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Continue LogoutThe European Union recently approved Science Corporation's new retinal implant that can partially restore vision loss in people with age-related macular degeneration, with a U.S. launch potentially coming in 2027.
Age-related macular degeneration (AMD) is a common eye disease and leading cause of blindness in older adults. Around 5 million people worldwide are affected by AMD.
Science Corp.'s PRIMA brain-computer interface (BCI) retinal implant aims to help restore vision in people with AMD. The device combines a tiny wireless chip with special glasses equipped with a camera. In a clinical trial of 38 patients, the device was able to help 84% of patients read letters, numbers, and words without negatively impacting their remaining natural vision.
"This is an early version. It's kind of like looking through a straw in the center of their vision," said Science Corp. CEO Max Hodak, noting that the device could currently only provide black-and-white images in a narrow field of view. "But it is a very powerful existence proof that we are on the track … We see in the future how to get to color pretty close to native acuity."
On Wednesday, Science Corp. announced that European regulators approved commercial sale of the PRIMA device. The device will initially launch in Germany, with plans to expand to Italy and the Netherlands soon after.
"We have a cochlear implant for vision now," Hodak said. "… This is a full-blown market approval in Europe for the world's first retinal prosthesis [since Second Sight's Argus device in 2011]. We've taken patients that can't recognize faces and enabled them to read a novel."
Although the PRIMA device is currently only available in Europe, it could launch in the United States as early as next year if it receives FDA approval. Earlier this year, FDA granted PRIMA a Humanitarian Use Device designation, which offers expedited review for medical devices designed to treat rare diseases or conditions. If approved, PRIMA would be the second BCI to enter the U.S. market.
According to Jacob Robinson, founder of Motif Neuroscience, a startup that uses a BCI to target treatment-resistant depression, "Science is showing that BCI companies have a path to real revenue now. These companies aren't all just making a bet on a market that is 10 to 15 years away."
David Putrino, a principal investigator with the BCI startup Synchron, said that PRIMA's regulatory approval in Europe is a "giant step forward for the BCI industry as a second commercial BCI company receives regulatory approval for clinical use in 2026."
Aside from Science Corp., only one other company has received regulatory approval for use of its BCI product. In March, Chinese regulators approved Shanghai-based Neuracle's brain implant designed to help paralyzed patients move their hands, making it the world's first commercially available invasive BCI product.
Other BCI companies include Neuralink, which was co-founded by Hodak and Elon Musk, and Merge Labs, which is backed by OpenAI CEO Sam Altman. Neuralink is currently developing its own implant for restoring vision called Blindsight and plans to start testing it in human trials this year.
According to Hodak, he hopes PRIMA's commercialization will help fund Science Corp.'s research into "biohybrid" BCI technology, which uses living neurons instead of wires to connect to the brain.
"This is the financial backbone," Hodak said. "This is the thing that pays for the rest."
(Broderick, STAT+ [subscription required], 7/22; Bradshaw, Financial Times, 7/22; Landymore, Futurism, 7/25; Brodie, Science Corporation, 7/22)
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