US start-up wins EU approval for sight-restoring bionic eye
Decision will allow Science Corp to treat patients with retina implants in coming months
A US start-up has received European regulatory approval for a bionic eye that can restore sight to the blind, in a commercial breakthrough for the growing number of companies working to connect brains with computers.
California-based Science Corp said on Wednesday it had received the EU’s Conformité Européenne (CE) mark for its Prima device, which treats age-related macular degeneration by using a retina implant and special glasses.
Science Corp was founded in 2021 by Max Hodak, who was previously a co-founder of brain-computer interface start-up Neuralink alongside Elon Musk.
CE mark approval paves the way for the first commercial patients to start receiving the treatment in the coming months, likely to start in Germany. Science Corp has also received humanitarian use device designation from the US Food and Drug Administration, an important step towards commercialisation in its home market.
The specific type of late-stage macular degeneration that Prima is designed to treat affects hundreds of thousands of people. In clinical trials involving 38 patients, the company found that the device helped 84 per cent to read letters, numbers and words, without the implant affecting their remaining natural vision.
“There’s just nothing else even comparable for these patients,” Hodak said.
He cautioned that the current version of the technology could provide only black-and-white images in a narrow field of view.
“This is an early version. It’s kind of like looking through a straw in the centre of their vision,” he said. “But it is a very powerful existence proof that we are on the right track . . . We see in the future how to get to colour pretty close to native acuity,” he said.
Prima’s tiny wireless implant is surgically implanted under the retina, receiving near-infrared light from its glasses and converting it into electrical stimulation signals that the brain can use to see.
The technology was originally invented at Stanford University in California. Science Corp acquired the French company that had been developing Prima in 2024, after it had already spent several years working on clinical trials and regulatory approval.
Another company working on eye implants, Second Sight, received CE approval for visual prosthesis system in 2011 but the company ran into financial difficulties in 2020, leaving early customers of its Argus system in doubt about the future functioning of their devices.
The company was later acquired, allowing development of its technology to continue. But its Argus product is no longer commercially available, leaving Prima as the only product of its kind on the market.
Musk’s Neuralink is also developing an implant for restoring vision, called Blindsight, which it plans to start testing in human trials this year.
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Despite the many challenges in commercialising the cutting-edge technology, brain-computer interface start-ups are proliferating around the world.
In March, Chinese regulators approved what is believed to be the world’s first commercially available invasive brain-computer interface product, allowing Shanghai-based Neuracle to sell a brain implant that can help paralysed patients to move their hands.
OpenAI chief Sam Altman is among the backers of Merge Labs, a Neuralink rival that hopes one day to combine humans with AI systems.
Science Corp has raised almost $500mn since it was founded, including $230mn in March this year from investors including Khosla Ventures and Lightspeed Venture Partners that reportedly valued the company at about $1.5bn.
Hodak hopes that the commercialisation of Prima will help to fund its research into “biohybrid” brain-computer interface technology, which uses living neurons to connect to the brain instead of wires. “This is the financial backbone,” he said. “This is the thing that pays for the rest.”