funding for the clinical trial comes from a US$1.45 million grant from the US Army to help develop regenerative medicine through the recently initiated Armed Forces Institute for Regenerative Medicine (AFIRM).