Overview
- Science Corporation, which won CE marking Wednesday, is launching PRIMA commercially across about 30 European countries with the first implant procedures expected in Germany.
- PRIMA is a two-part system combining an ultra‑thin subretinal photovoltaic microchip and camera‑equipped glasses that project near‑infrared light to convert images into electrical stimulation of retinal cells.
- Regulatory clearance was supported by the PRIMAvera clinical program in which 38 patients showed a mean gain of 25.5 ETDRS letters and functional central vision improvement in roughly 84 percent of cases.
- Science Corp. has FDA breakthrough and humanitarian‑use device designations and is working with U.S. regulators toward possible approval while warning unit prices in the hundreds of thousands of dollars will require reimbursement deals.
- Company leaders say bringing PRIMA to market will fund longer‑term bio‑hybrid BCI projects, and patients could regain reading and facial‑recognition abilities if payers and hospitals adopt the device and surgical pathways.