Avita seeks US market pre-approval

Health technology company Avita Medical has submitted a pre-market approval application to the US Food and Drug Administration for its ReCell regenerative medicine technology.

Avita submitted trial results from its ReCell devices- which was created by local medical entrepreneur Fiona Wood - in the US, whereby 131 patients across 12 burn centres across the country were treated with the technology.

Dr Wood will be a guest keynote speaker at Business News’ upcoming Success and Leadership breakfast on November 28. Click here to find out more.

“This PMA submission represents the culmination of years of effort by our Avita team and we are thrilled to have moved a step closer to making ReCell available to patients in the United States,” Avita chief executive Michael Perry said.

“Our clinical data is compelling and we look forward to providing a novel and innovative therapeutic for the treatment of burns.

“We continue to strengthen our organisation in preparation for a successful US commercial launch in 2018.”

The application follows Avita’s receipt of a $30.5 million expansion to its contract with a US government research agency, the Biomedical Advanced Research and Development Authority, last week.

The extension lengthened Avita’s clinical and health economics research partnership with BARDA by two years to 2022, with Avita expecting to supply up to 25,000 of its ReCell devices to the US department as part of the overall $US62 million agreement.

Avita shares were 8.6 per cent higher to 6.3 cents each at the close of trade.