拆分即上市，脑机接口赛道添“独角兽”

Core Viewpoint - Vivani Medical is splitting its subsidiary Cortigent, allowing both companies to focus on their respective business areas, with Vivani concentrating on micro drug delivery systems and Cortigent on neural modulation and brain-computer interface technologies [4][14]. Group 1: Vivani's Split of Cortigent - Vivani announced the split plan in May 2025 and confirmed the record date in September, with shareholders receiving shares of Cortigent based on their holdings [4]. - The split aims to create two independent companies that can generate value in their respective fields, enhancing strategic flexibility and optimizing capital structures [4][14]. Group 2: Vivani's Business Focus - Post-split, Vivani will focus on implantable drug delivery systems, particularly long-acting GLP-1 drug delivery devices, and will expand into other chronic disease treatments [5][10]. - The company plans to collaborate with pharmaceutical firms to accelerate clinical progress and commercialization, aligning with the trend of long-term treatment and chronic disease management [10]. Group 3: Cortigent's Business Layout - Cortigent will focus on neural modulation and brain-computer interface (BCI) technologies, aiming to help patients restore critical physiological functions through implanted neural stimulation and visual prosthetics [6][13]. - The product pipeline includes a stroke rehabilitation system designed to assist stroke patients in regaining motor and sensory functions [8]. Group 4: Clinical and Regulatory Progress - The Orion system has completed a six-year follow-up feasibility study, showing safety and functional improvement potential in severely blind patients [9]. - Cortigent plans to initiate pivotal clinical trials for Orion to facilitate FDA approval and conduct early clinical research for the stroke rehabilitation system [18]. Group 5: Capital Operations and Strategic Implications - The split enhances strategic flexibility, allowing both companies to independently develop R&D and commercialization plans, thus avoiding resource dilution [14]. - Each company can design financing models suited to their business characteristics, with Vivani focusing on drug delivery and Cortigent seeking capital in the neural modulation and BCI markets [15]. - Shareholders will benefit from continued growth in Vivani while also gaining exposure to the emerging field of neural modulation and BCI through their ownership in Cortigent [16]. Group 6: Industry Context and Trends - The split reflects the increasing interest in brain-computer interfaces and neural modulation, with companies like Neuralink and Synchron gaining attention [20]. - Regulatory bodies, such as the FDA, are showing more support for implantable BCI systems, indicating a shift towards clinical implementation [20][21]. - The industry is moving from conceptual stages to serious industrialization and capitalization, with companies seeking to enhance strategic clarity and financing efficiency through specialization [21].