Key Takeaways
Science Corporation received a European CE mark for PRIMA, a retinal implant that restores central vision lost to age-related macular degeneration, and began a commercial launch across 30 countries.
In the pivotal trial, 84 percent of 38 patients across 17 sites could read letters, numbers, and words again after the implant.
The device pairs a photovoltaic chip placed under the retina with glasses that beam near-infrared light, and a US launch could follow in 2027.
Science Corporation announced on July 22 that its PRIMA retinal implant received a CE mark in Europe, clearing the device for commercial sale and making it, by the company's account, the first treatment to restore functional central vision in people blinded by geographic atrophy from age-related macular degeneration. Business Wire carried the announcement, and STAT News and TechCrunch reported the launch.
Macular degeneration erases the center of a person's sight, the part used to read a face, a page, or a price tag. PRIMA places a tiny photovoltaic chip under the retina and pairs it with glasses that beam near-infrared light to the chip, which converts the light into electrical signals the eye sends on to the brain.
The trial numbers are why this is moving. Of 38 patients across 17 clinical sites in five countries, 84 percent could read letters, numbers, and words again, a return of the exact vision the disease takes first. The first commercial implant is expected in Germany, and each treatment is expected to cost in the low hundreds of thousands of dollars.
Science Corporation is led by Max Hodak, a co-founder of Neuralink, and it closed a $230 million round to fund the rollout. The company holds US Breakthrough Device and Humanitarian Use Device designations from the Food and Drug Administration, with a US launch possible in 2027.
None of this is new as an ambition. What is new is a shipping product with a regulator's sign-off. The same arc runs through WYDE's coverage of a single injection that restored hearing in ten patients and of Neuralink threading an implant through the intact dura. Worth watching whether the US timeline holds.
People Also Ask
What is PRIMA and how does it restore vision?
PRIMA is a retinal implant from Science Corporation that places a photovoltaic chip under the retina and uses glasses beaming near-infrared light to restore central vision lost to macular degeneration.
How well did PRIMA work in trials?
In the pivotal study, 84 percent of 38 patients across 17 sites could read letters, numbers, and words again, according to Science Corporation.
Who makes PRIMA and how much does it cost?
It is made by Science Corporation, led by Neuralink co-founder Max Hodak, and each treatment is expected to cost in the low hundreds of thousands of dollars.
When will PRIMA be available in the United States?
The device holds FDA Breakthrough Device and Humanitarian Use Device designations, and a US launch could come as early as 2027.
Sources: Business Wire, STAT News, TechCrunch, Science Corporation.