Science Corp Launches PRIMA, First CE-Marked BCI Implant for Vision Restoration in Dry AMD
核心洞察
Science Corporation (搜索) received CE marking for PRIMA (搜索), the first brain-computer interface device approved in Europe for restoring functional central vision in patients with geographic atrophy (搜索) caused by AMD.
In a NEJM-published clinical trial across 17 sites in five countries, 84% of 38 patients regained the ability to read letters, numbers, and words, with 80% achieving significant visual acuity improvements.
The thin, photovoltaic sub-retinal implant works with specialized glasses projecting near-infrared light, converting it into electrical stimulation to replace lost photoreceptor function.
Science Corporation (搜索), the neural engineering and brain-computer interface (BCI) company, today announced the European commercial launch of PRIMA (搜索), the first BCI device to receive CE marking under the European Union Medical Device Regulation for form vision restoration. The approval, granted by notified body DEKRA, authorizes commercial availability across 30 European countries for patients with geographic atrophy (搜索) (GA) caused by age-related macular degeneration (搜索) (AMD), a leading cause of irreversible blindness affecting more than five million people globally.
"We are proud to be the first BCI company with a CE marked device for the restoration of detailed form vision. For decades, losing central vision to this disease meant losing the ability to read, recognize faces, and ultimately losing independence. There was no viable treatment. Now there is," said Max Hodak, CEO and co-founder of Science Corporation (搜索). "We intend to make access to PRIMA (搜索) real and reimbursable, as quickly as possible."
Clinical Evidence Published in NEJM
The regulatory milestone is supported by clinical data recently published in the New England Journal of Medicine. The pivotal study enrolled 38 patients across 17 clinical sites in five countries. Results demonstrated that 84% of participants reported the ability to read letters, numbers, and words again, restoring functional central vision. Additionally, 80% of tested patients achieved significant visual acuity improvements.
"The CE marking is an exciting moment, making PRIMA (搜索) commercially available to patients," said Frank Holz, MD, lead author of the PRIMA NEJM paper, lead investigator, and Chair of the Department of Ophthalmology at the University Hospital of Bonn, Germany. "It has been demonstrated in clinical trials that with PRIMA, we can restore functional central vision in patients blinded by geographic atrophy (搜索). These patients, who had lost their central vision completely, have had it restored and can read letters, numbers, and words."
How PRIMA (搜索) Works
PRIMA (搜索) is a thin, photovoltaic sub-retinal implant designed to replace the function of photoreceptors destroyed by GA. The system pairs the implant with specialized glasses that project near-infrared light onto the retina. The implant converts this light into electrical stimulation signals that activate remaining retinal neurons, effectively bypassing the damaged photoreceptor layer. A built-in zoom-in feature enables users to magnify letters, enhancing reading capability.
Commercial Rollout and US Pathway
Country-specific reimbursement applications and clinical site activations are already underway across Europe, with the first commercial implant of PRIMA (搜索) expected soon in Germany. In the United States, Science Corporation (搜索) is working with the Food and Drug Administration to bring PRIMA to market. The device has received both FDA Breakthrough Device designation and Humanitarian Use Device designation, signaling a streamlined regulatory pathway.
Science Corporation (搜索), headquartered in Alameda, California with offices in Paris, has raised approximately $490 million in total capital since its founding in 2021, with much of that funding devoted to commercializing PRIMA (搜索). The company describes PRIMA as the first and only treatment shown in clinical trials to restore functional central vision to patients with GA caused by AMD.
AMD-associated geographic atrophy (搜索) causes the progressive destruction of photoreceptors at the center of the retina, which are responsible for reading and recognizing faces, ultimately leading to blindness. Until PRIMA (搜索), no viable treatment existed to restore vision once central vision loss had occurred.