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]

Core Viewpoint - Vivani Medical, Inc. has announced a temporary withdrawal of the previously set record date for the spin-off of its subsidiary Cortigent, due to delays caused by the U.S. federal government shutdown [1][2]. Group 1: Company Overview - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company focused on developing miniature, ultra long-acting drug implants [1]. - The company utilizes its proprietary NanoPortal™ platform to create biopharmaceutical implants aimed at delivering drug molecules steadily over extended periods, enhancing patient adherence and tolerance [3]. - Vivani is developing a portfolio of GLP-1 based implants targeting metabolic diseases such as obesity and type 2 diabetes [3]. Group 2: Cortigent Overview - Cortigent, a wholly-owned subsidiary of Vivani, is focused on developing brain implant devices that utilize advanced neuromodulation technology to aid patients in recovering critical body functions [2]. - The Orion Visual Cortical Prosthesis System, an investigational system by Cortigent, is designed to treat blindness from common conditions like glaucoma and diabetic retinopathy, and has received FDA Breakthrough Device designation [2]. - Cortigent's technology also aims to improve recovery of arm and hand motion in patients with paralysis due to stroke [2]. Group 3: Financial Advisory - ThinkEquity is serving as the exclusive financial advisor to Cortigent regarding the spin-off transaction [2].