Brain-computer interface (BCI) company Science Corporation has launched its Prima device commercially in Europe after receiving CE mark from DEKRA under the EU Medical Device Regulation.
This authorisation enables the system to be made commercially available in 30 European countries.
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Prima is said to be the first BCI device shown to restore functional central vision for patients affected by geographic atrophy (GA) due to age-related macular degeneration (AMD).
The device is intended for individuals whose central vision loss has previously restricted their ability to read, recognise faces and maintain independence, with no other viable treatments currently available.
AMD-related GA impacts more than five million people around the world and leads to the steady destruction of photoreceptors in the retina’s centre, which can result in blindness.
Prima was evaluated in a multi-centre study of 38 participants at 17 clinical locations in five countries.
The results revealed that the average improvement was 25.5 letters, over five lines, on the ETDRS letter chart.
In the study, 84% of patients regained the ability to read letters, numbers, and words, and 80% experienced significant gains of at least logMAR 0.2 (10 letters) on the ETDRS chart after 12 months, with statistical significance reported at p<0.001.
The implant procedure, which places the device under the atrophic macula, did not result in a decline in mean natural vision.
Science confirmed that country-specific reimbursement applications and clinical site activations are in progress across Europe. The first commercial surgical implantation is expected to take place in Germany.
The Prima system consists of a thin subretinal photovoltaic implant and a pair of glasses that project near-infrared light onto the implant, which then converts the light into electrical stimulation signals.
The glasses feature a magnification function for letter recognition, and the device allows for wireless integration.
In the US, Science is in discussions with the Food and Drug Administration (FDA) about market access, having received breakthrough device and humanitarian use device designations for Prima.
In April 2024, Science announced the acquisition of intellectual property and related assets for the Prima retinal implant from French bioelectronics company Pixium Vision.
