HealthNewswireQuick ReadsScienceTechnology

Science Corp’s vision-restoring chip receives EU approval

▼ Summary

– Science Corporation received European regulatory approval to sell its PRIMA device, which restores vision lost from age-related macular degeneration.
– The PRIMA device involves an outpatient procedure to implant a chip in the eye, paired with camera-equipped glasses that transmit visual data to the chip.
– PRIMA will cost hundreds of thousands of dollars, with Science Corp. negotiating reimbursement with European healthcare providers and planning its first procedure in Germany.
– Science Corp., founded by former Neuralink co-president Max Hodak, acquired the French company Pixium in 2024 to develop the PRIMA technology.
– The company aims for PRIMA sales to create a sustainable business that funds future development of a bio-hybrid brain sensor.

Science Corporation, a startup specializing in brain-computer interface (BCI) technology, has secured approval from Europe’s medical device regulator to market PRIMA, a device designed to restore vision lost due to age-related macular degeneration. This marks a significant milestone for the company, which also received a designation from the U.S. Food and Drug Administration that paves the way for an expedited regulatory review, potentially allowing the device to treat two rare forms of blindness.

Age-related macular degeneration impacts millions globally by destroying the light-sensitive cells at the back of the eye, making tasks like reading and recognizing faces increasingly difficult. PRIMA addresses this by requiring patients to undergo a one-hour outpatient procedure to implant a small chip in the back of the eye. Afterward, users wear glasses equipped with cameras that transmit visual information directly to the chip. According to Max Hodak, founder and CEO of Science Corp., the device provides functional vision to those who have lost it.

“One of our patients in France finished a 300-page novel a little while ago, and sent us the book,” Hodak told TechCrunch. “We have a sketch on the wall [that] one of our patients drew of the Sydney Opera House. There are videos of patients playing crossword puzzles and filling in Sudoku.”

Hodak, who co-founded and previously served as president of Elon Musk’s Neuralink before leaving in 2021, established Science Corp. with the ambition of creating a novel BCI that merges silicon chips with living cells. However, he recognized the need to first validate the company’s processes and build a viable business. “The thing that the space needs is a company making $100 million a year of revenue,” Hodak said. “There’s this risk that the whole thing enters a winter, and so we think it’s important to build a sustainable business as we develop these longer-term technologies.”

The path to sustainability, Hodak and his team believe, lies in restoring vision to individuals whose blindness originates from problems with the eye’s light-detecting cells. After evaluating various approaches, they acquired Pixium, a French company that had developed the PRIMA technology, in 2024. Science Corp. then used its internal platform to refine the product and compile the necessary documentation for regulatory approval and commercialization.

Each PRIMA device is expected to cost hundreds of thousands of dollars, and Science Corp. is currently negotiating reimbursement terms with healthcare providers in Europe. The company is preparing to launch PRIMA in Germany, where its clinical trials were conducted, with the first procedure potentially taking place in September.

Looking ahead, Science Corp. plans to enhance PRIMA’s vision capabilities with a new chip and improve the design of its glasses, which currently require a battery pack. The ultimate goal is to create something akin to Meta’s augmented reality glasses, though the power and computing demands for PRIMA are considerably higher. Separately, the company is collaborating with Dr. Murat Günel, chair of Yale Medical School’s Department of Neurosurgery, to develop procedures for human trials of a directly implanted bio-hybrid brain sensor.

For now, Hodak emphasizes that bringing PRIMA to market is paramount. “The most important thing for the company, because we don’t get to do the bio hybrid stuff long term if you don’t have a great vision business,” he said. “That’s what’s really financing the rest of it , that’s the thing that investors know how to build spreadsheets around.”

(Source: TechCrunch)

Topics

brain-computer interfaces 95% vision restoration 92% regulatory approval 88% age-related macular degeneration 85% medical device commercialization 83% startup business strategy 80% clinical trials 78% surgical implants 76% healthcare reimbursement 74% Wearable Technology 72%