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FDA breakthrough for Australian bionic eye

Australia’s world-first Bionic Eye System has been granted designation as a Breakthrough Device by the Food and Drug Administration (FDA) in the US.

Developed by Bionic Vision Technologies (BVT), the Centre for Eye Research Australia, the Bionics Institute, CSIRO’s Data61 and the University of Melbourne, the groundbreaking technology aims to give functional vision to millions of people who have lost their sight due to retinitis pigmentosa (RP).

The late-stage RP market is estimated to be worth more than US$3.5 billion (AU$4.9 b).

The FDA’s Breakthrough Devices Program speeds up the review and assessment of medical devices which provide “more effective treatment” than any alternatives currently available.

“This is a significant achievement and a key milestone for BVT,” CEO Dr Ash Attia said.

The system consists of a wearable device and visual implant similar to cochlear hearing implants. Image BVT

“The life-changing bionic eye can be brought more quickly to the people who need it the most.”

According to BVT, the technology features tiny cameras that are embedded within a pair of glasses that send electrical signals to a wearable processor. The processor transmits to an implant behind the retina, delivering visual information to the blind person, giving them functional vision.

A recently published peer-reviewed two-year study focused on four Australians using the bionic eye. They reported being able to recognise their loved ones in a cafe, identify vacant chairs, arrange their washing, and identify surroundings such as traffic lights, cars, people, trees and street poles.

Meanwhile, the University of Melbourne has been awarded a $1.14m grant from the National Health and Medical Research Council (NHMRC) to work with BVT on the next generation bionic eye.

The funds will be used to develop and test a retinal implant with closed loop multichannel stimulation to further improve what patients can see and do.

In 2023, BVT will conduct a global pivotal study as the next step towards the commercialisation of its device.

“RP is a debilitating disease, and the impacts are just devastating,” Dr Attia said.

“We are all proud to be part of BVT and our entire team is excited by leading the world in a project to restore functional vision to those who have lost their precious sight.”

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