Pixium Vision - Breakthrough designation provides validation

The US Food and Drug Administration (FDA) has granted Breakthrough Device designation (BDD) to Pixium’s wireless Prima bionic vision system (BVS), which is currently being assessed in the European PRIMAvera pivotal study in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). This achievement suggests that the FDA recognises GA-AMD is an irreversibly debilitating human disease and that Prima BVS has the potential to provide an effective treatment in this area of unmet need. Pixium remains on track to report top-line data from PRIMAvera in or around year-end 2023. If positive, a CE Mark regulatory marketing submission can be filed in 2024, which we estimate could lead to commercialisation of the Prima system in H125.