Science Corp. Rolls Out Vision-Restoring PRIMA BCI Device in Europe

Science Corporation has begun European launch of PRIMA, a treatment to restore functional central vision to patients with geographic atrophy (GA) caused by age-related macular degeneration (AMD).

PRIMA is the first brain-computer interface (BCI) device to earn CE marking for form vision restoration (reading letters, numbers, and words). The company also revealed country-specific reimbursement applications and clinical site activations are underway in Europe.

The PRIMA BCI system combines an ultra-thin, wireless subretinal photovoltaic implant with specialized glasses that project near-infrared light, which the implant converts into electrical stimulation. A built-in zoom feature enables patients to magnify letters.

The first commercial implant of PRIMA is anticipated soon in Germany. Science is working with the FDA to bring it to the U.S. market—it received FDA breakthrough status and Humanitarian Use Device designation.

The 38-patient multi-center clinical trial evaluating the PRIMA BCI system showed mean improvement of 25.5 letters on ETDRS letter chart. 84% of patients reported that ability to lead letters, numbers, and words, and 80% achieved significant prosthetic visual acuity improvements of at least logMAR 0.2 (equivalent to 10 letters on ETDRS chart) at 12 months.

The implant was placed under the atrophic macula without a decline in mean existing natural vision.

Comments from Science Corp. and clinicians

Max Hodak, CEO and co-founder of Science: “We are proud to be the first BCI company with a CE marked device for the restoration of detailed form vision. 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.”

Frank Holz, MD, lead author of the PRIMA NEJM paper, lead investigator, and Chair of the Department of Ophthalmology at the University Hospital of Bonn, Germany: “The CE marking is an exciting moment, making PRIMA commercially available to patients. It has been demonstrated in clinical trials that with PRIMA, we can restore functional central vision in patients blinded by geographic atrophy. These patients, who had lost their central vision completely, have had it restored and can read letters, numbers, and words.”