Vivani Medical, Inc. (NASDAQ: VANI) announced plans to spin off its Cortigent neurostimulation division as an independent, publicly-traded company by Q3 2025. The strategic move aims to create two focused entities that can better advance their respective technologies and maximize shareholder value.
The separation will allow Vivani to concentrate exclusively on developing its proprietary NanoPortal™ implant technology for long-acting GLP-1 therapies, while enabling Cortigent to accelerate its neurostimulation programs for blindness and stroke recovery.
"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," 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," Mendelsohn added.
Cortigent's Neurostimulation Platform
Cortigent, formerly Second Sight Medical Products, has established itself as a leader in precision neurostimulation technology. The company's approach involves implanting micro-electrode arrays on the brain's surface to deliver finely calibrated electrical pulses to neuron bundles, creating visual perception for blind individuals.
The company previously achieved a significant milestone with its Argus® II Retinal Prosthesis System, which became the first and only FDA-authorized artificial vision device under a Humanitarian Device Exemption for treating retinitis pigmentosa. The system has been implanted in hundreds of patients worldwide.
Cortigent's next-generation platform, the Orion® Cortical Visual Prosthesis System, targets more common causes of blindness including glaucoma and diabetic retinopathy. The system holds FDA Breakthrough Device designation and recently completed a 6-year Early Feasibility Study with encouraging safety and efficacy outcomes.
Beyond vision restoration, Cortigent is applying its neurostimulation expertise to develop therapies for recovering arm and hand motion in patients with paralysis due to stroke.
Jonathan Adams, who has served as Cortigent's CEO since 2023, will continue in this role post-spinoff. Adams brings 35 years of experience in biopharma and medical devices, including his previous role as founder and CEO of BioVie Inc., which listed on the Nasdaq Global Market in 2020.
"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 stated.
Vivani's Focus on Long-Acting GLP-1 Implants
Following the spinoff, Vivani will sharpen its focus on developing its portfolio of miniature, subdermal GLP-1 implants designed for once or twice-yearly administration. This technology aims to address the significant challenge of medication non-adherence, which affects approximately 50% of patients and contributes to over $500 billion in annual avoidable healthcare costs in the U.S. alone.
Vivani's lead program, NPM-115, is a six-month subdermal exenatide implant being developed for chronic weight management. The company's pipeline also includes NPM-139, a semaglutide implant with potential for once-yearly administration, and NPM-119, an exenatide implant for type 2 diabetes.
"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," Mendelsohn explained.
Strategic Rationale and Transaction Details
The spinoff 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. According to Vivani, creating two stand-alone companies with dedicated management teams will provide the necessary foundation for long-term value creation.
The company cited growing interest in neurostimulation technology, partially driven by high-profile ventures like Elon Musk's Neuralink, as a factor in its decision. The global neurostimulation market is experiencing substantial growth due to the rising prevalence of chronic diseases and increasing regulatory approvals for innovative neurostimulator devices.
Vivani had previously announced plans to submit a Form S-1 registration statement for an Initial Public Offering of Cortigent but has revised its strategy to file a Form 10 registration statement with the SEC. This approach will enable the spin-off of Cortigent as a fully independent, publicly traded company, allowing Vivani shareholders to directly participate in Cortigent's future.
The transaction is expected to be completed during or prior to Q3 2025, subject to final approval from Vivani's board of directors, receipt of a favorable tax opinion, and regulatory and Nasdaq approval. The spinoff is intended to be tax-free for U.S. federal income tax purposes.
ThinkEquity LLC is serving as the exclusive financial advisor to Cortigent for the spinoff transaction.
Market Impact and Outlook
The announcement comes at a time when the GLP-1 market is experiencing significant growth and competition, with over 50 new molecular entities under clinical development. Vivani believes its differentiated portfolio of long-acting GLP-1 implants can provide an attractive therapeutic option for patients, prescribers, and payers.
Similarly, the neurostimulation market presents substantial opportunities as technological advancements continue to expand the range of treatable conditions. By operating as independent entities, both Vivani and Cortigent aim to respond more quickly to developments in their respective markets and pursue strategic priorities specific to their core therapies and pipeline assets.
The spinoff represents a strategic pivot that could potentially unlock value for shareholders while allowing each company to optimize its capital structure and allocation strategies in alignment with its long-term objectives.
