Avita Medical has gained popularity by developing a medical device called "Spray-on-skin" which helps in treating burns on the skin.
The device was first developed by an Australian doctor Fiona Wood and it was used to help people injured in the 2005 Bali bombings. The company has taken a step further to make it commercial as ReCell and has started discussions with the FDA to make it available in the US market by 2017.
‘ReCell or ‘Spray-on-skin’ technology is a medical device that can be used in conjunction with conventional treatments for burns and reconstructive procedures.’
The US regulator has now given the company permission to apply for early regulatory approval for its spray-on skin technology. The ruling falls under new FDA guidelines, which are aimed at helping patients get more timely access to lifesaving medical devices.
"The FDA's decision that we meet the criteria tallies with our view that ReCell is a unique offering for helping burns victims, and as such, approval would be preferable sooner than later," said Andrew Quick, Avita's vice president of research and technology.
"We are excited that we can now advance discussions with the agency to determine exactly how this changes our time frames," he added.