8-K: Vivani Sets Record Date for Cortigent Spin-Off

Vivani Medical, Inc. announced October 8, 2025, as the record date for the spin-off of its neuromodulation subsidiary, Cortigent, Inc., to shareholders.

Summary

• Vivani Medical, Inc. has set October 8, 2025, as the record date for the previously announced spin-off of its wholly-owned subsidiary, Cortigent, Inc.
• Vivani shareholders holding common stock as of the record date will receive common stock in Cortigent upon completion of the spin-off.
• Cortigent, which develops brain implant devices with neuromodulation technology, is expected to trade on the Nasdaq Stock Market under the ticker symbol CRGT, subject to regulatory approvals and other conditions.
• Post-spin-off, Vivani will sharpen its focus on developing miniature, ultra long-acting GLP-1 implants for weight loss management and treatment of type 2 diabetes.
• Cortigent will focus on advancing its precision neurostimulation technology, including the Orion artificial vision system and a new medical device aimed at improving recovery of arm and hand motion in stroke patients.
• The spin-off is estimated to be complete by late-2025, contingent on the satisfaction of certain conditions, including a favorable tax opinion and the effectiveness of a Form 10 registration statement filed on August 20, 2025.

Sentiment

Score: 8

Explanation: The filing announces a significant strategic move (spin-off) with clear benefits outlined for both resulting companies and shareholders. The tone is highly positive, emphasizing future growth, focused operations, and promising clinical developments for Cortigent's products. Risks are disclosed as required for forward-looking statements but do not overshadow the positive strategic intent.

Positives

• The transaction is strategically designed to create two companies dedicated to driving value in their respective areas of expertise, enhancing strategic and operational flexibility.
• Vivani shareholders will have the opportunity to fully and directly participate in Cortigent's future as an independent, publicly traded company.
• The spin-off allows each company to adopt an optimal capital structure and improves the ability to attract and retain exceptional talent.
• Cortigent's Orion artificial vision system has successfully completed a 6-year Early Feasibility Study with promising safety and efficacy results.
• Cortigent's predecessor, Second Sight Medical Products, previously obtained FDA approval for Argus II, the first and only medical device to treat a rare form of blindness.
• Cortigent's Orion system has an FDA Breakthrough Device designation, highlighting its potential to address significant unmet medical needs.

Risks

• The spin-off may not be completed in a timely manner or at all.
• There is a risk of failure to satisfy any conditions required for the spin-off.
• The spin-off may not qualify for non-recognition of gain or loss for U.S. federal income tax purposes.
• Uncertainty exists regarding whether the anticipated benefits of the spin-off can be fully achieved.
• Potential for unexpected costs or delays associated with the transaction.
• Risks and uncertainties are associated with the development and commercialization of products and product candidates for both Vivani and Cortigent.
• Cortigent has a history of losses and its ability to access additional capital or otherwise fund its business and advance its product candidates and pre-clinical programs is a risk.
• Market conditions could impact the ability of Cortigent to complete its spin-off.

Future Outlook

The spin-off is expected to be completed by late-2025, subject to regulatory approvals and conditions. Cortigent plans to proceed with the Orion pivotal clinical trial to seek FDA approval and an Early Feasibility Study for its Stroke Recovery System. Vivani will focus on advancing its GLP-1 implant portfolio for metabolic diseases, aiming for once or twice-yearly administration.

Management Comments

• "The strategic goal of this transaction is to create two companies dedicated to driving value in their respective areas of expertise." Adam Mendelsohn, PhD, Vivani CEO.
• "This transaction will allow Vivani shareholders to fully and directly participate in Cortigent’s future." Adam Mendelsohn, PhD, Vivani CEO.
• "We are excited about Cortigent’s prospects as an independent, publicly traded company as it continues to advance its precision neurostimulation technology and build upon the promising results recently achieved in the 6-year Orion Early Feasibility Study in profoundly blind patients." Adam Mendelsohn, PhD, Vivani CEO.
• "The spin-off will position Cortigent among the few public companies focused on neuromodulation and brain-computer interface, or BCI, technologies, a new medical frontier leveraging artificial intelligence and other advanced technologies to address critical unmet patient needs." Jonathan Adams, MBA, Cortigent CEO.
• "Upon closing the transaction, we will proceed towards the planned Orion pivotal clinical trial that is designed to seek FDA approval, and the planned Early Feasibility Study of our Stroke Recovery System." Jonathan Adams, MBA, Cortigent CEO.

Industry Context

The spin-off strategically positions Cortigent within the rapidly evolving neuromodulation and brain-computer interface (BCI) market, a new medical frontier leveraging artificial intelligence and advanced technologies to address critical unmet patient needs. Vivani, post-spin-off, will concentrate on the metabolic disease market, specifically GLP-1 based implants, aiming to improve patient adherence and efficacy for conditions like obesity and type 2 diabetes. Both areas represent significant and growing segments within the biopharmaceutical and medical device industries, driven by technological advancements and increasing demand for innovative treatments.

Comparison to Industry Standards

• Cortigent is positioned among the few public companies focused on neuromodulation and brain-computer interface (BCI) technologies, highlighting its specialized market niche.
• Cortigent's predecessor, Second Sight Medical Products, successfully obtained FDA approval for Argus II, which was the first and only medical device to treat a rare form of blindness, setting a precedent for regulatory success in this field.
• Cortigent's Orion Visual Cortical Prosthesis System has received an FDA Breakthrough Device designation, indicating its potential to offer a more effective treatment for life-threatening or irreversibly debilitating conditions compared to existing alternatives.

Stakeholder Impact

• Shareholders: Will receive common stock in Cortigent, allowing direct participation in its future and investment in two distinct, focused companies, potentially unlocking greater value.
• Management/Employees: Enhanced strategic and operational flexibility, improved ability to attract and retain exceptional talent for both Vivani and Cortigent due to clearer focus and optimized capital structures.
• Patients: Potential for continued development of advanced medical devices for blindness and stroke recovery (Cortigent) and improved adherence/efficacy for metabolic disease treatments (Vivani), addressing significant unmet medical needs.

Next Steps

• Announcement of the distribution date and share dividend ratio for Cortigent common stock.
• Cortigent to proceed towards the planned Orion pivotal clinical trial designed to seek FDA approval.
• Cortigent to proceed with the planned Early Feasibility Study of its Stroke Recovery System.
• Completion of the spin-off by late-2025, subject to the satisfaction of certain conditions.

Key Dates

Recommendation

The spin-off of Cortigent is a strategic move that unlocks value by creating two focused entities. Vivani will concentrate on its promising GLP-1 implant platform, addressing a large market with a differentiated delivery mechanism. Cortigent, with its FDA Breakthrough Device designation for Orion and a history of FDA-approved devices, is positioned in the high-growth neuromodulation and BCI space. This separation allows for clearer investment theses, optimized capital structures, and dedicated management focus, which should benefit shareholders by potentially increasing the sum-of-the-parts valuation. The positive clinical results for Orion's Early Feasibility Study further de-risk Cortigent's pipeline. While risks associated with spin-offs and clinical development exist, the strategic rationale and potential for value creation make this an attractive opportunity.

Keywords

Vivani Medical, Cortigent, Spin-off, Neuromodulation, Brain Implants, GLP-1, Weight Loss, Type 2 Diabetes, Artificial Vision, Stroke Recovery, FDA Breakthrough Device, Orion System, Biopharmaceutical, NanoPortal