What just happened? Science Corp. recently confirmed that PRIMA is officially launching in 30 European countries, promising an effective solution for vision loss caused by geographic atrophy (GA), a condition associated with age-related macular degeneration (AMD). Science said AMD-related GA is a leading cause of blindness, and the PRIMA device has already demonstrated its ability to essentially restore sight in blind seniors.
Science describes PRIMA as an "investigational" retinal implant designed to combat vision loss caused by GA and AMD. For the time being, the device is commercially available only in the European market. The implant is actually part of a more complex system that includes both a subretinal photovoltaic chip and a pair of specialized glasses.
The glasses are designed to "project" near-infrared light signals onto the subretinal implant, which then converts the signals into electrical stimulation that is transmitted to the brain. The result is intended to give patients the ability to see shapes, letters, and other "real" objects again despite damage to the retinal cells. Science said the system even includes a "zoom-in" feature that allows patients to magnify letters while reading.
The ultra-thin implant can seamlessly integrate with the glasses through wireless communication. Even better, the device has demonstrated its effectiveness in several clinical trials involving 38 patients across five different countries.
According to research published in the New England Journal of Medicine, PRIMA's brain-computer interface (BCI) was able to restore patients' ability to read and perform other vision functions in 84% of cases. Furthermore, 80% of patients achieved "significant prosthetic visual acuity improvements," while the implant had no observable impact on residual natural vision outside the damaged central area of the retina.
Now that PRIMA has been approved under the European Union's Medical Device Regulation, the device can be commercially offered in Europe. Science expects to "sell" its first commercial implant in Germany, and the company is already in talks with country-specific, state-sponsored healthcare institutions to expand PRIMA's clinical availability and secure appropriate reimbursement programs.
Science was founded by Max Hodak, who was a co-founder and former chairman of Elon Musk's Neuralink BCI startup. The company acquired its sight-restoring technology after acquiring Pixium, the French startup that developed PRIMA.
Hodak said that bringing PRIMA to market is an essential step if Science wants to build a sustainable biotech venture with a long-term business "vision." The company has also applied to the US Food and Drug Administration for full approval of PRIMA.