PRIMA Eye Implant Wins CE Mark—Blind Patients Read Again Across 30 Countries
Science Corp's PRIMA retinal implant won a CE mark covering 30 European countries after trial patients blinded by macular degeneration could read again.
In Brief
- Science Corporation’s PRIMA retinal implant received a CE mark from DEKRA under the EU Medical Device Regulation, clearing commercial launch across 30 European countries
- In the NEJM trial of 38 patients, 84% reported the ability to read letters, numbers and words, with a mean improvement of 25.5 ETDRS letters—more than five lines
- The 2×2 mm photovoltaic chip sits under the retina and converts near-infrared light from special glasses into electrical stimulation, with the first commercial implant expected in Germany
PRIMA, a retinal implant that restores functional central vision to patients blinded by age-related macular degeneration, has been cleared for commercial launch across 30 European countries after receiving a CE mark under the EU Medical Device Regulation from notified body DEKRA, Science Corporation announced. TechSpot reported the approval as the device heads first to Germany.
“We are proud to be the first BCI company with a CE marked device for the restoration of detailed form vision,” said Max Hodak, CEO and co-founder of Science Corporation and a Neuralink co-founder. “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. We intend to make access to PRIMA real and reimbursable, as quickly as possible.”
The system pairs a 2×2 millimeter photovoltaic chip implanted under the retina with specialized glasses that project near-infrared light onto it; the chip converts that light into electrical stimulation of surviving retinal circuitry. A zoom feature magnifies letters. Geographic atrophy from AMD—the condition PRIMA treats—affects more than five million people globally, per the company.
What the PRIMA retinal implant trial showed
The pivotal evidence comes from a multicenter trial published in the New England Journal of Medicine covering 38 patients across 17 clinical sites in five countries. Patients gained a mean 25.5 ETDRS letters—more than five lines on an eye chart—and 84% reported the ability to read letters, numbers, and words. Eighty percent achieved a prosthetic visual acuity improvement of at least logMAR 0.2 at 12 months, with no decline in mean existing natural vision, according to the company’s announcement.
“It has been demonstrated in clinical trials that with PRIMA, we can restore functional central vision in patients blinded by geographic atrophy,” said Frank Holz, lead author of the NEJM publication and chair of ophthalmology at University Hospital Bonn, in remarks carried by Eyewire+. “These patients, who had lost their central vision completely, have had it restored and can read letters, numbers, and words.”
The technology has a transatlantic backstory: Science acquired PRIMA through its purchase of Pixium Vision, the French startup that developed it, per TechSpot. Hodak founded Science after leaving Neuralink, joining a wave of brain-computer interface ventures Frontierbeat has tracked in its explainer on BCIs from Neuralink to China’s Beinao.
From CE mark to patients’ eyes
A CE mark is regulatory conformity, not a purchase order: Science says country-specific reimbursement applications and clinical site activations are underway across Europe, with the first commercial implant expected in Germany. In the US, the company says it is working with the FDA, where PRIMA holds Breakthrough Device and Humanitarian Use Device designations.
The commercial milestone is notable for the whole neurotech field—it is the first CE-marked BCI device for restoring form vision, arriving as implant research accelerates worldwide, from China’s live-streamed BCI surgery to Neuralink’s expanding patient cohort.
“PRIMA is the first BCI device to receive CE marking for form vision restoration (reading letters, numbers, and words),” the company’s announcement states. For patients with geographic atrophy, the treatment gap that Hodak described—no viable option at all—is now, in 30 countries, formally closed.
FAQ
What is the PRIMA retinal implant?
A wireless 2×2 mm photovoltaic chip implanted under the retina that converts near-infrared light projected from special glasses into electrical stimulation, restoring central form vision lost to geographic atrophy from age-related macular degeneration.
How effective was PRIMA in clinical trials?
In the NEJM-published trial of 38 patients across 17 sites in five countries, participants gained a mean 25.5 ETDRS letters, 84% reported reading letters, numbers and words, and 80% improved at least logMAR 0.2 at 12 months.
When will PRIMA be available to patients?
Science Corporation is activating clinical sites and filing country-by-country reimbursement applications across the 30 CE-mark countries, with the first commercial implant expected in Germany; US availability depends on ongoing FDA work.
