PRIMAvera safety board recommends PRIMA for European approval submission

Science Corporation/PRIMA retinal implant

The PRIMAvera Data Safety Monitoring Board unanimously concluded that Neuralink's PRIMA retinal implant trial met all safety standards necessary to recommend the device for European CE mark approval. The independent three-member ophthalmology expert panel determined that benefits to patients outweighed any adverse impact risks.

• DSMB unanimous recommendation supports CE mark application filing with notified body DEKRA within two quarters; CE mark application will include over 1,000 pages of regulatory documentation.
• Safety bar met for European regulatory pathway; clears way for potential market entry in EU and other CE-accepting regions.
• Milestone represents completion of pivotal trial safety review; clinical efficacy data (23 letters average acuity improvement) previously announced in October 2024.