Brain-computer interface (BCI) developer Science Corporation today said it submitted its Prima retinal implant for CE mark approval.
Neuralink co-founder Max Hodak founded Science, which unveiled its Science Eye BCI platform in 2022. The Science Eye is a visual prosthesis that targets retinitis pigmentosa (RP) and dry age-related macular degeneration (AMD), two forms of serious blindness. Science featured on MassDevice‘s list of BCI companies you need to know in 2024.
Prima retinal implant technology — developed by Pixium Vision as well — is a photovoltaic substitute of photoreceptors. The technology has FDA breakthrough device designation. It provides simultaneous use of the central prosthetic and peripheral natural vision. The company reported positive clinical data for the platform last year.
Science says the submission brings it one step closer to “bringing to market the first brain-computer interface technology to restore functional form vision to patients blinded with late-stage macular degeneration.”
Prima already completed European trials, with patients able to recognize playing cards and fill in crossword puzzles, among other tasks.
What comes next for Science and Prima?
The company says it expects a decision on the CE mark submission next year. Once secured, it can market the device across Europe. Science also has the next version of the implant and glasses under development to optimize visual performance.
According to the company, it has discussions ongoing with the FDA about the right transitional pathway to bring Prima to the U.S. It plans to continue developing commercial-stage clinical infrastructure plans, collect more and complete a manufacturing scale-up to ensure supply chain readiness.
“The world has had cochlear implants for over 50 years now,” the company wrote in a news release. “It’s our sincere hope that soon we will enter an era where there are commercially available retinal prostheses too for patients who suffer from irreversible blindness due to loss of the rods and cones in the eye.
“We’re not quite there yet, but we believe the data package for PRIMA is complete and compelling, and we stand ready to work collaboratively with our notified body, national competent authorities, and others as PRIMA continues to progress towards the market.”
