Overview
- Science Corporation said regulators granted the CE mark on Wednesday, allowing the PRIMA retinal implant system to be sold across EU countries.
- PRIMA is a thin wireless photovoltaic chip implanted in an outpatient, roughly one-hour surgery and paired with camera-equipped glasses that send near-infrared images to the chip.
- Clinical evidence from the PRIMAvera trial published in the New England Journal of Medicine showed meaningful restoration of central vision for many patients and was central to the approval.
- The company is preparing a phased launch that targets Germany first with possible first commercial procedures as early as September while it negotiates reimbursement with European payers.
- Science Corporation says it has received an early FDA designation that could speed U.S. review, and it plans iterative upgrades to improve the implant’s vision performance and the glasses’ form factor.