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ALAMEDA, Calif. - Vivani Medical, Inc. (NASDAQ: VANI), a biopharmaceutical company with a market capitalization of $62.2 million, has announced its intention to spin off Cortigent, Inc., its division focused on neurostimulation technology, into a separate publicly traded company. The decision, coming as the company trades near its 52-week low of $1.03, is aimed at streamlining business operations and maximizing shareholder value by creating two companies with distinct strategic focuses. According to InvestingPro data, Vivani’s stock has experienced significant volatility with a beta of 3.5, suggesting higher market sensitivity than average.
Cortigent, known for its pioneering artificial vision system Orion®, designed to treat blindness, has completed a 6-year clinical study in 2024, showing promising safety and efficacy results. The company’s technology, which has previously received FDA authorization under a Humanitarian Device Exemption for its Argus® II device, is also being developed to aid in the recovery of arm and hand motion following a stroke. With a current ratio of 3.41, InvestingPro analysis shows Vivani maintains strong liquidity to support its development initiatives, though the company faces challenges with negative EBITDA of $24.02 million in the last twelve months.
The planned spin-off will allow Vivani to concentrate on its core business of developing drug implants for chronic weight management and type 2 diabetes, utilizing its proprietary NanoPortal™ technology for extended-release medication. Vivani’s current product pipeline includes a six-month subdermal GLP-1 implant for obesity and overweight management and a similar implant for type 2 diabetes treatment.
Cortigent’s CEO, Jonathan Adams, will continue to lead the company after the spin-off. The separation is intended to provide Cortigent with the independence to further its development and commercialization of medical devices for conditions with significant unmet medical needs.
Vivani has filed a Form 10 registration statement with the U.S. Securities and Exchange Commission (SEC), signaling a shift from its initial plan for an Initial Public Offering of Cortigent. The spin-off, expected to be completed by Q3 2025, is subject to regulatory and Nasdaq approvals, among other conditions. It is intended to be a tax-free transaction for U.S. federal income tax purposes, with Vivani stockholders receiving shares in the new entity.
This strategic move is anticipated to benefit both companies by allowing them to focus on their respective therapeutic areas, with separate capital structures and targeted strategic priorities. ThinkEquity LLC is serving as the exclusive financial advisor to Cortigent regarding the transaction.
The announcement comes at a time when the neurostimulation market is experiencing growth, partly driven by rising chronic disease prevalence and technological advancements.
This article is based on a press release statement from Vivani Medical, Inc.
In other recent news, Vivani Medical has initiated the LIBERATE-1 clinical trial for its exenatide implant, marking the company’s first human trial of this implantable drug aimed at treating obesity. The trial, conducted in Australia, evaluates the safety, tolerability, and pharmacokinetics of the implant in overweight or obese participants. Participants will undergo an initial phase with semaglutide injections before being randomized into three groups, receiving either a single administration of the exenatide implant, weekly exenatide injections, or weekly semaglutide injections. Vivani Medical anticipates releasing the trial’s top-line data by mid-2025 and plans to use this data to support regulatory submissions in various regions, including the United States. H.C. Wainwright has reaffirmed a Buy rating on Vivani Medical, with a price target of $3.00, reflecting confidence in the potential market impact of the exenatide implant. The firm suggests that the implant could demonstrate efficacy comparable to semaglutide, with the added convenience of biannual administration. Vivani Medical also plans to leverage Australian government incentives to offset some trial costs. These developments are part of Vivani’s broader strategy to address medication non-adherence in chronic disease management.
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