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 Insights - Cortigent is a leading developer of brain interface devices utilizing precision neurostimulation technology, with a focus on treating blindness and improving motor recovery in stroke patients [1][3] Group 1: Orion Cortical Stimulation System - The Orion cortical stimulation system is designed to treat common forms of blindness and has successfully completed a six-year Early Feasibility Study, showing promising safety and efficacy results [1][3] - The investigational Orion system features a compact design with one of the smallest and highest-count micro-electrode neurostimulators, implanted on the visual cortex to deliver controlled electrical charges that create visual perception [2][3] - The system includes an implantable pulse generator with 60 outputs and a 60-electrode cortical surface array, demonstrating safety and functionality for over 17 years in previous devices [2] Group 2: Company Background and Technology - Cortigent, a subsidiary of Vivani Medical, is focused on developing brain implant devices to restore critical body functions, leveraging a patent-protected precision neurostimulation technology platform [3] - The company’s predecessor, Second Sight Medical Products, previously marketed the Argus II, the first FDA-approved device for treating a rare form of blindness, which has helped hundreds of patients achieve meaningful visual perception [3] - Cortigent is also applying its technology to enhance recovery of arm and hand motion in patients with paralysis due to stroke [3] Group 3: Upcoming Presentation - Cortigent will present an award-winning poster on the Orion Visual Cortical Prosthesis System at the North American Neuromodulation Society annual meeting in Las Vegas on January 23, 2026 [1]

Core Insights - The article discusses the advancements in bionic vision technology, particularly focusing on the PRIMA implant that has enabled individuals with severe vision loss to regain partial sight, exemplified by Sheila Irvine's experience [1][18]. - The integration of artificial intelligence (AI) is crucial for enhancing the functionality of bionic eyes, as it helps interpret visual data and optimize the user experience [3][10]. Technology and Functionality - The PRIMA implant is a thin chip that converts light into electrical impulses, allowing the brain to interpret these as patterns of light, thus restoring some vision to legally blind patients [1][4]. - Current bionic vision systems, such as Argus II and Orion, utilize a limited number of electrodes compared to the natural retina, necessitating the use of AI to enhance image resolution and quality [5][6]. - Phosphenes serve as the basic "pixels" of artificial vision, with electrical pulses stimulating the retina to create visual perceptions, albeit at a lower resolution than natural vision [3][4]. AI's Role in Bionic Vision - AI is essential for filtering and prioritizing visual information, determining what is most important for the user to see in real-time [10][12]. - Techniques such as edge detection, object recognition, and depth perception are employed by AI to enhance the visual experience for users of bionic eyes [10][11]. - The AI system must adapt to individual user needs and environmental conditions to provide a personalized visual experience [13]. Challenges and Ethical Considerations - The field faces significant challenges, including the need for sustainable support for bionic vision devices, as demonstrated by the case of the Argus II system, which left many users without support after the manufacturer ceased operations [16][17]. - Ethical considerations include ensuring accessibility, addressing algorithmic bias, and maintaining privacy for users of visual data processing devices [16][17]. - The future of bionic vision requires not only technological innovation but also a commitment to infrastructure and ethical frameworks to support users long-term [17][18].

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].

Core Viewpoint - Vivani Medical, Inc. plans to spin off its subsidiary Cortigent, Inc. into an independent publicly traded company on Nasdaq by the third quarter of 2025, aiming to enhance value for both Vivani and Cortigent stockholders [1][3][6] Company Developments - Cortigent is developing the Orion Visual Cortical Prosthesis System to provide visual perception for the blind and a Stroke Recovery System to aid recovery of arm and hand movement post-stroke [1][8] - The Orion system has received FDA Breakthrough Device designation and completed a six-year Early Feasibility Study with promising results [2][8] - Cortigent's previous product, the Argus II, was the first FDA-authorized artificial vision device, successfully implanted in hundreds of patients [2][8] Strategic Focus - The spin-off will allow Vivani to concentrate on its proprietary NanoPortal drug implant technology, specifically for chronic weight management and type 2 diabetes [1][2][3] - Vivani's lead program includes a six-month subdermal GLP-1 implant for chronic weight management, with additional products in development for type 2 diabetes [9][11] Financial and Operational Structure - The spin-off is expected to provide clearer visibility into the financial and operational structures of both companies, enhancing understanding of their respective strategies and risks [5][10] - The transaction is subject to various conditions, including board approval and SEC and Nasdaq compliance [6] Management and Leadership - Cortigent's CEO, Jonathan Adams, has extensive experience in the biopharmaceutical field and aims to accelerate the development of Cortigent's technologies post-spin-off [2][8]

Core Insights - Vivani Medical, Inc. has successfully initiated the LIBERATE-1 study for its NPM-115 (exenatide implant) with full enrollment achieved, expecting top-line data in mid-2025 [1][4] - The company reported promising preclinical data for NPM-139 (semaglutide implant), indicating potential for once-yearly dosing comparable to existing treatments [1][3] - An additional $8.25 million in equity financing has been secured, ensuring financial stability into Q2 2026 to support ongoing development of NPM-115 and NPM-139 [1][3] Company Developments - Vivani transitioned to a clinical-stage biotechnology company in 2024, achieving significant milestones in its NPM-115 and NPM-139 programs [2] - The LIBERATE-1 study has successfully administered its first GLP-1 implant, addressing medication adherence challenges in chronic weight management and type 2 diabetes [4] - The company is advancing NPM-139 towards clinical phase development alongside the ongoing NPM-115 program [2][3] Financial Performance - As of December 31, 2024, Vivani reported a cash balance of $19.7 million, down from $22.0 million in 2023, primarily due to a net loss of $23.5 million [10] - Research and development expenses for Q4 2024 were $4.3 million, a decrease of 9% from $4.7 million in Q4 2023 [11] - General and administrative expenses increased by 43% to $2.1 million in Q4 2024 compared to $1.5 million in Q4 2023, attributed to higher professional services and stock-based compensation [12] Future Outlook - Key milestones for the LIBERATE-1 trial are anticipated, including the last subject implanted and top-line results expected in mid-2025 [15] - Vivani plans to file an Investigational New Drug Application for NPM-139 and advance its clinical trials [15] - The company is also preparing for the spin-off of its subsidiary Cortigent into an independent publicly traded company [5][15]