Vision-restoring chip gains EU approval
What's the story
Science Corporation, a start-up specializing in innovative brain-computer interfaces (BCI), has received approval from Europe's medical device regulator to market its vision-restoring device. The device, known as PRIMA, is designed to restore some sight lost due to age-related macular degeneration. Science Corporation's founder and CEO Max Hodak said the product provides functional vision for those who have lost it.
Regulatory milestones
Device also received FDA's expedited review
Along with the European approval, PRIMA has also been designated by the US Food and Drug Administration for expedited regulatory review.
This could open up possibilities for its use in treating two rare types of blindness.
The device works by implanting a tiny chip into the back of the eye during an hour-long outpatient procedure.
Patients then wear camera-equipped glasses that relay their surroundings to this chip.
Patient experiences
Patients have shared their experiences post-treatment
Hodak shared some inspiring stories of PRIMA's impact on patients.
"One of our patients in France finished a 300-page novel a little while ago, and sent us the book," he 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."
Business strategy
PRIMA could be available in Germany soon
Hodak, a former Neuralink co-founder, started Science Corporation with the vision of developing a unique BCI using silicon chips and living cells.
The company acquired French firm Pixium in 2024 to further this goal.
Each PRIMA device is expected to cost hundreds of thousands of dollars, with discussions currently underway with healthcare providers over reimbursement.
The first procedure could take place as early as September in Germany where clinical trials were conducted.
Tech advancements
What's next for Science Corporation?
Science Corporation plans to improve PRIMA's vision capabilities with a new chip and upgrade the glasses' form factor, which currently needs a battery-pack to operate.
The company is also collaborating with Dr. Murat Gunel, chair of Yale Medical School's Department of Neurosurgery, to develop procedures for human trials of a directly implanted bio-hybrid brain sensor.