Vivani Medical (VANI) to Spin Off Cortigent Neurostimulation Business

Vivani Medical, Inc. (NASDAQ: VANI) (“Vivani” or the “Company”), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, today announced that it intends to spin off Cortigent, Inc., a division that develops brain implant devices to help people recover critical body functions, as an independent publicly-traded company. The strategic goal of this transaction is to create two focused companies dedicated to driving current and future value in their respective therapeutic areas of expertise.

“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 Los Angeles area.

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 U.S. Securities and Exchange Commission (“SEC”), enabling the spin-off of Cortigent into a fully independent, publicly traded company subject to listing and regulatory requirements. This approach will allow Vivani shareholders to directly participate in Cortigent’s future and enable Vivani to focus exclusively on the development of NanoPortal drug implants. Vivani believes the spin-off of Cortigent will result in two distinct companies that will:

• 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 U.S. Food and Drug Administration (“FDA”) regulatory and CMS reimbursement capabilities when it commercialized, under a Humanitarian Device Exemption, the Argus II® Retinal Prosthesis System, the first and only artificial vision device authorized by the FDA to treat a rare form of blindness called retinitis pigmentosa. The Argus® II has helped hundreds of profoundly blind people to achieve meaningful visual perception. Based on Cortigent’s next generation platform, which is protected by an extensive intellectual property estate, the Orion® Cortical Visual Prothesis System 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. The company’s core precision neurostimulation technology is being leveraged for other indications including the recovery of arm and hand motion in paralysis due to stroke.

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 U.S. federal income tax purposes.

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.

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