Science Corp's PRIMA retinal implant gains EU approval and launches European rollout

Science Corporation’s PRIMA sub‑retinal photovoltaic implant received a CE mark under the EU Medical Device Regulation, allowing commercial availability in about 30 European countries. The device, paired with specially designed glasses, restores functional central vision for patients with geographic atrophy caused by age‑related macular degeneration (AMD).

In a multi‑centre study of 38 participants across five countries, 84 % of patients regained the ability to read letters, numbers and words, and 80 % achieved a clinically significant gain of at least 10 ETDRS letters, with an average improvement of 25.5 letters. The first commercial surgical implantation is expected in Germany, with rollout plans covering the EU and European Economic Area.

Science Corp is also engaging the U.S. Food and Drug Administration, having secured breakthrough and humanitarian use designations. Founder and CEO Max Hodak, a co‑founder of Neuralink, highlighted patient stories such as a French recipient who completed a 300‑page novel. Each PRIMA system costs several hundred thousand dollars and targets a condition affecting more than five million people worldwide.