Key takeaways:

• The microchip implant will be available in 30 European countries.
• Science Corp. is working with the FDA to launch Prima in the U.S. for patients with geographic atrophy.

Editor’s note: This is a developing news story. Please check back soon for updates.

The Prima photovoltaic retinal stimulation microchip, a brain-computer interface device designed to restore vision in patients with geographic atrophy, has launched commercially across 30 European countries.

Prima has received breakthrough Device designation and humanitarian use device designation from the FDA.

According to a press release from Science Corp., the implant is the first brain-computer interface (BCI) device to receive CE marking for vision restoration in dry age-related macular degeneration, with the first commercial implant procedure expected to take place in Germany. The launch is supported by positive data from 38 patients across 17 clinical sites, in which Prima yielded a mean visual acuity improvement of 25.5 letters on the ETDRS letter chart.

The device also restored functional central vision in 84% of patients who experienced improvements in reading letters, numbers and words. At 12 months, 80% of patients also achieved “significant prosthetic visual acuity improvements of at least logMAR 0.2,” or 10 ETDRS letters (P < .001), the release said.

The implant restores vision input to the brain by stimulating the bipolar cells and bypassing the photoreceptors, as Healio previously reported. It is paired with specialized glasses that project near-infrared light to the implant, which is then converted into electrical stimulation signals. Science Corp. is currently working with the FDA to bring the Prima implant to market in the U.S., with the device having previously received breakthrough device designation and humanitarian use device designation.

“We are proud to be the first BCI company with a CE marked device for the restoration of detailed form vision,” Max Hodak, CEO and cofounder of Science Corp., said in the release. “For decades, losing central vision to this disease meant losing the ability to read, recognize faces and ultimately losing independence. There was no viable treatment. Now there is. We intend to make access to Prima real and reimbursable, as quickly as possible.”