8-K: Vivani Medical Files Form 10 for Planned Spin-Off of Cortigent Neurostimulation Business

Vivani Medical, Inc. has announced the filing of a Form 10 registration statement with the SEC for the planned spin-off of its wholly-owned subsidiary, Cortigent, Inc., aiming to create two independent, publicly traded companies by Q3 2025.

Summary

• Vivani Medical, Inc. (NASDAQ: VANI) has filed a Form 10 registration statement with the U.S. Securities and Exchange Commission (SEC) for the spin-off of Cortigent, Inc., its wholly-owned neurostimulation business.
• The spin-off is anticipated to be completed in the third quarter of 2025, or otherwise in 2025, subject to various conditions including board, tax, SEC, and Nasdaq approvals.
• The strategic goal is to establish Cortigent as an independent, publicly traded Nasdaq company, allowing both Vivani and Cortigent to focus on their respective therapeutic areas.
• Vivani will concentrate on its proprietary NanoPortal drug implant technology, developing miniature, ultra long-acting GLP-1 implants for chronic weight management (NPM-115, NPM-139) and type 2 diabetes (NPM-119) with annual or bi-annual dosing.
• Cortigent will focus on brain implant devices, including the Orion Visual Cortical Prosthesis System for artificial vision (which has FDA Breakthrough Device designation and completed a six-year Early Feasibility Study in March 2025 with promising results) and the Stroke Recovery System for arm and hand movement recovery.
• Cortigent previously marketed the Argus II, the first and only FDA-authorized artificial vision device, which was implanted in hundreds of patients.
• The spin-off is expected to provide greater visibility into the financial and operational structures of both companies and enable separate capital structures and allocation strategies.
• The transaction is expected to be accomplished by distributing Cortigent shares to Vivani stockholders, qualifying for non-recognition of gain or loss for U.S. Federal Income Tax purposes.

Sentiment

Score: 8

Explanation: The sentiment is highly positive, emphasizing strategic benefits, value creation, and focused development for both entities. The language used by management is optimistic, highlighting milestones and future potential. Risks are disclosed as required for forward-looking statements but do not overshadow the overall positive framing of the strategic move.

Positives

• The spin-off aims to create two highly focused companies, potentially driving increased value for stockholders in their respective specialized therapeutic areas.
• Vivani will be able to fully concentrate on its NanoPortal drug implant technology and its portfolio of GLP-1 implants for chronic weight management and type 2 diabetes, which are designed to improve patient adherence.
• Cortigent will be better positioned to accelerate the development and commercialization of its pioneering neurostimulation technologies, including the Orion Visual Cortical Prosthesis System and the Stroke Recovery System.
• The Orion Visual Cortical Prosthesis System has an FDA Breakthrough Device designation and completed a six-year Early Feasibility Study in March 2025 with promising safety and efficacy results.
• Cortigent's technology platform has a proven track record, having achieved the first and only FDA authorization (under a Humanitarian Device Exemption) for an artificial vision device (Argus II).
• The spin-off is expected to provide investors with greater visibility into the financial and operational structures of both companies, leading to a clearer understanding of their strategies and risks.
• The creation of two stand-alone companies with dedicated management teams is believed to provide a strong foundation for long-term value creation.

Risks

• The spin-off may not be completed in a timely manner or at all.
• There is a risk of failure to satisfy any of the conditions required for the spin-off to proceed.
• The spin-off may not qualify for non-recognition of gain or loss for U.S. federal income tax purposes, which could have adverse tax implications for shareholders.
• There is uncertainty regarding whether the anticipated benefits of the spin-off, such as increased value and operational efficiencies, can actually be achieved.
• The transaction could incur unexpected costs or delays.
• Both Vivani and Cortigent have a history of losses and their ability to access additional capital or otherwise fund their respective businesses and advance product candidates is a risk.
• Risks and uncertainties are associated with the development and commercialization of products and product candidates, which may impact or alter anticipated business plans, strategies, and objectives.
• Delays and changes in the development of Vivani's products (NPM-115, NPM-139, NPM-119) may occur due to applicable laws, regulations, and guidelines.
• Potential delays in submitting and receiving regulatory clearance or approval to conduct development activities for both companies' products exist.
• Risks are related to the initiation, enrollment, and conduct of planned clinical trials and the results therefrom.

Future Outlook

The spin-off of Cortigent is planned for completion in the third quarter of 2025, or otherwise in 2025, subject to regulatory and board approvals. This strategic move is intended to position both Vivani and Cortigent for accelerated development in their respective therapeutic areas, with Vivani focusing on long-acting GLP-1 implants and Cortigent advancing its neurostimulation technologies for artificial vision and stroke recovery. Cortigent plans to prepare for a pivotal trial of the Orion Visual Cortical Prosthesis System and further clinical evaluation for commercialization, while also studying its technology for stroke recovery.

Management Comments

• Adam Mendelsohn, Ph.D., Vivani Chief Executive Officer, stated: "Filing the Form 10 registration statement is an important milestone in our journey to establish Cortigent as an independent, publicly traded company dedicated to advancing its pioneering neurostimulation technology."
• Jonathan Adams, MBA, Cortigent Chief Executive Officer, stated: "Our plan for Cortigent to trade as an independent public company on Nasdaq will best position Cortigent to accelerate development of the Orion Visual Cortical Prosthesis System and the Stroke Recovery System."
• Jonathan Adams also noted: "After successfully completing an Early Feasibility Study of Orion in 2025, which is our latest brain implant device for artificial vision, Cortigent is preparing for a pivotal trial of this breakthrough technology."
• Adams further commented: "We are confident that the important proprietary technology that underpins our platform will also allow us to address other critical unmet medical needs."

Industry Context

The announcement comes amidst renewed excitement in the brain implant field, highlighted by Elon Musk's Neuralink Corp. commencing its own Early Feasibility Study. Cortigent's focus on neurostimulation for artificial vision and stroke recovery positions it within this innovative and rapidly evolving sector. Concurrently, Vivani's concentration on GLP-1 implants places it in a highly competitive and growing market for chronic weight management and type 2 diabetes, where medication non-adherence remains a significant challenge, contributing to substantial healthcare costs and preventable deaths.

Comparison to Industry Standards

• Cortigent's Orion Visual Cortical Prosthesis System has an FDA Breakthrough Device designation, indicating its potential to provide more effective treatment for life-threatening or irreversibly debilitating conditions compared to existing options.
• Cortigent's prior device, Argus II, achieved the first and only FDA authorization (under a Humanitarian Device Exemption) for an artificial vision device, demonstrating a historical leadership position in this niche.
• The mention of Elon Musk's Neuralink Corp. and its six-year Early Feasibility Study (expected to complete in 2031) provides a benchmark for the long-term nature and complexity of brain-computer interface development, against which Cortigent's completed six-year Early Feasibility Study for Orion (March 2025) can be contextualized.
• Vivani's GLP-1 implant portfolio aims to address medication non-adherence, a widespread issue affecting approximately 50% of patients taking daily pills, which contributes to over $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths annually in the U.S. alone. This highlights a significant unmet need that Vivani's long-acting implants seek to resolve, differentiating them from the over 50 new molecular entities in the current GLP-1 landscape.

Stakeholder Impact

• **Shareholders:** Vivani stockholders are expected to directly participate in Cortigent's future through the distribution of shares, potentially benefiting from increased visibility and focused strategies of two distinct companies.
• **Patients:** The spin-off aims to accelerate the development of critical medical devices and drug implants, potentially leading to improved treatments for blindness, stroke recovery, chronic weight management, and type 2 diabetes, addressing issues like medication non-adherence.
• **Employees:** The creation of two stand-alone companies with dedicated management teams is intended to provide a necessary foundation for long-term value creation, which could imply stable or growing opportunities within each focused entity.
• **Creditors/Investors:** The spin-off is expected to provide greater clarity on the financial and operational structures of both Vivani and Cortigent, potentially aiding investment decisions and credit assessments.

Next Steps

• Completion of the spin-off transaction in the third quarter of 2025 or otherwise in 2025.
• Obtaining final approval from Vivani's board of directors for the spin-off.
• Receipt of a favorable opinion that the transaction will qualify for non-recognition of gain or loss for U.S. Federal Income Tax purposes.
• Securing SEC and Nasdaq approval for the spin-off and Cortigent's listing.
• Distribution of Cortigent shares to Vivani stockholders.
• Cortigent preparing for a pivotal trial of the Orion Visual Cortical Prosthesis System.
• Cortigent advancing clinical evaluation of Orion for commercialization.
• Cortigent studying the application of its precision neurostimulation technology to a device for the recovery of arm and hand movement after paralysis due to stroke.
• Vivani continuing the development of its portfolio of miniature, subdermal GLP-1 implants (NPM-115, NPM-139, NPM-119).

Key Dates

Keywords

Spin-off, Neurostimulation, GLP-1 implants, Brain implants, Artificial vision, Stroke recovery, Weight management, Type 2 diabetes, SEC filing, Form 10, Vivani Medical, Cortigent, Nasdaq listing, Biopharmaceutical, Medical devices, Clinical-stage, FDA Breakthrough Device, NanoPortal platform