Vivani Medical Announces Intent to Spin Off Cortigent Neurostimulation Business
Vivani Medical (NASDAQ: VANI) has announced plans to spin off its Cortigent neurostimulation business as an independent publicly-traded company. The spin-off, expected to complete by Q3 2025, aims to create two focused companies dedicated to their respective therapeutic areas.
Cortigent specializes in brain implant devices and is known for developing the Orion® artificial vision system and the FDA-authorized Argus® II Retinal Prosthesis System. The company recently completed a 6-year clinical study for Orion in 2024, showing promising safety and efficacy results. The technology is also being developed for recovery of arm and hand motion in stroke-related paralysis.
Post spin-off, Vivani will focus exclusively on developing miniature, ultra long-acting GLP-1 implants for chronic weight management and type 2 diabetes with once or twice-yearly administration. The transaction is intended to be tax-free for U.S. federal income tax purposes, with Vivani stockholders receiving shares in the new company.
Vivani Medical (NASDAQ: VANI) ha annunciato piani per scorporare la sua attività di neurostimolazione Cortigent come una società indipendente quotata in borsa. Lo scorporo, previsto per essere completato entro il terzo trimestre del 2025, mira a creare due aziende focalizzate dedicate ai rispettivi ambiti terapeutici.
Cortigent si specializza in dispositivi impiantabili per il cervello ed è nota per lo sviluppo del sistema di visione artificiale Orion® e del sistema di protesi retinica Argus® II autorizzato dalla FDA. L'azienda ha recentemente completato uno studio clinico di 6 anni per Orion nel 2024, mostrando risultati promettenti in termini di sicurezza ed efficacia. La tecnologia è anche in fase di sviluppo per il recupero del movimento di braccia e mani nella paralisi post-ictus.
Dopo lo scorporo, Vivani si concentrerà esclusivamente sullo sviluppo di impianti GLP-1 miniaturizzati e a lunga durata per la gestione del peso cronico e il diabete di tipo 2, con somministrazione una o due volte all'anno. La transazione è destinata a essere esente da tasse ai fini delle imposte sul reddito federale statunitensi, con gli azionisti di Vivani che riceveranno azioni nella nuova società.
Vivani Medical (NASDAQ: VANI) ha anunciado planes para escindir su negocio de neuroestimulación Cortigent como una empresa independiente que cotiza en bolsa. Se espera que la escisión se complete para el tercer trimestre de 2025 y tiene como objetivo crear dos empresas enfocadas dedicadas a sus respectivas áreas terapéuticas.
Cortigent se especializa en dispositivos implantables cerebrales y es conocida por desarrollar el sistema de visión artificial Orion® y el sistema de prótesis retinal Argus® II autorizado por la FDA. La compañía completó recientemente un estudio clínico de 6 años para Orion en 2024, mostrando resultados prometedores en términos de seguridad y eficacia. La tecnología también se está desarrollando para la recuperación del movimiento de brazos y manos en la parálisis relacionada con accidentes cerebrovasculares.
Después de la escisión, Vivani se centrará exclusivamente en desarrollar implantes de GLP-1 miniaturizados y de acción prolongada para el manejo del peso crónico y la diabetes tipo 2, con administración una o dos veces al año. Se pretende que la transacción esté exenta de impuestos para fines de impuestos federales sobre la renta de EE. UU., con los accionistas de Vivani recibiendo acciones en la nueva empresa.
비바니 메디컬 (NASDAQ: VANI)은 코르티젠 신경 자극 사업부를 독립적인 상장 회사로 분리할 계획을 발표했습니다. 이 분리는 2025년 3분기까지 완료될 예정이며, 각자의 치료 분야에 전념하는 두 개의 집중된 회사를 만드는 것을 목표로 합니다.
코르티젠은 뇌 이식 장치를 전문으로 하며, 오리온® 인공 시각 시스템과 FDA 승인된 아르구스® II 망막 보철 시스템을 개발한 것으로 알려져 있습니다. 이 회사는 2024년에 오리온에 대한 6년 임상 연구를 완료했으며, 안전성과 효능 결과가 유망하다는 것을 보여주었습니다. 이 기술은 또한 뇌졸중 관련 마비에서 팔과 손의 움직임 회복을 위해 개발되고 있습니다.
분리 후, 비바니는 만성 체중 관리 및 제2형 당뇨병을 위해 연 1회 또는 2회 투여하는 미세하고 초장기 작용 GLP-1 이식 장치 개발에 전념할 것입니다. 이 거래는 미국 연방 소득세 목적상 면세로 진행될 예정이며, 비바니 주주들은 새로운 회사의 주식을 받게 됩니다.
Vivani Medical (NASDAQ: VANI) a annoncé des projets de scission de son activité de neurostimulation Cortigent en tant qu'entreprise indépendante cotée en bourse. La scission, qui devrait être finalisée d'ici le troisième trimestre 2025, vise à créer deux entreprises ciblées dédiées à leurs domaines thérapeutiques respectifs.
Cortigent se spécialise dans les dispositifs implantables cérébraux et est connue pour avoir développé le système de vision artificielle Orion® et le système de prothèse rétinienne Argus® II autorisé par la FDA. L'entreprise a récemment achevé une étude clinique de 6 ans pour Orion en 2024, montrant des résultats prometteurs en termes de sécurité et d'efficacité. La technologie est également en cours de développement pour la récupération des mouvements des bras et des mains en cas de paralysie liée à un AVC.
Après la scission, Vivani se concentrera exclusivement sur le développement d'implants GLP-1 miniaturisés et à action prolongée pour la gestion du poids chronique et le diabète de type 2, avec une administration une ou deux fois par an. La transaction est destinée à être exonérée d'impôts pour les besoins de l'impôt fédéral sur le revenu des États-Unis, les actionnaires de Vivani recevant des actions dans la nouvelle entreprise.
Vivani Medical (NASDAQ: VANI) hat Pläne angekündigt, sein Neurostimulationsgeschäft Cortigent als unabhängiges, börsennotiertes Unternehmen auszugliedern. Die Ausgliederung, die bis zum dritten Quartal 2025 abgeschlossen sein soll, zielt darauf ab, zwei fokussierte Unternehmen zu schaffen, die sich ihren jeweiligen Therapiegebieten widmen.
Cortigent spezialisiert sich auf Gehirnimplantate und ist bekannt für die Entwicklung des Orion®-Systems zur künstlichen Sicht sowie des von der FDA genehmigten Argus® II-Retina-Prothesensystems. Das Unternehmen hat kürzlich eine 6-jährige klinische Studie für Orion im Jahr 2024 abgeschlossen, die vielversprechende Ergebnisse in Bezug auf Sicherheit und Wirksamkeit zeigt. Die Technologie wird auch zur Wiederherstellung der Arm- und Handbewegung bei durch Schlaganfall verursachter Lähmung entwickelt.
Nach der Ausgliederung wird Vivani sich ausschließlich auf die Entwicklung von miniaturisierten, ultralang wirkenden GLP-1-Implantaten zur chronischen Gewichtsregulation und zur Behandlung von Typ-2-Diabetes mit einmal oder zweimal jährlich durchgeführter Verabreichung konzentrieren. Die Transaktion soll steuerfrei für die Zwecke der US-amerikanischen Bundessteuer sein, wobei die Vivani-Aktionäre Anteile an dem neuen Unternehmen erhalten.
- Creation of two focused companies with dedicated management and capital structures
- Cortigent's Orion system showed encouraging safety and efficacy results
- Cortigent has proven FDA regulatory success with Argus II system
- Tax-free transaction structure for shareholders
- Strategic positioning in growing neurostimulation market
- Significant regulatory hurdles still pending for spin-off completion
- Potential operational disruption during transition period
- Additional costs associated with maintaining two public companies
Insights
Vivani Medical's announced spin-off of its Cortigent neurostimulation business represents a significant strategic restructuring that creates two distinct publicly-traded companies from the current singular entity. This transaction shifts from their previously announced IPO approach to a direct spin-off through a Form 10 registration, allowing existing Vivani shareholders to maintain ownership in both businesses through what is intended as a tax-free distribution.
The strategic rationale centers on creating focused entities with dedicated management and capital structures. Post-spin-off, Vivani will concentrate exclusively on its NanoPortal implant technology for developing long-acting GLP-1 therapeutics addressing the lucrative weight management and diabetes markets. Meanwhile, Cortigent will advance its neurostimulation platform targeting blindness and stroke recovery applications.
Cortigent brings meaningful assets to its independent future, including its Orion artificial vision system (which completed a 6-year clinical study with encouraging results), FDA Breakthrough Device designation, and proven regulatory capabilities demonstrated by its previously FDA-authorized Argus II system. The company's established regulatory pathway experience and reimbursement history provide substantial de-risking elements typically absent in early-stage medical device ventures.
The strategic timing aligns with increasing market interest in neurostimulation technologies, with the article explicitly noting parallels to high-profile ventures like Neuralink. This transaction potentially positions Cortigent to capture greater investor attention as a pure-play in this growing field, while allowing Vivani to present a clearer investment narrative focused on long-acting GLP-1 therapeutics.
The spin-off of Cortigent represents a rational therapeutic specialization strategy that should benefit both entities' technology development paths. Cortigent's neurostimulation platform has demonstrated meaningful clinical progress with its Orion visual prosthesis system completing a 6-year study with encouraging safety and efficacy results. The platform leverages precision micro-electrode arrays placed on the brain's cortex to deliver calibrated electrical stimulation to neuron bundles, inducing phosphenes (spots of light) that create visual perception for blind individuals.
Particularly notable is Cortigent's regulatory track record - it previously secured the first and only FDA authorization (under Humanitarian Device Exemption) for an artificial vision device with its Argus II system. This regulatory experience, including successful commercialization and CMS reimbursement pathways, represents significant value that's often underappreciated in neuromodulation ventures. The platform's expansion into stroke recovery applications demonstrates the technology's versatility beyond ophthalmology.
For Vivani, this divestiture allows concentrated focus on its NanoPortal implant technology for GLP-1 delivery with once or twice-yearly administration - addressing a critical adherence challenge in the rapidly expanding GLP-1 market. The current market leaders require weekly or daily administration, creating a substantial opportunity for extended-release formulations that can maintain therapeutic levels while reducing administration frequency.
The separation creates cleaner investment theses for both entities: Cortigent as a neurostimulation pure-play with clinical-stage assets and proven regulatory capabilities, and Vivani as a drug delivery platform addressing the high-growth GLP-1 market. The projected completion timeline (during/prior to Q3 2025) provides a reasonable horizon for execution while maintaining continuity through experienced leadership with Jonathan Adams continuing as Cortigent CEO.
Planned Cortigent Nasdaq listing intended to drive value for Vivani and Cortigent shareholders
Cortigent’s Orion® artificial vision system, which is in development to treat blindness, completed an initial 6-year clinical study in 2024, with encouraging safety and efficacy results
Formerly Second Sight Medical Products, Cortigent achieved the first and only FDA authorization (under a Humanitarian Device Exemption) for an artificial vision device called the
Cortigent’s precision neurostimulation technology is also being developed for the recovery of arm and hand motion in paralysis due to stroke
Spin-off will allow Vivani to focus on developing miniature, ultra long-acting GLP-1 implants for chronic weight management and type 2 diabetes with once or twice-yearly administration
“Since the merger of legacy companies Nano Precision Medical and Second Sight Medical Products in August 2023, and the formation of Cortigent, we have been committed to identifying and pursuing strategic options to advance Cortigent’s pioneering technology. We expect that Cortigent will continue to be a leader in discovering, developing, and commercializing innovative therapies for vision, stroke recovery and other critical body functions that can benefit from neurostimulation technology,” said Vivani Chief Executive Officer Adam Mendelsohn, Ph.D. “We believe that the best way to realize the full potential of Cortigent is to enable it to operate independently with a management team dedicated to advancing its proprietary neuromodulation technology and developing medical devices that address human conditions where there is significant unmet medical need. Our mission at Vivani remains unchanged as we continue to leverage our proprietary NanoPortal™ implant technology and advance the development of our portfolio of miniature, subdermal GLP-1 implants with once or twice-yearly dosing for chronic weight management, type 2 diabetes, and other chronic diseases.”
“Today’s announcement is a major milestone for Cortigent,” said Cortigent Chief Executive Officer Jonathan Adams, MBA. “As an independent company, we will intensify our efforts to develop and commercialize life-changing medical devices for people with critical unmet medical needs such as blindness, paralysis due to stroke, and potentially other conditions.”
Adams has served as Cortigent’s CEO since 2023 and will retain that position after the spin-off. Prior to joining Cortigent, he founded and was CEO of the biopharma company BioVie Inc., which listed on the Nasdaq Global Market in 2020. He has 35 years of experience in biopharma and medical devices including technology commercialization, financial management, operations, marketing and sales, and has assisted in the launch of dozens of new drugs and medical devices. Cortigent will continue to be headquartered in the
Vivani previously announced the submission of a Form S-1 registration statement to support an Initial Public Offering of Cortigent and has now revised its strategy to file a Form 10 registration statement with the
- focus on and pursue strategic priorities specific to their core commercial therapies and pipeline assets;
- benefit from separate capital structures and capital allocation strategies;
- achieve additional operating efficiencies consistent with their respective long-term strategic objectives; and
- respond more quickly to the rapidly changing developments and global opportunities in their respective patient markets.
The spin-off is expected to provide investors with greater visibility into the financial and operational structures of each company and a clearer understanding of their respective strategies. Vivani believes creating two stand-alone companies with dedicated and talented management teams will provide the necessary foundation for long term value creation for each company.
There is significant interest in neurostimulation technology, driven in part by companies like Elon Musk’s Neuralink, with the global neurostimulation market experiencing substantial growth driven by rising prevalence of chronic diseases and advancements in technology increasing regulatory approvals for innovative neurostimulator devices. Vivani believes it is in the best interest of shareholders to spin off Cortigent into an independently operated, publicly traded company to deliver enhanced value to Vivani and Cortigent shareholders.
Cortigent is a global leader in precision neurostimulation technology that seeks to provide meaningful visual perception (“artificial vision”) for blind people. This involves implanting a micro-electrode array on the surface of the brain (cortex) to deliver finely tuned electrical pulses to neuron bundles to elicit spots of light called phosphenes. The company proved its
Vivani’s board of directors has authorized management to proceed with a plan to spin off its Cortigent neuromodulation business and Vivani is expected to provide certain transition services. The spin-off is planned to be completed during or prior to Q3 2025, subject to the satisfaction of certain conditions, including, among others, final approval of Vivani’s board of directors, receipt of a favorable opinion with respect to the tax-free nature of the transaction, and regulatory and Nasdaq approval. The spin-off is expected to be accomplished by distribution of the requisite number of shares of the new publicly traded company to Vivani stockholders that would result in a transaction intended to be tax-free for
ThinkEquity LLC is acting as the exclusive financial advisor to Cortigent, Inc. with respect to the spin-off transaction. For more information, please visit: www.think-equity.com.
About Cortigent, Inc.
Cortigent, Inc., formerly Second Sight Medical Products and a wholly owned subsidiary of Vivani, is developing brain implant devices to help people recover critical body functions. Cortigent is a global leader in precision neurostimulation technology that provides meaningful visual perception (“artificial vision”) for blind people. Cortigent previously marketed the Argus II, the first and only artificial vision device approved by the FDA, to treat a rare form of blindness. The Argus II has helped hundreds of profoundly blind people to achieve meaningful visual perception. Cortigent’s next generation investigational system, the Orion, has been designed to treat blindness due to glaucoma, diabetic retinopathy, and other common causes. Orion has an FDA Breakthrough Device designation and in 2024, completed a 6-year Early Feasibility Study with encouraging safety and efficacy results. Cortigent’s platform technology combines advanced neuroscience with proprietary microelectronics, software, and data processing capabilities to create medical devices for alleviating serious medical conditions that cannot be treated with drugs. It is protected by an extensive intellectual property estate. Cortigent is also applying its core precision neurostimulation technology to the recovery of arm and hand motion in paralysis due to stroke. For more information and patient videos, please visit: www.cortigent.com.
About Vivani Medical, Inc.
Leveraging its proprietary NanoPortal™ platform, Vivani develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, and potentially to improve patient tolerance to their medication. Vivani’s lead program, NPM-115, is a six-month, subdermal, GLP-1 (exenatide) implant under development for chronic weight management in obese or overweight individuals. Vivani’s emerging pipeline includes NPM-139 (semaglutide implant) which is also under development for chronic weight management. The semaglutide implant has the added potential benefit of once-yearly administration. NPM-119 refers to the Company’s six-month, subdermal, GLP-1 (exenatide) implant under development for the treatment of type 2 diabetes. These NanoPortal implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the challenges associated with the daily or weekly administration of orals and injectables. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately
Forward-Looking Statements
This press release contains certain “forward-looking statements” within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “planned,” “positioned,” “future,” and other similar expressions that in this press release, including statements regarding Vivani’s business, products in development, including the therapeutic potential thereof, the planned development therefor, the completion of the LIBERATE-1 trial and reporting of trial results, Vivani’s emerging development plans for NPM-115, NPM-139, NPM-119 or Vivani’s plans with respect to Cortigent and its proposed spin-off, technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Vivani’s current beliefs, expectations, and assumptions. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation, risks that the spin-off will be completed in a timely manner or at all; risks of failure to satisfy any conditions to the spin-off; risks of failure of the spin-off to qualify as a tax-free transaction for
View source version on businesswire.com: https://www.businesswire.com/news/home/20250311539715/en/
Company Contact:
Donald Dwyer
Chief Business Officer
info@vivani.com
(415) 506-8462
Investor Relations Contact:
Jami Taylor
Investor Relations Advisor
investors@vivani.com
(415) 506-8462
Media Contact:
Sean Leous
ICR Healthcare
Sean.Leous@icrhealthcare.com
(646) 866-4012
Source: Vivani Medical, Inc.
FAQ
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