Vision restoration chip developed by Science Corporation wins EU approval

Science Corporation, a startup company developing new brain-computer interfaces (BCI), He won approval From Europe’s Medical Devices Regulatory Authority to start selling a device that restores vision lost due to age-related macular degeneration.

The device, called PRIMA, has also received clearance from the US Food and Drug Administration, the company said, a first step towards an accelerated regulatory review, which could see the device used to treat two rare types of blindness.

Millions of people around the world suffer from age-related macular degeneration, which destroys light-sensitive cells at the back of the eye, making it difficult to read and recognize faces.

In the new procedure, patients with vision loss undergo an hour-long outpatient procedure in which a small chip is implanted in the back of their eye. They then wear glasses equipped with a camera that transmits a view of the world to the slide. Max Hudak, founder and CEO of Science Corporation, says the product gives functional insight to people who have lost it.

“One of our patients in France finished a 300-page novel a short while ago and sent us the book,” Hudak told TechCrunch. “We have a sketch on the wall, drawn by one of our patients, of the Sydney Opera House. There are videos of patients playing crosswords and filling out Sudoku.”

Hudak is known as the co-founder and former president of Neuralink, Elon Musk’s startup. He left in 2021 to start the Science project, with plans to develop a new BCI based on a combination of silicon chips and living cells. But first, the company had to prove its operations and develop a sustainable business.

“What the space needs is a company that does $100 million in revenue a year,” Hudak said. “There’s a risk of the whole thing going into winter, so we think it’s important to build a sustainable business as we develop these long-term technologies.”

Hudak and his colleagues believe sustainable actions will restore sight to blind people, especially patients whose condition is caused by problems with the cells that detect light at the back of the eye. After exploring multiple approaches, they determined that Pixium, a French company that developed the PRIMA technology, was on the right path forward, and acquired the company in 2024. Science used its internal platform to build documentation and develop the product to prepare it for regulatory approval and commercialization.

Each Prima device is expected to cost hundreds of thousands of dollars; Science and its medical partners in Europe are currently in discussions with healthcare providers about reimbursement. The company is laying the groundwork to begin introducing Prima in Germany, where its clinical trials were conducted, and could see the first action in September.

Science expects to further improve PRIMA’s vision capabilities with a new chip and form factor of its glasses, which currently require a battery pack to operate. The goal is to offer something like the Meta’s AR glasses, but the power and computing requirements of PRIMA are more significant.

Science as well Working with Dr. Murat Gunelchair of the Department of Neurosurgery at Yale University School of Medicine, to develop human trial procedures for the direct implantable hybrid brain biosensor.

Bringing Prima to market is “the most important thing for the company,” says Hudak, “because we can’t do the dynamic hybrid stuff over the long term if you don’t have a great visionary business. That’s what really funds the rest of the project — that’s the thing that investors know how to build spreadsheets around.”