July 22 marks the European commercial launch of PRIMA, the first and only treatment shown in clinical trials to restore functional central vision to patients with geographic atrophy (GA) caused by age-related macular degeneration (AMD), a leading cause of blindness. PRIMA has received a CE (Conformité Européenne) mark under the European Union Medical Device Regulation from DEKRA, authorizing its commercial availability across 30 European countries.
Papers recently published by the New England Journal of Medicine (NEJM) [original article, editorial] showed that PRIMA restored vision to patients suffering from GA due to AMD.
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In the United States, the company is working with the Food and Drug Administration (FDA) to bring PRIMA to the US market. PRIMA has received FDA Breakthrough Device designation and Humanitarian Use Device designation.
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The multi-center clinical trial published by the NEJM evaluated the PRIMA BCI implant system in 38 patients across 17 clinical sites in five countries. The study results include:
- Mean improvement of 25.5 letters (more than 5 lines) on ETDRS letter chart.
- 84% of patients reported the ability to read letters, numbers, and words, restoring functional central vision.
- 80% of patients achieved significant prosthetic visual acuity improvements of at least logMAR 0.2 (equivalent to 10 letters on ETDRS chart) at 12 months (p<0.001).
- The implant was placed under the atrophic macula without a decline in mean existing natural vision.
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Sure, but that's completely different than "provide parts and support for the life of the patients". Open source is feasible in my opinion too.