Science Corporation, a start-up developing novel brain-computer interfaces (BCI), has won approval from the European medical device regulator to begin marketing a device that restores vision lost due to age-related macular degeneration.
The company said the device, called PRIMA, has also received a designation from the US Food and Drug Administration which is the 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 the light-sensitive cells at the back of the eyes, making it difficult to read and see faces.
In order to use this device, patients with this type of vision loss undergo an hour-long outpatient surgery to implant the defect behind their eye. Then, they wear glasses equipped with a camera that transmits the view of the world to the chip. Max Hodak, founder and CEO of Science Corporation, says this product provides effective vision for people who have lost it.
“One of our patients in France finished a 300-page novel a short time ago, and we sent this book,” Hodak told TechCrunch. “We have a mural [that] one of our patients painted the Sydney Opera House. There are videos of patients playing crossword puzzles and completing Sudoku.”
Hodak is known as the founder and former president of Neuralink, Elon Musk’s BCI startup. He left in 2021 to start Science, with plans to develop a novel BCI based on a combination of silicon chips and living cells. But first, the company had to reveal its processes and develop a sustainable business.
“It’s a $100 billion a year company that needs space,” Hodak said. “There’s this risk that everything goes into hibernation, so we think it’s important to build a sustainable business as we develop this long-term technology.”
Hodak and his colleagues believe that the sustainable business will restore sight to the blind, especially patients whose conditions are caused by problems with the light-sensing cells at the back of the eye. After evaluating many options, they decided that Pixium, the French company that developed PRIMA technology, had the right way forward, and acquired the company in 2024. Science used its internal platform to develop documentation and modify the product to prepare it for regulatory approval and commercialization.
Each PRIMA device is expected to cost hundreds of thousands of dollars; Our science and medical partners in Europe are currently in discussions with healthcare providers about reimbursement. The company is laying the groundwork to start offering PRIMA in Germany, where its clinical trials are being conducted, and could see the process begin in September.
Science expects to continue improving PRIMA’s optical capabilities with the new chip, as well as the form factor of its glasses, which currently require a battery-pack to operate. The goal is to offer something similar to Meta’s AR glasses, but PRIMA’s power and computing requirements are more important.
Science also works with Dr. Murat Günel, chair of the Yale School of Medicine’s Department of Neurosurgery, to develop procedures for human testing of a directly implanted bio-hybrid brain nerve.
Hodak says that bringing PRIMA to market is “a very important thing for the company, because we can’t do bio hybrid stuff for a long time if you don’t have a good business idea. That’s really what funds everything else – that’s what investors are able to build spreadsheets around.”
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