PRIMA的临床證据来自《新英格兰醫學杂志》（NEJM）颁發的多中間钻研（DOI: 10.1056/NEJMoa2501396，2025年10月20日在線颁發，2026年1月15日印刷版）。钻研由波恩大學病院眼科Frank G. Holz傳授领衔，在法國、德國、英國、荷兰和意大利5國的17個临床中間展開，属于國際PRIMAvera項目（ClinicalTrials.gov: NCT04676854）。
Science Corp. launched its Prima retinal implant in Europe after receiving CE mark approval under the Medical Device Regulation, a significant milestone for the brain-computer interface (BCI) field. However, unlike most BCIs, which decode neural activity to translate thoughts into actions, Prima writes visual information into the nervous system to restore vision.
INT News: PRIMA Retinal Implant Gets CE Mark (July 27, 2026)
The PRIMA retinal implant has received CE marking. It is the first device authorised in Europe to restore functional central vision in patients with advanced geographic atrophy (dry macular degeneration). The CE mark allows sales in 30 European countries. The first co妹妹ercial implant will soon take place in Germany.
The microchip measures just 2x2 millimetres and is about 30 microns thick, roughly a third the width of a human hair. The glasses house a camera that captures images of the surrounding environment. This camera projects the images as near-infrared light directly onto the microchip implant身體乳液,ed beneath the retina.
Surgeons implant葉和軒, the microchip through vitrectomy, a minimally invasive procedure. The operation takes about ninety minutes and is usually performed under local anaesthesia.
Geographic atrophy is linked to age-related macular degeneration. It is the leading cause of irreversible blindness worldwide and affects more than 5 million people.
PRIMA's development began with the French company Pixium Vision, which specialised in electronic systems for vision restoration. Science Corp later acquired the project. The company, founded in 2021 in Alameda, California, also has offices in Paris and has raised around $490 million to date.
Science Corp is also working with the FDA to bring the device to the United States. PRIMA has already received Breakthrough Device and Humanitarian Use Device designations.
Max Hodak, CEO of Science Corp: We are the first company in the brain-computer interface space to receive CE marking for a device that restores detailed shape vision. Until now, losing central vision to this disease meant losing the ability to read, recognise faces, and ultimately, personal independence. No effective treatment existed. Now it does.
Frank Holz heads the Department of Ophthalmology at the University Hospital of Bonn and is the lead author of the study published in the New England Journal of Medicine.
The PRIMA retinal implant does not cure macular degeneration and does not stop the disease from progressing. The device replaces, where possible, the function of damaged ph止咳貼,otoreceptors.
NEJM Abstract: Subretinal Photovoltaic Implant to Restore Vision in GA (DOI: 10.1056/NEJMoa2501396)
A total of 38 participants received a PRIMA implant, of whom 32 were assessed at 12 months. Of the 6 participants who were not assessed, 3 had died, 1 had withdrawn, and 2 were unavailable for testing. Among the 32 participants who completed 12 months of follow-up, the PRIMA system led to a clinically meaningful improvement in visual acuity from baseline in 26 (81%; 95% confidence interval, 64 to 93; P<0.001). Using multiple imputation to account for the 6 participants with missing data, we estimated that 80% (95% CI, 66 to 94; P<0.001) of all participants would have had a clinically meaningful improvement.
Frontierbeat: PRIMA Eye Implant Wins CE Mark (July 25, 2026)
The system pairs a 2x2 millimeter photovoltaic chip implanted under the治療哮喘咳嗽, retina with specialized glasses that project near-infrared light onto it; the chip converts that light into electrical stimulation of surviving retinal circuitry. A zoom feature magnifies letters.
Science Corp's PRIMA retinal implant received a CE mark from DEKRA under the EU Medical Device Regulation, clearing co妹妹ercial launch across 30 European countries.
We are proud to be the first BCI company with a CE marked device for the restoration of detailed form vision, said Max Hodak, CEO and co-founder of Science Corporation and a Neuralink co-founder.