Science Corporation, a neural engineering and brain-computer interface (BCI) company, today announced the European commercial launch of PRIMA, a treatment shown in clinical trials to restore functional central vision to patients with geographic atrophy (GA) caused by age-related macular degeneration (AMD), a leading cause of blindness.
PRIMA has received a CE (Conformité Européenne) mark under the European Union Medical Device Regulation from DEKRA, authorizing its commercial availability across 30 European countries.
PRIMA is the first BCI device to receive CE marking for form vision restoration (reading letters, numbers, and words). The first commercial implant of PRIMA is expected soon in Germany.
The PRIMA BCI system is a novel subretinal photovoltaic implant paired with specialized glasses. The glasses project near-infrared light to the implant which converts it into electrical stimulation signals. A “zoom-in” feature provides patients with the ability to magnify letters. The implant has an ultra-thin profile and seamless, wireless integration.
Science Corporation
A multi-center clinical trial evaluated the PRIMA BCI implant system in 38 patients across 17 clinical sites in five countries. The study results, published by the NEJM, include:
- Mean improvement of 25.5 letters (more than 5 lines) on ETDRS letter chart.
- 84% of patients reported the ability to read letters, numbers, and words, restoring functional central vision.
- 80% of patients achieved significant prosthetic visual acuity improvements of at least logMAR 0.2 (equivalent to 10 letters on ETDRS chart) at 12 months (p<0.001).
- The implant was placed under the atrophic macula without a decline in mean existing natural vision.
Science has raised approximately $490 million in total capital (much of it devoted to the commercialization of PRIMA).
In the United States, Science is working with the FDA to bring PRIMA to the U.S. market. PRIMA has received FDA Breakthrough Device designation and Humanitarian Use Device designation.
