Core Insights - Cortigent is a leading developer of brain implant devices utilizing precision neurostimulation technology, and it is the only company with FDA approval for a device providing artificial vision for the profoundly blind [1][7] - The Orion Visual Cortical Prosthesis System, developed by Cortigent, aims to deliver meaningful visual perception to blind individuals and has shown promising results in a 6-year Early Feasibility Study [1][3] - The company is also working on a new medical device to enhance recovery of arm and hand motion in patients with paralysis due to stroke [1][7] Study Results - The Early Feasibility Study involved six subjects implanted between January 2018 and January 2019, concluding in March 2025 [6] - All subjects demonstrated improvement in visual function tests with the Orion system activated, achieving positive or mild positive scores on the Functional Low-vision Observer Rated Assessment (FLORA) [6] - The study reported a loss of functionality in fewer than 4% of electrodes, with only one serious adverse event (a seizure) occurring early in the study [6] Future Plans - Cortigent plans to conduct a larger pivotal clinical trial to seek marketing approval for the Orion system, pending discussions with the U.S. Food and Drug Administration [3][5] - The company aims to advance the Orion cortical stimulation system in 2026, collaborating with leading experts and regulatory bodies [5] Technology Overview - The Orion system features a wirelessly powered implantable pulse generator connected to an array of 60 micro-electrodes for implantation on the visual cortex of blind patients [2] - A small processing unit worn on the belt converts real-time video from specialized glasses into wireless commands to stimulate neurons, creating visual perception through phosphenes [2] Company Background - Cortigent is a wholly-owned subsidiary of Vivani Medical, Inc., which is focused on developing advanced medical devices through its proprietary neurostimulation technology platform [1][7] - The Orion system has received FDA Breakthrough Device designation and is protected by an extensive intellectual property estate [7]