Science Corporation receives CE Mark in Europe for retinal prosthesis that restores vision to the blind

Science Corporation receives CE Mark for retinal prosthesis

Science Corporation has received CE Mark approval in Europe for PRIMA, a chip implanted in the eye that restores partial vision to patients who have lost sight due to macular degeneration. It is the first device to produce what Hodak describes as genuinely useful form vision — something that looks like an image — in the mind's eye of a blind patient.

The approval covers roughly 30 countries. Country-level registrations are already underway in Germany, Italy, the Netherlands, Spain, and the UK, a process Hodak says takes about a month. The first patient implant is roughly six weeks away.

“We got marketing approval in Europe. We've received the CE mark — it will be shortly available to consumers. The first patient is probably six weeks away or so. We also got two humanitarian use device designations from the FDA, which unlocks an expedited approval pathway called the humanitarian device exemption that we're submitting for imminently. We're hoping that early next year it'll be available to some set of American patients.”

What the device does — and doesn't — do

PRIMA delivers black-and-white, high-contrast vision through the center of the visual field, enough for a couple of letters or a word at a time. It is not high-resolution, full-field, or color vision. Hodak describes it as looking through a straw at the center of where high-acuity perception has been lost. Next-generation versions are already in preclinical studies, with targets including expanded field of view, red-green color (blue is harder), and higher resolution. He expects a three-to-five-year cycle between versions, gated by intervening clinical trials.

Go-to-market

The commercial model is direct to hospitals, which then implant and bill patients. The procedure is a one-hour outpatient operation performed by a surgeon. Because ophthalmologists have had nothing to offer macular degeneration patients for years — in some cases actively telling elderly AMD patients they no longer needed appointments — the addressable pool is already partially identified and doctors are now re-engaging those patients.

The go-to-market motion is conference-heavy, with scientific results presented by academic collaborators and hospital surgeons rather than company reps. Hodak says the retinal disease specialist community is small and densely interconnected, so advisory boards and data safety monitoring board relationships matter more than paid media.

Surgeon training runs through wet labs where physicians practice the procedure before treating patients. Rehab specialists are also deployed in the early commercial phase, since patients require guided exercises to learn to use the implant — work Hodak expects to migrate into the wearable glasses component over time.

US pathway

Science Corporation also disclosed two Humanitarian Use Device designations obtained from the FDA in March. Those unlock an expedited Humanitarian Device Exemption pathway with a 75-day review target. The company is submitting imminently. Hodak expects US availability for some set of patients in early 2027, pending FDA review cycles.

He pushes back on the framing that Europe moving faster signals an FDA problem, saying accidents of history drove the sequencing rather than a meaningful difference in regulatory standards.